Clotrimazole And Betamethasone Dipropionate
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Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Clotrimazole and Betamethasone Dipropionate Cream is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of clotrimazole and betamethasone dipropionate cream for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis) has not been established. Several cases of treatment failure of clotrimazole and betamethasone dipropionate cream in the treatment of infections caused by Microsporum canis have been reported
History
There is currently no drug history available for this drug.
Other Information
Clotrimazole and Betamethasone Dipropionate Cream USP contains a combination of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic use.
Chemically, clotrimazole is 1-(o-chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C22H17ClN2, a molecular weight of 344.84, and the following structural formula:
Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol.
Betamethasone dipropionate has the chemical name 9-fluoro-11(,17,21-trihydroxy-16(-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.59, and the following structural formula:
Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.
Each gram of Clotrimazole and Betamethasone Dipropionate Cream contains 10 mg clotrimazole and 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in a hydrophilic cream.
INACTIVE INGREDIENTS
Cetereath-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol and white petrolatum; benzyl alcohol as preservative.
Clotrimazole and betamethasone dipropionate cream is smooth, uniform, and white to off-white in color.
Sources
Clotrimazole And Betamethasone Dipropionate Manufacturers
- Remedyrepack Inc.
![Clotrimazole And Betamethasone Dipropionate Cream [Remedyrepack Inc. ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Clotrimazole And Betamethasone Dipropionate | Remedyrepack Inc.
Gently massage sufficient clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day, in the morning and evening.
Clotrimazole and betamethasone dipropionate cream should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
Clotrimazole and betamethasone dipropionate cream should not be used longer than 4 weeks in the treatment of tinea pedis and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
Clotrimazole and betamethasone dipropionate cream should not be used with occlusive dressings.
- E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Clotrimazole And Betamethasone Dipropionate | Cardinal Health
HypertensionIndividualize the dosage of metoprolol tartrate tablets. Metoprolol tartrate tablets should be taken with or immediately following meals.
The usual initial dosage of metoprolol tartrate tablets is 100 mg daily in single or divided doses, whether used alone or added to a diuretic. Increase the dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after one week of therapy. The effective dosage range of metoprolol tartrate tablets is 100 mg to 450 mg per day. Dosages above 450 mg per day have not been studied. While once daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta1 selectivity diminishes as the dose of metoprolol is increased.
Angina PectorisThe dosage of metoprolol tartrate tablets should be individualized. Metoprolol tartrate tablets should be taken with or immediately following meals.
The usual initial dosage of metoprolol tartrate tablets is 100 mg daily, given in two divided doses. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range of metoprolol tartrate tablets is 100 mg to 400 mg per day. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, gradually decrease the dosage over a period of 1 to 2 weeks (see WARNINGS).
Myocardial Infarction Early TreatmentDuring the early phase of definite or suspected acute myocardial infarction, initiate treatment with metoprolol tartrate tablets as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized.
Begin treatment in this early phase with the intravenous administration of three bolus injections of 5 mg of metoprolol tartrate each; give the injections at approximately 2 minute intervals. During the intravenous administration of metoprolol, monitor blood pressure, heart rate, and electrocardiogram.
In patients who tolerate the full intravenous dose (15 mg), initiate metoprolol tartrate tablets, 50 mg every 6 hours, 15 minutes after the last intravenous dose and continue for 48 hours. Thereafter, the maintenance dosage is 100 mg twice daily (see Late Treatment below).
Start patients who appear not to tolerate the full intravenous dose on metoprolol tartrate tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, discontinue metoprolol tartrate tablets (see WARNINGS).
Late TreatmentStart patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason on metoprolol tartrate tablets, 100 mg twice daily, as soon as their clinical condition allows. Continue therapy for at least 3 months. Although the efficacy of metoprolol beyond 3 months has not been conclusively established, data from studies with other beta-blockers suggest that treatment should be continued for 1 to 3 years.
Special Populations Pediatric PatientsNo pediatric studies have been performed. The safety and efficacy of metoprolol in pediatric patients have not been established.
Renal ImpairmentNo dose adjustment of metoprolol tartrate tablets is required in patients with renal impairment.
Hepatic ImpairmentMetoprolol blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, metoprolol tartrate tablets should be initiated at low doses with cautious gradual dose titration according to clinical response.
Geriatric Patients (> 65 Years)In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Method of AdministrationFor oral treatment, the tablets should be swallowed unchewed with a glass of water. Metoprolol tartrate tablets should always be taken in standardized relation with meals. If the physician asks the patient to take metoprolol tartrate tablets either before breakfast or with breakfast, then the patient should continue taking metoprolol tartrate tablets with the same schedule during the course of therapy.
- Rebel Distributors Corp
Clotrimazole And Betamethasone Dipropionate | Rebel Distributors Corp
Gently massage sufficient Clotrimazole and Betamethasone Dipropionate Cream or Lotion into the affected skin areas twice a day, in the morning and evening.
Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 g per week of Clotrimazole and Betamethasone Dipropionate Cream, USP or amounts greater than 45 mL per week of Clotrimazole and Betamethasone Dipropionate Lotion should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after one week of treatment with Clotrimazole and Betamethasone Dipropionate Cream or Lotion, the diagnosis should be reviewed.
Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used longer than 4 weeks in the treatment of tinea pedis, and amounts greater than 45 g per week of Clotrimazole and Betamethasone Dipropionate Cream, USP or amounts greater than 45 mL per week of Clotrimazole and Betamethasone Dipropionate Lotion should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with Clotrimazole and Betamethasone Dipropionate Cream or Lotion, the diagnosis should be reviewed.
Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used with occlusive dressings.
- Physicians Total Care, Inc.
Clotrimazole And Betamethasone Dipropionate | Physicians Total Care, Inc.
Gently massage sufficient Clotrimazole and Betamethasone Dipropionate Cream or Lotion into the affected skin areas twice a day, in the morning and evening.
Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 g per week of Clotrimazole and Betamethasone Dipropionate Cream, USP or amounts greater than 45 mL per week of Clotrimazole and Betamethasone Dipropionate Lotion should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after one week of treatment with Clotrimazole and Betamethasone Dipropionate Cream or Lotion, the diagnosis should be reviewed.
Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used longer than 4 weeks in the treatment of tinea pedis, and amounts greater than 45 g per week of Clotrimazole and Betamethasone Dipropionate Cream, USP or amounts greater than 45 mL per week of Clotrimazole and Betamethasone Dipropionate Lotion should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with Clotrimazole and Betamethasone Dipropionate Cream or Lotion, the diagnosis should be reviewed.
Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used with occlusive dressings.
- Actavis Mid Atlantic Llc
Clotrimazole And Betamethasone Dipropionate | Actavis Mid Atlantic Llc
Gently massage sufficient clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day, in the morning and evening.
Clotrimazole and betamethasone dipropionate cream should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
Clotrimazole and betamethasone dipropionate cream should not be used longer than 4 weeks in the treatment of tinea pedis and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
Clotrimazole and betamethasone dipropionate cream should not be used with occlusive dressings.
- Lake Erie Medical Dba Quality Care Products Llc
Clotrimazole And Betamethasone Dipropionate | Lake Erie Medical Dba Quality Care Products Llc
Gently massage sufficient Clotrimazole and Betamethasone Dipropionate Cream or Lotion into the affected skin areas twice a day, in the morning and evening.
Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 g per week of Clotrimazole and Betamethasone Dipropionate Cream, USP or amounts greater than 45 mL per week of Clotrimazole and Betamethasone Dipropionate Lotion should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after one week of treatment with Clotrimazole and Betamethasone Dipropionate Cream or Lotion, the diagnosis should be reviewed.
Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used longer than 4 weeks in the treatment of tinea pedis, and amounts greater than 45 g per week of Clotrimazole and Betamethasone Dipropionate Cream, USP or amounts greater than 45 mL per week of Clotrimazole and Betamethasone Dipropionate Lotion should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with Clotrimazole and Betamethasone Dipropionate Cream or Lotion, the diagnosis should be reviewed.
Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used with occlusive dressings.
- Remedyrepack Inc.
Clotrimazole And Betamethasone Dipropionate | Remedyrepack Inc.
Gently massage sufficient clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day, in the morning and evening.
Clotrimazole and betamethasone dipropionate cream should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
Clotrimazole and betamethasone dipropionate cream should not be used longer than 4 weeks in the treatment of tinea pedis and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
Clotrimazole and betamethasone dipropionate cream should not be used with occlusive dressings.
- Proficient Rx Lp
Clotrimazole And Betamethasone Dipropionate | Proficient Rx Lp
Gently massage sufficient clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day, in the morning and evening.
Clotrimazole and betamethasone dipropionate cream should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
Clotrimazole and betamethasone dipropionate cream should not be used longer than 4 weeks in the treatment of tinea pedis and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
Clotrimazole and betamethasone dipropionate cream should not be used with occlusive dressings.
- Prasco Laboratories
Clotrimazole And Betamethasone Dipropionate | Pd-rx Pharmaceuticals, Inc.
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets, USP and other treatment options before deciding to use diclofenac sodium delayed-release. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with diclofenac sodium delayed-release, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg b.i.d. or t.i.d., or 75 mg b.i.d.).
For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg t.i.d. or q.i.d., or 75 mg b.i.d.).
For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg q.i.d., with an extra 25-mg dose at bedtime if necessary.
Different formulations of diclofenac (diclofenac sodium delayed-release tablets; diclofenac sodium extended-release tablets, USP; diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
- Taro Pharmaceuticals U.s.a., Inc.
Clotrimazole And Betamethasone Dipropionate | Taro Pharmaceuticals U.s.a., Inc.
Treatment of tinea corporis or tinea cruris:
Apply a thin film of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for one week. Do not use more than 45 grams per week. Do not use with occlusive dressings. If a patient shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Do not use longer than 2 weeks.Treatment of tinea pedis:
Gently massage a sufficient amount of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for two weeks. Do not use more than 45 grams per week. Do not use with occlusive dressings. If a patient shows no clinical improvement after 2 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Do not use longer than 4 weeks.Clotrimazole and betamethasone dipropionate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
![Clotrimazole And Betamethasone Dipropionate Cream [E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6399f2c3-7799-4f8b-b8b7-8d2137b1f852&name=image-01.jpg)
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![Clotrimazole And Betamethasone Dipropionate Cream Clotrimazole And Betamethasone Dipropionate Lotion [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=030a1460-3522-43af-a75d-29c99570698f&name=4546-45g.jpg)
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![Clotrimazole And Betamethasone Dipropionate Cream [Proficient Rx Lp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3d235926-6f17-4aa5-be82-7f1b4357e247&name=bf85f2b7-figure-03.jpg)
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