Axcel Miconazole

Axcel Miconazole

miconazole

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Full Prescribing Info
Contents
Miconazole.
Description
Miconazole Nitrate (micronised) 2% w/w.
Chlorocresol 0.1% w/w as preservative.
Action
Pharmacology: Mechanism of Action: Miconazole is an imidazole antifungal agent with some antibacterial activity. It has some activity against Aspergillus spp., Cryptococcus neoformans, Pseudallescheria boydii, and some Gram-positive bacteria including staphylococci and streptococci.
Pharmacokinetics: Miconazole is absorbed from the gastrointestinal tract. Up to 20% of a dose given by mouth is excreted mainly as metabolites in the urine over 4 days. Up to 55% is excreted unchanged in the faeces over 6 days. There is little absorption through skin or mucous membranes.
Indications/Uses
Miconazole is used topically in the management of superficial candidiasis and fungal skin infections, such as; mucocutaneous candidiasis, dermatophytosis, and pityriasis versicolor.
Dosage/Direction for Use
For external use only.
Apply cream (according to the size of lesion) to the lesion twice daily. Rub gently until the cream has been completely absorbed by the skin. The treatment should be continued without interruption until the lesion has completely disappeared (usually after 2 to 5 weeks). Continue treatment for at least 1 week after the lesion has completely disappeared to prevent relapse. If irritation occurs or if there is no improvement in 4 weeks (for athlete's foot) or 2 weeks (for jock itch), discontinue and consult doctor or pharmacist.
Overdosage
Topical application of Miconazole Nitrate is well tolerated as there is little absorption through the skin. No known systemic toxicity of the drug has been reported when applied topically. In cases of accidental ingestion of large quantities of the product, an appropriate method of gastric emptying may be used if considered necessary.
Contraindications
No known contraindication.
Special Precautions
Do not use in children under 2 years of age except under the advice and supervision of a doctor. Avoid contact with eyes.
Side Effects
Local irritation and sensitivity reactions may occur when used topically.
Storage
Keep container well closed. Store below 30°C.
Protect from light.
ATC Classification
D01AC02 - miconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Presentation/Packing
Cream 2% w/w (white, water-miscible) x 15 g x 1's.
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