NDATOPICAL, VAGINALCREAM, TABLET
Approved
Apr 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
3/8 — Basic
GYNE-LOTRIMIN COMBINATION PACK (clotrimazole) by Bayer is clinical pharmacology clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, and malassezia furfur . First approved in 1993.
Drug data last refreshed 14h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GYNE-LOTRIMIN COMBINATION PACK is a topical and vaginal broad-spectrum antifungal agent containing clotrimazole, indicated for vulvovaginal candidiasis, oral candidiasis, and other candida infections. It works by disrupting fungal cell membranes through inhibition of ergosterol synthesis, causing leakage of intracellular contents and fungal cell death. The combination pack format enhances patient compliance by providing coordinated topical and vaginal dosing.
LOE Approaching
Product approaching loss of exclusivity with mature market presence; brand team focused on generic transition strategy and cost management rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, and Malassezia furfur . The primary action of clotrimzole is against dividing and growing organisms. In vitro ,…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.