Flotizol Cream: A Comprehensive Guide to Clotrimazole (USP)

Flotizol Cream contains Clotrimazole (USP) as its active ingredient, presenting a dermatological formulation designed to effectively combat diverse skin infections caused by dermatophytes, yeasts, molds, and other fungal agents. This article delivers an in-depth overview of Flotizol Cream, covering its composition, therapeutic indications, posology, contraindications, special warnings, and more.

Composition:

Flotizol Cream comprises Clotrimazole (USP) at a concentration of 10mg per gram.

Therapeutic Indications:

Flotizol Cream is indicated for treating dermatomycoses caused by dermatophytes, yeasts, molds, etc. This includes conditions like tinea pedum, tinea corporis, tinea inguinalis, pityriasis versicolor, cutaneous candidiasis, and erythrasma. Additionally, it is effective in treating fungal infections of the glans and prepuce of the penis in males, specifically candidal vulvitis and candidal balanitis.

Posology and Method of Administration:

The recommended treatment duration varies depending on the specific indication:
– Dermatomycoses: 3-4 weeks
– Males with fungal infections of the glans and prepuce: 12 weeks
– Erythrasma: 2-4 weeks
– Pityriasis versicolor: 1-3 weeks
– Candida vulvitis and candida balanitis: 12 weeks

The cream should be applied thinly 2-3 times a day and gently rubbed in. A small strip of cream (1/2 cm long) is sufficient to treat an area approximately the size of the hand.

Contraindications:

Flotizol Cream is contraindicated in individuals with hypersensitivity to the active substance (Clotrimazole) or any of the excipients.

Special Warnings and Precautions for Use:

– Clotrimazole cream may temporarily reduce the effectiveness and safety of latex products (e.g., condoms, diaphragms) when applied in the genital area.
– Pregnant women are advised to avoid using Clotrimazole during the first trimester.
– Breastfeeding should be discontinued during treatment with Clotrimazole. The cream should not be ingested, and contact with eyes should be avoided.

Interactions with Other Medicinal Products:

There is a potential interaction between Clotrimazole and latex products, impacting their effectiveness and safety during treatment.

Pregnancy and Lactation:

Limited data on Clotrimazole use during pregnancy indicate no direct or indirect harmful effects on reproductive toxicity. However, it is advisable to avoid its use in the first trimester. Breastfeeding should be discontinued during treatment.

Undesirable Effects:

Adverse reactions to Clotrimazole may include immune system disorders, allergic reactions, and various skin and subcutaneous tissue disorders such as blisters, discomfort/pain, edema, irritation, peeling/exfoliation, pruritus, rash, and stinging/burning.

Pharmacological Properties:

*Mechanism of Action:* Clotrimazole inhibits ergosterol synthesis, leading to structural and functional impairment of the cytoplasmic membrane in fungi. It exhibits a broad antifungal spectrum against dermatophytes, yeasts, molds, and has additional activity against certain gram-positive and gram-negative microorganisms.

Pharmacokinetic Properties

Topical application of Clotrimazole results in minimal absorption into the bloodstream. Peak serum concentrations are below detectable limits, suggesting negligible systemic effects or side effects.

Preclinical Safety Data:

Nonclinical studies indicate no special hazards for humans based on pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.

Presentation:

Flotizol Cream comes in 15-gram aluminum tubes packed in unit cartons.

Directions for Storage:

To ensure the integrity of the product, protect Flotizol Cream from light, heat, and moisture. Store it below 30°C, as improper storage may result in product deterioration.

In conclusion

Flotizol Cream with Clotrimazole (USP) offers a targeted and effective solution for various dermatological fungal infections. Patients should follow the prescribed posology and adhere to contraindications and warnings for optimal therapeutic outcomes. Always consult a healthcare professional for personalized advice and guidance.