clotrimazole and betamethasone dipropionate
Pharmaranks rates Clotrimazole and Betamethasone Dipropionate 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Clotrimazole and Betamethasone Dipropionate is a combination medicine containing Betamethasone Dipropionate and Clotrimazole.
Betamethasone Dipropionate and Clotrimazole · by Fougera Pharms
Generic of Lotrisone
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Betamethasone Dipropionate and Clotrimazole
- Form
- Topical
- Strength
- Betamethasone Dipropionate EQ 0.05% Base; Clotrimazole 1%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Fougera Pharms
- FDA application
- ANDA075502
What is Clotrimazole and Betamethasone Dipropionate?
From the FDA label:Clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base) contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use. Chemically, clotrimazole is 1–(o-chloro-α,α-diphenylbenzyl) imidazole, with the molecular formula C 22 H 17 CLN 2 , 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 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C 28 H 37 FO 7 , 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 USP, 1%/0.05% (base) contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of purified water, mineral oil, white petrolatum, cetostearyl alcohol, ceteareth-30, propylene glycol, monobasic sodium phosphate monohydrate, and benzyl alcohol as a preservative. ChemicalStructure ChemicalStructure
How to use
Treatment of tinea corporis or tinea cruris: • Apply a thin film of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) 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, 1%/0.05% (base), 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, 1%/0.05% (base) 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, 1%/0.05% (base) the diagnosis should be reviewed. • Do not use longer than 4 weeks. Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) 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 4 weeks. ( 2 ) • Tinea cruris and tinea corporis : Apply a thin film to the affected skin area twice a day for 1 week. Do…
Side effects
Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) 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 Fougera Pharmaceuticals Inc. at 1-800-645-9833 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, 1%/0.05% (base) was paresthesia in 1.9% of patients. Adverse reactions reported at a frequency < 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 corticosteroids: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis,…
Warnings
Important safety information
Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of the treatment. Risk factor(s) are: use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and young age. Modify use should HPA axis suppression develop. ( 5.1 , 8.4 ) • Pediatric patients may be more susceptible to systemic toxicity. ( 5.1 , 8.4 ) • The use of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) in the treatment of diaper dermatitis is not recommended. ( 5.2 ) • Topical corticosteroid products may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.3 ) 5.1 Effects on Endocrine System Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Cushing's syndrome and hyperglycemia may also occur due to the systemic effect of corticosteroids while on treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure, and young age. Because of the potential for systemic corticosteroid effects, patients may need to be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a small trial, clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) was applied using large dosages, 7 g daily for 14 days (BID) to the crural area of normal adult subjects. Three of the 8 normal subjects on whom clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) was applied exhibited low morning plasma cortisol levels during treatment. One of these subjects had an abnormal cosyntropin test. The effect on morning plasma cortisol was transient and subjects recovered 1 week after discontinuing dosing. In addition, 2 separate trials in pediatric subjects demonstrated adrenal suppression as determined by cosyntropin testing [see Use in Specific Populations (8.4) ] . If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Pediatric patients may be more susceptible to systemic toxicity due to their larger skin-surface-to-body mass ratios [see Use in Specific Populations (8.4) ] . 5.2 Diaper Dermatitis The use of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) in the treatment of diaper dermatitis is not recommended. 5.3 Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products, including topical betamethasone products [see Adverse Reactions (6.2) ]. Avoid contact of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
Who should not take Clotrimazole and Betamethasone Dipropionate
None. • None. ( 4 )
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- How is Clotrimazole and Betamethasone Dipropionate rated?
- pharmaranks gives Clotrimazole and Betamethasone Dipropionate a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Clotrimazole and Betamethasone Dipropionate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Clotrimazole and Betamethasone Dipropionate. To pay less, Clotrimazole and Betamethasone Dipropionate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Clotrimazole and Betamethasone Dipropionate?
- Clotrimazole and Betamethasone Dipropionate is marketed by Fougera Pharms. You can see Fougera Pharms's full profile, rating, and other products on pharmaranks.
- Is Clotrimazole and Betamethasone Dipropionate a brand-name or generic drug?
- Clotrimazole and Betamethasone Dipropionate is a generic medication; its active ingredient is Betamethasone Dipropionate and Clotrimazole. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Clotrimazole and Betamethasone Dipropionate available over the counter?
- No. Clotrimazole and Betamethasone Dipropionate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Clotrimazole and Betamethasone Dipropionate come in?
- Clotrimazole and Betamethasone Dipropionate is currently marketed as topical, per the FDA's National Drug Code Directory.
- Is Clotrimazole and Betamethasone Dipropionate FDA-registered?
- Clotrimazole and Betamethasone Dipropionate is on record with the U.S. FDA under application number ANDA075502. You can verify this on its official FDA label.
- Has Clotrimazole and Betamethasone Dipropionate been recalled by the FDA?
- Clotrimazole and Betamethasone Dipropionate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Clotrimazole and Betamethasone Dipropionate safe?
- There's no single safe-or-not verdict. pharmaranks gives Clotrimazole and Betamethasone Dipropionate a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Clotrimazole and Betamethasone Dipropionate?
- Clotrimazole and Betamethasone Dipropionate's side effects are taken directly from its FDA label. From the label: Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
abiraterone acetate
Abiraterone Acetate
acular
Ketorolac Tromethamine
acular ls
Ketorolac Tromethamine
aimovig
Erenumab-Aooe
albendazole
Albendazole
alphagan p
Brimonidine Tartrate
Compare Clotrimazole and Betamethasone Dipropionate head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
clotrimazole and betamethasone dipropionate
70/100