Description

Doxofylline Film-Coated Tablets (400 mg)

Healthy Inc is a specialized global supplier and exporter of advanced pulmonology, respiratory medicine, and targeted bronchodilator therapeutics. We provide ultra-high-purity, kinetically optimized Doxofylline Film-Coated Tablets (400 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Novel Xanthine Derivative & Phosphodiesterase Inhibitor” is a massive-volume, highly strategic export to pulmonology centers, asthma/COPD clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally preferred, cardiac-safe intervention for chronic, severe bronchospasm and airway obstruction.

Product Overview

This highly advanced formulation operates as a profound, structural relaxant for the lungs. It actively targets the smooth muscle surrounding the bronchial tubes, forcing them to violently dilate and stay open, while uniquely bypassing the central nervous system and cardiac receptors that make older asthma drugs so dangerous.

The “Cardiac-Safe Bronchodilator & PDE Inhibitor” Specialist:

• Mechanism 1 (The Targeted PDE Inhibition): Like older methylxanthines, Doxofylline acts as a Phosphodiesterase (PDE) inhibitor. By blocking the breakdown of cyclic AMP (cAMP) inside the bronchial smooth muscle cells, it forces a massive intracellular accumulation of this signaling molecule. This directly deactivates the contractile proteins, causing profound, sustained relaxation of the airways, instantly reversing the suffocating bronchospasm of a severe asthma or COPD attack.
• Mechanism 2 (The Adenosine Receptor Bypass): The lethal flaw of traditional Theophylline is that it violently blocks Adenosine Receptors in the heart and brain, triggering agonizing palpitations, tachycardia, and central nervous system toxicity. Doxofylline is engineered with a unique dioxalane ring. This structural alteration prevents it from binding to adenosine receptors almost entirely. It delivers the massive lung-opening power of a xanthine with virtually zero cardiac or neurological toxicity.
• Mechanism 3 (The Anti-Inflammatory Synergy): Beyond pure muscle relaxation, Doxofylline actively suppresses the release of inflammatory mediators from macrophages and eosinophils in the lungs, reducing the underlying airway swelling and hyper-reactivity that drives chronic COPD progression.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Macrodose Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the xanthine derivative.

*Pack Sizes: 10×10 Blisters (Optimized specifically for strict chronic respiratory dispensing regimens).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Macrodose Compression & Dissolution Profiling (CRITICAL COMPLIANCE): Compressing a 400mg xanthine active ingredient into a swallowable tablet requires elite pharmaceutical engineering. If a generic tablet is pressed too hard, it becomes a “brick” that fails to dissolve, leaving the patient gasping for air. Our pulmonology suites utilize advanced high-shear wet granulation and rigorous in-vitro dissolution testing to guarantee a pharmacokinetic profile that matches the originator, ensuring doctors deliver a flawless, highly predictable bronchodilation curve.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized symptomatic management of severe obstructive airway diseases:

• Bronchial Asthma: Maintenance treatment and prophylactic management of chronic asthma to prevent severe bronchospastic attacks.
• Chronic Obstructive Pulmonary Disease (COPD): Relief of chronic suffocating bronchospasm, hyper-secretion, and airway inflammation associated with severe COPD, chronic bronchitis, and emphysema.

Dosage & Administration

Recommended Dosage (Strictly as per Pulmonologist Guidelines):

• Standard Adult Dosing: 400 mg taken orally once daily (OD) in mild cases, or 400 mg twice daily (BID) for severe, refractory bronchospasm.
• Administration: Can be taken with or without food. Tablets must be swallowed whole with a full glass of water.
• Elderly Patients: The dosage must be carefully titrated down in elderly patients or those with severe hepatic impairment, as their ability to clear the drug is significantly reduced.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• The Ephedrine / Caffeine Paradox: Co-administration with other xanthines (like heavy caffeine intake) or sympathomimetics (like Ephedrine) will violently amplify the drug’s effects, potentially pushing a cardiac-safe drug into a state of severe central nervous system toxicity and cardiac overstimulation.
• Hepatic Clearance Warning: Doxofylline is heavily metabolized by the liver. Patients with severe hepatic failure or congestive heart failure will accumulate the drug in their bloodstream to toxic levels, mimicking traditional Theophylline poisoning (nausea, vomiting, seizures).
• Acute Myocardial Infarction Contraindication: Strictly contraindicated in patients actively suffering from an acute myocardial infarction (heart attack) or experiencing severe hypotension.
• Peptic Ulcer Caution: Like all xanthines, Doxofylline can stimulate gastric acid secretion. It must be used with extreme caution in patients with active peptic ulcer disease to prevent exacerbating gastrointestinal bleeding.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Respiratory Medicine Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Bronchodilators, Xanthine Derivatives, and High-Compression Tableting Formulations. Whether you are looking for a reliable Government Tender Supplier for COPD clinics 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.