Drotaverine Hydrochloride & Aceclofenac Film-Coated Tablets (80 mg / 100 mg)
Healthy Inc is a specialized global supplier and exporter of advanced gastroenterology, gynecology, and targeted multi-pathway analgesic therapeutics. We provide ultra-high-purity, kinetically synchronized Drotaverine Hydrochloride & Aceclofenac Film-Coated Tablets (80 mg / 100 mg), manufactured in WHO–GMP certified, high-precision bi-layer oral solid dosage facilities. This “Spasmolytic & NSAID FDC” is a massive-volume, highly lucrative export to emergency colic wards, gastroenterology networks, maternity hospitals, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for agonizing renal colic, biliary spasms, and severe primary dysmenorrhea.
Product Overview
This highly advanced formulation operates as a coordinated, two-front biochemical assault on acute abdominal and pelvic pain. It does not just mask the pain; it targets the mechanical root cause (the violently contracting smooth muscle) while simultaneously silencing the chemical distress signals (prostaglandins) radiating from the traumatized tissue.
The “PDE4 Inhibitor & Prostaglandin Synthesis Blocker” Specialist:
- Mechanism 1 (The Mechanical Spasm Halt – Drotaverine): During a kidney stone attack or severe menstrual cramp, smooth muscle goes into a state of hyper-contraction (spasm), causing 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), deactivating the myosin light chain kinase, and physically forcing the violently contracting muscle to instantly relax and dilate the affected duct.
- Mechanism 2 (The Inflammatory Pain Crush – Aceclofenac): The initial spasm heavily damages the surrounding tissue, triggering the release of inflammatory prostaglandins that amplify the pain to agonizing levels. Aceclofenac is a highly potent Non-Steroidal Anti-Inflammatory Drug (NSAID) with preferential action on the COX-2 enzyme. It aggressively shuts down the synthesis of Prostaglandin E2 (PGE2), instantly neutralizing the swelling, fever, and radiating pain.
- The “Dual-Strike” Synergy: Using either drug alone leaves the patient in partial agony. Drotaverine stops the cramp, but the tissue is still inflamed. Aceclofenac stops the inflammation, but the muscle keeps cramping. By fusing them into a single, rapid-burst tablet, the patient achieves absolute, comprehensive pain relief within 30 minutes, bypassing the need for intravenous painkillers.
Product Composition & Strength
We supply this product as a Precision-Blended, Bi-Layer Macrodose FDC Tablet, packed exclusively in highly secure, moisture-resistant 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 ureters, biliary tract, and uterus. |
| Aceclofenac USP/Ph.Eur. | 100 mg | The Anti-Inflammatory Payload: The potent COX-2 preferential NSAID required to crush the radiating inflammatory pain and tissue swelling. |
| Excipients | Microcrystalline Cellulose / Croscarmellose Sodium / Povidone K-30 / Colloidal Silicon Dioxide / Magnesium Stearate / Premium Enteric-Like Polymeric Film | Diluent / Superdisintegrant / Binder / Glidant / Heavy Film-Coating (Engineered specifically utilizing Bi-Layer Compression Technology to physically separate the two highly reactive APIs, guaranteeing maximum shelf-life and ensuring rapid, simultaneous gastric dissolution without the APIs degrading each other) |
*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict, short-term acute emergency dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Emergency Care Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Analgesics/Antispasmodics) |
| CAS Numbers | 985-12-6 (Drotaverine HCl) / 89796-99-6 (Aceclofenac) |
| Dosage Form | Bi-Layer Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-Alu Blisters (STRICTLY MANDATORY). Ensures the physical integrity of the complex bi-layer tablet and protects the intensely moisture-sensitive 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 180mg of active ingredients requires absolute mastery of pharmaceutical physics. Aceclofenac is notoriously harsh on the stomach, 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 survives the esophagus but shatters instantly in the stomach, providing maximum absorption speed while shielding the mucosal lining from direct NSAID toxicity.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized rapid termination of acute spasmodic and inflammatory pain:
- Renal & Urogenital Colic: Agonizing pain associated with nephrolithiasis (kidney stones), ureterolithiasis, and severe cystitis or pyelitis.
- Biliary Colic: Severe spasms and radiating pain caused by cholelithiasis (gallstones) and cholecystitis.
- Severe Dysmenorrhea & Gynecology: Primary dysmenorrhea (debilitating menstrual cramps) and pelvic inflammatory pain.
- Gastrointestinal Spasms: Acute exacerbations of Irritable Bowel Syndrome (IBS), severe enteritis, and intestinal colic.
Dosage & Administration
Recommended Dosage (Strictly as per Physician Guidelines):
- Standard Adult Dosing: 1 tablet taken orally twice daily (BID), typically not exceeding 2 tablets in a 24-hour period.
- The Full Stomach Mandate (CRITICAL): This tablet MUST be taken after a full meal with a large glass of water. Because Aceclofenac inhibits protective prostaglandins in the stomach, 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): Aceclofenac, like all NSAIDs, violently increases the risk of serious, fatal gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines. It is strictly contraindicated in patients with active peptic ulcer disease.
- BLACK BOX WARNING (Cardiovascular Thrombotic Events): NSAIDs cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke. It is completely contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
- 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. Patients must be warned against driving or operating heavy machinery immediately after taking the pill.
- Renal Toxicity: Long-term use of NSAIDs causes renal papillary necrosis. It is contraindicated in patients with severe, pre-existing renal impairment.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and 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 acute care 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.