Description

Itraconazole Capsules

Healthy Inc is a specialized global supplier and exporter of advanced anti-fungal, dermatological, and infectious disease therapeutics. We provide ultra-high-purity Itraconazole Capsules (100 mg / 200 mg), manufactured in WHO–GMP certified, advanced multi-particulate pelletization facilities. This “Broad-Spectrum Triazole Antifungal” is a massive-volume, premium export to dermatology clinics, infectious disease hospitals, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the definitive, globally trusted intervention for severe systemic mycoses, recalcitrant dermatophytosis, and onychomycosis.

Product Overview

This formulation contains Itraconazole, a highly potent, broad-spectrum synthetic triazole that aggressively targets fungal cell walls while leaving human cellular structures unharmed.

The “Ergosterol Eradication & Systemic Defense” Specialist:

• Mechanism (Membrane Collapse): Fungi rely absolutely on a molecule called ergosterol to maintain the structural integrity of their cell membranes. Itraconazole binds to and aggressively inhibits the fungal enzyme lanosterol 14-α-demethylase, completely halting ergosterol production. Without it, the fungal cell membrane becomes highly porous, leaks vital cellular contents, and undergoes rapid cell death.
• The Broad-Spectrum Champion: While older antifungals have narrow target ranges, Itraconazole provides sweeping coverage. It is highly lethal to dermatophytes (ringworm), yeasts (Candida), and life-threatening systemic fungi (Aspergillus, Histoplasma, and Blastomyces), making it an indispensable tool for severe or immunocompromised fungal infections.
• Tissue Penetration Advantage: Itraconazole is highly lipophilic (fat-loving) and keratinophilic (keratin-loving). It aggressively concentrates in the skin, sebum, and nails, maintaining highly therapeutic, fungus-killing levels in the nail bed for up to 6 months after the patient stops taking the medication.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule containing Bio-Enhanced Micro-Pellets, packed strictly in high-barrier Alu-Alu or heavy-gauge Alu-PVC blister strips to ensure API stability in extreme tropical climates.

*Pack Sizes: 1×4, 1×10, or 1×15 Blisters (Specifically optimized for specialized “Pulse Therapy” dermatology dispensing).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Dermatology Distributors.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Advanced Spray-Coating Pelletization: Raw Itraconazole powder is practically insoluble in water, meaning a standard compressed tablet would pass straight through the body unabsorbed. Our facilities utilize advanced fluid-bed technology to dissolve the API in a highly specialized polymer matrix, which is then microscopically spray-coated onto inert sugar spheres. This massively increases the surface area and transforms an insoluble drug into a highly bioavailable therapy.
• Dissolution Profiling: Rigorous in vitro dissolution testing is performed via HPLC on every batch in strictly controlled acidic mediums to guarantee that the drug releases instantly in the stomach for maximum systemic absorption.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of superficial and deep-tissue fungal infections:

• Onychomycosis (Fungal Nail Infection): Treatment of severe, recalcitrant dermatophyte infections of the toenails and fingernails, frequently utilizing “Pulse Therapy.”
• Dermatophytosis: Eradication of severe Tinea corporis (ringworm), Tinea cruris (jock itch), and Tinea pedis (athlete’s foot) that do not respond to topical creams.
• Vulvovaginal Candidiasis: Rapid treatment of acute or recurrent yeast infections.
• Systemic Mycoses: Life-saving intervention for severe systemic infections including Aspergillosis, Blastomycosis, and Histoplasmosis, particularly in immunocompromised patients (HIV/AIDS).

Dosage & Administration

Recommended Dosage (Strictly as per Dermatologist/Physician):

• Administration (ACIDITY IS CRITICAL): Itraconazole capsules require a highly acidic stomach environment to dissolve. They MUST be taken immediately after a full, heavy meal. For patients with low stomach acid (or those taking PPIs like Omeprazole), the capsules should be swallowed with an acidic beverage, such as a cola.
• Pulse Therapy (Onychomycosis): A standard pulse consists of 200 mg taken twice daily for 1 week, followed by 3 weeks completely OFF the drug. Fingernails typically require 2 pulses; toenails require 3 pulses.

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Congestive Heart Failure): Itraconazole has negative inotropic effects (it physically weakens the contraction of the heart muscle). It is strictly contraindicated in patients with evidence of ventricular dysfunction or a history of Congestive Heart Failure (CHF).
• BLACK BOX WARNING (Drug Interactions): Itraconazole is one of the most potent inhibitors of the hepatic CYP3A4 enzyme. It massively spikes the blood levels of co-administered drugs. Co-administration with certain statins (Simvastatin, Lovastatin) causes fatal muscle breakdown (rhabdomyolysis), and combining it with QT-prolonging drugs can cause fatal cardiac arrhythmias.
• Hepatotoxicity: Rare cases of severe, potentially fatal hepatotoxicity, including liver failure, have been reported. Liver function enzymes must be monitored during continuous, prolonged therapy.

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 Advanced Dermatological and Antifungal Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for infectious disease programs 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.