Itopride Hydrochloride Tablets
Healthy Inc is a specialized global supplier and exporter of advanced gastro-prokinetic agents. We provide high-purity Itopride Hydrochloride Tablets, sourced from WHO–GMP certified solid dosage facilities. This “Dual-Action” motility booster is a top export to gastroenterology clinics, internal medicine wards, and pharmacy chains in Africa, LATAM, and Southeast Asia, serving as the safer, modern alternative for treating functional dyspepsia and delayed gastric emptying.
Product Overview
This formulation contains Itopride Hydrochloride, a novel prokinetic agent with a unique dual mechanism of action.
The “Upper GI” Specialist:
- Dual Mechanism:
- Dopamine D2 Antagonism: It blocks dopamine D2 receptors in the gut, removing the “brakes” on muscle contractions.
- AChE Inhibition: It inhibits the enzyme acetylcholinesterase, which prevents the breakdown of acetylcholine. This increases the concentration of acetylcholine, the primary chemical signal for muscle movement.
- Result: This synergy significantly accelerates gastric emptying and improves the transit of food through the stomach and small intestine, relieving the feeling of fullness and bloating.
- Cardiac Safety: Unlike older prokinetics (like Cisapride or Mosapride), Itopride has no affinity for 5-HT4 receptors and does not cause QT prolongation or cardiac arrhythmias.
- Minimal CNS Effects: It acts peripherally and does not readily cross the blood-brain barrier, making extrapyramidal side effects (tremors) extremely rare compared to Metoclopramide.
Product Composition & Strength
We supply this product as Film Coated Tablets (typically White or Off-White) to mask the bitter taste.
| Active Ingredient | Strength (Standard) | Role |
|---|---|---|
| Itopride HCl | 50 mg | Standard Therapeutic Dose |
| Itopride HCl | 150 mg (SR) | Sustained Release (Once Daily) |
| Excipients | Q.S. | Lactose (Filler) / HPMC (Binder) |
*Pack Sizes: Blister packs of 10s (Box of 10×10), 15s, or Bulk HDPE Jars.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Film Coated Tablet (Oral) |
| Packaging | Alu-Alu Blister or PVC-PVDC/Alu Blister |
| Storage | Store below 30°C. 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.
- Hygroscopicity: Itopride HCl is highly hygroscopic (absorbs moisture). We manufacture in low-humidity environments (< 40% RH) and package in high-barrier Alu-Alu blisters to prevent the tablets from becoming soft or sticky.
- Release Profile: Optimized disintegration time ensuring the drug is available for absorption in the upper GI tract where it is most effective.
Therapeutic Indications (Human Use)
Indicated for the treatment of gastrointestinal symptoms caused by reduced gastric motility:
- Functional Dyspepsia: Non-ulcer dyspepsia characterized by sensation of bloating, early satiety (fullness), upper abdominal pain, nausea, and vomiting.
- Gastroparesis: Delayed stomach emptying (often in diabetics).
- GERD: Sometimes used as an adjunct to PPIs to prevent acid reflux by tightening the lower esophageal sphincter.
Dosage & Administration
Recommended Dosage (Strictly as per Gastroenterologist):
- Route: Oral.
- Adults: 50 mg taken three times daily.
- Total Daily Dose: 150 mg.
- Timing: Best taken before meals to prime the stomach for digestion.
Safety Warnings:
- Prolactin Levels: By inhibiting dopamine, Itopride can occasionally raise prolactin levels, leading to galactorrhea (breast milk production) or gynecomastia. Discontinue if these occur.
- GI Obstruction: Contraindicated in patients with gastrointestinal hemorrhage, mechanical obstruction, or perforation.
- Drug Interactions: Anticholinergic drugs (like Hyoscine or Dicyclomine) reduce the effect of Itopride.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for OSD (Oral Solid Dosage) forms, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in