Description

Domperidone & Paracetamol Film-Coated Tablets (10 mg / 500 mg)

Healthy Inc is a specialized global supplier and exporter of advanced neurology, gastroenterology, and targeted multi-pathway analgesic therapeutics. We provide ultra-high-purity, kinetically synchronized Domperidone & Paracetamol Film-Coated Tablets (10 mg / 500 mg), manufactured in WHO–GMP certified, high-precision rapid-release oral solid dosage facilities. This “Prokinetic & Analgesic Rescue FDC” is a massive-volume, highly lucrative export to neurology centers, emergency migraine clinics, general practitioner networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for acute migraine attacks, tension headaches, and severe pain accompanied by violent nausea.

Product Overview

This highly advanced formulation operates as a coordinated, biochemical “battering ram” against migraine-induced gastric paralysis. It chemically silences the brain’s vomiting center, physically forces the paralyzed stomach to empty, and delivers a massive analgesic payload directly into the intestines for lightning-fast absorption.

The “Gastric Stasis Bypass & Central Analgesic” Specialist:

• Mechanism 1 (The Gastric Stasis Override – Domperidone): During a severe migraine, the sympathetic nervous system triggers gastric stasis—the stomach stops contracting. Domperidone, a peripheral D2-receptor antagonist, aggressively blocks dopamine in the upper GI tract. This violently restarts gastric motility and opens the pyloric sphincter, physically pushing the contents of the stomach into the duodenum (small intestine).
• Mechanism 2 (The Central Pain Crush – Paracetamol): Paracetamol (Acetaminophen) is a highly potent central analgesic. It acts primarily in the central nervous system to elevate the pain threshold by inhibiting COX enzymes (specifically COX-2 and COX-3 variants in the brain), instantly neutralizing the radiating head and neck pain without causing the severe gastrointestinal bleeding associated with NSAIDs.
• Mechanism 3 (The Synergistic Pharmacokinetic Spike): Paracetamol is absorbed in the small intestine, not the stomach. Because a migraine paralyzes the stomach, taking Paracetamol alone is useless—it won’t reach the intestines. Domperidone acts as the “delivery vehicle,” forcing the Paracetamol into the duodenum where it is absorbed almost instantly. This cuts the onset of pain relief from hours down to just 20-30 minutes, while simultaneously paralyzing the Chemoreceptor Trigger Zone (CTZ) to stop the vomiting reflex.

Product Composition & Strength

We supply this product as a Precision-Blended, Rapid-Burst 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.

*Pack Sizes: 10×10 Blisters (Optimized specifically for rapid-response outpatient pain management and acute neurology dispensing).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Macrodose Compression & Cardiac Impurity Profiling (CRITICAL COMPLIANCE): Fusing a microscopic 10mg dose with a massive 500mg dose requires elite geometric dilution. If poorly blended, the Domperidone will cluster into toxic “hot spots.” Furthermore, global regulators place strict warnings on Domperidone regarding QTc prolongation. Our CNS suites utilize advanced HPLC analytical testing to guarantee zero cardiotoxic impurities and flawless 10mg uniformity, ensuring absolute compliance with European Medicines Agency (EMA) cardiac safety limits.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized rapid termination of acute neurological and somatic pain:

• Acute Migraine Attacks: First-line symptomatic relief of acute migraine attacks, severely debilitating tension headaches, and cluster headaches accompanied by profound nausea, vomiting, or gastric stasis.
• Post-Operative Pain: Management of mild-to-moderate surgical pain where the patient is experiencing opioid-induced or anesthesia-induced post-operative nausea and vomiting (PONV).
• Dysmenorrhea with Nausea: Management of severe menstrual cramps complicated by severe systemic nausea.

Dosage & Administration

Recommended Dosage (Strictly as per Physician Guidelines):

• The “First Sign” Protocol: 1 to 2 tablets taken at the absolute first sign of a migraine attack.
• The Maximum Limit Mandate (CRITICAL): Due to the Domperidone component, the maximum daily dose MUST NOT exceed 3 tablets (30 mg Domperidone) in a 24-hour period. Therapy should be restricted to the shortest possible duration (typically not exceeding one week).
• Administration: Can be taken with or without food, but taking it on an empty stomach drastically accelerates the onset of action.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX EQUIVALENT (QTc Prolongation & Sudden Cardiac Death): Domperidone is associated with an increased risk of severe cardiac arrhythmias and sudden cardiac death. It is strictly contraindicated in patients with known prolonged cardiac conduction intervals, heart failure, or underlying cardiac disease.
• Hepatotoxicity (Paracetamol Overdose): Paracetamol is violently toxic to the liver in high doses. Taking more than 4,000 mg of Paracetamol per day, or combining this drug with other Paracetamol-containing cold/flu medications, will cause irreversible, fatal acute liver failure.
• CYP3A4 Inhibitor Contraindication (FATAL): It is strictly contraindicated to co-administer this FDC with potent CYP3A4 inhibitors (e.g., Ketoconazole, Erythromycin). These drugs block the liver from clearing Domperidone, causing blood levels to spike and triggering fatal cardiac arrest.
• Hyperprolactinemia: Blocking D2 receptors causes prolactin levels to surge, which can lead to galactorrhea (abnormal breast milk production) and gynecomastia (breast enlargement in men).

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Neurology/Emergency Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antiemetic FDCs, Migraine Rescue Therapeutics, and Rapid-Burst Macrodose Formulations. Whether you are looking for a reliable Government Tender Supplier for acute care wards in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.