Drotaverine Hydrochloride & Mefenamic Acid Film-Coated Tablets (80 mg / 250 mg)
Healthy Inc is a specialized global supplier and exporter of advanced gynecology, gastroenterology, and targeted multi-pathway analgesic therapeutics. We provide ultra-high-purity, kinetically synchronized Drotaverine Hydrochloride & Mefenamic Acid Film-Coated Tablets (80 mg / 250 mg), manufactured in WHO–GMP certified, high-precision bi-layer oral solid dosage facilities. This “Spasmolytic & Fenamate NSAID FDC” is a massive-volume, highly lucrative export to maternity hospitals, gynecology networks, emergency colic wards, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for agonizing primary dysmenorrhea, pelvic inflammatory pain, and severe uterine spasms.
Product Overview
This highly advanced formulation operates as a coordinated, three-front biochemical assault on acute pelvic and abdominal pain. It targets the mechanical root cause (the violently contracting smooth muscle), halts the synthesis of new inflammatory chemicals, and uniquely blocks the receptors from receiving existing pain signals.
The “PDE4 Inhibitor & Dual-Action Fenamate” Specialist:
- Mechanism 1 (The Mechanical Spasm Halt – Drotaverine): During a severe menstrual cycle or biliary attack, smooth muscle goes into a state of hyper-contraction (spasm), causing agonizing tissue ischemia (lack of oxygen). Drotaverine selectively inhibits the Phosphodiesterase-4 (PDE4) enzyme inside these cells. This forces a massive influx of cyclic AMP (cAMP), completely deactivating the contractile proteins and physically forcing the violently spasming uterus or biliary duct to instantly relax.
- Mechanism 2 (Prostaglandin Synthesis Blockade – Mefenamic Acid): The initial spasm and shedding of the uterine lining trigger a massive release of inflammatory prostaglandins. Mefenamic Acid is a highly potent anthranilic acid derivative (NSAID). It aggressively inhibits the Cyclooxygenase (COX-1 and COX-2) enzymes, instantly neutralizing the synthesis of Prostaglandin E2 (PGE2) and stopping the generation of new pain and fever signals.
- Mechanism 3 (The Prostaglandin Receptor Antagonism): Unlike almost all other NSAIDs, Mefenamic Acid has a unique secondary mechanism: it acts as a direct antagonist at the prostaglandin receptor sites. It physically blocks existing, already-synthesized prostaglandins from binding to the uterine wall, providing significantly faster and more profound relief for dysmenorrhea than standard painkillers like Ibuprofen or Diclofenac.
Product Composition & Strength
We supply this product as a Precision-Blended, Bi-Layer Macrodose FDC Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or heavy-gauge Alu-Alu blister strips to ensure the absolute chemical stability of both active pharmaceutical ingredients.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Drotaverine Hydrochloride USP/Ph.Eur. | 80 mg | The Spasmolytic Anchor (Forte Dose): The massive isoquinoline payload required to rapidly force smooth muscle relaxation in the uterus, biliary tract, and intestines. |
| Mefenamic Acid USP/Ph.Eur. | 250 mg | The Gynecological Analgesic Payload: The potent, dual-action fenamate NSAID required to crush radiating inflammatory pain and block uterine prostaglandin receptors. |
| Excipients | Microcrystalline Cellulose / Sodium Starch Glycolate / Povidone K-30 / Colloidal Silicon Dioxide / Magnesium Stearate / Premium Enteric-Like Polymeric Film | Diluent / Superdisintegrant / High-Shear Binder / Glidant / Heavy Film-Coating (Engineered specifically utilizing Bi-Layer Compression Technology to physically separate the two active APIs, guaranteeing maximum shelf-life and ensuring rapid gastric dissolution without the APIs chemically degrading each other) |
*Pack Sizes: 10×10 Blisters (Optimized specifically for strict, short-term acute gynecological and emergency dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Gynecology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Analgesics/Antispasmodics) |
| CAS Numbers | 985-12-6 (Drotaverine HCl) / 61-68-7 (Mefenamic Acid) |
| Dosage Form | Bi-Layer Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters (STRICTLY MANDATORY). Ensures the physical integrity of the massive 330mg active bi-layer tablet and protects the formulation from degradation across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture and Direct Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Bi-Layer Compression & Gastro-Protective Profiling (CRITICAL COMPLIANCE): Fusing 330mg of active ingredients requires absolute mastery of pharmaceutical physics. Mefenamic acid is highly bulky and notoriously harsh on the stomach lining, while Drotaverine requires lightning-fast absorption. Our FDC suites utilize specialized rotary presses to compress the APIs into distinct layers (Bi-Layer). We then coat the massive tablet with a specialized polymeric film that guarantees rapid, synchronized dissolution while shielding the gastric mucosa from direct NSAID toxicity, preventing severe ulceration.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized rapid termination of acute spasmodic and inflammatory pain:
- Severe Dysmenorrhea & Gynecology: The absolute gold standard for primary dysmenorrhea (debilitating menstrual cramps), pelvic inflammatory disease (PID), and post-IUD insertion pain.
- Biliary & Intestinal Colic: Severe spasms and radiating pain caused by cholelithiasis (gallstones), severe enteritis, and intestinal colic.
- Renal Colic: Adjunct pain relief for nephrolithiasis (kidney stones).
Dosage & Administration
Recommended Dosage (Strictly as per Physician/Gynecologist Guidelines):
- Standard Adult Dosing: 1 tablet taken orally two to three times daily (BID/TID) during acute pain episodes. Treatment should generally not exceed 7 consecutive days.
- The Full Stomach Mandate (CRITICAL): This tablet MUST be taken after a full meal with a large glass of water. Mefenamic Acid is highly gastro-erosive; taking this drug on an empty stomach will rapidly induce severe gastric erosions and potentially fatal bleeding.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Severe Gastrointestinal Bleeding): Mefenamic Acid, like all NSAIDs, violently increases the risk of serious, fatal gastrointestinal adverse events including bleeding, ulceration, and perforation. It is strictly contraindicated in patients with active peptic ulcer disease or inflammatory bowel disease (IBD).
- BLACK BOX WARNING (Cardiovascular Thrombotic Events): NSAIDs cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke.
- NSAID-Induced Asthma & Bronchospasm: Strictly contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs, as it can trigger fatal anaphylaxis.
- Hypotension & Vertigo (Drotaverine Alert): The massive dose of Drotaverine can rapidly relax systemic blood vessels, causing a sudden drop in blood pressure and severe dizziness.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Gynecology/Emergency Medical Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antispasmodic FDCs, Dual-Action Analgesics, and Bi-Layer Tableting Formulations. Whether you are looking for a reliable Government Tender Supplier for maternity wards in Africa or a B2B Pharma Marketplace partner for Southeast Asia, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.