Fungidal BT 10 Tablet

Indications

Tinea capitis, corporis, manuum, pedis, barbae, cruris, unguium, or onychomycosis are examples of skin and nail infections caused by dermatophytes, yeasts, and other fungi. Pityriasis versicolor, skin and nail candidiasis, angular stomatitis, otitis externa Miconazole Topical Cream can be utilized in mycoses that are secondary infected with Gram-positive bacteria since it has an antibacterial effect.

Pharmacology

The active ingredient of Fungidal® BT buccal tablet is Miconazole which is a synthetic imidazole anti-fungal agent with a broad spectrum of activity against pathogenic fungi (including yeast and dermatophytes) and gram-positive bacteria (Staphylococcus and Streptococcus spp). It may act by interfering with the permeability of the fungal cell membranes.When administered orally, Miconazole is incompletely absorbed from the gastrointestinal tract, peak plasma levels of about 1 µgm per ml have been achieved after a dose of 1 gm per day. Miconazole is inactivated in the body and 10-20% of an oral dose is excreted in the urine, mainly as metabolites, within 6 days.About 50% of an oral dose may be excreted unchanged in the faeces.

Dosage & Administration

1 tablet daily (apply in the morning) for 7 days. Miconazole should be applied to the gingiva in the morning, i.e. above the eye tooth, once daily, for one week. Do not swallow.A second week of treatment may be indicated. The use of Miconazole in children below the age of 7 is not recommended.

Once a tablet is removed from the blister, it should be used immediately.

Interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to limited systemic availability after Miconazole buccal tablet application, clinically relevant interactions are unlikely to occur. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effectsshould be monitored.

Contraindications

Known hypersensitivity to Miconazole Nitrate or to any of the other ingredients of the product.

Side Effects

Irritation, burning, maceration and allergic contact dermatitis may occur.

Pregnancy & Lactation

During pregnancy, this medication should be used only when clearly needed. It is not known whether this drug passes into breast milk.

Precautions & Warnings

Harmful effects are not expected following accidental ingestion of the Miconazole buccal tablet. However, reapplication of a new tablet may be required. In cases of reduced salivary production, tablet erosion may be prolonged or inhibited. A minimal salivary production is required to guarantee complete disintegration of the tablet and release of the active drug substance.

Therapeutic Class

Topical Antifungal preparations

Storage Conditions

Store below 25°C and in a dry place, protected from light and moisture. Keep all medicines out of reach of children.

Pharmaceutical Name

Square Pharmaceuticals Ltd.