Kadian

Generic Name: morphine (Oral route)

MOR-feen

Oral route(Capsule, Extended Release)

Kadian(R): Capsule contains morphine sulfate, an opioid agonist and Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Kadian(R) is indicated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The 100-mg and 200-mg capsules are for use in opioid-tolerant patients only. Kadian(R) capsules should be swallowed whole or the contents sprinkled on applesauce. Do not crush, chew, or dissolve capsule pellets due to the risk of rapid release and absorption of a potentially fatal dose of morphine .

Oral route(Capsule, Extended Release, 24 HR)

Avinza(R): Capsules are a modified-release formulation of morphine sulfate indicated for once daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. Avinza(R) capsules should be swallowed whole or the contents sprinkled on applesauce. Do not crush, chew, or dissolve capsule beads due to the risk of rapid release and absorption of a potentially fatal dose of morphine. Avoid alcohol and alcohol-containing medications as consumption of alcohol may result in the rapid release and absorption of a potentially fatal dose of morphine .

Oral route(Solution)

Morphine oral solution is available in 10 mg/5 mL, 20 mg/5 mL and 100 mg/5 mL (20 mg/mL) concentrations. The 100 mg/5 mL (20 mg/mL) concentration is indicated for use in opioid-tolerant patients only. Take care to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Keep morphine oral solution out of the reach of children .

Oral route(Tablet, Extended Release)

MS Contin(R): 100 mg and 200 mg tablets are for use in opioid-tolerant patients only. MS Contin(R) tablets are a controlled-release formulation, should be swallowed whole and are not to be broken, chewed, dissolved, or crushed due to the risk of rapid release and absorption of a potentially fatal dose of morphine . Oramorph(R) SR: This is a sustained-release dosage form. Swallow the tablet whole; the tablet should not be broken in half, nor should it be crushed or chewed .

Commonly used brand name(s)

In the U.S.

• Avinza


• Kadian


• Kadian ER


• MS Contin


• MSIR


• Oramorph SR


• Roxanol


• Roxanol-T

Available Dosage Forms:

• Capsule, Extended Release


• Capsule, Extended Release, 24 HR


• Tablet, Extended Release


• Capsule


• Tablet


• Powder for Suspension, Extended Release


• Solution


• Capsule, Delayed Release


• Syrup

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Kadian

Morphine is used to relieve moderate to severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Morphine acts on the central nervous system (CNS) to relieve pain.

When morphine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Before Using Kadian

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 morphine 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 morphine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving morphine.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Brofaromine


• Clorgyline


• Furazolidone


• Iproniazid


• Isocarboxazid


• Lazabemide


• Linezolid


• Moclobemide


• Naltrexone


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Toloxatone


• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adinazolam


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Aprobarbital


• Bromazepam


• Brotizolam


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorpromazine


• Chlorzoxazone


• Cimetidine


• Clobazam


• Clonazepam


• Clorazepate


• Codeine


• Dantrolene


• Dezocine


• Diazepam


• Estazolam


• Ethchlorvynol


• Fentanyl


• Flunitrazepam


• Fluphenazine


• Flurazepam


• Halazepam


• Hydrocodone


• Hydromorphone


• Ketazolam


• Levorphanol


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Midazolam


• Morphine


• Morphine Sulfate Liposome


• Nalbuphine


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Pentazocine


• Pentobarbital


• Perphenazine


• Phenobarbital


• Prazepam


• Prochlorperazine


• Promazine


• Promethazine


• Propoxyphene


• Quazepam


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Temazepam


• Thiethylperazine


• Thiopental


• Thioridazine


• Triazolam


• Trifluoperazine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine


• Esmolol


• Gabapentin


• Rifampin


• Somatostatin


• Yohimbine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal gland problem) or


• Alcohol abuse, or history of or


• Chronic obstructive pulmonary disease (COPD) or


• Cor pulmonale (serious heart condition) or


• Drug dependence, especially with narcotics, or history of or


• Enlarged prostate (BPH, prostatic hypertrophy) or


• Gallbladder disease or gallstones or


• Head injuries, history of or


• Heart disease or


• Hypothyroidism (an underactive thyroid) or


• Hypovolemia (low blood volume) or


• Kyphoscoliosis (curvature of the spine with breathing problems) or


• Pancreatitis (inflammation of the pancreas) or


• Problems with passing urine or


• Swallowing problems—Use with caution. May increase risk for more serious side effects.

• Asthma, severe or


• Breathing problems, severe (e.g., hypoxia) or


• Paralytic ileus (intestine stops working and may be blocked) or


• Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.

• Hypotension (low blood pressure) or


• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of morphine

This section provides information on the proper use of a number of products that contain morphine. It may not be specific to Kadian. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

You may take this medicine with or without food.

Morphine extended-release capsules and tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.

Swallow the extended-release capsules and tablets whole. Do not break, crush, dissolve, or chew them. Do not use extended-release tablets that are broken.

If you cannot swallow the extended-release capsule, you may open it and pour the medicine into a small amount of applesauce. Stir this mixture well and swallow it right away without chewing.

While taking the extended-release tablet, part of the tablet may pass into your stool. This is normal and nothing to worry about.

Morphine extended-release capsules or tablets work differently from the regular morphine oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of this medicine 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 this medicine. 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 oral dosage form (extended-release capsules):
  
  • For moderate to severe pain:
    
    • Patients switching from regular morphine forms:
      
      • Adults—The capsule is given once a day. The initial dose in milligrams (mg) per day is the same as the total amount of regular morphine that is taken per day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1600 mg per day.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
    • Patients who are not taking narcotic medicines:
      
      • Adults—At first, 30 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1600 mg per day.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
  
  


• For oral dosage form (extended-release tablets):
  
  • For moderate to severe pain:
    
    • Patients switching from regular morphine forms:
      
      • Adults—The tablet is given every 8 hours or every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular morphine that is taken per day. The total amount per day will be divided and given as 2 or 3 doses during the day. Your doctor may adjust your dose if needed.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
  
  


• For oral dosage form (solution):
  
  • For moderate to severe pain:
    
    • Adults—10 to 20 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (tablets):
  
  • For moderate to severe pain:
    
    • Adults—15 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Morphine can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Flush the unused capsules, liquid, and tablets down the toilet.

Precautions While Using Kadian

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, confused, or disoriented. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Kadian 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

• Abdominal or stomach pain


• blurred vision


• bulging soft spot on the head of an infant


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• change in the ability to see colors, especially blue or yellow


• chest pain or discomfort


• chills


• confusion


• cough


• decreased urination


• difficulty with breathing


• difficulty with swallowing


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fainting


• fast, pounding, or irregular heartbeat or pulse


• headache


• hives


• increased sweating


• insomnia


• itching


• loss of appetite


• nausea


• nervousness


• noisy breathing


• pounding in the ears


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• severe constipation


• severe vomiting


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• skin rash


• slow or irregular heartbeat


• sweating


• swelling


• tightness in the chest


• trembling or shaking of the hands or feet


• trouble with breathing


• trouble with urinating


• unusual tiredness or weakness


• vomiting


• wheezing

Incidence not known

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• bluish lips or skin


• change in consciousness


• chest pain or discomfort


• cold, clammy skin


• convulsions


• decrease in the amount of urine


• decrease in the frequency of urination


• difficulty in passing urine (dribbling)


• extremely shallow or slow breathing


• fast, weak pulse


• feeling of warmth or heat


• flushing or redness of the skin, especially on the face and neck


• irregular, fast or slow, or shallow breathing


• lightheadedness


• loss of consciousness


• low blood pressure or pulse


• nervousness


• painful urination


• pale or blue lips, fingernails, or skin


• pale skin


• pinpoint red spots on the skin


• pounding in the ears


• shakiness and unsteady walk


• troubled breathing with exertion


• unconsciousness


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual bleeding or bruising


• very slow breathing


• very slow heartbeat

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Bloody urine


• constricted, pinpoint, or small pupils (black part of the eye)


• dark-colored urine


• decreased awareness or responsiveness


• extreme drowsiness


• fever


• increased blood pressure


• increased thirst


• lower back or side pain


• muscle cramps or spasms


• muscle pain or stiffness


• no muscle tone or movement


• severe sleepiness


• swelling of the face, fingers, or lower legs


• weight gain

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

• Cramps


• diarrhea


• difficulty having a bowel movement (stool)


• drowsiness


• false or unusual sense of well-being


• relaxed and calm feeling


• sleepiness or unusual drowsiness


• weight loss

Less common

• Absent, missed, or irregular menstrual periods


• acid or sour stomach


• agitation


• bad, unusual, or unpleasant (after) taste


• belching


• blurred or loss of vision


• change in taste


• decreased interest in sexual intercourse


• depression


• disturbed color perception


• double vision


• dry mouth


• face is warm or hot to touch


• fear


• floating feeling


• halos around lights


• heartburn


• inability to have or keep an erection


• indigestion


• loss in sexual ability, desire, drive, or performance


• muscle stiffness or tightness


• nervousness


• night blindness


• overbright appearance of lights


• problems with muscle control


• redness of the skin


• seeing double


• skin rash


• sleeplessness


• stomach discomfort, upset, or pain


• stopping of menstrual bleeding


• trouble sleeping


• tunnel vision


• unable to sleep


• uncontrolled eye movements


• upper abdominal or stomach pain


• weakness

Incidence not known

• Abnormal dreams


• belching


• burning while urinating


• change in vision


• change in walking and balance


• change or problem with discharge of semen


• clumsiness or unsteadiness


• confusion as to time, place, or person


• delusions


• dementia


• dry skin


• eye pain


• feeling of constant movement of self or surroundings


• general feeling of discomfort or illness


• hiccup


• holding false beliefs that cannot be changed by fact


• impaired vision


• indigestion


• loss of memory


• problems with memory


• seeing, hearing, or feeling things that are not there


• sensation of spinning


• thirst


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness


• unusual excitement, nervousness, or restlessness

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: Kadian 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.

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More Kadian resources

• Kadian Side Effects (in more detail)
• Kadian Use in Pregnancy & Breastfeeding
• Drug Images
• Kadian Drug Interactions
• Kadian Support Group
• 30 Reviews for Kadian - Add your own review/rating

• Kadian Prescribing Information (FDA)


• Kadian Consumer Overview


• Kadian Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Morphine Concentrate MedFacts Consumer Leaflet (Wolters Kluwer)


• Astramorph PF Prescribing Information (FDA)


• Astramorph PF Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Avinza Prescribing Information (FDA)


• Avinza Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Avinza Consumer Overview


• Infumorph Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• MS Contin Consumer Overview


• MS Contin Prescribing Information (FDA)


• MS Contin Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Morphine Sulfate Monograph (AHFS DI)


• Oramorph SR Prescribing Information (FDA)


• RMS Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Kadian with other medications

• Pain

Miostat

Generic Name: carbachol ophthalmic (KAR ba kall)

Brand Names: Carbachol Ophthalmic, Carboptic, Isopto Carbachol, Miostat

What is Miostat (carbachol ophthalmic)?

Carbachol ophthalmic reduces the pressure in the eye by increasing the amount of fluid that drains from the eye. Carbachol ophthalmic also causes the pupil to become smaller and reduces its response to light or dark conditions.

Carbachol ophthalmic is used to treat glaucoma by lowering the pressure inside the eye.

Carbachol ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Miostat (carbachol ophthalmic)?

Contact your doctor immediately if you notice any decrease in vision or an increase in "floaters" in your visual field. Rarely, carbachol ophthalmic may cause retinal detachment. Retinal detachment can lead to blind spots, floaters in your visual field, and even blindness. Your doctor will want to check your retina before you use this medicine to determine if you have an increased risk of retinal detachment. Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

Apply light pressure to the inside corner of the eye (near the nose) after each drop to prevent the fluid from draining down the tear duct.

Use caution when driving, operating machinery, or performing other hazardous activities. Carbachol ophthalmic may cause decreased vision at night. If you experience decreased vision, avoid these activities.

What should I discuss with my healthcare provider before using Miostat (carbachol ophthalmic)?

Rarely, carbachol ophthalmic may cause retinal detachment. Tell your doctor if you have any type of retinal disease, if you have had a retinal tear, if you are nearsighted, or if you have had cataract surgery. These conditions may increase the risk of retinal detachment.

Before using this medication, tell your doctor if you have

• 
  

  heart failure,

  
  


• 
  

  high or low blood pressure,

  
  


• 
  

  ever had a heart attack,

  
  


• 
  

  asthma,

  
  


• 
  

  a stomach ulcer or stomach spasms,

  
  


• 
  

  epilepsy,

  
  


• 
  

  hyperthyroidism (an overactive thyroid),

  
  


• 
  

  blockage of your urinary tract or difficulty urinating, or

  
  


• 
  

  Parkinson's disease.

  
  

You may not be able to use carbachol ophthalmic, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Carbachol ophthalmic is in the FDA pregnancy category C. This means that it is not known whether carbachol ophthalmic will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether carbachol passes into breast milk. Do not use carbachol ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use Miostat (carbachol ophthalmic)?

Use carbachol ophthalmic eye drops exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, pharmacist, or nurse to explain them to you.

Wash your hands before using the eye drops.

If you wear contact lenses, remove them before applying carbachol ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Carbachol ophthalmic may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

To apply the eye drops:

• 
  

  Tilt the head back slightly and pull down on the lower eyelid. Position the dropper above the eye. Look up and away from the dropper. Squeeze out a drop and close the eye. Apply gentle pressure to the inside corner of the eye (near the nose) for about 1 minute to prevent the liquid from draining down the tear duct. If you are using more than 1 drop in the same eye, repeat the process with about 5 minutes between drops. Repeat the process in the other eye if needed.

  
  

Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye. Do not use any eye drop that is discolored or has particles in it. Store carbachol ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected or if the drops have been ingested.

Symptoms of a carbachol ophthalmic overdose may include sweating, nausea, vomiting, diarrhea, watering mouth, and tearing eyes.

What should I avoid while using Miostat (carbachol ophthalmic)?

Use caution when driving, operating machinery, or performing other hazardous activities. Carbachol ophthalmic may cause decreased vision at night. If you experience decreased vision, avoid these activities. Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

If you wear contact lenses, remove them before applying carbachol ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Carbachol ophthalmic may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

Do not use other eye medications during treatment with carbachol ophthalmic except under the direction of your doctor.

Miostat (carbachol ophthalmic) side effects

Contact your doctor immediately if you notice any decrease in vision or an increase in "floaters" in your visual field. Rarely, carbachol ophthalmic may cause retinal detachment. Retinal detachment can lead to blind spots, floaters in your visual field, and even blindness. Your doctor will want to check your retina before you use this medicine to determine if you have an increased risk of retinal detachment.

Other, less serious side effects may be more likely to occur. Continue to use carbachol ophthalmic and talk to your doctor if you experience

• 
  

  burning, stinging, or tearing eyes;

  
  


• 
  

  decreased vision in poor light;

  
  


• 
  

  headache;

  
  


• 
  

  watering mouth;

  
  


• 
  

  sweating;

  
  


• 
  

  increased urination;

  
  


• 
  

  nausea, vomiting, or diarrhea; or

  
  


• 
  

  dizziness.

  
  

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. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Miostat (carbachol ophthalmic)?

Before using this medication, tell your doctor if you are using another eye medication, especially if it is a nonsteroidal anti-inflammatory drug (NSAID) such as flurbiprofen (Ocufen), suprofen (Profenal), diclofenac (Voltaren), or ketorolac (Acular).

Do not use other eye medications during treatment with carbachol ophthalmic except under the direction of your doctor.

Drugs other than those listed here may also interact with carbachol ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Miostat resources

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

• Miostat Prescribing Information (FDA)


• Miostat Ocular MedFacts Consumer Leaflet (Wolters Kluwer)


• Carbastat Prescribing Information (FDA)


• Carboptic Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Isopto Carbachol Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Miostat with other medications

• Glaucoma
• Intraocular Hypertension
• Production of Miosis

Where can I get more information?

• Your pharmacist has additional information about carbachol ophthalmic written for health professionals that you may read.

See also: Miostat side effects (in more detail)

Prednisolone/Sulfacetamide Drops

Pronunciation: pred-NISS-oh-lone/sul-fa-SEE-ta-mide
Generic Name: Prednisolone/Sulfacetamide
Brand Name: Generic only. No brands available.

Prednisolone/Sulfacetamide Drops are used for:

Treating inflammation (swelling, warmth, redness, pain) of the eyes and eyelids when infection or risk of infection is present.

Prednisolone/Sulfacetamide Drops are an antibacterial and corticosteroid combination. It works by reducing the itching, redness, and swelling of the eye. It also works to stop the growth of certain bacteria that cause eye infections.

Do NOT use Prednisolone/Sulfacetamide Drops if:

• you are allergic to any ingredient in Prednisolone/Sulfacetamide Drops, to other corticosteroids (eg, dexamethasone), or to other sulfonamides (eg, acetazolamide, celecoxib, hydrochlorothiazide, glyburide, probenecid, sulfamethoxazole, valdecoxib, zonisamide)


• you have a viral eye infection (eg, herpes simplex, vaccinia, chickenpox), tuberculosis eye infection, or fungal infection of the eye or eye structures


• you have thinning of the cornea of the eye

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prednisolone/Sulfacetamide Drops:

Some medical conditions may interact with Prednisolone/Sulfacetamide Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have thinning of the eye tissues (eg, cornea, sclera), other eye problems (eg, glaucoma, cataracts, nerve damage), severe dry eyes, or diabetes


• if you have recently had cataract surgery

Some MEDICINES MAY INTERACT with Prednisolone/Sulfacetamide Drops. Tell your health care provider if you are taking any other medicine, especially any of the following:

• Silver-containing medicines (eg, silver nitrate) because the risk of side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prednisolone/Sulfacetamide Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prednisolone/Sulfacetamide Drops:

Use Prednisolone/Sulfacetamide Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• To use Prednisolone/Sulfacetamide Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• To clear up your infection completely, use Prednisolone/Sulfacetamide Drops for the full course of treatment. Keep using it even if you feel better in a few days.


• Do not use Prednisolone/Sulfacetamide Drops if it is dark brown or has darkened since you began using it. Contact your doctor or pharmacist if you have questions about whether you should use Prednisolone/Sulfacetamide Drops.


• Do not wear contact lenses while you are using Prednisolone/Sulfacetamide Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.


• If you miss a dose of Prednisolone/Sulfacetamide Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Prednisolone/Sulfacetamide Drops.

Important safety information:

• Prednisolone/Sulfacetamide Drops may cause blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Prednisolone/Sulfacetamide Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• If your symptoms do not get better within 2 days or if they get worse, check with your doctor.


• Be sure to use Prednisolone/Sulfacetamide Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Prednisolone/Sulfacetamide Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Tell your doctor or dentist that you take Prednisolone/Sulfacetamide Drops before you receive any medical or dental care, emergency care, or surgery.


• Do not use Prednisolone/Sulfacetamide Drops for future eye problems unless directed by your doctor.


• Lab tests, including eye pressure, may be performed while you use Prednisolone/Sulfacetamide Drops. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Prednisolone/Sulfacetamide Drops should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prednisolone/Sulfacetamide Drops while you are pregnant. It is not known if Prednisolone/Sulfacetamide Drops are found in breast milk. Do not breast-feed while using Prednisolone/Sulfacetamide Drops.

Possible side effects of Prednisolone/Sulfacetamide Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Temporary burning or stinging.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; eye pain, itching, redness, swelling, irritation, or sores not present when you began using Prednisolone/Sulfacetamide Drops; fever, chills, or sore throat; red, swollen, or blistered skin; severe or persistent blurred vision; unusual tiredness or weakness; yellowing of the eyes or skin

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Prednisolone/Sulfacetamide side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Prednisolone/Sulfacetamide Drops:

Store Prednisolone/Sulfacetamide Drops at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Do not freeze. Store away from heat and light. Keep Prednisolone/Sulfacetamide Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Prednisolone/Sulfacetamide Drops, please talk with your doctor, pharmacist, or other health care provider.


• Prednisolone/Sulfacetamide Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prednisolone/Sulfacetamide Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Prednisolone/Sulfacetamide resources

• Prednisolone/Sulfacetamide Side Effects (in more detail)
• Prednisolone/Sulfacetamide Use in Pregnancy & Breastfeeding
• Prednisolone/Sulfacetamide Drug Interactions
• Prednisolone/Sulfacetamide Support Group
• 1 Review for Prednisolone/Sulfacetamide - Add your own review/rating

Compare Prednisolone/Sulfacetamide with other medications

• Blepharitis
• Conjunctivitis, Bacterial
• Keratitis
• Keratoconjunctivitis
• Uveitis

Miglitol

Pronunciation: MIG-li-tol
Generic Name: Miglitol
Brand Name: Glyset

Miglitol is used for:

Treating type 2 diabetes in adults whose diabetes cannot be managed with diet alone. Miglitol may be used alone, in combination with other oral diabetes medicines, or with insulin.

Acarbose is a glucosidase inhibitor. It works by slowing down the enzyme that turns carbohydrates into glucose. This decreases blood sugar levels following a meal.

Do NOT use Miglitol if:

• you are allergic to any ingredient in Miglitol


• you have blockage of the stomach or intestine or are at risk for these problems


• you have long-term (chronic) bowel inflammation, colon ulcers, or stomach or intestine problems that interfere with digestion or nutrient absorption


• you have diabetic ketoacidosis (high ketone levels) or moderate to severe kidney problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Miglitol:

Some medical conditions may interact with Miglitol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have stomach or intestinal problems, liver problems, or kidney problems

Some MEDICINES MAY INTERACT with Miglitol. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Insulin or sulfonylureas (eg, glyburide) because side effects may be increased by Miglitol


• Digoxin, propranolol, or ranitidine because their effectiveness may be decreased by Miglitol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Miglitol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Miglitol:

Use Miglitol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Miglitol with the first bite of each main meal, unless directed otherwise by your doctor.


• If you are also taking charcoal or digestive enzyme preparations with Miglitol, space them at least 2 to 4 hours apart for maximum effectiveness.


• Carefully follow the diet and exercise program given to you by your health care provider.


• Temporary insulin therapy may be necessary during stressful periods (such as fever, trauma, infection, or surgery).


• If you miss a dose of Miglitol, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Miglitol.

Important safety information:

• Notify your dentist or doctor that you are taking Miglitol before you have any dental work or surgery.


• Carefully follow the regular testing of urine or blood glucose schedules given to you by your health care provider.


• Miglitol, used with other diabetes medicines, may cause a loss of blood sugar control. Your health care provider may need to change the amount of medicine that you are taking. Because Miglitol prevents the breakdown of table (cane) sugar, be sure to use glucose (dextrose), not sugar or fruits, to treat symptoms of low blood sugar (tiredness, excessive hunger and sweating, numbness in arms or legs). Contact your health care provider if these symptoms occur.


• LAB TESTS, including blood glucose and glycosylated hemoglobin levels, may be performed to monitor your progress and to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Miglitol with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Miglitol, discuss with your doctor the benefits and risks of using Miglitol during pregnancy. Miglitol is excreted in breast milk. Do not breast feed while taking Miglitol.

Possible side effects of Miglitol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloating; diarrhea; gas; soft stools; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe stomach pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Miglitol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe or persistent diarrhea, gas, or stomach pain or discomfort.

Proper storage of Miglitol:

Store Miglitol at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Miglitol out of the reach of children and away from pets.

General information:

• If you have any questions about Miglitol, please talk with your doctor, pharmacist, or other health care provider.


• Miglitol is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is summary only. It does not contain all information about Miglitol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Miglitol resources

• Miglitol Side Effects (in more detail)
• Miglitol Use in Pregnancy & Breastfeeding
• Miglitol Drug Interactions
• Miglitol Support Group
• 1 Review for Miglitol - Add your own review/rating

• Miglitol Monograph (AHFS DI)


• Miglitol Professional Patient Advice (Wolters Kluwer)


• miglitol Concise Consumer Information (Cerner Multum)


• miglitol Advanced Consumer (Micromedex) - Includes Dosage Information


• Glyset Prescribing Information (FDA)

Compare Miglitol with other medications

• Diabetes, Type 2

Histoplasmosis, Immunocompenent Host Medications

Drugs associated with Histoplasmosis, Immunocompenent Host

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

Drug List:

Amphocin

Fungizone

Fungizone-For-Tissue-Culture

Calprofen 100mg / 5ml Oral Suspension Ibuprofen

1. Name Of The Medicinal Product

Calprofen 100mg/5ml Oral Suspension Ibuprofen

2. Qualitative And Quantitative Composition

Ibuprofen 100 mg/5 ml

For excipients – see section 6.1

3. Pharmaceutical Form

Oral Suspension

Sugar Free, Colour Free and Strawberry Flavour

4. Clinical Particulars

4.1 Therapeutic Indications

Children aged 3 months to 12 years:

Mild to moderate pain, post-immunisation pyrexia, rheumatic or muscular pain, headache, reduction of fever, sore throat, teething pain, toothache, minor aches and pains, symptoms of cold and influenza.

4.2 Posology And Method Of Administration

To be taken orally. For short term use only.

Children aged 3 months to 12 years:

Not recommended for children weighing less than 5 kg.

For pain and fever – 20mg/kg/day in divided doses.

Infants 3-6 months: 2.5 ml three times a day. Do not use for more than 24 hours.

Infants 6-12 months: 2.5 ml three times a day.

Children 1-2 years: 2.5 ml three to four times a day

Children 3-7 years: 5 ml three to four times a day

Children 8-12 years: 10 ml three to four times a day

Doses should be taken every 6 – 8 hours when required, and at least 4 hours should be left between doses.

Post-immunisation fever:

2.5 ml (50 mg) followed by one further dose of 2.5 ml (50mg) six hours later if necessary. No more than 2 doses in 24 hours. If fever is not reduced, consult a doctor.

Do not give to children under 3 months of age.

For children aged 3-6 months: If the child's symptoms persist for more than 24 hours, consult a doctor.

For children over 6 months: If the child's symptoms persist for more than 3 days, consult a doctor.

4.3 Contraindications

Hypersensitivity to Ibuprofen or any of the excipients in the product.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.

Active or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Severe heart failure, renal failure or hepatic failure (see section 4.4).

Last trimester of pregnancy (See section 4.6)

4.4 Special Warnings And Precautions For Use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below).

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation, which may be fatal.

Respiratory:

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.

Other NSAIDs:

The use of ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).

SLE and mixed connective tissue disease:

Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see Section 4.8).

Renal:

Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8).

Hepatic:

Hepatic dysfunction (see sections 4.3 and 4.8)

Cardiovascular and cerebrovascular effects:

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical trial and epidermiological data suggest that use of ibuprofen, particularly at high doses (2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g.

Impaired female fertility:

There is limited evidence that drugs which inhibit cyclooxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. The use of Ibuprofen is therefore not recommended in women attempting to conceive.

Gastrointestinal:

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3) and in the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

Where GI bleeding or ulceration occurs in patients receiving Ibuprofen, the treatment should be withdrawn.

Dermatological:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson Syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

The Label will include:

Read the enclosed leaflet before taking this product.

Do not give this product if your baby or child

• Has (or has had two or more episodes of) a stomach ulcer, perforation or bleeding

• Is allergic to Ibuprofen or any other ingredient of the product, aspirin or other related painkillers

• Is taking other NSAID painkillers, or aspirin with a daily dose above 75mg

Speak to a pharmacist or your doctor before giving this product if your baby or child

• Has or has had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems

If you are an adult taking this product you should not take this product in the last 3 months of pregnancy and you should contact your doctor or pharmacist before taking it in the first 6 months of pregnancy, if trying to get pregnant, if you are elderly or if you are a smoker.

Do not give to babies aged 3-6 months for more than 24 hours.

Do not give to children aged 6 months and older for more than 3 days.

If symptoms persist or worsen, consult your doctor promptly.

Do not exceed the stated dose.

Not recommended for children under 3 months.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Ibuprofen should be avoided in combination with:

Aspirin: Unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (See section 4.4).

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.4).

Ibuprofen should be used with caution in combination with:

Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4)

Anti-hypertensives and diuretics: NSAIDs may diminish the effect of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4)

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Lithium: There is evidence for potential increases in plasma levels of lithium.

Methotrexate: There is potential for an increase in plasma methotrexate.

Ciclosporin: Increased risk of nephrotoxicity.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and Ibuprofen.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

4.6 Pregnancy And Lactation

While no teratogenic effects have been demonstrated in animal experiments, the use of Ibuprofen should, if possible, be avoided during the first 6 months of pregnancy.

During the 3^rd trimester, Ibuprofen is contraindicated as there is a risk of premature closure of foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. (See section 4.3 Contraindications).

In limited studies, Ibuprofen appears in breast milk in very low concentration and is unlikely to affect breast-fed infants adversely.

See section 4.4 regarding female fertility.

4.7 Effects On Ability To Drive And Use Machines

It is not expected that Calprofen 100 mg/5 ml Oral Suspension would interfere with the ability to drive or operate machinery at the recommended dose and duration of therapy.

4.8 Undesirable Effects

Hypersensitivity reactions have been reported and these may consist of:

a) non-specific allergic reactions and anaphylaxis,

b) respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm or dyspnoea,

c) various skin reactions, e.g. pruritis, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

The following list of adverse effects relates to those experienced with Ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Hypersensitivity reactions:

Uncommon: Hypersensitivity reactions with urticaria and pruritus.

Very rare: Severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema, or severe shock).

Exacerbation of asthma and bronchospasm.

Gastrointestinal:

The most commonly-observed adverse events are gastro-intestinal in nature.

Uncommon: abdominal pain, nausea and dyspepsia.

Rare: diarrhoea, flatulence, constipation and vomiting.

Very rare: peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis.

Exacerbation of colitis and Crohn's disease (see section 4.4).

Nervous System:

Uncommon: headache

Very rare: Aseptic meningitis – single cases have been reported very rarely.

Renal:

Very rare: acute renal failure, papillary necrosis especially in long term use, associated with increased serum urea and oedema.

Hepatic:

Very rare: liver disorders.

Haematological:

Very rare: haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.

Dermatological:

Uncommon: various skin rashes

Very rare: severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis can occur.

Immune System:

In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with Ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see section 4.4).

Cardiovascular and Cerebrovascular:

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

4.9 Overdose

In children, ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effect is less clear-cut. The half-life in overdose is 1.5 –3 hours.

Symptoms

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans Ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, Ibuprofen reversibly inhibits platelet aggregation.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400 mg was taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81 mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

5.2 Pharmacokinetic Properties

Ibuprofen is rapidly absorbed from the gastro-intestinal tract and rapidly distributed throughout the whole body. Peak plasma concentrations occur about 1 to 2 hours after ingestion with food or in 45 minutes if taken on an empty stomach. These times may vary with different dosage forms.

The excretion is rapid and complete via the kidneys.

The elimination half-life is about 2 hours.

It is metabolized to two inactive metabolites and these are rapidly excreted in urine. About 1 percent is excreted in urine as unchanged Ibuprofen and about 14 percent as conjugated Ibuprofen.

Ibuprofen is extensively bound to plasma proteins.

In limited studies, Ibuprofen appears in breast milk in very low concentrations.

5.3 Preclinical Safety Data

No relevant information additional to that contained elsewhere in the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerol (E422), xanthan gum, maltitol syrup (Lycasin 80/55 (E965)), polysorbate 80, saccharin sodium (E954), citric acid monohydrate, sodium methylhydroxybenzoate, sodium propylhydroxybenzoate, purified water and strawberry flavour.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25ºC.

Keep out of reach and sight of children.

6.5 Nature And Contents Of Container

Amber glass bottle sealed with a child resistant, tamper evident cap.

Pack sizes: 50ml and 100ml

6.6 Special Precautions For Disposal And Other Handling

Shake well before use. Return any left over medicine to the Pharmacist.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0147

9. Date Of First Authorisation/Renewal Of The Authorisation

21^st July 2006

10. Date Of Revision Of The Text

11^th August 2010

Iodo

Iodo may be available in the countries listed below.

Ingredient matches for Iodo

Povidone Iodine

Povidone-Iodine is reported as an ingredient of Iodo in the following countries:

• Argentina

International Drug Name Search

Pamine

Pronunciation: meth-skoe-POL-uh-meen
Generic Name: Methscopolamine
Brand Name: Pamine and Pamine Forte

Pamine is used for:

Treating peptic ulcers in combination with other medicines. It also may be used for other conditions as determined by your doctor.

Pamine is an anticholinergic. It works by decreasing stomach acid production and by relaxing the muscles in the stomach and intestines.

Do NOT use Pamine if:

• you are allergic to any ingredient in Pamine


• you have glaucoma, blockage of the bladder, certain problems with your esophagus (eg, decreased esophageal motility, severe irritation caused by reflux), certain stomach or intestinal problems (eg, blockage, lack of muscle tone, or ulcerative colitis), heart problems caused by blood loss, or muscle problems (eg, myasthenia gravis)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pamine:

Some medical conditions may interact with Pamine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have nerve problems, severe bowel problems, prostate problems, heart problems, heart failure, a hernia, a predisposition of glaucoma or open-angle glaucoma, or urinary retention

Some MEDICINES MAY INTERACT with Pamine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticholinergic medicines (eg, benztropine, hyoscyamine, or trihexyphenidyl), certain medicines for mental or mood disorders (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Pamine's side effects


• Beta-blockers (eg, propanolol) or digoxin because the risk of their side effects may be increased by Pamine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pamine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pamine:

Use Pamine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pamine by mouth 30 minutes before meals and at bedtime, or as directed by your health care provider.


• Do not take an antacid within 1 hour before or 2 hours after you take Pamine.


• If you miss a dose of Pamine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pamine.

Important safety information:

• Pamine may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pamine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Pamine may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Pamine may make your eyes more sensitive to sunlight. It may help to wear sunglasses.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pamine without checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Antacids may decrease the effectiveness of Pamine. Talk to your doctor before taking any antacids while taking Pamine.


• Use Pamine with caution in the ELDERLY; they may be more sensitive to its effects, especially if they have weak intestines or constipation.


• Pamine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pamine while you are pregnant. It is not known if Pamine is found in breast milk. Do not breast-feed while taking Pamine.

Possible side effects of Pamine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; blurred vision; constipation; decreased sweating; difficulty sleeping; dilation of pupils; dizziness; drowsiness; dry mouth; headache; loss of taste; nausea; nervousness; urinary hesitancy or retention.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in heartbeat; diarrhea; difficulty focusing your eyes; difficulty urinating; pounding in the chest; rapid heart rate; unusual weakness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pamine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal behavior; blurred vision; circulatory problems; coma; difficulty breathing; dilated pupils; disorientation; excessive thirst; excitement; flushing; low blood pressure; muscle weakness; nausea; paralysis; restlessness; seizures; unusual dizziness or drowsiness; unusually dry mouth; vomiting.

Proper storage of Pamine:

Store Pamine between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pamine out of the reach of children and away from pets.

General information:

• If you have any questions about Pamine, please talk with your doctor, pharmacist, or other health care provider.


• Pamine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pamine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Pamine resources

• Pamine Side Effects (in more detail)
• Pamine Use in Pregnancy & Breastfeeding
• Drug Images
• Pamine Drug Interactions
• Pamine Support Group
• 2 Reviews for Pamine - Add your own review/rating

• Pamine Prescribing Information (FDA)


• Pamine Concise Consumer Information (Cerner Multum)


• Pamine Monograph (AHFS DI)


• Methscopolamine Prescribing Information (FDA)

Compare Pamine with other medications

• Irritable Bowel Syndrome
• Peptic Ulcer