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Thursday, June 14, 2012

Prochieve

progesterone

Dosage Form: gel
Prochieve® 4%

Prochieve® 8%

(progesterone gel)

Prochieve Description

Prochieve® (progesterone gel) is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system, which is contained in single use, one piece polyethylene vaginal applicators. The carrier vehicle is an oil in water emulsion containing the water swellable, but insoluble polymer, polycarbophil. The progesterone is partially soluble in both the oil and water phase of the vehicle, with the majority of the progesterone existing as a suspension. Physically, Prochieve® has the appearance of a soft, white to off-white gel.

The active ingredient, progesterone, is present in either a 4% or an 8% concentration (w/w). The chemical name for progesterone is pregn-4-ene-3,20-dione. It has an empirical formula of C21H30O2 and a molecular weight of 314.5.

The structural formula is:

Progesterone exists in two polymorphic forms. Form 1, which is the form used in Prochieve®, exists as white orthorhombic prisms with a melting point of 127-131°C.

Each applicator delivers 1.125 grams of Prochieve® gel containing either 45 mg (4% gel) or 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide.

Prochieve - Clinical Pharmacology

Progesterone is a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal gland. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. Progesterone is essential for the development of decidual tissue, and the effect of progesterone on the differentiation of glandular epithelia and stroma has been extensively studied. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo is implanted, progesterone acts to maintain the pregnancy. Normal or near-normal endometrial responses to oral estradiol and intramuscular progesterone have been noted in functionally agonadal women through the sixth decade of life. Progesterone administration decreases the circulatory levels of gonadotropins.

Pharmacokinetics

Absorption

Due to the sustained release properties of Prochieve®, progesterone absorption is prolonged with an absorption half-life of approximately 25-50 hours, and an elimination half-life of 5-20 minutes. Therefore, the pharmacokinetics of Prochieve® are rate-limited by absorption rather than by elimination.

The bioavailability of progesterone in Prochieve® was determined relative to progesterone administered intramuscularly. In a single dose crossover study, 20 healthy, estrogenized postmenopausal women received 45 mg or 90 mg progesterone vaginally in Prochieve® 4% or Prochieve® 8%, or 45 mg or 90 mg progesterone intramuscularly. The pharmacokinetic parameters (mean ± standard deviation) are shown in Table 1.

TABLE 1 Single Dose Relative Bioavailability
	Prochieve® 4%	45 mg Intramuscular Progesterone	Prochieve® 8%	90 mg Intramuscular Progesterone
Cmax - maximum progesterone serum concentration Cavg 0-24 - average progesterone serum concentration over 24 hours AUC0-96 - area under the drug concentration versus time curve from 0-96 hours post dose Tmax - time to maximum progesterone concentration t1/2 - elimination half-life F - relative bioavailability
Cmax (ng/mL)	13.15±6.49	39.06±13.68	14.87±6.32	53.76±14.9
Cavg 0-24 (ng/mL)	6.94±4.24	22.41±4.92	6.98±3.21	28.98±8.75
AUC0-96 (ng∙hr/mL)	288.63±273.72	806.26±102.75	296.78±129.90	1378.91±176.39
Tmax (hr)	5.6±1.84	8.2±6.43	6.8±3.3	9.2±2.7
t1/2 (hr)	55.13±28.04	28.05±16.87	34.8±11.3	19.6±6.0
F (%)	27.6		19.8

The multiple dose pharmacokinetics of Prochieve® 4% and Prochieve® 8% administered every other day and Prochieve® 8% administered daily or twice daily for 12 days were studied in 10 healthy, estrogenized postmenopausal women in two separate studies. Steady state was achieved within the first 24 hours after initiation of treatment. The pharmacokinetic parameters (mean ± standard deviation) after the last administration of Prochieve® 4% or 8% derived from these studies are shown in Table 2.

TABLE 2 Multiple Dose Pharmacokinetics
	Assisted Reproductive Technology		Secondary Amenorrhea
	Daily Dosing 8%	Twice Daily Dosing 8%	Every Other Day Dosing 4%	Every Other Day Dosing 8%
Cmax (ng/mL)	15.97± 5.05	14.57 ± 4.49	13.21± 9.46	13.67 ± 3.58
Cavg (ng/mL)	8.99 ± 3.53	11.6 ± 3.47	4.05 ± 2.85	6.75 ± 2.83
Tmax (hr)	5.40 ± 0.97	3.55 ± 2.48	6.67 ± 3.16	7.00 ± 2.88
AUC0-t (ng∙hr/mL)	391.98 ±153.28	138.72 ± 41.58	242.15 ± 167.88	438.36 ± 223.36
t1/2 (hr)	45.00 ± 34.70	25.91 ± 6.15	49.87 ± 31.20	39.08 ± 12.88

Distribution

Progesterone is extensively bound to serum proteins (~96-99%), primarily to serum albumin and corticosteroid binding globulin.

Metabolism

The major urinary metabolite of oral progesterone is 5β-pregnan-3α, 20α-diol glucuronide which is present in plasma in the conjugated form only. Plasma metabolites also include 5β-pregnan-3α-ol-20-one (5β-pregnanolone) and 5α-pregnan-3α-ol-20-one (5β-pregnanolone).

Excretion

Progesterone undergoes both biliary and renal elimination. Following an injection of labeled progesterone, 50-60% of the excretion of progesterone metabolites occurs via the kidney; approximately 10% occurs via the bile and feces, the second major excretory pathway. Overall recovery of labeled material accounts for 70% of an administered dose, with the remainder of the dose not characterized with respect to elimination. Only a small portion of unchanged progesterone is excreted in the bile.

Clinical Studies

Assisted Reproductive Technology

In a single-center, open-label study (COL1620-007US), 99 women (aged 28-47 years) with either partial (n=84) or premature ovarian failure (n=15) who were candidates to receive a donor oocyte transfer as an Assisted Reproductive Technology ("ART") procedure were randomized to receive either Prochieve® 8% twice daily (n=68) or intramuscular progesterone 100 mg daily (n=31). The study was divided into three phases (Pilot, Donor Egg and Treatment). The first phase of the study consisted of a test Pilot Cycle to ensure that the administration of transdermal estradiol and progesterone would adequately prime the endometrium to receive the donor egg. The second phase was the Donor Egg Cycle during which a fertilized oocyte was implanted. Prochieve® 8% was administered beginning the evening of Day 14 of the Pilot and Donor Egg cycles. Subjects with partial ovarian function also underwent a Pre-Pilot Cycle and a Pre-Donor Egg Cycle during which time they were administered only leuprolide acetate to suppress remaining ovarian function. The Pre-Pilot Cycle, Pilot Cycle, Pre-Donor Egg Cycle, and Donor Egg Cycle each lasted approximately 34 days. The third phase of the study consisted of a 10-week treatment period to maintain a pregnancy until placental autonomy was achieved.

Sixty-one women received Prochieve® 8% as part of the Pilot Cycle to determine their endometrial response. Of the 55 evaluable endometrial biopsies in the Prochieve® 8% group performed on Day 25-27, all were histologically "in-phase", consistent with luteal phase biopsy specimens of menstruating women at comparable time intervals. Fifty-four women who received Prochieve® 8% and had a histologically "in-phase" biopsy received a donor oocyte transfer. Among these 54 Prochieve®-treated women, clinical pregnancies (assessed about week 10 after transfer by clinical examination, ultrasound and/or ß-hCG levels) occurred in 26 women (48%). Seventeen women (31%) delivered a total of 25 newborns, seven women (13%) had spontaneous abortions and two women (4%) had elective abortions.

In a second study (COL1620-F01), Prochieve® 8% was used in luteal phase support of women with tubal or idiopathic infertility due to endometriosis and normal ovulatory cycles, undergoing in vitro fertilization ("IVF") procedures. All women received a GnRH analog to suppress endogenous progesterone, human menopausal gonadotropins, and human chorionic gonadotropin. In this multi-center, open-label study, 139 women (aged 22-38 years) received Prochieve® 8% once daily beginning within 24 hours of embryo transfer and continuing through Day 30 post-transfer. Clinical pregnancies assessed at Day 90 post-transfer were seen in 36 (26%) of women. Thirty-two women (23%) delivered newborns and four women (3%) had spontaneous abortions. (See PRECAUTIONS, subsection Pregnancy)

Secondary Amenorrhea

In three parallel, open-label studies (COL1620-004US, COL1620-005US, COL1620-009US), 127 women (aged 18-44) with hypothalamic amenorrhea or premature ovarian failure were randomized to receive either Prochieve® 4% (n=62) or Prochieve® 8% (n=65). All women were treated with either conjugated estrogens 0.625 mg daily (n=100) or transdermal estradiol (delivering 50 mcg/day) twice weekly (n=27).

Estrogen therapy was continuous for the entire three 28-day cycle studies. At Day 15 of the second cycle (six weeks after initiating estrogen replacement), women who demonstrated adequate response to estrogen therapy (by ultrasound) and who continued to be amenorrheic received Prochieve® every other day for six doses (Day 15 through Day 25 of the cycle).

In cycle 2, Prochieve® 4% induced bleeding in 79% of women and Prochieve® 8% induced bleeding in 77% of women. In the third cycle, estrogen was continued and Prochieve® was administered every other day beginning on Day 15 for six doses. On Day 24 an endometrial biopsy was performed. In 53 women who received Prochieve® 4%, biopsy results were as follows: 7% proliferative, 40% late secretory, 19% mid secretory, 13% early secretory, 7% atrophic, 6% menstrual endometrium, 6% inactive endometrium and 2% negative endometrium. In 54 women who received Prochieve® 8%, biopsy results were as follows: 44% late secretory, 19% mid secretory, 11% early secretory, 19% atrophic, 5% menstrual endometrium and 2% "oral contraceptive like" endometrium.

Indications and Usage for Prochieve

Assisted Reproductive Technology

Prochieve® 8% is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ("ART") treatment for infertile women with progesterone deficiency.

Secondary Amenorrhea

Prochieve® 4% is indicated for the treatment of secondary amenorrhea. Prochieve® 8% is indicated for use in women who have failed to respond to treatment with Prochieve® 4%.

Contraindications

Prochieve® should not be used in individuals with any of the following conditions:

Known sensitivity to Prochieve® (progesterone or any of the other ingredients)

Undiagnosed vaginal bleeding

Liver dysfunction or disease

Known or suspected malignancy of the breast or genital organs

Missed abortion

Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders

Warnings

The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately.

Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses. No adequate evidence is available to show that they are effective for this purpose.

Precautions

General

The pretreatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear.

In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, nonfunctional causes should be considered. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures should be undertaken.

Because progestogens may cause some degree of fluid retention, conditions which might be influenced by this factor (e.g., epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation.

The pathologist should be advised of progesterone therapy when relevant specimens are submitted.

Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.

A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen-progestin combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progestin therapy.

Information for Patients

The product should not be used concurrently with other local intravaginal therapy. If other local intravaginal therapy is to be used concurrently, there should be at least a 6-hour period before or after Prochieve® administration. Small, white globules may appear as a vaginal discharge possibly due to gel accumulation, even several days after usage.

Drug Interactions

No drug interactions have been assessed with Prochieve®.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Nonclinical toxicity studies to determine the potential of Prochieve® to cause carcinogenicity or mutagenicity have not been performed. The effect of Prochieve® on fertility has not been evaluated in animals.

Pregnancy

(See CLINICAL PHARMACOLOGY, subsection Clinical Studies)

Prochieve® 8% has been used to support embryo implantation and maintain pregnancies through its use as part of ART treatment regimens in two clinical studies (studies COL1620-007US and COL1620-F01). In the first study (COL1620-007US), 54 Prochieve®-treated women had donor oocyte transfer procedures, and clinical pregnancies occurred in 26 women (48%). The outcomes of these 26 pregnancies were as follows: one woman had an elective termination of pregnancy at 19 weeks due to congenital malformations (omphalocele) associated with a chromosomal abnormality; one woman pregnant with triplets had an elective termination of her pregnancy; seven women had spontaneous abortions; and 17 women delivered 25 apparently normal newborns.

In the second study (COL1620-F01), Prochieve® 8% was used in the luteal phase support of women undergoing in vitro fertilization ("IVF") procedures. In this multi-center, open-label study, 139 women received Prochieve® 8% once daily beginning within 24 hours of embryo transfer and continuing through Day 30 post-transfer.

Clinical pregnancies assessed at Day 90 post-transfer were seen in 36 (26%) of women. Thirty-two women (23%) delivered newborns and four women (3%) had spontaneous abortions. Of the 47 newborns delivered, one had a teratoma associated with a cleft palate; one had respiratory distress syndrome; 44 were apparently normal and one was lost to follow-up.

Geriatric Use

The safety and effectiveness in geriatric patients (over age 65) have not been established.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Nursing Mothers

Detectable amounts of progestins have been identified in the milk of mothers receiving them. The effect of this on the nursing infant has not been determined.

Adverse Reactions

Assisted Reproductive Technology

In a study of 61 women with ovarian failure undergoing a donor oocyte transfer procedure receiving Prochieve® 8% twice daily, treatment-emergent adverse events occurring in 5% or more of the women are shown in Table 3.

TABLE 3 Treatment-Emergent Adverse Events in ≥5% of Women Receiving Prochieve® 8% Twice Daily Study COL1620-007US (n=61)
Body as a Whole
Bloating	7%
Cramps NOS	15%
Pain	8%
Central and Peripheral Nervous System
Dizziness	5%
Headache	13%
Gastro-Intestinal System
Nausea	7%
Reproductive, Female
Breast Pain	13%
Moniliasis Genital	5%
Vaginal Discharge	7%
Skin and Appendages
Pruritus Genital	5%

In a second clinical study of 139 women using Prochieve® 8% once daily for luteal phase support while undergoing an in vitro fertilization procedure, treatment-emergent adverse events reported in ≥5% of the women are shown in Table 4.

TABLE 4 Treatment-Emergent Adverse Events in ≥5% of Women Receiving Prochieve® 8% Once Daily Study COL1620-F01 (n=139)
Body as a Whole
Abdominal Pain	12%
Perineal Pain Female	17%
Central and Peripheral Nervous System
Headache	17%
Gastro-Intestinal System
Constipation	27%
Diarrhea	8%
Nausea	22%
Vomiting	5%
Musculo-Skeletal System
Arthralgia	8%
Psychiatric
Depression	11%
Libido Decreased	10%
Nervousness	16%
Somnolence	27%
Reproductive, Female
Breast Enlargement	40%
Dyspareunia	6%
Urinary System
Nocturia	13%

Secondary Amenorrhea

In three studies, 127 women with secondary amenorrhea received estrogen replacement therapy and Prochieve® 4% or 8% every other day for six doses. Treatment emergent adverse events during estrogen and Prochieve® treatment that occurred in 5% or more of women are shown in Table 5.

TABLE 5 Treatment-Emergent Adverse Events in ≥5% of Women Receiving Estrogen Treatment and Prochieve® Every Other Day Studies COL1620-004US, COL1620-005US, COL1620-009US
	Estrogen + Prochieve® 4% n=62	Estrogen + Prochieve® 8% n=65
Body as a Whole
Abdominal Pain	3 (5%)	6 (9%)
Appetite Increased	3 (5%)	5 (8%)
Bloating	8 (13%)	8 (12%)
Cramps NOS	12 (19%)	17 (26%)
Fatigue	13 (21%)	14 (22%)
Central and Peripheral Nervous System
Headache	12 (19%)	10 (15%)
Gastro-Intestinal System
Nausea	5 (8%)	4 (6%)
Musculo-Skeletal System
Back Pain	5 (8%)	2 (3%)
Myalgia	5.(8%)	0 (0%)
Psychiatric
Depression	12 (19%)	10 (15%)
Emotional Lability	14 (23%)	14 (22%)
Sleep Disorder	11 (18%)	12 (18%)
Reproductive, Female
Vaginal Discharge	7 (11%)	2 (3%)
Resistance Mechanism
Upper Respiratory Tract Infection	3 (5%)	5 (8%)
Skin and Appendages
Pruitis genital	1 (2%)	4 (6%)

Additional adverse events reported in women at a frequency <5% in Prochieve® ART and secondary amenorrhea studies and not listed in the tables above include:

Autonomic Nervous System–mouth dry, sweating increased

Body as a Whole–abnormal crying, allergic reaction, allergy, appetite decreased, asthenia, edema, face edema, fever, hot flushes, influenza-like symptoms, water retention, xerophthalmia

Cardiovascular, General–syncope

Central and Peripheral Nervous System–migraine, tremor

Gastro-Intestinal–dyspepsia, eructation, flatulence, gastritis, toothache

Metabolic and Nutritional–thirst

Musculo-Skeletal System–cramps legs, leg pain, skeletal pain

Neoplasm–benign cyst

Platelet, Bleeding & Clotting–purpura

Psychiatric–aggressive reactions, forgetfulness, insomnia

Red Blood Cell–anemia

Reproductive, Female–dysmenorrhea, premenstrual tension, vaginal dryness

Resistance Mechanism–infection, pharyngitis, sinusitis, urinary tract infection

Respiratory System–asthma, dyspnea, hyperventilation, rhinitis

Skin and Appendages–acne, pruritis, rash, seborrhea, skin discoloration, skin disorder, urticaria

Urinary System–cystitis, dysuria, micturition frequency

Vision Disorders–conjunctivitis

Overdosage

There have been no reports of overdosage with Prochieve®. In the case of overdosage, however, discontinue Prochieve®, treat the patient symptomatically, and institute supportive measures.

As with all prescription drugs, this medicine should be kept out of the reach of children.

Prochieve Dosage and Administration

Assisted Reproductive Technology

Prochieve® 8% is administered vaginally at a dose of 90 mg once daily in women who require progesterone supplementation. Prochieve® 8% is administered vaginally at a dose of 90 mg twice daily in women with partial or complete ovarian failure who require progesterone replacement. If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10-12 weeks.

Secondary Amenorrhea

Prochieve® 4% is administered vaginally every other day up to a total of six doses. For women who fail to respond, a trial of Prochieve® 8% every other day up to a total of six doses may be instituted.

It is important to note that a dosage increase from the 4% gel can only be accomplished by using the 8% gel. Increasing the volume of gel administered does not increase the amount of progesterone absorbed.

SEE Prochieve® PATIENT INFORMATION SHEET - HOW TO USE Prochieve®.

Note: The PATIENT INFORMATION SHEET contains special instructions for using the applicator at altitudes above 2500 feet in order to avoid a partial release of Prochieve® before vaginal insertion.

How is Prochieve Supplied

Prochieve® is available in the following strengths:

4% gel (45 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.

NDC-55056-0406-1 - 6 Single-use prefilled applicators.

8% gel (90 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.

NDC-55056-1601-6 - 6 Single-use prefilled applicators

NDC-55056-1601-5 - 15 Single-use prefilled applicators

NDC-55056-1601-8 - 18 Single-use prefilled applicators

Each applicator is wrapped and sealed in a foil overwrap.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Rx only.

U.S. Patent Number 5,543,150.

Manufactured for: Columbia Laboratories, Inc. Livingston, NJ 07039

Manufactured by: Fleet Laboratories Ltd., Watford, United Kingdom

Revised May 2009

PATIENT INFORMATION

Prochieve® 8%

(progesterone gel)

For Vaginal Use Only

FOR PROGESTERONE SUPPLEMENTATION OR REPLACEMENT AS PART OF AN ASSISTED REPRODUCTIVE TECHNOLOGY ("ART") TREATMENT FOR INFERTILE WOMEN WITH PROGESTERONE DEFICIENCY

Please read this information carefully before you start to use Prochieve® and each time your prescription is renewed, in case anything has changed. This leaflet does not take the place of discussions with your doctor. If you still have any questions, ask your doctor or health-care provider.

What Prochieve® is

Prochieve® is a specially formulated gel that you insert in your vagina. It contains the natural female hormone called progesterone. Prochieve® 8% is used as part of a program for women who are undergoing fertility treatment.

Understanding the role of Prochieve® in your infertility treatment

Progesterone is one of the hormones essential for maintaining a pregnancy. If you are undergoing ART treatment and your doctor has determined your body does not produce enough progesterone on its own, Prochieve® may be prescribed to provide the progesterone you need.

The progesterone in Prochieve® will help prepare the lining of your uterus so that it is ready to receive and nourish a fertilized egg. If pregnancy occurs, Prochieve® may be supplemented for 10-12 weeks until production of progesterone by the placenta is adequate.

When you should not use Prochieve®

If you are allergic to progesterone, progesterone-like drugs, or any of the inactive ingredients in the gel (ask a pharmacist if you are not sure about the inactive ingredients in Prochieve®).

If you have unusual vaginal bleeding which has not been evaluated by a doctor.

If you have a liver disease.

If you have known or suspected cancer of the breast or genital organs.

If you have a miscarriage and your physician suspects some tissue is still in the uterus.

If you have or have had blood clots in the legs, lungs, eyes, or elsewhere.

Risks of Prochieve®

Risk to the fetus. Birth defects have been reported in the offspring of women who were using Prochieve® during early pregnancy. These included an abdominal wall defect and a cleft palate. A causal association has been neither confirmed nor refuted. You should check with your doctor about the risks to your unborn child of any medication used during pregnancy.

Blood clots and related health problems. Blood clots have been reported with the use of estrogens and progestational drugs (alone or in combination). If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), or other problems. Any of these conditions may cause death or serious long-term disability. Call your doctor immediately if you suspect you have any of these conditions. He or she may advise you to stop using this drug.

PRECAUTIONS

Be alert for unusual signs and symptoms. If any of these warning signals (or any other unusual symptoms) happen while you are using Prochieve®, call your doctor immediately:

Abnormal bleeding from the vagina.

Pains in the calves or chest, a sudden shortness of breath or coughing blood indicating possible clots in the legs, heart, or lungs.

Severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or numbness of an arm or leg indicating possible clots in the brain or eye.

Breast lumps, which could be associated with fibrocystic disorders, fibroadenoma, or breast cancer. (Ask your doctor or health-care provider to show you how to examine your breasts monthly.)

Yellowing of the skin and/or white of the eyes indicating possible liver problems.

You should also notify your doctor if you experience depression, worsening of your diabetic condition, or fluid retention.

Possible side effects of Prochieve®

In addition to the risks listed above, the following side effects have been reported with Prochieve® used either for progesterone supplementation or for replacement as part of an ART treatment for infertile women with progesterone deficiency. Consult your doctor if you experience any of the side effects mentioned below, or other side effects.

SIDE EFFECTS REPORTED AT A FREQUENCY OF 5% OR GREATER

abdominal pain; perineal pain (the perineum is the area between the vagina and the rectum)

headache

constipation; diarrhea; nausea

joint pain

depression; decreased libido; nervousness; sleepiness1

breast enlargement

excessive urination at night

SIDE EFFECTS REPORTED AT A FREQUENCY RANGING FROM 1% TO 5%

allergy; bloating; cramps; fatigue; pain

dizziness1

vomiting

mood swings

breast pain

difficult or painful intercourse; genital itching; genital yeast infection; vaginal discharge

urinary tract infection

SIDE EFFECTS REPORTED AT A FREQUENCY OF LESS THAN 1%

fever; flu-like symptoms

water retention2

gastrointestinal discomfort; gas; abdominal swelling

back pain; leg pain

insomnia

sinusitis; upper respiratory tract infection

asthma

acne; itching

painful or difficult urination; frequent urination

How Prochieve® works

Prochieve® has been formulated to be administered through the vagina. The moisturizing gel in Prochieve® forms a coating on the walls of the vagina which allows for absorption of progesterone through the vaginal tissue. Small, white globules may appear as a vaginal discharge possibly due to gel accumulation, even several days after usage. Prochieve® contains no irritating perfumes or dyes.

Other information

Your doctor has prescribed this drug for you and you alone. Do not give this drug to anyone else.

This medication was prescribed for your particular medical condition. Do not use it for another condition.

Keep this and all drugs out of the reach of children.

How to use Prochieve®

The dosage is one application of the 8% gel (90 mg of progesterone) vaginally, daily or twice daily as directed by your doctor. If you become pregnant, your doctor may decide to continue treatment for up to 10 to 12 weeks.

Prochieve® is to be applied directly from the specially designed sealed applicator into the vagina. The applicator is designed to deliver a premeasured dose of Prochieve®. A small amount of gel will be left in the tube after usage. Do not be concerned because you will still be receiving the appropriate, measured dosage.

Under certain rare circumstances, such as high altitude, brief exposure to high temperature, sudden changes in atmospheric/barometric pressure, and pressure controlled environments such as airplanes or high-rise buildings, the internal pressure of the applicator may become higher than the air pressure. This imbalance between the internal and external pressure may cause the gel to expel from the applicator when the twist-off tab is removed. If you should experience the gel expelling from the applicator upon opening, please follow the SPECIAL INSTRUCTIONS FOR USE AT ALTITUDES ABOVE 2500 FEET.

1.: Remove the applicator from the sealed wrapper. DO NOT remove the twist-off tab at this time. For use at altitudes above 2500 feet, see special instructions below.
2.: Hold the applicator between the thumb and forefinger along the seam on the sides of the bulb. Shake down vigorously 3 to 4 times (like a thermometer) to ensure that the contents are at the thin end of the applicator.
3.: Hold the applicator by the flat section of the bulb. Twist off the tab at the thin end and throw away. DO NOT squeeze the bulb while twisting the tab. This could force some gel to be released before it is inserted.

Twist off completely – Do not pull off
4.: The applicator may be inserted into the vagina while you are in a sitting position or when lying on your back with your knees bent. Gently insert the thin end well into the vagina.
5.: Squeeze the bulb of the applicator to deposit the gel into the vagina. Remove the applicator and throw it away in a waste container. Do not be concerned if a small amount of gel is left in the applicator. You will still be receiving the appropriate, measured dosage.

SPECIAL INSTRUCTIONS FOR USE AT ALTITUDES ABOVE 2500 FEET

Remove the applicator from the sealed wrapper. DO NOT remove the twist-off tab at this time. Hold the applicator on both sides of the bulb, as shown. Using a lancet or a stick pin, make a single puncture in the flat part of the bulb. This will relieve the difference in air pressure between the inside and outside of the applicator caused by high altitudes. It will not affect the amount of gel administered. You will still be receiving the appropriate, measured dosage.

See Step 2 above.

See Step 3 above.

See Step 4 above.

Place your thumb or finger over the puncture that you made in the bulb of the applicator. Squeeze the bulb of the applicator to deposit the gel into the vagina. Remove the applicator and throw it away in a waste container. Do not be concerned if a small amount of gel is left in the applicator. You will still be receiving the appropriate, measured dosage.

Prochieve® coats the vaginal lining to provide long-lasting release of progesterone. Small, white globules may appear as a vaginal discharge possibly due to gel accumulation, even several days after usage. It is not unusual, but if you are concerned, discuss this with your doctor.

If you forget a dose of Prochieve®, use it as soon as you remember, but do not use more than the recommended daily dose. Prochieve® should not be used at the same time that you are using other vaginal therapy.

This leaflet provides the most important information about Prochieve®. If you want to read more, ask your doctor or pharmacist about the professional leaflet. You may need their help to understand some of the information.

How Supplied

Prochieve® is available in two strengths: 4% gel (45 mg of progesterone) and 8% gel (90 mg of progesterone).

Each box of the 4% gel contains six single use, disposable vaginal applicators with a twist-off tab. Each box of the 8% gel contains either six, fifteen, or eighteen single use, disposable vaginal applicators with a twist-off tab. Each applicator is wrapped and sealed in a foil overwrap.

Prochieve® should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Do not use Prochieve® after the expiration date which is printed on the box.

Manufactured for: Columbia Laboratories, Inc., Livingston, NJ 07039

Manufactured by: Fleet Laboratories Ltd., Watford, United Kingdom

Revised May 2009

1: If you experience dizziness or sleepiness, do not drive or operate machinery.
2: This may worsen some conditions such as asthma, epilepsy, migraine, heart disease, or kidney disease.

PATIENT INFORMATION

Prochieve® 4% and Prochieve® 8% (progesterone gel)

For Vaginal Use Only

FOR THE TREATMENT OF SECONDARY AMENORRHEA (ABSENCE OF MENSES IN WOMEN WHO HAVE PREVIOUSLY HAD A MENSTRUAL PERIOD)

What Prochieve® is

Prochieve® is a specially formulated gel that you insert in your vagina. It contains the natural female hormone called progesterone. The 4% gel is used for women whose menstrual cycle has stopped. The 8% gel is to be used when the 4% gel has not worked.

Understanding the role of Prochieve® in the treatment of your menstrual irregularities

Progesterone is one of the hormones essential for regular menstrual periods. If your doctor has determined your body does not produce enough progesterone on its own, Prochieve® may be prescribed to provide the progesterone you need.

When you do not produce enough progesterone, menstrual irregularities can occur. Prochieve® can provide you with the progesterone needed during a normal menstrual cycle.

When you should not use Prochieve®

If you are allergic to progesterone, progesterone-like drugs, or any of the inactive ingredients in the gel (ask a pharmacist if you are not sure about the inactive ingredients in Prochieve®).

If you have unusual vaginal bleeding which has not been evaluated by a doctor.

If you have a liver disease.

If you have known or suspected cancer of the breast or genital organs.

If you have a miscarriage and your physician suspects some tissue is still in the uterus.

If you have or have had blood clots in the legs, lungs, eyes, or elsewhere.

Risks of Prochieve®

Risk to the fetus. Birth defects have been reported in the offspring of women who were using Prochieve® during early pregnancy. These included an abdominal wall defect and a cleft palate. A causal association has been neither confirmed nor refuted. You should check with your doctor about the risks to your unborn child of any medication used during pregnancy.

Blood clots and related health problems. Blood clots have been reported with the use of estrogens and progestational drugs (alone or in combination). If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), or other problems. Any of these conditions may cause death or serious long-term disability. Call your doctor immediately if you suspect you have any of these conditions. He or she may advise you to stop using this drug.

PRECAUTIONS

Be alert for unusual signs and symptoms. If any of these warning signals (or any other unusual symptoms) happen while you are using Prochieve®, call your doctor immediately:

Abnormal bleeding from the vagina.

Pains in the calves or chest, a sudden shortness of breath or coughing blood indicating possible clots in the legs, heart, or lungs.

Severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or numbness of an arm or leg indicating possible clots in the brain or eye.

Breast lumps, which could be associated with fibrocystic disorders, fibroadenoma, or breast cancer. (Ask your doctor or health-care provider to show you how to examine your breasts monthly.)

Yellowing of the skin and/or white of the eyes indicating possible liver problems.

You should also notify your doctor if you experience depression, worsening of your diabetic condition, or fluid retention.

Possible side effects of Prochieve®

In addition to the risks listed above, the following side effects have been reported in studies with Prochieve® used for the treatment of menstrual irregularities due to progesterone deficiency. In these studies, women were treated with estrogen prior to and during Prochieve® therapy. All side effects reported at a frequency of 5% or greater after Prochieve® was added to estrogen therapy also were reported with estrogen therapy alone. Consult your doctor if you experience any of the side effects mentioned below, or other side effects.

SIDE EFFECTS REPORTED AT A FREQUENCY OF 5% OR GREATER

abdominal pain; increased appetite; bloating; cramps; fatigue

headache

nausea

back pain

depression; mood swings; sleep disorder

vaginal discharge

upper respiratory tract infection

SIDE EFFECTS REPORTED AT A FREQUENCY RANGING FROM 1% TO 5%

increased sweating

allergy; flu-like symptoms; hot flushes; pain

dizziness3

migraine; tremor

gas; gastrointestinal discomfort

thirst

leg pain; muscle pain

insomnia; nervousness; sleepiness3

K-Lyte

Generic Name: potassium bicarbonate and potassium citrate (poe TASS ee um bye KAR boe nate and poe TASS ee um SIT rate)

Brand Names: K-Lyte

What is K-Lyte (potassium bicarbonate and potassium citrate)?

Potassium is a mineral that is found in many foods and is needed for several functions of your body, especially the beating of your heart.

Potassium bicarbonate and potassium citrate is used to prevent or to treat low blood levels of potassium (hypokalemia). Potassium levels can be low as a result of a disease or from taking certain medicines, or after a prolonged illness with diarrhea or vomiting.

Potassium bicarbonate and potassium citrate may also be used for other purposes other than those listed in this medication guide.

What is the most important information I should know about K-Lyte (potassium bicarbonate and potassium citrate)?

You should not use this medication if you have kidney failure, Addison's disease, severe burns or other tissue injury, if you are dehydrated, if you take certain diuretics (water pills), or if you have high levels of potassium in your blood (hyperkalemia). Do not chew the effervescent tablet or swallow it whole. It must be dissolved in water or fruit juice before you take it. Avoid lying down for at least 30 minutes after you take this medication. Take this medication with food or just after a meal.

To be sure this medication is helping your condition, your blood may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. This test will help your doctor determine how long to treat you with potassium. Do not miss any scheduled appointments.

Serious side effects of potassium include uneven heartbeat, muscle weakness or limp feeling, severe stomach pain, and numbness or tingling in your hands, feet, or mouth.

Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse.

What should I discuss with my healthcare provider before taking K-Lyte (potassium bicarbonate and potassium citrate)?

You should not use this medication if you are allergic to it, or if you have certain conditions. Be sure your doctor knows if you have:

high levels of potassium in your blood (hyperkalemia);

kidney failure;

Addison's disease (an adrenal gland disorder);

a large tissue injury such as a severe burn;

if you are severely dehydrated; or

if you are taking a "potassium-sparing" diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), triamterene (Dyrenium, Dyazide, Maxzide).

Before using potassium bicarbonate and potassium citrate, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease;

heart disease or high blood pressure;

a blockage in your stomach or intestines; or

chronic diarrhea (such as ulcerative colitis, Crohn's disease).

If you have any of these conditions, you may need a dose adjustment or special tests to safely take potassium bicarbonate and potassium citrate.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether potassium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take K-Lyte (potassium bicarbonate and potassium citrate)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Do not chew the effervescent tablet or swallow it whole. Drop the tablet into a glass and add at least 4 ounces (one-half cup) of cold water or fruit juice. When the tablet has completely dissolved, begin drinking the mixture slowly, over 5 to 10 minutes in all.

To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Take this medication with food or just after a meal. Your treatment may include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.

Potassium-rich foods include: squash, baked potatoes (skin on), spinach, lentils, broccoli, brussels sprouts, zucchini, kidney or navy beans, raisins, watermelon, orange juice, bananas, cantaloupe, and low-fat milk or yogurt. Consume only the daily amounts recommended by your doctor or nutrition counselor.

Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse. Store potassium bicarbonate and potassium citrate at room temperature away from moisture and heat. Keep the medication in a closed container.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include heavy feeling in your arms or legs, confusion, weak or shallow breathing, slow or uneven heartbeat, seizure (convulsions), or feeling like you might pass out.

What should I avoid while taking K-Lyte (potassium bicarbonate and potassium citrate)?

Avoid lying down for at least 30 minutes after you take this medication.

Avoid taking potassium supplements or using other products that contain potassium without first asking your doctor. Salt substitutes or low-salt dietary products often contain potassium. If you take certain products together you may accidentally get too much potassium. Read the label of any other medicine you are using to see if it contains potassium.

K-Lyte (potassium bicarbonate and potassium citrate) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

confusion, anxiety, feeling like you might pass out;

uneven heartbeat;

extreme thirst, increased urination;

leg discomfort;

muscle weakness or limp feeling;

numbness or tingly feeling in your hands or feet, or around your mouth;

severe stomach pain, ongoing diarrhea or vomiting;

black, bloody, or tarry stools; or

coughing up blood or vomit that looks like coffee grounds.

Less serious side effects may include:

mild nausea or upset stomach;

mild or occasional diarrhea; or

slight tingling in your hands or feet.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect K-Lyte (potassium bicarbonate and potassium citrate)?

The following drugs can interact with potassium bicarbonate and potassium citrate. Tell your doctor if you are using any of these:

eplerenone (Inspra);

digoxin (digitalis, Lanoxin);

quinidine (Quinaglute, Quinidex, Quin-Release);

a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva);

an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik); or

any type of diuretic (water pill) such as bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Hygroton, Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), indapamide (Lozol), metolazone (Mykrox, Zarxolyn), or torsemide (Demadex).

This list is not complete and there may be other drugs that can interact with potassium bicarbonate and potassium citrate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More K-Lyte resources

K-Lyte Side Effects (in more detail)
K-Lyte Drug Interactions
K-Lyte Support Group
0 Reviews for K-Lyte - Add your own review/rating

K-Lyte Advanced Consumer (Micromedex) - Includes Dosage Information

Compare K-Lyte with other medications

Hypokalemia
Prevention of Hypokalemia

Where can I get more information?

Your pharmacist can provide more information about potassium bicarbonate and potassium citrate.

See also: K-Lyte side effects (in more detail)

Tuesday, June 12, 2012

histrelin Subcutaneous

his-TREL-in

Commonly used brand name(s)

In the U.S.

Supprelin LA

Vantas

Available Dosage Forms:

Implant

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Gonadotropin Releasing Hormone Agonist

Uses For histrelin

Histrelin is a man-made version of a hormone that is similar to the one normally released from the hypothalamus gland in the brain. It works in the brain to reduce the blood levels of sex hormones, such as testosterone and estrogen. The histrelin implant is placed under the skin. The implant releases small amounts of histrelin in the body every day for 12 months.

Histrelin (Vantas®) is used to treat advanced prostate cancer in adults. It will reduce the level of testosterone, a male hormone, in the blood. Testosterone makes most prostate cancers grow. Histrelin is not a cure for prostate cancer, but it may help relieve the symptoms.

Histrelin (Supprelin® LA) is used to treat central precocious puberty (CPP) in children. CPP is a condition where puberty begins at an unusually early age. This usually means puberty occurs before 8 years of age in girls and before 9 years of age in boys. Histrelin works by reducing the amount of sex hormones (eg, estrogen and testosterone) in the blood.

histrelin is available only with your doctor's prescription.

Before Using histrelin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For histrelin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to histrelin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

The Vantas® form of histrelin should not be used in children.

Appropriate studies have not been performed on the relationship of age to the effects of the Supprelin® LA form of histrelin in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of histrelin (eg, Supprelin® LA, Vantas®) in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of histrelin

A doctor or other trained health professional will give you or your child histrelin. The histrelin implant will be placed under the skin of the upper arm.

Your doctor will treat the upper arm with a numbing medicine and then cut a small incision to insert the implant. The incision will be closed with either stitches or surgical strips. A pressure bandage will be placed over the arm and left in place for 24 hours.

Do not remove the surgical strips. Allow them to fall off on their own after several days. If the incision has been stitched, your doctor will remove the stitches or they will dissolve after several days.

After the implant is inserted, you or your child should keep the arm clean and dry. Do not swim or bathe for 24 hours. You should avoid any heavy lifting or strenuous exercise for the first 7 days after the implant is inserted.

You or your child may have some pain, redness, or bruising at the site where the implant is placed. If your arm has not healed within 2 weeks after you received the implant or if you continue to have redness or pain, call your doctor.

The implant will be left in place for one year (12 months) and then removed. If needed, your doctor will insert a new implant to continue treatment for another year.

histrelin comes with patient instructions. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using histrelin

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the implant is in the proper place and if it is working properly.

For female patients: You should not receive histrelin if you are pregnant or may become pregnant. Using histrelin while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

For children using Supprelin® LA: The medicine can cause a brief increase in blood levels of some hormones. During this time, you may notice more signs of puberty in your child, including light vaginal bleeding and breast enlargement in girls. If your child's symptoms do not improve within 4 weeks, or if they get worse, call your doctor.

For male patients:

When you start using histrelin, some of your symptoms might get worse for a short time. You might also have new symptoms such as bone pain, back pain, a tingling or numbness in the body, blood in the urine, or trouble urinating. The symptoms should improve in a few weeks. Tell your doctor if you have any new symptoms or your symptoms get worse.

histrelin may cause your blood sugar level to increase. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

histrelin may increase your risk of having a heart attack or stroke. Check with your doctor right away if you have chest pain or discomfort; difficulty with speaking; headache; pain or discomfort in the arms, jaw, back or neck; shortness of breath; sweating; or vomiting while using the medicine.

histrelin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

Bloody urine

decreased frequency or amount of urine

increased thirst

loss of appetite

lower back or side pain

nausea

swelling of the face, fingers, or lower legs

trouble with breathing

unusual tiredness or weakness

vomiting

weight gain

Incidence not known

Abdominal or stomach pain

bloating of the abdomen or stomach

dark urine

light-colored stools

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Decrease in testicle size

feeling of warmth

local infection, irritation, redness, or swelling on the skin where the implant was placed

redness of the face, neck, arms, and upper chest

sudden sweating

Less common

Decreased interest in sexual intercourse

difficulty having a bowel movement (stool)

flushing or redness of the skin

headache

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

sleeplessness

swelling of the breast or breast soreness in both females and males

trouble sleeping

unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: histrelin Subcutaneous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More histrelin Subcutaneous resources

Histrelin Subcutaneous Side Effects (in more detail)
Histrelin Subcutaneous Use in Pregnancy & Breastfeeding
Histrelin Subcutaneous Drug Interactions
Histrelin Subcutaneous Support Group
3 Reviews for Histrelin Subcutaneous - Add your own review/rating

Compare histrelin Subcutaneous with other medications

Precocious Puberty
Prostate Cancer

Sunday, June 10, 2012

KG-Hist D

Generic Name: pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine (fen IR a meen/pie RILL a meen/fen ill toe LOX a meen/fen ill proe pa NOLE a meen)

Brand Names: Delhist D, Delhistine D, Histine-D, Iohist D, KG-Hist D, Liqui-Histine-D, Metahistine D, Multihist D, Multihistamine-D, Poly-D, Poly-Histine-D, Prohistine-D, Trihist-D

What is KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Pheniramine, pyrilamine, and phenyltoloxamine are antihistamines. They block the effects of the naturally occurring chemical histamine in the body. Pheniramine, pyrilamine, and phenyltoloxamine prevent sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal and respiratory (breathing) passages to open up.

Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking this medication.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.

Who should not take KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Do not take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

kidney disease,

liver disease,

diabetes,

glaucoma,

any type of heart disease or high blood pressure,

thyroid disease,

emphysema or chronic bronchitis, or

difficulty urinating or an enlarged prostate.

You may not be able to take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure about the formulation of the medicine, ask your pharmacist for help.

If you cannot swallow the tablets or capsules, look for a liquid form of this medication.

To ensure that you get a correct dose, measure the liquid form of pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication than is recommended. An overdose can cause serious harm.

Do not take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Store pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.

What should I avoid while taking KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine) side effects

Serious side effects are unlikely to occur. Stop taking pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

dryness of the eyes, nose, and mouth;

drowsiness or dizziness;

blurred vision;

difficulty urinating; or

excitation in children.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain pheniramine, pyrilamine, phenyltoloxamine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More KG-Hist D resources

KG-Hist D Drug Interactions
KG-Hist D Support Group
0 Reviews for KG-Hist D - Add your own review/rating

Compare KG-Hist D with other medications

Allergies
Eye Dryness/Redness
Eye Redness/Itching
Hay Fever
Nasal Congestion
Rhinorrhea
Sinusitis
Upper Respiratory Tract Infection

Where can I get more information?

Your pharmacist has additional information about pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is available with a prescription under the brand names Poly-Histine-D (capsules and elixir) and Liqui-Histine Elixir. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Thursday, June 7, 2012

Erythrocin

Dosage Form: tablet, film coated
Erythrocin® STEARATE

ERYTHROMYCIN STEARATE

TABLETS, USP

Film-coated Tablets

Rx only

Erythrocin Description

Erythrocin STEARATE Film-coated tablets (erythromycin stearate tablets, USP) are an antibacterial product containing the stearate salt of erythromycin in a unique film coating.

Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin stearate is known chemically as erythromycin octadecanoate. The molecular formula of erythromycin stearate is C37 H67 NO13 •C18H36O2 , and the molecular weight is 1018.43. The structural formula is:

Inactive Ingredients

250 mg tablet: Cellulosic polymers, corn starch, D&C Red No. 7, polacrilin potassium, polyethylene glycol, povidone, propylene glycol, sodium carboxymethylcellulose, sodium citrate, sorbic acid, sorbitan monooleate and titanium dioxide.

Erythrocin - Clinical Pharmacology

Orally administered erythromycin base and its salts are readily absorbed in the microbiologically active form. Interindividual variations in the absorption of erythromycin are, however, observed, and some patients do not achieve optimal serum levels. Erythromycin is largely bound to plasma proteins. After absorption, erythromycin diffuses readily into most body fluids. In the absence of meningeal inflammation, low concentrations are normally achieved in the spinal fluid but the passage of the drug across the blood-brain barrier increases in meningitis. Erythromycin crosses the placental barrier, but fetal plasma levels are low. The drug is excreted in human milk. Erythromycin is not removed by peritoneal dialysis or hemodialysis.

In the presence of normal hepatic function, erythromycin is concentrated in the liver and is excreted in the bile; the effect of hepatic dysfunction on biliary excretion of erythromycin is not known. After oral administration, less than 5% of the administered dose can be recovered in the active form in the urine.

Orally administered Erythrocin STEARATE tablets are readily and reliably absorbed. Optimal serum levels of erythromycin are reached when the drug is taken in the fasting state or immediately before meals.

Microbiology

Erythromycin acts by inhibition of protein synthesis by binding 50 S ribosomal subunits of susceptible organisms. It does not affect nucleic acid synthesis. Antagonism has been demonstrated in vitro between erythromycin and clindamycin, lincomycin, and chloramphenicol.

Many strains of Haemophilus influenzae are resistant to erythromycin alone, but are susceptible to erythromycin and sulfonamides used concomitantly.

Staphylococci resistant to erythromycin may emerge during a course of erythromycin therapy. Erythromycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Gram-positive organisms:

: Corynebacterium diphtheriae

Corynebacterium minutissimum

Listeria monocytogenes

Staphylococcus aureus(resistant organisms may emerge during treatment)

Streptococcus pneumoniae

Streptococcus pyogenes

Gram-negative organisms:

: Bordetella pertussis

Legionella pneumophila

Neisseria gonorrhoeae

Other microorganisms:

: Chlamydia trachomatis

Entamoeba histolytica

Mycoplasma pneumoniae

Treponema pallidum

Ureaplasma urealyticum

The following in vitro data are available, but their clinical significance is unknown.

Erythromycin exhibits in vitro minimal inhibitory concentrations (MIC's) of 0.5 µg/mL or less against most (≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of erythromycin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.

Gram-positive organisms:

: Viridans group streptococci

Gram-negative organisms:

: Moraxella catarrhalis

Susceptibility Tests

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MIC's). These MIC's provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MIC's should be determined using a standardized procedure. Standardized procedures are based on a dilution method1(broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of erythromycin powder. The MIC values should be interpreted according to the following criteria:

MIC (µg/mL)	Interpretation
≤0.5	Susceptible (S)
1-4	Intermediate (I)
≥8	Resistant (R)

A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of "Intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard erythromycin powder should provide the following MIC values:

Microorganism	MIC (µg/mL)
S. aureus ATCC 29213	0.12-0.5
E. faecalis ATCC 29212	1-4

Diffusion Techniques

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 15-µg erythromycin to test the susceptibility of microorganisms to erythromycin.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 15-µg erythromycin disk should be interpreted according to the following criteria:

Zone Diameter (mm)	Interpretation
≥23	Susceptible (S)
14-22	Intermediate (I)
≤13	Resistant (R)

Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for erythromycin.

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 15-µg erythromycin disk should provide the following zone diameters in these laboratory test quality control strains:

Microorganism	Zone Diameter (mm)
S. aureus ATCC 25923	22-30

Indications and Usage for Erythrocin

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythrocin STEARATE Film-coated tablets and other antibacterial drugs, Erythrocin STEARATE Film-coated tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Erythrocin STEARATE tablets are indicated in the treatment of infections caused by susceptible strains of the designated micro organisms in the diseases listed below:

Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzaeare not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.)

Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae.

Listeriosis caused by Listeria monocytogenes.

Respiratory tract infections due to Mycoplasma pneumoniae.

Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment).

Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.

Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers.

Erythrasma: In the treatment of infections due to Corynebacterium minutissimum.

Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents.

Acute Pelvic Inflammatory Disease Caused by Neisseria gonorrhoeae: Erythrocin®Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a followup serologic test for syphilis after 3 months.

Erythromycins are Indicated for Treatment of the Following Infections Caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.

When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum.

Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy.

Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.

Prophylaxis

Prevention of Initial Attacks of Rheumatic Fever–Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).3 Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days.

Prevention of Recurrent Attacks of Rheumatic Fever–Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3

Contraindications

Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic.

Erythromycin is contraindicated in patients taking terfenadine, astemizole, pimozide or cisapride. (See PRECAUTIONS - Drug Interactions.)

Warnings

There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral erythromycin products.

There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Erythrocin® STEARATE Film-coated Tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels. (See package insert for lovastatin.)

Precautions

General

Prescribing Erythrocin STEARATE Film-coated tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Since erythromycin is principally excreted by the liver, caution should be exercised when erythromycin is administered to patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY and WARNINGS.)

Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome have been reported in patients receiving erythromycin therapy.

There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following erythromycin therapy. In one cohort of 157 newborns who were given erythromycin for pertussis prophylaxis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. A possible dose-response effect was described with an absolute risk of IHPS of 5.1% for infants who took erythromycin for 8-14 days and 10% for infants who took erythromycin for 15-21 days.4 Since erythromycin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or neonatal Chlamydia trachomatis infections), the benefit of erythromycin therapy needs to be weighed against the potential risk of developing IHPS. Parents should be informed to contact their physician if vomiting or irritability with feeding occurs.

Prolonged or repeated use of erythromycin may result in an overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted.

When indicated, incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy.

Information for Patients

Patients should be counseled that antibacterial drugs including Erythrocin STEARATE Film-coated tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Erythrocin STEARATE Film-coated tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Erythrocin STEARATE Film-coated tablets or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions

Erythromycin use in patients who are receiving high doses of theophylline may be associated with an increase in serum theophylline levels and potential theophylline toxicity. In case of theophylline toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is receiving concomitant erythromycin therapy.

Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent verapamil, belonging to the calcium channel blockers drug class.

Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin serum levels.

There have been reports of increased anticoagulant effects when erythromycin and oral anticoagulants were used concomitantly. Increased anticoagulation effects due to interactions of erythromycin with oral anticoagulants may be more pronounced in the elderly.

Erythromycin is a substrate and inhibitor of the 3A isoform subfamily of the cytochrome p450 enzyme system (CYP3A). Coadministration of erythromycin and a drug primarily metabolized by CYP3A may be associated with elevations in drug concentrations that could increase or prolong both the therapeutic and adverse effects of the concomitant drug. Dosage adjustments may be considered, and when possible, serum concentrations of drugs primarily metabolized by CYP3A should be monitored closely in patients concurrently receiving erythromycin.

The following are examples of some clinically significant CYP3A based drug interactions. Interactions with other drugs metabolized by the CYP3A isoform are also possible. The following CYP3A based drug interactions have been observed with erythromycin products in post-marketing experience:

Ergotamine/dihydroergotamine

Concurrent use of erythromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.

Triazolobenzodiazepines (such as triazolam and alprazolam) and Related Benzodiazepines

Erythromycin has been reported to decrease the clearance of triazolam and midazolam, and thus, may increase the pharmacologic effect of these benzodiazepines.

HMG-CoA Reductase Inhibitors

Erythromycin has been reported to increase concentrations of HMG-CoA reductase inhibitors (e.g., lovastatin and simvastatin). Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly.

Sildenafil (Viagra)

Erythromycin has been reported to increase the systemic exposure (AUC) of sildenafil. Reduction of sildenafil dosage should be considered. (See Viagra package insert.)

There have been spontaneous or published reports of CYP3A based interactions of erythromycin with cyclosporine, carbamazepine, tacrolimus, alfentanil, disopyramide, rifabutin, quinidine, methylprednisolone, cilostazol, vinblastine, and bromocriptine.

Concomitant administration of erythromycin with cisapride, pimozide, astemizole, or terfenadine is contraindicated. (See CONTRAINDICATIONS.)

In addition, there have been reports of interactions of erythromycin with drugs not thought to be metabolized by CYP3A, including hexobarbital, phenytoin, and valproate.

Erythromycin has been reported to significantly alter the metabolism of the nonsedating antihistamines terfenadine and astemizole when taken concomitantly. Rare cases of serious cardiovascular adverse events, including electrocardiographic QT/QTc interval prolongation, cardiac arrest, torsades de pointes, and other ventricular arrhythmias, have been observed. (See CONTRAINDICATIONS.) In addition, deaths have been reported rarely with concomitant administration of terfenadine and erythromycin.

There have been post-marketing reports of drug interactions when erythromycin was co-administered with cisapride, resulting in QT prolongation, cardiac arrhythmias, ventricular tachycardia, ventricular fibrillation, and torsades de pointes, most likely due to the inhibition of hepatic metabolism of cisapride by erythromycin. Fatalities have been reported. (See CONTRAINDICATIONS).

Drug/Laboratory Test interactions

Erythromycin interferes with the fluorometric determination of urinary catecholamines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term (2-year) oral studies conducted in rats with erythromycin base did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25 percent of diet.

Pregnancy

Teratogenic Effects

Pregnancy Category B

There is no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25 percent of diet) prior to and during mating, during gestation, and through weaning of two successive litters. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

The effect of erythromycin on labor and delivery is unknown.

Nursing Mothers

Erythromycin is excreted in human milk. Caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.

Geriatric Use

Elderly patients, particularly those with reduced renal or hepatic function, may be at increased risk for developing erythromycin-induced hearing loss. (See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).

Elderly patients may be more susceptible to the development of torsades de pointes arrhythmias than younger patients. (See ADVERSE REACTIONS).

Elderly patients may experience increased effects of oral anticoagulant therapy while undergoing treatment with erythromycin. (See PRECAUTIONS - Drug Interactions).

Erythrocin Stearate Film-coated Tablets (250 mg) contain 56.7 mg (2.5 mEq) of sodium and 5.0 mg (0.1 mEq) of potassium per tablet.

The geriatric population may respond with a blunted natriuresis to salt loading. This may be clinically important with regard to such diseases as congestive heart failure.

Adverse Reactions

The most frequent side effects of oral erythromycin preparations are gastrointestinal and are doserelated. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur. (See WARNINGS.)

Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. (See WARNINGS.)

Erythromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes.

Allergic reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely.

There have been rare reports of pancreatitis and convulsions.

There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of erythromycin.

Overdosage

In case of overdosage, erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted.

Erythromycin is not removed by peritoneal dialysis or hemodialysis.

Erythrocin Dosage and Administration

Optimal serum levels of erythromycin are reached when Erythrocin STEARATE (erythromycin stearate) is taken in the fasting state or immediately before meals.

Adults

The usual dosage is 250 mg every 6 hours; or 500 mg every 12 hours. Dosage may be increased up to 4 g per day according to the severity of the infection. However, twice-a-day dosing is not recommended when doses larger than 1 g daily are administered.

Children

Age, weight, and severity of the infection are important factors in determining the proper dosage. The usual dosage is 30 to 50 mg/kg/day, in equally divided doses. For more severe infections this dosage may be doubled but should not exceed 4 g per day.

In the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of erythromycin should be administered for at least ten days.

The American Heart Association suggests a dosage of 250 mg of erythromycin orally, twice a day in long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides.3

Conjunctivitis of the Newborn Caused by Chlamydia trachomatis

Oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks.3

Pneumonia of Infancy Caused by Chlamydia trachomatis

Although the optimal duration of therapy has not been established, the recommended therapy is oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks.

Urogenital Infections During Pregnancy Due to Chlamydia trachomatis

Although the optimal dose and duration of therapy have not been established, the suggested treatment is 500 mg of erythromycin by mouth four times a day or two erythromycin 333 mg tablets orally every 8 hours on an empty stomach for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of one erythromycin 500 mg tablet orally every 12 hours, one 333 mg tablet orally every 8 hours or 250 mg by mouth four times a day should be used for at least 14 days.5

For Adults With Uncomplicated Urethral, Endocervical, or Rectal Infections Caused by Chlamydia trachomatis, When Tetracycline is Contraindicated or Not Tolerated

500 mg of erythromycin by mouth four times a day or two 333 mg tablets orally every 8 hours for at least 7 days.5

For Patients With Nongonococcal Urethritis Caused by Ureaplasma urealyticum When Tetracycline is Contraindicated or Not Tolerated

500 mg of erythromycin by mouth four times a day or two 333 mg tablets orally every 8 hours for at least seven days.5

Primary Syphilis

30 to 40 g given in divided doses over a period of 10 to 15 days.

Acute Pelvic Inflammatory Disease Caused by N. gonorrhoeae

500 mg Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP) every 6 hours for 3 days, followed by 500 mg of erythromycin base orally every 12 hours, or 333 mg of erythromycin base orally every 8 hours for 7 days.

Intestinal Amebiasis

Adults

500 mg every 12 hours, 333 mg every 8 hours or 250 mg every 6 hours for 10 to 14 days.

Children

30 to 50 mg/kg/day in divided doses for 10 to 14 days.

Pertussis

Although optimal dosage and duration have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.

Legionnaires' Disease

Although optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g daily in divided doses.

How is Erythrocin Supplied

Erythrocin STEARATE Film-coated Tablets (erythromycin stearate tablets, USP) are supplied in the following strengths and packages.

Erythrocin STEARATE Film-coated, 250 mg pink tablets imprinted with the corporate logo

Bottles of 100 (NDC 24338-106-20)

The

in various jurisdictions and is used under license.

Recommended Storage

Store below 86°F (30°C).

REFERENCES

National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25 NCCLS, Villanova, PA, December 1993.

National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests, Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24 NCCLS, Villanova, PA, December 1993.

Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, the American Heart Association: Prevention of Rheumatic Fever. Circulation. 78(4):1082-1086, October 1988.

Honein, M.A., et. al.: Infantile hypertrophic pyloric stenosis after pertussis prophylaxis with erythromycin: a case review and cohort study. The Lancet 1999;354 (9196):2101-5.

Data on file, Arbor Pharmaceuticals, Inc.

03-A430-R1

Revised: February, 2011

Arbor Pharmaceuticals, Inc.

Raleigh, NC 27606 USA

(Nos. 6346)

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 24338-106-20

100 Tablets

Erythrocin®

STEARATE FILM-COATED TABLETS

ERYTHROMYCIN STEARATE

TABLETS, USP

250 mg

Erythromycin

activity

Rx only

arbor™

PHARMACEUTICALS, INC.

www.arborpharma.com

Erythrocin STEARATE
erythromycin stearate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	24338-106
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ERYTHROMYCIN STEARATE (ERYTHROMYCIN)	ERYTHROMYCIN	250 mg

Inactive Ingredients
Ingredient Name	Strength
powdered cellulose
starch, corn
D&C Red No. 7
polacrilin potassium
polyethylene glycols
povidone
propylene glycol
carboxymethylcellulose sodium
sodium citrate
sorbic acid
sorbitan monooleate
titanium dioxide

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	ES
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	24338-106-20	100 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA060359	08/01/2011

Labeler - Arbor Pharmaceuticals, Inc. (781796417)

Revised: 12/2011Arbor Pharmaceuticals, Inc.

Monday, June 4, 2012

Sjogren's Syndrome Medications

Definition of Sjogren's Syndrome: An immunologic disorder characterised by progressive destruction of the exocrine glands

Drugs associated with Sjogren's Syndrome

The following drugs and medications are in some way related to, or used in the treatment of Sjogren's Syndrome. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Sjogren's Syndrome

Medical Encyclopedia:

Sjogren syndrome

Harvard Health Guide:

Symptoms and treatment for Sjogren's Syndrome

Drug List:

Friday, June 1, 2012

efalizumab Subcutaneous

ef-a-LIZ-oo-mab

Subcutaneous routePowder for Solution

Risk of Progressive Multifocal Leukoencephalopathy (PML):
- Efalizumab increases the risk for PML, a rapidly progressive viral infection of the central nervous system that has no known treatment and that leads to death or severe disability. The risk of PML may markedly increase with longer duration of efalizumab exposure. The time dependent threshold when the risk for PML increases is unknown.
- Patients on efalizumab should be monitored frequently to ensure they are receiving significant clinical benefit, to ensure they understand the significance of the risk of PML, and for any sign or symptom that may be suggestive of PML.
- Efalizumab dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, brain magnetic resonance imaging (MRI) and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.

Risk of Serious Infections:
- Infections, including serious infections leading to hospitalizations or death, have been observed in patients treated with efalizumab. These infections have included bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections. Patients should be educated about the symptoms of infection and be closely monitored for signs and symptoms of infection during and after treatment with efalizumab. If a patient develops a serious infection, efalizumab should be discontinued and appropriate therapy instituted .

Efalizumab increases the risk for progressive multifocal leukoencephalopathy (PML). The risk of PML may markedly increase with longer duration of efalizumab exposure. Monitor patients for signs and symptoms of PML and discontinue therapy if any sign or symptom of PML develops. Serious infections, some leading to hospitalizations or death, have been observed in patients treated with efalizumab and include bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections. Educate patients about the symptoms of infection and monitor for signs and symptoms of infection during and after treatment. Discontinue efalizumab if a serious infection develops .

Commonly used brand name(s):

In the U.S.

Raptiva

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Immune Suppressant

Pharmacologic Class: Monoclonal Antibody

Uses For efalizumab

Efalizumab is used in adult patients to treat moderate-to-severe psoriasis.

efalizumab was available only with your doctor's prescription.

Genentech announced on April 8, 2009 that all products containing efalizumab will no longer be available on the market after June 8, 2009, because it may cause a rare but serious side effect.

Before Using efalizumab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For efalizumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to efalizumab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of efalizumab in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of efalizumab in the elderly. However, elderly patients are more likely to have infections, which may require caution in patients receiving efalizumab.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of efalizumab

efalizumab is given as a shot under your skin. Your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

efalizumab comes with a medication guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You will be shown the body areas where this shot can be given (e.g., the thigh or upper leg, upper arm, abdomen, or buttocks). Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

Dosing

The dose of efalizumab will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of efalizumab. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form:
- For treatment of psoriasis:
  - Adults—The dose is based on your body weight and must be determined by your doctor.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using efalizumab

It is very important that your doctor check you at regular visits for any blood problems or any other side effects that may be caused by efalizumab.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking efalizumab.

While you are being treated with efalizumab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Efalizumab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, the other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also avoid persons who have recently taken oral polio vaccine. Do not get close to them or stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective mask that covers the nose and mouth.

efalizumab may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Check with your doctor right away if you are having more than one of these symptoms: back pain; blurred vision; confusion; convulsions; dizziness; drowsiness; fever; headache; or unusual tiredness or weakness.

It is important to check with your doctor if you have any symptoms of an infection such as fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination. If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Check with your doctor right away if you start having numbness, tingling, or weakness in your arms, legs, or face; or problems with thinking, balance, talking, walking, or vision. These could be symptoms of a nervous system disorder.

Check with you doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.

When you first start using efalizumab, you may have a headache, fever, muscle aches, nausea, and vomiting, especially after your first dose. These symptoms usually clear up once you are using the medicine regularly.

Tell your doctor if you want to stop using efalizumab. Your psoriasis may become worse if you miss a dose or stop using the medicine altogether.

efalizumab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Accumulation of pus

chest pain

cough

cough producing mucus

diarrhea

difficulty in breathing or swallowing

fast heartbeat

fever or chills

headache

increased bone pain in vertebrae

itching, pain, redness, swelling, tenderness, or warmth on the skin

loss of appetite

muscle or joint stiffness, tightness, or rigidity

nausea

pain or tenderness around the eyes and cheekbones

rash or redness

shortness of breath

skin itching

sneezing

sore throat

stiff neck or back

stomach pain

stuffy or runny nose

swelling of the face, throat, or tongue

swollen, red, or tender area of infection

tightness in the chest

vomiting

weakness

wheezing

Rare

Back pain

black, tarry stools

bleeding gums

blood in the urine or stools

dark urine

difficulty in moving

general tiredness and weakness

hearing loss

light-colored stools

muscle pain

pain, swelling, or redness in the joints

pinpoint, red spots on the skin

small usually colored spots on the skin

spots on your skin resembling a blister or pimple

sudden and severe muscle weakness, sudden and progressing

swollen salivary glands

unusual bleeding or bruising

unusual lumps or skin changes

upper right abdominal pain

yellow eyes and skin

Incidence not known

Back pain, sudden and severe

blistering, peeling, or loosening of the skin

blurred vision

cold or flu-like symptoms

confusion

convulsions

dizziness

drowsiness

general feeling of illness

headache

inability to move arms and legs

increased sensitivity of the skin to sunlight

lower back or side pain

muscle weakness, sudden and progressing

numbness, tingling, pain, or weakness in the hands or feet

painful or difficult urination

red skin lesions, often with a purple center

red, irritated eyes

redness or other discoloration of the skin

severe sunburn

skin rash

sores, ulcers, or white spots in the mouth or on the lips

sudden numbness and weakness in the arms and legs

swollen glands

unusual tiredness or weakness

weakness of the muscles in your face

weight loss

More common

Difficulty in moving

general feeling of discomfort or illness

joint pain

loss of appetite

muscle cramping

shivering

sweating

swollen joints

trouble sleeping

Less common

Blemishes on the skin

lack or loss of strength

pimples

swelling of the hands, ankles, feet, or lower legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: efalizumab Subcutaneous side effects (in more detail)

More efalizumab Subcutaneous resources

Efalizumab Subcutaneous Side Effects (in more detail)
Efalizumab Subcutaneous Use in Pregnancy & Breastfeeding
Efalizumab Subcutaneous Drug Interactions
Efalizumab Subcutaneous Support Group
4 Reviews for Efalizumab Subcutaneous - Add your own review/rating

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Psoriasis

Thursday, June 14, 2012

Prochieve Description

Prochieve - Clinical Pharmacology

Pharmacokinetics

Clinical Studies

Assisted Reproductive Technology

Secondary Amenorrhea

Indications and Usage for Prochieve

Assisted Reproductive Technology

Secondary Amenorrhea

Contraindications

Warnings

Precautions

General

Information for Patients

Drug Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Geriatric Use

Pediatric Use

Nursing Mothers

Adverse Reactions

Assisted Reproductive Technology

Secondary Amenorrhea

Overdosage

Prochieve Dosage and Administration

Assisted Reproductive Technology

Secondary Amenorrhea

How is Prochieve Supplied

PATIENT INFORMATION

PATIENT INFORMATION

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What is the most important information I should know about K-Lyte (potassium bicarbonate and potassium citrate)?

What should I discuss with my healthcare provider before taking K-Lyte (potassium bicarbonate and potassium citrate)?

How should I take K-Lyte (potassium bicarbonate and potassium citrate)?

What happens if I miss a dose?

What happens if I overdose?

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Tuesday, June 12, 2012

Commonly used brand name(s)

Uses For histrelin

Before Using histrelin

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of histrelin

Precautions While Using histrelin

histrelin Side Effects

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Sunday, June 10, 2012

What is KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

What is the most important information I should know about KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Who should not take KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

How should I take KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine) side effects

What other drugs will affect KG-Hist D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

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Thursday, June 7, 2012

Erythrocin Description

Inactive Ingredients

Erythrocin - Clinical Pharmacology

Microbiology

Dilution Techniques