The following drugs and medications are in some way related to, or used in the treatment of Generalized Anxiety Disorder. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
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Tozaar may be available in the countries listed below.
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Tozaar in the following countries:
International Drug Name Search
Monopack may be available in the countries listed below.
Isosorbide Mononitrate is reported as an ingredient of Monopack in the following countries:
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Progro S may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Estradiol 3-benzoate (a derivative of Estradiol) is reported as an ingredient of Progro S in the following countries:
Progesterone is reported as an ingredient of Progro S in the following countries:
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In the US, Femsept is a member of the drug class estrogens and is used to treat Atrophic Urethritis, Atrophic Vaginitis, Breast Cancer - Palliative, Hypoestrogenism, Oophorectomy, Osteoporosis, Postmenopausal Symptoms, Primary Ovarian Failure and Prostate Cancer.
Estradiol hemihydrate (a derivative of Estradiol) is reported as an ingredient of Femsept in the following countries:
International Drug Name Search
Ranitidina TAD may be available in the countries listed below.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranitidina TAD in the following countries:
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See also: Generic Capozide 25/15, Generic Capozide 25/25, Generic Capozide 50/15
Capozide 50/25 is a brand name of captopril/hydrochlorothiazide, approved by the FDA in the following formulation(s):
Yes. The following products are equivalent to Capozide 50/25:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Capozide 50/25. 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 Capozide 50/25.
Troxérutine Biogaran may be available in the countries listed below.
Troxerutin is reported as an ingredient of Troxérutine Biogaran in the following countries:
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Tenomilol may be available in the countries listed below.
Atenolol is reported as an ingredient of Tenomilol in the following countries:
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Tamoxifen Mylan may be available in the countries listed below.
Tamoxifen citrate (a derivative of Tamoxifen) is reported as an ingredient of Tamoxifen Mylan in the following countries:
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Lexis may be available in the countries listed below.
Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Lexis in the following countries:
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Exibral may be available in the countries listed below.
Valproic Acid magnesium (a derivative of Valproic Acid) is reported as an ingredient of Exibral in the following countries:
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Toux-San Codeine may be available in the countries listed below.
Codeine monohydrate (a derivative of Codeine) is reported as an ingredient of Toux-San Codeine in the following countries:
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Dociteren may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Dociteren in the following countries:
Propranolol hydrochloride (a derivative of Propranolol) is reported as an ingredient of Dociteren in the following countries:
Triamterene is reported as an ingredient of Dociteren in the following countries:
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Benalet may be available in the countries listed below.
Diphenhydramine hydrochloride (a derivative of Diphenhydramine) is reported as an ingredient of Benalet in the following countries:
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Doss may be available in the countries listed below.
Alfacalcidol is reported as an ingredient of Doss in the following countries:
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Letrol may be available in the countries listed below.
Letrozole is reported as an ingredient of Letrol in the following countries:
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Alminox DAK may be available in the countries listed below.
Aluminium Acetate is reported as an ingredient of Alminox DAK in the following countries:
Magnesium Oxide is reported as an ingredient of Alminox DAK in the following countries:
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Mestinon is a brand name of pyridostigmine, approved by the FDA in the following formulation(s):
Yes. The following products are equivalent to Mestinon:
Note: No generic formulation of the following products are available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Mestinon. 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 Mestinon.
Tensocardil may be available in the countries listed below.
Fosinopril sodium salt (a derivative of Fosinopril) is reported as an ingredient of Tensocardil in the following countries:
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Triflusal Edigen may be available in the countries listed below.
Triflusal is reported as an ingredient of Triflusal Edigen in the following countries:
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Cromedil may be available in the countries listed below.
Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Cromedil in the following countries:
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Iqfadina may be available in the countries listed below.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Iqfadina in the following countries:
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Acetylsalicylic Acid is reported as an ingredient of Methocarbamol and Aspirin in the following countries:
Methocarbamol is reported as an ingredient of Methocarbamol and Aspirin in the following countries:
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Laxasan may be available in the countries listed below.
Sodium Picosulfate is reported as an ingredient of Laxasan in the following countries:
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Tamoxifeno Dosa may be available in the countries listed below.
Tamoxifen citrate (a derivative of Tamoxifen) is reported as an ingredient of Tamoxifeno Dosa in the following countries:
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Generic Name: riboflavin (Oral route)
RYE-boe-flay-vin
In the U.S.
Available Dosage Forms:
Therapeutic Class: Nutritive Agent
Pharmacologic Class: Vitamin B
Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Riboflavin (vitamin B 2) is needed to help break down carbohydrates, proteins, and fats. It also makes it possible for oxygen to be used by your body.
Lack of riboflavin may lead to itching and burning eyes, sensitivity of eyes to light, sore tongue, itching and peeling skin on the nose and scrotum, and sores in the mouth. Your doctor may treat this condition by prescribing riboflavin for you.
Some conditions may increase your need for riboflavin. These include:
In addition, riboflavin may be given to infants with high blood levels of bilirubin (hyperbilirubinemia).
Increased need for riboflavin should be determined by your health care professional.
Claims that riboflavin is effective for treatment of acne, some kinds of anemia (weak blood), migraine headaches, and muscle cramps have not been proven.
Oral forms of riboflavin are available without a prescription.
For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.
Riboflavin is found in various foods, including milk and dairy products, fish, meats, green leafy vegetables, and whole grain and enriched cereals and bread. It is best to eat fresh fruits and vegetables whenever possible since they contain the most vitamins. Food processing may destroy some of the vitamins, although little riboflavin is lost from foods during ordinary cooking.
Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.
The daily amount of riboflavin needed is defined in several different ways.
Normal daily recommended intakes for riboflavin are generally defined as follows:
| Persons | U.S. (mg) | Canada (mg) |
| Infants and children Birth to 3 years of age | 0.4–0.8 | 0.3–0.7 |
| 4 to 6 years of age | 1.1 | 0.9 |
| 7 to 10 years of age | 1.2 | 1–1.3 |
| Adolescent and adult males | 1.4–1.8 | 1–1.6 |
| Adolescent and adult females | 1.2–1.3 | 1–1.1 |
| Pregnant females | 1.6 | 1.1–1.4 |
| Breast-feeding females | 1.7–1.8 | 1.4–1.5 |
If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, 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.
Problems in children have not been reported with intake of normal daily recommended amounts.
Problems in older adults have not been reported with intake of normal daily recommended amounts.
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
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.
This section provides information on the proper use of a number of products that contain riboflavin. It may not be specific to Ribo-100. Please read with care.
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, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the dietary supplement 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.
Along with its needed effects, a dietary supplement may cause some unwanted effects. Riboflavin may cause urine to have a more yellow color than normal, especially if large doses are taken. This is to be expected and is no cause for alarm. Usually, however, riboflavin does not cause any side effects. Check with your health care professional if you notice any other unusual effects while you are using it.
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In the US, Cleocin Phosphate (clindamycin systemic) is a member of the drug class lincomycin derivatives and is used to treat Aspiration Pneumonia, Babesiosis, Bacteremia, Bacterial Endocarditis Prevention, Bacterial Infection, Bacterial Vaginitis, Bone infection, Deep Neck Infection, Diverticulitis, Intraabdominal Infection, Joint Infection, Malaria, Pelvic Inflammatory Disease, Peritonitis, Pneumocystis Pneumonia, Pneumonia, Prevention of Perinatal Group B Streptococcal Disease, Sinusitis, Skin Infection, Surgical Prophylaxis, Toxoplasmosis and Toxoplasmosis - Prophylaxis.
US matches:
Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Cleocin Phosphate in the following countries:
International Drug Name Search
Trinitrine Merck may be available in the countries listed below.
Nitroglycerin is reported as an ingredient of Trinitrine Merck in the following countries:
International Drug Name Search
Paralink may be available in the countries listed below.
Paracetamol is reported as an ingredient of Paralink in the following countries:
International Drug Name Search
Tamoxis may be available in the countries listed below.
Tamoxifen citrate (a derivative of Tamoxifen) is reported as an ingredient of Tamoxis in the following countries:
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Temporarily relieving cough due to minor throat and airway irritation associated with upper respiratory tract infections or inhaled irritants.
Dextromethorphan/Potassium Guaiacolsulfonate is a combination of an expectorant and a cough suppressant. It works by loosening mucus and lung secretions in the chest and making coughs more productive.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Dextromethorphan/Potassium Guaiacolsulfonate. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Dextromethorphan/Potassium Guaiacolsulfonate. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Dextromethorphan/Potassium Guaiacolsulfonate 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.
Use Dextromethorphan/Potassium Guaiacolsulfonate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Dextromethorphan/Potassium Guaiacolsulfonate.
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:
Dizziness; drowsiness; stomach upset.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
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: Dextromethorphan/Potassium Guaiacolsulfonate side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; excitement; hallucinations; slowed breathing.
Store Dextromethorphan/Potassium Guaiacolsulfonate at room temperature, 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 Dextromethorphan/Potassium Guaiacolsulfonate out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Dextromethorphan/Potassium Guaiacolsulfonate. 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.
Evitol may be available in the countries listed below.
Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Evitol in the following countries:
International Drug Name Search
Urispadol may be available in the countries listed below.
Flavoxate hydrochloride (a derivative of Flavoxate) is reported as an ingredient of Urispadol in the following countries:
International Drug Name Search
Altima may be available in the countries listed below.
Pemetrexed disodium (a derivative of Pemetrexed) is reported as an ingredient of Altima in the following countries:
International Drug Name Search
Bacitracine may be available in the countries listed below.
Bacitracine (DCF) is known as Bacitracin in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
MST Mundipharma may be available in the countries listed below.
Morphine sulphate pentahydrate (a derivative of Morphine) is reported as an ingredient of MST Mundipharma in the following countries:
International Drug Name Search
Garamicina may be available in the countries listed below.
Gentamicin is reported as an ingredient of Garamicina in the following countries:
Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Garamicina in the following countries:
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Omilipis may be available in the countries listed below.
Carboplatin is reported as an ingredient of Omilipis in the following countries:
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Tolin may be available in the countries listed below.
Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Tolin in the following countries:
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Novacler may be available in the countries listed below.
Metamizole sodium anhydrous (a derivative of Metamizole) is reported as an ingredient of Novacler in the following countries:
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Terbinafine Ratiopharm may be available in the countries listed below.
Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbinafine Ratiopharm in the following countries:
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In the US, Tylenol PM (acetaminophen/diphenhydramine systemic) is a member of the drug class analgesic combinations and is used to treat Headache, Insomnia and Pain.
US matches:
Diphenhydramine hydrochloride (a derivative of Diphenhydramine) is reported as an ingredient of Tylenol PM in the following countries:
Paracetamol is reported as an ingredient of Tylenol PM in the following countries:
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Nevirapine Stada may be available in the countries listed below.
Nevirapine is reported as an ingredient of Nevirapine Stada in the following countries:
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Ethylmorphine Hydrochloride may be available in the countries listed below.
Ethylmorphine Hydrochloride (BANM, JAN) is also known as Ethylmorphine (BAN)
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| JAN | Japanese Accepted Name |
Glycomet may be available in the countries listed below.
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Glycomet in the following countries:
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Coltramyl may be available in the countries listed below.
Thiocolchicoside is reported as an ingredient of Coltramyl in the following countries:
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Onemin may be available in the countries listed below.
Loratadine is reported as an ingredient of Onemin in the following countries:
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Enanton Depot Dual may be available in the countries listed below.
Leuprorelin acetate (a derivative of Leuprorelin) is reported as an ingredient of Enanton Depot Dual in the following countries:
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Flucofin may be available in the countries listed below.
Fluconazole is reported as an ingredient of Flucofin in the following countries:
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Hyperium may be available in the countries listed below.
Rilmenidine is reported as an ingredient of Hyperium in the following countries:
Rilmenidine dihydrogen phosphate (a derivative of Rilmenidine) is reported as an ingredient of Hyperium in the following countries:
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Depo-Medrol + Lidocaina may be available in the countries listed below.
Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Depo-Medrol + Lidocaina in the following countries:
Methylprednisolone 21-acetate (a derivative of Methylprednisolone) is reported as an ingredient of Depo-Medrol + Lidocaina in the following countries:
International Drug Name Search
Alopurinol Teva may be available in the countries listed below.
Allopurinol is reported as an ingredient of Alopurinol Teva in the following countries:
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Di-iodohydroxyquinoline may be available in the countries listed below.
Di-iodohydroxyquinoline (BAN) is also known as Diiodohydroxyquinoline (Rec.INN)
International Drug Name Search
Glossary
| BAN | British Approved Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Towamin may be available in the countries listed below.
Atenolol is reported as an ingredient of Towamin in the following countries:
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Perosa may be available in the countries listed below.
Permethrin is reported as an ingredient of Perosa in the following countries:
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Acecat may be available in the countries listed below.
Paracetamol is reported as an ingredient of Acecat in the following countries:
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brand of augmented betamethasone dipropionate1
Cream 0.05%
(potency expressed as betamethasone)
For Dermatologic Use Only – Not for Ophthalmic Use
PRODUCT INFORMATION
DIPROLENE® AF Cream 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone.
Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:
Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.
Each gram of Diprolene AF Cream 0.05% contains: 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in an emollient cream base of purified water; chlorocresol; propylene glycol; white petrolatum; white wax; cyclomethicone; sorbitol solution; glyceryl oleate/propylene glycol; ceteareth-30; carbomer 940; and sodium hydroxide.
The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects.
Topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION).
Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
DIPROLENE® AF Cream 0.05% was applied once daily at 7 grams per day for 1 week to diseased skin, in adult patients with psoriasis or atopic dermatitis, to study its effects on the hypothalamic-pituitary-adrenal (HPA) axis. The results suggested that the drug caused a slight lowering of adrenal corticosteroid secretion, although in no case did plasma cortisol levels go below the lower limit of the normal range.
Sixty-seven pediatric patients ages 1 to 12 years, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study. Diprolene AF Cream 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable patients, adrenal suppression was indicated by either a ≤5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dL and/or an increase of <7 mcg/dL from the baseline cortisol. Studies performed with Diprolene AF Cream 0.05% indicate that it is in the high range of potency as compared with other topical corticosteroids.
DIPROLENE® AF Cream 0.05% is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.
DIPROLENE® AF Cream 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure (see DOSAGE AND ADMINISTRATION).
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary-free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. In an open-label pediatric study of 60 evaluable patients, of the 19 who showed evidence of suppression, 4 patients were tested 2 weeks after discontinuation of DIPROLENE® AF Cream 0.05%, and 3 of the 4 (75%) had complete recovery of HPA axis function. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use section).
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Patients using topical corticosteroids should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
The following tests may be helpful in evaluating HPA axis suppression:
Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.
Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone.
Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1.0 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species. These doses are approximately 5- and 38-fold the human dose based on a mg/m2 comparison, respectively.
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately 0.2-fold the maximum human dose based on a mg/m2 comparison. The abnormalities observed included umbilical hernias, cephalocele, and cleft palates.
Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, 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.
Use of Diprolene AF Cream 0.05% in pediatric patients 12 years of age and younger is not recommended (see CLINICAL PHARMACOLOGY and ADVERSE REACTIONS). In an open-label study, 19 of 60 (32%) evaluable pediatric patients (aged 3 months–12 years old) using Diprolene AF Cream 0.05% for treatment of atopic dermatitis demonstrated HPA axis suppression. The proportion of patients with adrenal suppression in this study was progressively greater, the younger the age group (see CLINICAL PHARMACOLOGY, Pharmacokinetics section).
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. The study described above supports this premise, as adrenal suppression in 9–12 year olds, 6–8 year olds, 2–5 year olds, and 3 months–1 year old was 17%, 32%, 38%, and 50%, respectively.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Chronic corticosteroid therapy may interfere with the growth and development of children.
Clinical studies of Diprolene AF Cream 0.05% included 104 subjects who were 65 years of age and over and 8 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.
The only local adverse reaction reported to be possibly or probably related to treatment with DIPROLENE® AF Cream 0.05% during adult-controlled clinical studies was stinging. It occurred in 1 patient, 0.4%, of the 242 patients or subjects involved in the studies.
Adverse reactions reported to be possibly or probably related to treatment with Diprolene AF Cream 0.05% during a pediatric clinical study include signs of skin atrophy (telangiectasia, bruising, shininess). Skin atrophy occurred in 7 of 67 (10%) patients, involving all age groups from 3 months–12 years of age.
The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
Apply a thin film of DIPROLENE® AF Cream 0.05% to the affected skin areas once or twice daily. Treatment with Diprolene AF Cream 0.05% should be limited to 50 g per week.
Diprolene AF Cream 0.05% is not to be used with occlusive dressings.
DIPROLENE® AF Cream 0.05% is supplied in 15-g (NDC 0085-0517-01) and 50-g (NDC 0085-0517-04) tubes; boxes of one.
Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].
Manufactured by: Schering-Plough Canada, Inc., Pointe Claire, Quebec, Canada
Distributed by: Schering Corporation, a subsidiary of
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA
Copyright © 1987, 2001 Schering Corporation, a subsidiary of Merck & Co., Inc.
All rights reserved.
Rev. 08/10
34489300T
NDC 0085-0517-04
50 g
Diprolene®AF
brand of augmented
betamethasone
dipropionate*
Cream, 0.05%
(Potency expressed
as betamethasone)
*Vehicle augments the
penetration of the steroid.
For dermatologic
use only.
Not for
ophthalmic use.
Rx only
| Diprolene AF betamethasone dipropionate cream | ||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA019555 | 06/23/2011 | |
| Labeler - Schering Corporation (001317601) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| SCHERING CANADA INC | 207093332 | MANUFACTURE | |
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