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Antifungal Cream


Antifungal Cream is a water-miscible white cream containing 2% Miconazole Nitrate, 1 - [2, 4 - dichloro - β - (2, 4 - dichlorobenzyloxy) Phenethyl] imidazole Nitrate as the active ingredient.

Ingredient(s)
Each gram contains:

Miconazole Nitrate .......................... 20mg

Preservatives:

Methyl Paraben ................................1 mg
Propyl Paraben ................................1 mg

Action(s)
Miconazole Nitrate is a synthetic antifungal agent that is chemically unrelated to other fungicidal compounds. Although its pharmacologic mode of action has not been established, in vitro studies show that it possesses fungicidal action against Candida albicans and other species of this genus. It has also been found to inhibit the growth of the common dermatophytes, Trichophyton rubrum. Trichophyton mentagrophytes, and Epidermophyton floccosum, and the organism responsible for Tinea versicolor. Its therapeutic value appears to be due to its action primarily on the yeast cell membrane resulting in selective inhibition of the uptake of those components necessary for cell reproduction and growth.


Clinical trials have shown it to be well-tolerated and effective in both pregnant and non-pregnant women as well as those taking oral contraceptives.

Indication(s)
For topical application in the treatment of Tinea pedis (athlete's foot), Tinea cruris, and Tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum, and in the treatment of Tinea versicolor.

Dosage and Administration
Sufficient Antifungal cream should be applied to cover affected areas twice daily (morning and evening) in patients with Tinea pedis, Tinea cruris, Tinea corporis, and cutaneous Candidiasis, and once daily in patients with Tinea versicolor.

 

Early relief of symptoms (2 to 3 days) is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, Candida infections and Tinea cruris and corporis should be treated for two weeks and Tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after a month of treatment, the diagnosis should be redetermined. Patients with Tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

Contraindication(s)
Patients known to be hypersensitive to this drug.

Precaution(s) / Warning(s)
1. Do not use in children under 2 years of age except under the advice and supervision of a doctor,
2. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor or pharmacist.

Side Effect(s) / Adverse Reaction(s)
Most complaints are vulvovaginal burning, itching or irritation. Other complaints such as vaginal burning, pelvic cramps, hives, skin rashes and headache occurred rarely. Irritation, burning, maceration and allergic contact dermatitis associated with application of Miconazole.

 

Symptoms and Treatment for Overdosage, and Antidote(s)

Overdosage in humans has not been reported to date.

 

Shelf-Life

3 years from the date of manufacture

 

Storage Condition(s)

Keep in an airtight container. Store at temperature below 30. Protect from light and moisture.

 

Packing(s)

Aluminium tube of 10g and 20g

Plastic jar of 500g ( for export only )

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