Terbinafine Tablets

Healthy Inc is a specialized global supplier and exporter of advanced dermatological, podiatric, and systemic anti-infective therapeutics. We provide ultra-high-purity, highly lipophilic Terbinafine Hydrochloride Tablets (250 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Fungicidal Allylamine” is a massive-volume, premium export to dermatology centers, podiatry networks, primary care clinics, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, definitive oral intervention for severe, treatment-resistant onychomycosis and widespread dermatophyte infections.

Product Overview

This formulation contains Terbinafine (as Terbinafine Hydrochloride), a highly advanced synthetic allylamine antifungal that attacks the fungal cell wall earlier in the synthesis pathway than older “azole” drugs, resulting in vastly superior clinical cure rates for skin and nail infections.

The “Nail Matrix & Dermatophyte Eradication” Specialist:

• Mechanism (The Squalene Epoxidase Blockade): Standard antifungals only stop fungi from growing (fungistatic). Terbinafine is actively fungicidal (it kills the fungus outright). It aggressively binds to and blocks the fungal enzyme squalene epoxidase. This triggers a dual-lethal effect: first, it starves the cell of essential ergosterol. Second, it causes a massive, toxic buildup of squalene inside the fungal cell, which violently ruptures the cell membrane from the inside out.
• The Onychomycosis Gold Standard: Fungal nail infections are notoriously difficult to cure because topical creams cannot penetrate the hard keratin of the nail. Oral Terbinafine is highly lipophilic (fat-soluble) and keratinophilic. Once swallowed, it travels through the bloodstream and actively concentrates directly within the nail bed, hair follicles, and sebum, destroying the fungus at its deepest root.
• Sustained Post-Treatment Protection: Because Terbinafine binds so tightly to keratin, it remains active in the nail and skin tissues for weeks or even months after the patient has stopped taking the pills, preventing rapid relapse.

Product Composition & Strength

We supply this product as a Precision-Blended Scored Uncoated Tablet, packed in highly secure, moisture-resistant Alu-PVC or opaque Alu-Alu blister strips, optimized for long-term chronic dermatology dispensing regimens.

*Pack Sizes: 10×10 or 10×14 Blisters (Optimized specifically for 6-week to 12-week chronic dosing schedules).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Dermatology Clinics, and Podiatry Networks.

Manufacturing Authority

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

• Lipophilic Bioavailability Engineering: Terbinafine is a highly lipophilic (fat-loving) molecule, which can make consistent gastric absorption challenging. Our facilities utilize advanced high-shear wet granulation and strictly validated multipoint dissolution profiling to guarantee that every tablet disperses rapidly, achieving predictable, peak plasma concentrations required to flood the nail matrix.

Therapeutic Indications (Human Use)

Indicated for the comprehensive systemic management of severe, deep-tissue fungal infections:

• Onychomycosis (Fungal Nail Infection): Treatment of confirmed dermatophyte infections of the toenail or fingernail.
• Tinea Capitis (Scalp Ringworm): The definitive oral treatment for severe fungal infections of the scalp and hair follicles, particularly in pediatric and adolescent populations.
• Widespread Fungal Skin Infections: Treatment of severe, extensive, or refractory Tinea Corporis (body ringworm), Tinea Cruris (jock itch), and Tinea Pedis (athlete’s foot) where topical therapy has failed or is clinically inappropriate.
• Note: Oral Terbinafine is not effective for Pityriasis versicolor.

Dosage & Administration

Recommended Dosage (Strictly as per Dermatologist/Podiatrist Guidelines):

• Standard Adult Dosing: One 250 mg tablet taken once daily.
• Treatment Duration (CRITICAL ADHERENCE): Fungal nail eradication is a slow process that relies on new, healthy nail growth.
  • Fingernails: Typically requires 6 weeks of continuous daily therapy.
  • Toenails: Typically requires 12 weeks of continuous daily therapy.
• Administration: Can be taken on an empty stomach or with a meal, as food does not significantly alter its high bioavailability.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Hepatotoxicity (Liver Failure): Rare cases of severe liver failure, some leading to death or liver transplant, have occurred in patients taking oral Terbinafine (even in those without pre-existing liver disease). It is strictly required to perform Liver Function Tests (ALT, AST) prior to initiating therapy. The drug must be discontinued immediately if biochemical or clinical evidence of liver injury develops (jaundice, dark urine, upper abdominal pain).
• Taste Disturbance (Dysgeusia) & Smell Loss: Terbinafine uniquely causes taste disturbances, metallic taste, or complete loss of taste/smell in some patients. This can lead to decreased appetite and severe weight loss. While usually reversible within weeks of stopping the drug, it can sometimes be prolonged or permanent.
• Severe Skin Reactions: Can rarely trigger catastrophic, life-threatening skin reactions, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Therapy must be stopped at the first sign of a progressive skin rash.
• Neutropenia: Severe, transient drops in white blood cell counts have been reported. Monitor complete blood counts if the patient develops signs of a secondary infection.

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 Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Dermatological Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for podiatry clinics 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.