- Stock: In Stock
- Brand: Square Pharmaceuticals
- Product ID: Ketoconazole
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| Generic Name | Ketoconazole |
|---|---|
| Strength | 200 mg |
| Dosage Form | Tablet |
| Manufacturer | Square Pharmaceuticals PLC |
| Therapeutic Class | Drugs for subcutaneous and mycoses |
| Pack Size | 4 × 10 tablets (40's) |
Overview
Ketoral (Ketoconazole) 200 mg Tablet is an azole antifungal agent manufactured by Square Pharmaceuticals PLC. It inhibits fungal 14-α-sterol demethylase (a cytochrome P-450 enzyme), blocking the conversion of lanosterol to ergosterol, thereby disrupting fungal cell membrane integrity and increasing cellular permeability. Ketoral tablets are indicated for the treatment of systemic and resistant superficial fungal infections including candidiasis (oral, systemic, vaginal), dermatophytosis, pityriasis versicolor, onychomycosis, mycoses of the hair and scalp, chronic mucocutaneous candidiasis, histoplasmosis, and paracoccidioidomycosis.
Dosage and Administration
Adults: 1 tablet (200 mg) once daily with food, until at least one week after symptoms have resolved and cultures are negative. Vaginal candidiasis: 1 tablet twice daily for 5 days. Children: 3–5 mg/kg/day. Treatment duration varies by indication: pityriasis versicolor 1–6 weeks, dermatomycoses 2–8 weeks, onychomycosis 1–12 months, hair/scalp mycoses 1–2 months, chronic mucocutaneous candidiasis up to 12 months, systemic candidiasis 1–2 months, paracoccidioidomycosis/histoplasmosis 1 month to 2 years. Drugs that reduce gastric acidity (antacids, H2 blockers, PPIs) impair absorption — take Ketoral at least 2 hours before these agents.
Interaction
Drugs that reduce gastric acidity (antacids, H2 receptor antagonists, proton pump inhibitors) significantly reduce Ketoconazole absorption. Ketoconazole is a potent CYP3A4 inhibitor and may increase plasma levels of many drugs metabolized by this pathway including anticoagulants, benzodiazepines, calcium channel blockers, and statins. Consult your physician for a full drug interaction review.
Contraindications
Contraindicated in patients with known hypersensitivity to ketoconazole or any component of the formulation.
Side Effects
Common side effects of Ketoral tablets include nausea, headache, diarrhea, abdominal pain, and vomiting. Rare but serious: hepatotoxicity (monitor liver enzymes, particularly with prolonged use). Discontinue immediately if signs of liver disease develop (jaundice, pale stools, dark urine, fatigue, nausea).
Pregnancy and Lactation
Pregnancy category C. No adequate well-controlled studies in pregnant women. Ketoconazole is excreted in breast milk — mothers taking Ketoral tablets should not breastfeed.
Precautions and Warnings
Monitor liver enzyme levels before and during treatment, especially in patients with a history of liver disease. Discontinue immediately if symptoms of hepatotoxicity occur. Take with food to enhance absorption and reduce GI side effects. Avoid concurrent use of gastric acid-reducing agents. Use with caution in patients taking CYP3A4-metabolized drugs due to significant interaction potential.
Storage Conditions
Keep below 25°C, away from light and moisture. Keep out of the reach of children.
Frequently Asked Questions
Q: How long does Ketoral 200 mg tablet treatment last?
A: Duration varies by infection type — from 5 days for vaginal candidiasis to up to 12 months for onychomycosis or chronic mucocutaneous candidiasis. Always follow the full course as directed by your physician.
Q: Should I take Ketoral tablet with food?
A: Yes — taking Ketoral with food improves absorption and helps reduce gastrointestinal side effects. Avoid taking it with antacids or acid-reducing medications, as these can significantly decrease ketoconazole absorption.
