FLUCONAZOLE & IVERMECTIN TABLETS

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Description

Fluconazole & Ivermectin Film-Coated Tablets (150 mg / 6 mg)

Healthy Inc is a specialized global supplier and exporter of advanced dermatology, tropical medicine, and targeted dual-pathogen eradication therapeutics. We provide ultra-high-purity, kinetically synchronized Fluconazole & Ivermectin Film-Coated Tablets (150 mg / 6 mg), manufactured in WHO–GMP certified, high-precision micro-dosing oral solid dosage facilities. This “Antifungal & Macrolide Antiparasitic FDC” is a massive-volume, highly critical export to dermatology centers, tropical disease NGOs, rural health networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, syndromic intervention for severe, co-occurring fungal and parasitic skin infections, including crusted scabies complicated by widespread dermatophytosis.


Product Overview

This highly advanced formulation operates as a devastating, two-pronged biochemical assault against complex skin diseases. It simultaneously paralyzes and destroys invading parasites while chemically shattering the cell walls of rapidly spreading fungal spores, offering complete dermatological clearance in a single therapeutic regimen.

The “Chloride-Channel Paralyzer & Ergosterol Blocker” Specialist:

  • Mechanism 1 (The Antifungal Cell-Wall Breach – Fluconazole): Fluconazole is a highly potent, systemic triazole antifungal. It aggressively inhibits the fungal enzyme cytochrome P450 14α-demethylase. This violently halts the production of ergosterol, a crucial building block of the fungal cell membrane. Without ergosterol, the fungal cell wall collapses, causing the cell contents to leak out, resulting in rapid fungal death (fungicidal activity against severe Tinea, Candida, and Cryptococcus).
  • Mechanism 2 (The Parasitic Paralysis – Ivermectin): Ivermectin is a massive macrocyclic lactone. It specifically targets the nervous system of invertebrate parasites (like the Sarcoptes scabiei mite). It binds forcefully to glutamate-gated chloride ion channels in the parasite’s nerve and muscle cells. This massive influx of chloride ions hyperpolarizes the nerve, instantly paralyzing the parasite and causing rapid, fatal starvation.
  • The “Tropical Co-Infection” Synergy: In hot, humid environments, a patient suffering from intense itching caused by Scabies will inevitably scratch their skin open, allowing aggressive fungal spores to invade the deep tissue. Prescribing separate treatments often leads to patient non-compliance. This FDC acts as a “smart bomb,” systematically hunting down both the mites deep in the epidermis and the fungal networks spreading across the dermis, providing total symptomatic relief.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Microdose FDC Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of both active pharmaceutical ingredients.

Active IngredientStrengthPrimary Clinical Function
Fluconazole USP/Ph.Eur.150 mgThe Antifungal Anchor (Macro-Dose): The foundational triazole payload required to systematically eradicate widespread dermatophytes and yeasts.
Ivermectin EP/USP6 mg / 12 mgThe Antiparasitic Assassin (Micro-Dose): The highly potent, targeted neurotoxin required to paralyze burrowing mites, lice, and severe helminthic infections.
ExcipientsMicrocrystalline Cellulose / Croscarmellose Sodium / Povidone K-30 / Colloidal Silicon Dioxide / Magnesium Stearate / Premium Polymeric FilmDiluent / Superdisintegrant / High-Shear Binder / Glidant / Film-Coating (Engineered specifically utilizing advanced multi-stage geometric dilution to ensure the lethal 6mg micro-dose of Ivermectin is flawlessly distributed throughout the massive Fluconazole matrix, preventing toxic “hot spots”)

*Pack Sizes: Single-Dose Blister Packs (1×1 or 1×2) or 10×10 Blisters (Optimized specifically for rapid NGO deployment and “stat” dosing protocols).


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Dermatology Distributors, and Hospital Procurement Boards.

HS Code3004.90.99 (Medicaments containing other active substances – Dermatology/Anti-Infective FDC)
CAS Numbers86386-73-4 (Fluconazole) / 70288-86-7 (Ivermectin)
Dosage FormFilm-Coated Tablet (Immediate Gastric Release)
PackagingHigh-Density Alu-Alu Blisters (STRICTLY MANDATORY). Protects the formulation from environmental humidity across Zone IVb tropical climates, preventing the degradation of the complex macrolide structure of Ivermectin.
StorageStore strictly below 30°C in a dry place. Protect heavily from Moisture and Light.

Manufacturing Authority

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

  • Macro/Micro Content Uniformity (CRITICAL COMPLIANCE): The engineering challenge of this FDC dictates its safety profile. Standard generic manufacturers struggle to blend a potent 6 mg active ingredient evenly into a massive 150 mg base. If Content Uniformity fails, a patient could ingest an overdose of Ivermectin, triggering severe neurotoxicity (tremors, ataxia, and coma). Our dermatology suites utilize elite dry-blending and high-shear wet granulation, validated by intensive HPLC batch-testing, to guarantee 100% uniformity. This proves to major hospital boards that our dosing is clinically flawless.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized syndromic management of severe skin and systemic co-infections:

  • Complex Scabies & Dermatophytosis: Treatment of severe, crusted (Norwegian) scabies complicated by widespread secondary fungal infections (Tinea corporis, Tinea cruris).
  • Syndromic Tropical Skin Clearance: Mass drug administration (MDA) programs targeting multi-pathogen outbreaks in immunocompromised populations or heavily crowded rural settlements.

Dosage & Administration

Recommended Dosage (Strictly as per Dermatologist / Infectious Disease Guidelines):

  • Standard Adult Dosing: Frequently prescribed as a single “STAT” dose, or repeated once after 7 to 14 days depending on the life cycle of the targeted parasite and the severity of the fungal infection.
  • Administration: Should be taken on an empty stomach with a full glass of water to maximize the systemic bioavailability of Ivermectin.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

  • Severe Hepatotoxicity (Fluconazole): Fluconazole can cause severe, sometimes fatal, hepatic toxicity. Liver enzymes must be monitored in patients requiring prolonged therapy or those with underlying liver disease.
  • The Mazzotti Reaction (Ivermectin Alert): When Ivermectin triggers the massive, sudden death of microfilariae (parasites) in the body, it can cause a severe, life-threatening allergic and inflammatory response known as the Mazzotti Reaction (fever, rash, severe hypotension, and lymph node swelling).
  • CYP450 Enzyme Interactions (FATAL WARNING): Fluconazole is a massive inhibitor of CYP2C9, CYP2C19, and CYP3A4 liver enzymes. Co-administration with drugs metabolized by these pathways (like Warfarin, Phenytoin, or certain statins) will cause a massive, potentially fatal overdose of the co-administered drug.
  • Teratogenic Warning: Strictly contraindicated in pregnant women. Both Fluconazole (at high doses) and Ivermectin are associated with severe fetal harm and congenital abnormalities.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Dermatology/NGO Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antifungals, Antiparasitics, and Macro/Micro Tableting Formulations. Whether you are looking for a reliable Government Tender Supplier for tropical disease clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.

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