Description
Ketoconazole Tablets
Healthy Inc is a specialized global supplier and exporter of potent broad-spectrum antifungals. We provide high-purity Ketoconazole Tablets, sourced from WHO–GMP certified solid dosage facilities. While topical forms are common, this oral “Systemic Specialist” is a critical export to dermatology centers, endocrinology clinics, and government health tenders in Africa, LATAM, and Southeast Asia, reserved for treating severe, resistant fungal infections and managing specific hormonal disorders (Cushing’s Syndrome).
[Image of Ketoconazole mechanism of action inhibiting lanosterol 14 alpha-demethylase]
Product Overview
This formulation contains Ketoconazole, a synthetic imidazole antifungal agent.
The “Deep Tissue” Antifungal:
- Mechanism: It works by inhibiting the enzyme **lanosterol 14α-demethylase** (a CYP450 enzyme). This blocks the synthesis of **ergosterol**, a vital component of the fungal cell membrane. Without ergosterol, the membrane becomes leaky, leading to cell death.
- Broad Spectrum: Highly effective against dermatophytes, yeasts (Candida), and dimorphic fungi (Histoplasma, Blastomyces).
- Hormonal Modulation (Off-Label): At higher doses, Ketoconazole inhibits steroid synthesis in the adrenal glands. This unique property makes it a valuable off-label treatment for **Cushing’s Syndrome** to lower excess cortisol levels.
- Reserve Status: Due to potential liver toxicity, oral Ketoconazole is typically used when other effective antifungal therapy is not available or tolerated.
Product Composition & Strength
We supply this product as Uncoated Tablets (scored). The standard strength is 200 mg.
| Active Ingredient | Strength (Standard) | Role |
|---|---|---|
| Ketoconazole USP/BP | 200 mg | Standard Adult Dose |
| Excipients | Q.S. | Colloidal Silicon Dioxide / Starch |
*Pack Sizes: Blister packs of 10s (Box of 10×10) or Bulk HDPE Jars of 100s/500s.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.20.19 (Medicaments containing other antibiotics/antifungals) |
| Dosage Form | Tablet (Oral) |
| Packaging | Alu-Alu Blister or PVC-PVDC/Alu Blister |
| Storage | Store below 25°C. Protect from moisture and light. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Dissolution Profile: Ketoconazole is a weak base and requires an acidic environment to dissolve. Our formulation includes specific disintegrants that ensure rapid breakup in the stomach to maximize contact with gastric acid.
- Content Uniformity: Precise blending ensures that the potent 200mg dose is evenly distributed, which is critical for maintaining therapeutic blood levels.
Therapeutic Indications (Human Use)
Indicated for the treatment of susceptible fungal infections:
- Systemic Mycoses: Blastomycosis, Coccidioidomycosis, Histoplasmosis, Chromomycosis, and Paracoccidioidomycosis (when other drugs have failed).
- Chronic Mucocutaneous Candidiasis: Severe infections of the skin and nails unresponsive to topical treatment.
- Recurrent Dermatophytosis: Severe ringworm or athlete’s foot resistant to Griseofulvin.
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Route: Oral.
- Adults: 200 mg (one tablet) once daily. In severe infections, the dose may be increased to 400 mg once daily.
- Acid Requirement (Critical): Absorption requires stomach acid.
- Take with food to increase acid secretion.
- Do NOT take with antacids, PPIs (Omeprazole), or H2 blockers (Ranitidine). If necessary, take these drugs at least 2 hours after Ketoconazole.
- Patients with Achlorhydria (no stomach acid) should dissolve the tablet in a 4ml solution of 0.2N HCl or take it with an acidic beverage like Coca-Cola or Pepsi.
Safety Warnings:
- Hepatotoxicity (Black Box Warning): Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation, has occurred. Liver Function Tests (LFTs) must be performed before starting treatment and weekly during treatment.
- QT Prolongation: Can cause life-threatening heart rhythm disorders. Contraindicated with other drugs that prolong the QT interval (e.g., Terfenadine, Astemizole, Cisapride).
- Drug Interactions: Potent inhibitor of CYP3A4. It significantly increases the blood levels of many other drugs (Statins, Benzodiazepines, Warfarin), leading to toxicity.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for OSD (Oral Solid Dosage) forms, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
