Description

Ebastine Film-Coated Tablets (10 mg / 20 mg)

Healthy Inc is a specialized global supplier and exporter of advanced immunology, dermatology, and targeted non-sedating antihistamine therapeutics. We provide ultra-high-purity, kinetically optimized Ebastine Film-Coated Tablets (10 mg / 20 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Second-Generation H1-Receptor Antagonist & Prodrug” is a highly lucrative, premium export to allergy centers, specialized dermatology networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally preferred, zero-drowsiness intervention for severe Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria.

Product Overview

This highly advanced formulation operates as a sophisticated, metabolically activated allergy shield. Unlike older antihistamines that flood the entire central nervous system, Ebastine uses the body’s own liver enzymes to unlock its power, exclusively targeting peripheral allergy receptors while leaving the brain completely untouched.

The “Carebastine Prodrug & Peripheral H1 Blockade” Specialist:

• Mechanism 1 (The Hepatic Prodrug Activation): Ebastine itself is almost entirely inactive when swallowed. Once absorbed, it is immediately routed to the liver where the cytochrome P450 enzyme CYP3A4 violently metabolizes it into its highly potent, active form: Carebastine. This conversion ensures a sustained, smooth release of the active antihistamine into the bloodstream, providing true 24-hour coverage from a single dose.
• Mechanism 2 (Selective Peripheral H1 Antagonism): Carebastine exhibits an incredibly high affinity for peripheral H1-histamine receptors located in the skin, nasal passages, and respiratory tract. By locking onto these receptors, it physically prevents the histamine released by mast cells from binding, instantly shutting down the cascade of itching, swelling, sneezing, and vasodilation.
• Mechanism 3 (The Absolute Blood-Brain Barrier Exclusion): First-generation antihistamines (like Diphenhydramine) cross the blood-brain barrier, causing profound, dangerous sedation. Carebastine’s molecular structure physically prohibits it from entering the central nervous system. This guarantees that patients experience profound allergy relief with absolutely zero “hangover” lethargy, daytime somnolence, or cognitive impairment, making it the premier choice for pilots, drivers, and heavy machinery operators.

Product Composition & Strength

We supply this product as a Precision-Blended, Rapid-Dissolution Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the piperidine derivative API.

*Pack Sizes: 10×10 Blisters (Optimized specifically for strict, 30-day chronic allergy and dermatology dispensing regimens).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Prodrug Bioavailability & Dissolution Profiling (CRITICAL COMPLIANCE): The clinical success of Ebastine is entirely dependent on its absorption and subsequent hepatic conversion. A poorly compressed generic tablet that dissolves too slowly will result in erratic Carebastine blood levels and therapeutic failure. Our immunology suites utilize advanced high-shear granulation and rigorous in-vitro dissolution testing to guarantee a pharmacokinetic profile perfectly matching the originator brand, ensuring doctors deliver a flawless, predictable 24-hour allergy shield.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized symptomatic management of histamine-mediated disorders:

• Allergic Rhinitis: Symptomatic relief of seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis, effectively targeting sneezing, rhinorrhea (runny nose), and nasal pruritus (itching).
• Chronic Idiopathic Urticaria: First-line symptomatic relief of severe, unexplained chronic hives, significantly reducing the size, number, and intense pruritus of wheals.
• Allergic Dermatitis: Adjunct management of severely itchy, histamine-driven skin conditions.

Dosage & Administration

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

• Standard Adult Dosing: 10 mg or 20 mg taken orally once daily, depending on symptom severity.
• Administration: Can be taken with or without food. Taking it with a meal slightly increases the AUC (Area Under the Curve) of the active metabolite, but does not significantly alter clinical efficacy.
• Hepatic Impairment Rule: In patients with severe liver failure, the dose must strictly not exceed 10 mg per day, as their compromised liver cannot metabolize the drug efficiently, leading to dangerous accumulation.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• QTc Prolongation & CYP3A4 Interactions (FATAL WARNING): Because Ebastine is metabolized by the CYP3A4 enzyme, it is strictly contraindicated with strong CYP3A4 inhibitors like Ketoconazole, Itraconazole, Erythromycin, or Clarithromycin. Co-administration will violently spike Ebastine blood levels, potentially leading to fatal cardiac arrhythmias and severe QTc prolongation.
• Cardiac Arrhythmia Caution: While safer than older astemizole/terfenadine class drugs, Ebastine must be prescribed with extreme caution in patients with known prolonged QT syndrome, severe hypokalemia, or taking concurrent arrhythmogenic drugs.
• Pregnancy & Lactation: Should not be used during pregnancy or lactation unless the clinical benefit strictly outweighs the potential risk to the fetus/infant, as human safety data is limited.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Allergy/Dermatology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antihistamines, Prodrug Formulations, and Rapid-Dissolution Tableting. Whether you are looking for a reliable Government Tender Supplier for seasonal allergy programs in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.