Description

Drotaverine Hydrochloride Film-Coated Tablets (40 mg / 80 mg)

Healthy Inc is a specialized global supplier and exporter of advanced gastroenterology, urology, and targeted smooth-muscle spasmolytic therapeutics. We provide ultra-high-purity, kinetically optimized Drotaverine Hydrochloride Film-Coated Tablets (40 mg / 80 mg), manufactured in WHO–GMP certified, high-precision rapid-release oral solid dosage facilities. This “Selective Phosphodiesterase-4 (PDE4) Inhibitor” is a massive-volume, highly strategic export to gastroenterology networks, maternity hospitals, emergency colic wards, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally preferred, non-anticholinergic intervention for severe biliary, renal, and uterine smooth muscle spasms.

Product Overview

This highly advanced formulation operates as a direct, targeted mechanical relaxant. Instead of shutting down the entire parasympathetic nervous system to stop a cramp, it acts exclusively on the smooth muscle cells themselves, neutralizing the spasm at the cellular level while leaving the brain, eyes, and heart completely unaffected.

The “Selective PDE4 Inhibitor & Non-Anticholinergic” Specialist:

• Mechanism 1 (The PDE4 Blockade): Drotaverine is a highly potent isoquinoline derivative. It selectively inhibits the enzyme Phosphodiesterase-4 (PDE4) directly within smooth muscle cells. By blocking this enzyme, it forces a massive intracellular accumulation of cyclic AMP (cAMP).
• Mechanism 2 (Myosin Light Chain Kinase Deactivation): The sudden spike in cAMP triggers a cascade that violently drives calcium ions out of the cell’s cytosol. Without intracellular calcium, the myosin light chain kinase enzyme is deactivated, and the violently contracting smooth muscle (whether in the gallbladder, ureter, or uterus) is physically forced into immediate, profound relaxation.
• The “Non-Anticholinergic” Supremacy: Traditional antispasmodics (like Dicyclomine or Atropine) work by blocking acetylcholine. This stops the spasm, but also causes severe systemic toxicity: profound dry mouth, extreme blurred vision, tachycardia, and dangerous intraocular pressure spikes. Because Drotaverine bypasses the autonomic nervous system entirely, it delivers massive spasmolytic power with an exceptionally clean, highly tolerable safety profile.

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Rapid-Burst Disintegration & Bioequivalence (CRITICAL COMPLIANCE): A patient suffering from a passing kidney stone is in agonizing, blinding pain. They cannot wait an hour for a badly compressed generic tablet to dissolve. Our GI suites utilize elite Crospovidone superdisintegrants and highly calibrated rotary presses. This ensures the 80mg “Forte” tablet remains rock-solid during global logistics but violently expands and shatters the moment it hits stomach acid, guaranteeing maximum systemic absorption and rapid clinical rescue.

Therapeutic Indications (Human Use)

Indicated for the targeted, rapid management of severe smooth muscle spasms:

• Biliary Colic & Gallbladder Spasms: Cholelithiasis (gallstones), cholecystitis, and spasms of the biliary tract.
• Renal Colic & Urogenital Spasms: Nephrolithiasis (kidney stones), ureterolithiasis, pyelitis, and severe cystitis.
• Gynecology & Obstetrics: Severe dysmenorrhea (menstrual cramps), adnexitis, and specifically used by obstetricians to accelerate cervical dilation during the active phase of labor (to prevent prolonged labor).
• Gastrointestinal Spasms: Adjunct therapy for gastric and duodenal ulcers, irritable bowel syndrome (IBS), and severe enteritis.

Dosage & Administration

Recommended Dosage (Strictly as per Physician Guidelines):

• Standard Adult Dosing: 40 mg to 80 mg taken orally 2 to 3 times a day. Maximum daily oral dose should generally not exceed 240 mg.
• Administration: Can be taken with or without food. Tablets must be swallowed whole with a full glass of water.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Hypotension & Vertigo Warning: Drotaverine is a potent smooth muscle relaxant; it can rapidly relax blood vessels, causing a sudden, dangerous drop in blood pressure (hypotension) and severe dizziness, particularly if the patient is dehydrated.
• Severe Heart Failure Contraindication: The drug can have mild negative inotropic effects (weakening the force of the heartbeat). It is strictly contraindicated in patients suffering from severe heart failure or severe cardiogenic shock.
• Parkinson’s Disease Interaction (Levodopa): Drotaverine significantly decreases the anti-Parkinsonian effect of Levodopa. Co-administration will cause a rapid worsening of the patient’s tremors and rigidity.
• Porphyria Contraindication: Caution is advised, as isoquinoline derivatives have occasionally been linked to exacerbations in patients with a history of acute porphyria.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Gastroenterology/Maternity Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Spasmolytics, Non-Anticholinergic Therapeutics, and Rapid-Burst Tableting Formulations. Whether you are looking for a reliable Government Tender Supplier for maternity hospitals in the CIS or a B2B Pharma Marketplace partner for Southeast Asia, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.