Drugplain

Clotrimazole and Betamethasone Dipropionate .5 mg/g

Clotrimazole and Betamethasone Dipropionate · CREAM · A-S Medication Solutions

2 Recalls on Record
Plain English

Clotrimazole and Betamethasone Dipropionate is a cream containing clotrimazole and betamethasone dipropionate at .5 mg/g, taken topical. Manufactured by A-S Medication Solutions.

Key Facts

Brand Name
Clotrimazole and Betamethasone Dipropionate
Generic Name
Clotrimazole and Betamethasone Dipropionate
NDC Code (Product)
50090-6474
Manufacturer
A-S Medication Solutions
Strength
.5 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA075673
Drug Class
Azole Antifungal [EPC]
Marketing Start
05/29/2001

Recall History

2 Recalls on Record
Class III08/07/2019

Glenmark Pharmaceuticals Inc., USA

Temperature Abuse: Complaints received of liquidy texture.

TerminatedVoluntary: Firm initiated
Class III02/25/2022

Taro Pharmaceuticals U.S.A., Inc.

Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

chronic kidney disease55 reports
fatigue37 reports
renal failure34 reports
acute kidney injury24 reports
drug ineffective23 reports
nausea23 reports
dyspnoea21 reports
rash20 reports
dizziness18 reports
pain17 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older. Clotrimazole and betamethasone dipropionate cream contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION 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 weeks 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. Avoid contact with eyes. Wash hands after each application. Tinea pedis: Apply a thin film to the affected skin areas twice a day for 2 weeks. Do not use longer than …

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials common adverse reaction reported for clotrimazole and betamethasone dipropionate cream was paresthesia in 1.9% of patients. Adverse reactions reported at a frequency less than 1% included rash, edema, and secondary infection. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following local adverse reactions have been reported with topical …

Frequently Asked Questions

What is Clotrimazole and Betamethasone Dipropionate used for?

Clotrimazole and Betamethasone Dipropionate contains Clotrimazole and Betamethasone Dipropionate. It is a cream taken topical. Consult your doctor for specific uses.

Is Clotrimazole and Betamethasone Dipropionate a controlled substance?

Clotrimazole and Betamethasone Dipropionate is not classified as a controlled substance by the DEA.

What is the generic name for Clotrimazole and Betamethasone Dipropionate?

The generic name for Clotrimazole and Betamethasone Dipropionate is Clotrimazole and Betamethasone Dipropionate. There are no other listed brand versions of Clotrimazole and Betamethasone Dipropionate.

What is the NDC code for Clotrimazole and Betamethasone Dipropionate .5 mg/g?

The NDC (National Drug Code) for Clotrimazole and Betamethasone Dipropionate .5 mg/g is 50090-6474, listed by A-S Medication Solutions.

Product NDC

50090-6474

Package NDC

50090-6474-0

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)