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.
Each gram contains:
Miconazole Nitrate .......................... 20mg
Methyl Paraben ................................1 mg
Propyl Paraben ................................1 mg
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.
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
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
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.
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.
3 years from the date of
Keep in an airtight container.
Store at temperature below 30. Protect from light and moisture.
Aluminium tube of 10g and 20g
Plastic jar of 500g ( for export