Indications:
- Oral Gel: Treats oral and gastrointestinal candidiasis, eliminates fungal colonization in the mouth and gut, and addresses super infections caused by gram-positive bacteria.
- Cream: Effective for various dermatomycoses including athlete’s foot (tinea pedis), ringworm (tinea corporis), hand fungus (tinea manuum), jock itch (tinea cruris), and candidial infections. Also useful for perianal infections, angular cheilitis, balanoposthitis, otitis externa, and skin infections like intertrigo and tinea versicolor.
Pharmacology:
- Mechanism: Miconazole, the active ingredient, combats fungal infections by disrupting ergosterol biosynthesis, essential for fungal cell membrane integrity. This disruption causes leakage and death of fungal cells.
- Absorption: Oral bioavailability is low (25-30%) with minimal intestinal absorption. Systemically absorbed Miconazole binds extensively to plasma proteins and is metabolized in the liver. Less than 1% is excreted unchanged in urine, with a terminal half-life of 20-25 hours.
Dosage:
- Oral Gel:
- Oropharyngeal Candidiasis: Infants (4-24 months) use 1.25 ml, and children 2 years and older and adults use 2.5 ml, applied 4 times daily after meals.
- Gastrointestinal Candidiasis: Dosage for those who can’t swallow tablets is 20 mg/kg body weight daily in divided doses, not exceeding 250 mg (10 ml gel) four times daily.
- Cream: Apply to affected areas twice daily for conditions like tinea pedis and candidiasis, and once daily for tinea versicolor. Treatment may last 2 to 5 weeks, with extended use recommended to prevent recurrence.
Administration:
Apply a small amount of oral gel to localized mouth lesions 2-4 times a day with a clean finger, keeping the gel in contact with the affected area as long as possible. Continue for at least one week after symptoms resolve.
Interactions:
Avoid: Concurrent use with Terfenadine, Astemizole, and Cisapride due to potential metabolic inhibition. Monitor levels if used with Phenytoin and Cyclosporine, as Miconazole may delay their metabolism.
Contraindications:
Do not use in patients with hypersensitivity to Miconazole.
Side Effects:
- Common: Nausea, vomiting, diarrhea with long-term use; rare allergic reactions.
- Cream: May cause local irritation, redness, or rash.
Pregnancy & Lactation:
- Pregnancy: Use only if absolutely necessary, balancing risks and benefits.
- Lactation: Minimal Miconazole is excreted in breast milk; exercise caution.
Precautions:
- Monitoring: Regular checks needed if used with anticoagulants or Phenytoin. Ensure gel does not obstruct the throat in young children.
Overdose Effects:
- Symptoms: Vomiting and diarrhea. Symptomatic and supportive treatment recommended; no specific antidote available.
Therapeutic Class:
Antifungal preparations for dermatologic and oral conditions.
Storage Conditions:
Store in a cool, dry place away from light and heat. Keep out of reach of children.
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