Clotrimazole 1% Topical

Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, moulds and bacteroids. Clotrimazole is also active against certain gram-positive bacteria especially Staphylococci and Trichomonas. Like other imidazoles, Clotrimazole alters the permeability of fungal cell walls by interfering with cell wall lipids. At fungistatic levels the main effect is inhibition of ergosterol synthesis but at higher concentrations there is an additional mechanism of membrane damage unrelated to sterol synthesis.

• Dermatomycoses due to dermatophytes (Trichophyton species)
• Dermatomycoses due to yeasts (Candida species)
• Dermatomycoses due to moulds and other fungi
• Skin diseases showing superinfections with these fungi
• Interdigital mycoses (athlete's foot)
• Paronychias (associated with nail mycoses)
• Mycoses in skin folds
• Candida vulvitis
• Candida balanitis
• Pityriasis versicolor
• Erythrasma

Clotrimazole acts primarily by damaging the permeability barrier in the cell membrane of fungi. Clotrimazole causes inhibition of ergosterol biosynthesis, an essential constituent of fungal cell membranes. If ergosterol synthesis is either completely or partially inhibited, the cell is no longer able to construct an intact and functional cell membrane. Because ergosterol directly promotes the growth of fungal cells in a hormone-like fashion, rapid onset of the above events leads to dose-dependent inhibition of fungal growth.

Clotrimazole is a broad-spectrum antifungal which binds to phospholipids in the cell membrane altering cell wall permeability causing a loss in essential intracellular elements.

Adult Dose (Topical): Apply 2-3 times daily to the infected sites and rub in. Dermatomycoses: 3-4 weeks; Candida vulvitis & balanitis: 1-2 weeks; Erythrasma & Pityriasis versicolor: approx 3 weeks; Onychomycosis: 6 months; Tinea pedis: 4 weeks.

Pediatric Dose (>2 years): Tinea cruris: 2 weeks; Tinea corporis/pedis: 4 weeks; Candidiasis/Versicolor: 4 weeks (reconsider if no improvement).

This medicine is for external use only. Apply thinly 2-3 times daily to the affected area and rub in gently. Wash hands before and after application (unless hands are the affected area).

If you miss a dose of Clotrimazole 1% Topical, apply it as soon as you remember. However, if it is almost time for your next application, skip the missed dose. Do not double the dose.

Common Side Effects:

• Elevated serum AST (SGOT) concentrations (15%)
• Erythema (redness)
• Stinging
• Irritation
• Hypersensitivity reactions
• Contact dermatitis
• Edema
• Pruritus
• Burning
• Peeling
• Urticaria
• Skin fissures

Local Reactions: Local irritation or burning sensation may occur in very few cases; these are not considered harmful.

• Avoid contact with eyes.
• If local intolerance develops, consider withdrawal of the medicine and institution of appropriate therapy.
• Caution during pregnancy and lactation.
• Use with caution in children under 3 years.

• Hypersensitivity.

Antagonism with polyene antibiotics.

No food interactions have been found or established.

Small amounts of imidazoles may be absorbed systemically following topical and vaginal administration. Should be used during pregnancy only when considered necessary by the physician. Pregnancy Category B.

Excretion in milk is unknown; use with caution.

Pediatric dose (>2 years): Tinea cruris: 2 weeks; Tinea corporis/pedis: 4 weeks; Candidiasis/Versicolor: 4 weeks. Use with caution in children under 2 years.

Limited information is available regarding dose adjustment for elderly patients.

For topical use, no dose adjustment is required in renal or hepatic impairment.

Overdose may cause severe irritation. Consult a physician if overdose is suspected.

Keep below 25°C temperature, away from light & moisture. Keep out of reach of children.

Clotrimazole 1%