Dicyclomine Hydrochloride & Mefenamic Acid Film-Coated Tablets (10 mg / 250 mg)
Healthy Inc is a specialized global supplier and exporter of advanced gynecology, gastroenterology, and targeted multi-pathway antispasmodic therapeutics. We provide ultra-high-purity, kinetically synchronized Dicyclomine Hydrochloride & Mefenamic Acid Film-Coated Tablets (10 mg / 250 mg), manufactured in WHO–GMP certified, high-precision bi-layer oral solid dosage facilities. This “Anticholinergic & Fenamate NSAID FDC” is a massive-volume, highly lucrative export to maternity hospitals, gynecology networks, primary care clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as a globally trusted, first-line intervention for agonizing primary dysmenorrhea, intestinal colic, and severe IBS flare-ups.
Product Overview
This highly advanced formulation operates as a coordinated, multi-receptor blockade against acute pelvic and abdominal trauma. It violently paralyzes the hyperactive nerves causing the muscle cramp, while simultaneously neutralizing the chemical distress signals (prostaglandins) radiating from the shedding uterine lining or inflamed bowel.
The “Muscarinic Antagonist & Dual-Action Fenamate” Specialist:
- Mechanism 1 (The Anticholinergic Spasm Halt – Dicyclomine): During a severe intestinal or uterine attack, the parasympathetic nervous system floods the smooth muscle with acetylcholine, causing it to violently contract. Dicyclomine is a potent antimuscarinic (anticholinergic) agent. It competitively blocks acetylcholine from binding to muscarinic receptors on the smooth muscle cells. This instantly paralyzes the hyperactive contractions, forcing the violently spasming uterus or bowel to physically relax.
- Mechanism 2 (Prostaglandin Synthesis Blockade – Mefenamic Acid): The initial cramp and tissue shedding trigger a massive release of inflammatory prostaglandins. Mefenamic Acid (an anthranilic acid derivative NSAID) aggressively inhibits the Cyclooxygenase (COX-1 and COX-2) enzymes, neutralizing the synthesis of Prostaglandin E2 (PGE2) to stop the generation of radiating pain and fever.
- Mechanism 3 (The Prostaglandin Receptor Antagonism): Uniquely among NSAIDs, Mefenamic Acid also acts as a direct antagonist at the prostaglandin receptor sites. It physically blocks already-synthesized prostaglandins from binding to the uterine wall, providing profoundly faster relief for dysmenorrhea than standard painkillers like Ibuprofen.
Product Composition & Strength
We supply this product as a Precision-Blended, Bi-Layer 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 |
|---|---|---|
| Dicyclomine Hydrochloride USP/Ph.Eur. | 10 mg | The Anticholinergic Anchor: The potent antimuscarinic payload required to rapidly force smooth muscle relaxation and dry up hyper-secretions in the gut. |
| Mefenamic Acid USP/Ph.Eur. | 250 mg | The Gynecological Analgesic Payload: The 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 / Binder / Glidant / Heavy Film-Coating (Engineered specifically utilizing Bi-Layer Compression Technology to physically separate the highly reactive Dicyclomine from the bulky Mefenamic Acid, ensuring rapid, synchronized gastric dissolution without the APIs degrading each other) |
*Pack Sizes: 10×10 Blisters (Optimized specifically for strict, short-term acute gynecological and GI 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 | 67-92-5 (Dicyclomine 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. Ensures the physical integrity of the 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): Mefenamic acid is a bulky, highly gastro-erosive molecule, while Dicyclomine requires lightning-fast absorption to stop an active spasm. Our FDC suites utilize specialized rotary presses to compress the APIs into distinct layers (Bi-Layer). We then coat the 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, rapid termination of acute spasmodic and inflammatory pain:
- Severe Dysmenorrhea: The definitive management of primary dysmenorrhea (debilitating menstrual cramps) and pelvic inflammatory pain.
- Irritable Bowel Syndrome (IBS) & Colic: Relief of severe, acute intestinal cramping, hyper-motility, and abdominal pain associated with IBS and functional bowel disorders.
- Biliary & Renal Colic: Adjunct pain relief for spasms in the biliary tract or ureters.
Dosage & Administration
Recommended Dosage (Strictly as per Physician Guidelines):
- Standard Adult Dosing: 1 tablet taken orally three times daily (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):
- Anticholinergic Toxicity (Glaucoma & BPH Contraindication): Dicyclomine dries up bodily secretions and paralyzes smooth muscle. It is strictly contraindicated in patients with narrow-angle glaucoma (can trigger acute blindness) and severe benign prostatic hyperplasia (can trigger acute urinary retention). Patients must be warned about dry mouth, blurred vision, and dizziness.
- BLACK BOX WARNING (Severe Gastrointestinal Bleeding): Mefenamic Acid violently increases the risk of serious, fatal gastrointestinal bleeding 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.
- Heat Prostration Alert: Because Dicyclomine inhibits sweating (anhidrosis), patients taking this medication in extremely hot climates (Zone IVb environments) are at high risk of suffering fatal heatstroke.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Gynecology/GI 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 primary care clinics 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.