Famotidine & Domperidone Tablets (20 mg / 10 mg)
Healthy Inc is a specialized global supplier and exporter of advanced gastroenterological, anti-emetic, and gut-motility therapeutics. We provide ultra-high-purity, kinetically synchronized Famotidine (20 mg) & Domperidone (10 mg) Film-Coated Tablets, manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Dual-Action Acid Suppressor & Prokinetic” is a massive-volume, highly compliant export to gastroenterology clinics, general practice networks, retail pharmacy chains, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, NDMA-free intervention for the rapid relief of Gastroesophageal Reflux Disease (GERD) and functional dyspepsia.
Product Overview
This highly advanced Fixed-Dose Combination masterfully synchronizes a potent, safe H2-receptor antagonist with a highly targeted peripheral dopamine antagonist, delivering a complete mechanical and chemical cure for acid reflux and indigestion.
The “GERD & Dyspepsia Dual-Action” Specialist:
- Mechanism 1 (The Acid Blocker – Famotidine 20mg): Famotidine is the global clinical standard replacement for banned Ranitidine. It aggressively and selectively binds to the Histamine H2 receptors on the parietal cells in the stomach lining. By blocking histamine, it shuts down the stomach’s acid pumps, violently reducing both the volume and concentration of gastric acid, providing rapid relief from severe heartburn.
- Mechanism 2 (The Motility Engine – Domperidone 10mg): While Famotidine stops the acid, Domperidone fixes the plumbing. In GERD, the stomach empties too slowly, and the valve at the top of the stomach is too loose, allowing acid to splash up. Domperidone blocks peripheral D2 receptors in the gut. This physically tightens the Lower Esophageal Sphincter (preventing upward splashing) and stimulates vigorous, coordinated peristalsis to rapidly empty the stomach contents into the intestines.
- The Blood-Brain Barrier Advantage: Unlike older prokinetics like Metoclopramide, Domperidone does not easily cross the blood-brain barrier. This means it aggressively treats nausea and motility issues in the gut without causing the severe, crippling neurological side effects (like involuntary muscle spasms or Tardive Dyskinesia) associated with older drugs.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, OTC Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Gastrointestinal) |
| CAS Numbers | 76824-35-6 (Famotidine) / 85966-89-8 (Domperidone Maleate) |
| Dosage Form | Film-Coated Tablet (Immediate Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Protects the formulation from environmental humidity across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- API Compatibility Engineering: Combining an H2 antagonist with a prokinetic requires strict compatibility testing to ensure the APIs do not degrade each other over the product’s shelf life. Our facilities utilize advanced dry-blending and moisture-controlled granulation to ensure absolute stability, guaranteeing full therapeutic potency from the factory to the patient’s stomach.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of upper gastrointestinal motility and acid disorders:
- Gastroesophageal Reflux Disease (GERD): Treatment of symptomatic GERD where acid suppression alone is insufficient to control symptoms of upward splashing.
- Functional (Non-Ulcer) Dyspepsia: Relief of symptoms such as stomach fullness, early satiety, bloating, belching, nausea, and vomiting.
- Diabetic Gastroparesis: Management of delayed stomach emptying associated with diabetes.
Dosage & Administration
Recommended Dosage (Strictly as per Physician Guidelines):
- Standard Adult Dosing: 1 tablet taken 2 to 3 times daily, depending on symptom severity.
- Administration (THE MEALTIME RULE): Because Domperidone works to empty the stomach, and Famotidine needs to block meal-induced acid, the tablet MUST be taken 15 to 30 minutes before a meal. Taking it after eating significantly delays the absorption of Domperidone.
- Duration of Therapy: Due to cardiac safety protocols regarding Domperidone, this combination is typically recommended for short-term use (usually not exceeding 7 to 14 days without medical reassessment).
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Domperidone Cardiac Risk (QT Prolongation): Domperidone has been associated with an increased risk of serious cardiac arrhythmias and sudden cardiac death, particularly in patients over 60 years old or those taking daily doses greater than 30 mg. It is strictly contraindicated in patients with known prolonged cardiac conduction intervals (QT prolongation) or significant electrolyte disturbances.
- CYP3A4 Drug Interactions: Domperidone is heavily metabolized by CYP3A4. Co-administration with strong CYP3A4 inhibitors (like Ketoconazole or Erythromycin) will massively spike Domperidone levels in the blood, dangerously increasing the risk of fatal cardiac arrhythmias.
- Prolactin Elevation: Domperidone increases prolactin levels, which may cause galactorrhea (milk production) or gynecomastia (breast enlargement) with prolonged use.
- Renal Impairment: Famotidine is cleared by the kidneys. Dose adjustments are required in patients with moderate to severe 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 Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Gastroenterological Formulations. Whether you are looking for a reliable Pharmacy Chain Supplier for OTC GI medications in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery of WHO-GMP certified products.