Description

Ketoconazole Tablets (200mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Ketoconazole Tablets in India. Ketoconazole is a potent Broad-Spectrum Azole Antifungal used to treat serious systemic fungal infections when other therapies are not available or tolerated. It is also widely recognized for its off-label utility in managing Cushing’s Syndrome due to its ability to suppress cortisol production.

Important Note: Due to the risk of hepatotoxicity, this is a prescription-only specialist drug. We offer Contract Manufacturing (Third Party) services with strict adherence to safety protocols. Our WHO-GMP certified facility in Mumbai utilizes advanced formulation techniques to ensure optimal disintegration and dissolution, which are critical for this pH-dependent drug. Healthy Inc manages the export logistics, supplying endocrinology clinics and infectious disease departments across globally regulated markets.

2. Product Specifications

3. Manufacturing Technology

Absorption depends heavily on formulation acidity.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • pH-Dependent Solubility: Ketoconazole is a weak base and requires an acidic environment to dissolve. We formulate the tablet with specific disintegrants that function effectively even if the patient has varying gastric pH levels, ensuring consistent bioavailability.

  • Content Uniformity: We use high-shear granulation to ensure a homogenous mix, critical for ensuring the patient receives exactly 200mg to manage the delicate balance between efficacy and toxicity.

  • Purity Profiling: We rigorously test for organic impurities to minimize the burden on the liver, as the drug itself is metabolized hepatically.

• The Exporter: Healthy Inc

  • Safety Packaging: We provide packaging that includes clear patient information leaflets (PILs) highlighting the liver warning signs, which is a regulatory requirement in many export destinations.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles in simulated gastric fluid (0.1N HCl) to ensure >80% release in 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for degradation products to ensure safety.

5. Why Use Ketoconazole?

It is a “Reserve” Antifungal and a powerful Cortisol Blocker.

• Mechanism (Antifungal): It inhibits the enzyme Lanosterol 14α-demethylase (a CYP450 enzyme). This blocks the synthesis of Ergosterol, a vital component of the fungal cell membrane, causing the fungus to leak and die.

• Mechanism (Anti-Cortisol): At higher doses, it inhibits the enzymes (17,20-lyase) responsible for steroid synthesis in the human adrenal glands, effectively lowering testosterone and cortisol levels.

• Key Indications:

  • Systemic Fungal Infections: Blastomycosis, Histoplasmosis, Chromomycosis (when Itraconazole/Fluconazole fail).

  • Cushing’s Syndrome: (Off-label) Used to lower cortisol levels in patients with endogenous Cushing’s syndrome who cannot have surgery.

  • Prostate Cancer: (Off-label) Used to lower testosterone levels.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Ketoconazole Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Nizoral?

  A: Nizoral is the brand name (Janssen). We manufacture the Generic Equivalent (Ketoconazole), which acts exactly the same.

• Q: Can I use it for nail fungus?

  A: Generally NO. Oral use for skin/nail infections is now restricted in many countries due to liver risks. Topical creams or safer orals (Terbinafine) are preferred. This is reserved for serious systemic infections.

• Q: Why do I need an acidic drink?

  A: If you have low stomach acid (achlorhydria), take the tablet with an acidic beverage (like Cola) to help it dissolve and absorb.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Fungal Infections: 200mg once daily. (Max 400mg).

• Cushing’s Syndrome: 600mg to 1200mg daily (titrated carefully).

• Administration: Take with food to increase absorption and reduce nausea.

9. Side Effects and Precautions

• Hepatotoxicity: Black Box Warning: Serious liver damage (hepatitis), sometimes fatal, has occurred. Monitor Liver Function Tests (LFTs) before starting and weekly during treatment.

• QT Prolongation: Black Box Warning: Can cause life-threatening heart rhythm issues. Do not combine with Cisapride, Terfenadine, or Pimozide.

• Adrenal Suppression: Can lower cortisol and testosterone (causes gynecomastia, impotence, or adrenal insufficiency).

• Drug Interactions: Potent CYP3A4 Inhibitor. It creates dangerous interactions with many drugs (Statins, Benzos, etc.).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture.