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✅ Description:
Indications
Dermatophytes, yeasts, and other fungi can cause skin and nail diseases such as Tinea capitis, corporis, manuum, pedis, Barbie, cruris, unguium, or onychomycosis. Pityriasis versicolor, nail- and skin-candidiasis, angular stomatitis, and otitis externa. Miconazole Topical Cream may be utilized in mycoses that are secondarily infected with such bacteria since it has an antibacterial impact on Gram-positive bacteria.
Pharmacology
Miconazole, a synthetic imidazole anti-fungal drug having broad-spectrum activity against pathogenic fungi (including yeast and dermatophytes) and gram-positive bacteria, is the primary component of Fungidal® BT buccal tablets (Staphylococcus and Streptococcus spp). It might work by affecting how permeable the fungal cell membranes are. Miconazole is an oral medication that is only partially absorbed from the gastrointestinal tract. After a dose of 1 g per day, peak plasma levels of roughly 1 g per ml have been reached. In the body, miconazole is inactivated, and within 6 days, 10-20% of an oral dose is eliminated in the urine, primarily as metabolites. A dose taken orally may be eliminated in the feces in an amount of up to 50%.
Dosage and 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. The second week of treatment may be indicated. The use of Miconazole in children below the age of 7 is not recommended.
Method of administration: Once a tablet is removed from the blister, it should be used immediately. Tablet intended for the buccal cavity; do not crush, chew, or swallow the tablet.
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 effects should be monitored.
Contraindications
Known hypersensitivity to Miconazole Nitrate or to any of the other ingredients of the product.
Side effects: Nausea and taste perversion are common side effects experienced with Miconazole buccal tablet. Allergic reaction is rarely observed. Mouth irritation, oral numbness, vomiting, diarrhea & dizziness are uncommon side effects.
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, the 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 the complete disintegration of the tablet and release of the active drug substance.
Storage Conditions
Store below 25°C and in a dry place, protected from light and moisture. Keep all medicines out of reach of children.
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