Danilon may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Norfloxacin is reported as an ingredient of Danilon in the following countries:
Suxibuzone is reported as an ingredient of Danilon in the following countries:
International Drug Name Search
Ondansetron Mylan may be available in the countries listed below.
Ondansetron hydrochloride (a derivative of Ondansetron) is reported as an ingredient of Ondansetron Mylan in the following countries:
Ondansetron hydrochloride dihydrate (a derivative of Ondansetron) is reported as an ingredient of Ondansetron Mylan in the following countries:
International Drug Name Search
Venlasan may be available in the countries listed below.
Venlafaxine hydrochloride (a derivative of Venlafaxine) is reported as an ingredient of Venlasan in the following countries:
International Drug Name Search
In the US, Loxitane (loxapine systemic) is a member of the drug class miscellaneous antipsychotic agents and is used to treat Schizophrenia.
US matches:
Loxapine succinate (a derivative of Loxapine) is reported as an ingredient of Loxitane in the following countries:
International Drug Name Search
Donarthril may be available in the countries listed below.
Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Donarthril in the following countries:
International Drug Name Search
Sanasthmax may be available in the countries listed below.
Beclometasone 17α,21-dipropionate (a derivative of Beclometasone) is reported as an ingredient of Sanasthmax in the following countries:
International Drug Name Search
Gamamax may be available in the countries listed below.
Ciprofloxacin is reported as an ingredient of Gamamax in the following countries:
International Drug Name Search
Thrombin I may be available in the countries listed below.
Thrombin is reported as an ingredient of Thrombin I in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
In the US, Dantrolene (dantrolene systemic) is a member of the drug class skeletal muscle relaxants and is used to treat Malignant Hyperthermia and Spasticity.
US matches:
Rec.INN
M03CA01
0007261-97-4
C14-H10-N4-O5
314
Muscle relaxant
2,4-Imidazolidinedione, 1-[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Stiemycin may be available in the countries listed below.
UK matches:
Ciclopirox olamine (a derivative of Ciclopirox) is reported as an ingredient of Stiemycin in the following countries:
Erythromycin is reported as an ingredient of Stiemycin in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Dacam may be available in the countries listed below.
Betamethasone 21-(disodium phosphate) (a derivative of Betamethasone) is reported as an ingredient of Dacam in the following countries:
International Drug Name Search
Tamsulosine may be available in the countries listed below.
Tamsulosine (DCF) is known as Tamsulosin in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
Diltiazem Farmoz may be available in the countries listed below.
Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Diltiazem Farmoz in the following countries:
International Drug Name Search
Spiramycine Métronidazole Sandoz may be available in the countries listed below.
Metronidazole is reported as an ingredient of Spiramycine Métronidazole Sandoz in the following countries:
Spiramycin is reported as an ingredient of Spiramycine Métronidazole Sandoz in the following countries:
International Drug Name Search
Domperidona Ciclum may be available in the countries listed below.
Domperidone is reported as an ingredient of Domperidona Ciclum in the following countries:
International Drug Name Search
Sultopride Panpharma may be available in the countries listed below.
Sultopride hydrochloride (a derivative of Sultopride) is reported as an ingredient of Sultopride Panpharma in the following countries:
International Drug Name Search
SPMC Salbutamol may be available in the countries listed below.
Salbutamol is reported as an ingredient of SPMC Salbutamol in the following countries:
International Drug Name Search
Amiplin may be available in the countries listed below.
Amitriptyline hydrochloride (a derivative of Amitriptyline) is reported as an ingredient of Amiplin in the following countries:
International Drug Name Search
Natazia is a brand name of dienogest/estradiol, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Natazia available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Natazia. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Ambroxolum may be available in the countries listed below.
Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Ambroxolum in the following countries:
International Drug Name Search
DTM may be available in the countries listed below.
Diltiazem is reported as an ingredient of DTM in the following countries:
International Drug Name Search
Sucraid is a brand name of sacrosidase, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Sucraid available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Sucraid. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
There are no current U.S. patents associated with Sucraid.
Kardegic may be available in the countries listed below.
Acetylsalicylic Acid lysine (a derivative of Acetylsalicylic Acid) is reported as an ingredient of Kardegic in the following countries:
International Drug Name Search
Aclotine may be available in the countries listed below.
Antithrombin III is reported as an ingredient of Aclotine in the following countries:
International Drug Name Search
Devitol may be available in the countries listed below.
Ergocalciferol is reported as an ingredient of Devitol in the following countries:
International Drug Name Search
Generic Name: benzocaine (Oral route, Oromucosal route)
BEN-zoe-kane
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Anesthetic, Local
Chemical Class: Amino Ester
Benzocaine lozenges are used to relieve pain and irritation caused by sore throat, sore mouth, or canker sores.
This medicine is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.
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:
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.
No information is available on the relationship of age to the effects of benzocaine lozenges in the pediatric population. Safety and efficacy have not been established in children below 5 years of age.
No information is available on the relationship of age to the effects of benzocaine in geriatric patients.
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.
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.
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:
This section provides information on the proper use of a number of products that contain benzocaine. It may not be specific to Oracaine. Please read with care.
Use this medicine exactly as directed by your doctor. Do not use more of this medicine, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the risk of side effects.
This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present.
Do not use this medicine for more than 2 days without checking first with your doctor.
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.
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.
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.
If your condition does not improve within 7 days, or if it becomes worse, check with your doctor.
Call your doctor right away if you start to have a severe sore throat or sore throat that occurs with a high fever, headache, nausea, or vomiting. These maybe signs of an infection.
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:
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.
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.
Dalmasin may be available in the countries listed below.
Metamizole sodium anhydrous (a derivative of Metamizole) is reported as an ingredient of Dalmasin in the following countries:
International Drug Name Search
Somatostatina may be available in the countries listed below.
Somatostatina (DCIT) is also known as Somatostatin (Rec.INN)
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Univit-A may be available in the countries listed below.
Retinol palmitate (a derivative of Retinol) is reported as an ingredient of Univit-A in the following countries:
International Drug Name Search
Acatar may be available in the countries listed below.
Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Acatar in the following countries:
Guaifenesin is reported as an ingredient of Acatar in the following countries:
Oxymetazoline hydrochloride (a derivative of Oxymetazoline) is reported as an ingredient of Acatar in the following countries:
International Drug Name Search
Aldometil may be available in the countries listed below.
Methyldopa is reported as an ingredient of Aldometil in the following countries:
International Drug Name Search
Aerox may be available in the countries listed below.
Budesonide is reported as an ingredient of Aerox in the following countries:
Simeticone is reported as an ingredient of Aerox in the following countries:
International Drug Name Search
Canovel may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Permethrin is reported as an ingredient of Canovel in the following countries:
Piperazine phosphate (a derivative of Piperazine) is reported as an ingredient of Canovel in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Benzylpenicillin procaine (a derivative of Benzylpenicillin) is reported as an ingredient of Quartermaster in the following countries:
Dihydrostreptomycin sulfate (a derivative of Dihydrostreptomycin) is reported as an ingredient of Quartermaster in the following countries:
International Drug Name Search
Betaxolol Hydrochloride (BANM, USAN) is known as Betaxolol in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| USAN | United States Adopted Name |
In some countries, this medicine may only be approved for veterinary use.
BAN
0000051-03-6
C19-H30-O5
338
Insecticide
1,3-Benzodioxole, 5-((2-(2-butoxyethoxy)ethoxy)methyl)-6-propyl-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
Ronizol may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ronidazole is reported as an ingredient of Ronizol in the following countries:
International Drug Name Search
Antiallersin may be available in the countries listed below.
Promethazine hydrochloride (a derivative of Promethazine) is reported as an ingredient of Antiallersin in the following countries:
International Drug Name Search
Minoxidil Bailleul may be available in the countries listed below.
Minoxidil is reported as an ingredient of Minoxidil Bailleul in the following countries:
International Drug Name Search
In the US, Erythra-Derm (erythromycin topical) is a member of the following drug classes: topical acne agents, topical antibiotics and is used to treat Acne and Perioral Dermatitis.
US matches:
Erythromycin is reported as an ingredient of Erythra-Derm in the following countries:
International Drug Name Search
Theolinate may be available in the countries listed below.
Choline Theophyllinate is reported as an ingredient of Theolinate in the following countries:
International Drug Name Search
Toltracox may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Toltrazuril is reported as an ingredient of Toltracox in the following countries:
International Drug Name Search
Daman may be available in the countries listed below.
Trandolapril is reported as an ingredient of Daman in the following countries:
International Drug Name Search
In the US, Dilatrate-SR (isosorbide dinitrate systemic) is a member of the drug class antianginal agents and is used to treat Angina, Angina Pectoris Prophylaxis, Esophageal Spasm, Heart Failure and Pulmonary Arterial Hypertension.
US matches:
Isosorbide Dinitrate is reported as an ingredient of Dilatrate-SR in the following countries:
International Drug Name Search
Sertralin 1A Farma may be available in the countries listed below.
Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Sertralin 1A Farma in the following countries:
International Drug Name Search
Nicor may be available in the countries listed below.
Nicorandil is reported as an ingredient of Nicor in the following countries:
International Drug Name Search
Lactulosestroop PCH may be available in the countries listed below.
Lactulose is reported as an ingredient of Lactulosestroop PCH in the following countries:
International Drug Name Search
Dogissimo may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Dimpylate is reported as an ingredient of Dogissimo in the following countries:
International Drug Name Search
Dolocyl may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Dolocyl in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
R03DA01,R03DA01
0000479-18-5
C10-H14-N4-O4
254
Antiasthmatic agent
Cardiac stimulant, cardiotonic agent
Diuretic agent
1H-Purine-2,6-dione, 7-(2,3-dihydroxypropyl)-3,7-dihydro-1,3-dimethyl-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Foxtin-20 may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Foxtin-20 in the following countries:
International Drug Name Search
Citicoline Sodium may be available in the countries listed below.
Citicoline Sodium (USAN) is known as Citicoline in the US.
International Drug Name Search
Glossary
| USAN | United States Adopted Name |
Zactin may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Zactin in the following countries:
Ranitidine is reported as an ingredient of Zactin in the following countries:
International Drug Name Search
Ampicyn may be available in the countries listed below.
Ampicillin sodium salt (a derivative of Ampicillin) is reported as an ingredient of Ampicyn in the following countries:
International Drug Name Search
Licoklor may be available in the countries listed below.
Chloramphenicol is reported as an ingredient of Licoklor in the following countries:
International Drug Name Search
Doxyson may be available in the countries listed below.
Doxycycline is reported as an ingredient of Doxyson in the following countries:
International Drug Name Search
Trimébutine RPG may be available in the countries listed below.
Trimebutine maleate (a derivative of Trimebutine) is reported as an ingredient of Trimébutine RPG in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
0112398-08-0
C19-H20-F-N3-O3
357
Antibacterial: Gyrase inhibitor
3-Quinolinecarboxylic acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-7-(5-methyl-2,5-diazabicyclo[2.2.1]hept-2-yl)-4-oxo-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Omeprazol Decrox may be available in the countries listed below.
Omeprazole is reported as an ingredient of Omeprazol Decrox in the following countries:
International Drug Name Search
Decosan may be available in the countries listed below.
Dequalinium Chloride is reported as an ingredient of Decosan in the following countries:
International Drug Name Search
Dropflam may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Dropflam in the following countries:
International Drug Name Search
Difonate may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Difonate in the following countries:
International Drug Name Search
Depoluteine may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Hydroxyprogesterone caproate (a derivative of Hydroxyprogesterone) is reported as an ingredient of Depoluteine in the following countries:
International Drug Name Search
Acido Mefenamico may be available in the countries listed below.
Acido Mefenamico (DCIT) is known as Mefenamic Acid in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Sompraz may be available in the countries listed below.
Esomeprazole magnesium, trihydrate (a derivative of Esomeprazole) is reported as an ingredient of Sompraz in the following countries:
International Drug Name Search
Clarithromycine Almus may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Clarithromycine Almus in the following countries:
International Drug Name Search
Dexamethasone tablets USP, 1.5mg for oral administration. Inactive ingredients are microcrystalline cellulose NF, anhydrous lactose NF, FD&C Red #40 aluminum lake, croscarmellose sodium NF, and magnesium stearate NF. The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The empirical formula is C22H29F05 and the structural formula is:
Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water.
Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Glucocorticoids cause varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have sodium-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs including dexamethasone are primarily used for their anti-inflammatory effects in disorders of many organ systems. At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness.
Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome)
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis.
To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.
Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia.
Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
For the palliative management of leukemias and lymphomas.
Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury.
Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Systemic fungal infections (see WARNINGS, Fungal infections).
Dexamethasone tablets are contraindicated in patients who are hypersensitive to any components of this product.
Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation.
Average and large doses of corticosteroids can cause elevation of blood pressure, sodium and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.
Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.
Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents. These infections may be mild to severe. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Corticosteroids may also mask some signs of current infection.
Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS, Drug Interactions, Amphotericin B injection and potassium-depleting agents).
Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma.
It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria.
The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted. Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison’s disease.
Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with immune globulin (lG) may be indicated. (See the respective package inserts for VZIG and IG for complete prescribing information.) If chickenpox develops, treatment with antiviral agents should be considered
Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex.
The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with corticosteroids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.
As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.
Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.
Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy.
Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION.)
An acute myopathy has been observed with the use of high doses of corticosteroids most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.
Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.
Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.
Aminoglutethimide may diminish adrenal suppression by corticosteroids.
When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see Drug Interactions, Hepatic Enzyme lnducers, Inhibitors and Substrates).
Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
Serum concentrations of isoniazid may be decreased.
Cholestyramine may increase the clearance of corticosteroids
Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
False-negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients.
Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
Ephedrine may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring an increase in corticosteroid dosage.
Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, macrolide antibiotics such as erythromycin) have the potential to result in increased plasma concentrations of corticosteroids. Dexamethasone is a moderate inducer of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin) may increase their clearance, resulting in decreased plasma concentration.
Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.
Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.
In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control.
Corticosteroids may suppress reactions to skin tests.
Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.
Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS, Infections, Vaccination).
No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients.
Pregnancy Category C. Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.
The following adverse reactions have been reported with dexamethasone or other corticosteroids:
Anaphylactoid reaction, anaphylaxis, angioedema.
Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS, Cardio-renal), edema, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.
Acne, allergic dermatitis, dry scaly skin, ecchymoses and petechiae, erythema, impaired wound healing, increased sweating, rash, striae, suppression of reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.
Decreased carbohydrate and glucose tolerance, development of cushingoid state, hyperglycemia, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.
Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.
Abdominal distention, elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.
Negative nitrogen balance due to protein catabolism.
Aseptic necrosis of femoral and humeral heads, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures.
Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.
Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts. Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.
Treatment of overdosage is by supportive and symptomatic therapy. In the case of acute overdosage, according to the patient’s condition, supportive therapy may include gastric lavage or emesis.
For oral administration: The initial dosage of dexamethasone varies from 0.75 to 9 mg a day depending on the disease being treated.
It Should Be Emphasized That Dosage Requirements Are Variable And Must Be Individualized On The Basis Of The Disease Under Treatment And The Response Of The Patient.
After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that maintains an adequate clinical response is reached.
Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of dexamethasone for a week followed by 4 to 12 mg every other day for one month have been shown to be effective (see PRECAUTIONS, Neuropsychiatric).
In pediatric patients, the initial dose of dexamethasone may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m2bsa/day).
| Dexamethasone, 1.5 | Methylprednisolone, 8 |
| Prednisone, 10 | Triamcinolone, 8 |
| Prednisolone, 10 | Betamethasone, 1.5 |
| Hydrocortisone, 40 | Paramethasone, 4 |
| Cortisone, 50 |
These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested: Dexamethasone Sodium Phosphate injection, USP 4 mg per mL:
First Day
I or 2 mL, intramuscularly
Dexamethasone Tablets, USP, 1.5 mg, one-half tablet:
Second Day
2 tablets in two divided doses
Third Day
2 tablets in two divided doses
Forth Day
I tablet in two divided doses
Fifth Day
One half tablet
Sixth Day
One half tablet
Seventh Day
No treatment
Eighth Day
Follow-up visit
This schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk of overdosage in chronic cases.
In cerebral edema, Dexamethasone Sodium Phosphate injection, USP is generally administered initially in a dosage of 10 mg intravenously followed by 4 mg every six hours intramuscularly until the symptoms of cerebral edema subside. Response is usually noted within 12 to 24 hours and dosage may be reduced after two to four days and gradually discontinued over a period of five to seven days. For palliative management of patients with recurrent or inoperable brain tumors, maintenance therapy with either Dexamethasone Sodium Phosphate injection, USP or dexamethasone tablets in a dosage of 2 mg two or three times daily may be effective. Dexamethasone suppression tests:
1. Tests for Cushing’s syndrome.
Give 1 mg of Dexamethasone USP orally at 11:00 p.m. Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning.
For greater accuracy, give 0.5 mg of Dexamethasone USP orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.
2. Test to distinguish Cushing’s syndrome due to pituitary AGTH excess from Cushing’s syndrome due to other causes.
Give 2 mg of Dexamethasone USP orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.
Dexamethasone tablets USP 1.5mg are scored, pink, pentagonal-shaped tablets debossed “ECR 86”. These are available in compliance packages of 21 tablets (DexPak® 6 Day TaperPak®, NDC#00095-0089-21), 35 tablets (DexPak® 10 Day TaperPak®, NDC#00095-0087-35) and 51 tablets (DexPak® 13 Day TaperPak®, NDC #00095-0088-51).
Store at controlled room temperature 20º to 25ºC (68º to 77ºF), see USP.
Dispense in tight, light resistant container as defined in the USP/NF.
Rx Only
Keep This and All Medications Out of the Reach of Children
Manufactured for:
ECR Pharmaceuticals
Richmond, Virginia 23255
Manufactured by:
Mikart, Inc.
Atlanta, GA 30318
MI 0087/88/89
Rev. 11/08
Code 970A00
Rev. 06/08
NDC 0095-0088-51
51 Tablets
DEXPAK
13 DAY
TaperPak®
TAPERED ORAL STEROID THERAPY
Dexamethasone Tablets USP
1.5 mg
Rx ONLY
See enclosed product literature for additional information.
Use Only as Directed by Physician.
ECR PHARMACEUTICALS
Richmond, Virginia 23255
Store at controlled room temperature
20 to 25°C (68 to 77°F), See USP.
DISPENSE ONLY IN ORIGINAL PACKAGE
Package Label
| DexPak 13 Day TaperPak dexamethasone tablet | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA040700 | 04/01/2000 | |
| Labeler - ECR Pharmaceuticals (831116350) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Mikart, Inc. | 030034847 | MANUFACTURE | |
