Description
Loperamide Capsules
Healthy Inc is a specialized global supplier and exporter of essential gastrointestinal and acute care therapeutics. We provide high-purity Loperamide Hydrochloride Capsules (2 mg), manufactured in WHO–GMP certified, high-capacity oral solid dosage facilities. This “Peripheral Mu-Opioid Receptor Agonist” is a massive-volume, foundational export to primary care networks, retail pharmacy distributors, NGO epidemic response teams, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the globally trusted, first-line antimotility intervention for acute non-specific diarrhea and traveler’s diarrhea.
Product Overview
This formulation contains Loperamide Hydrochloride, a synthetic piperidine derivative that acts as a potent, gut-selective opiate receptor agonist.
The “Antimotility & Transit Control” Specialist:
- Mechanism (Peristalsis Inhibition): Loperamide binds directly to the mu-opioid receptors located in the myenteric plexus of the intestinal wall. This binding aggressively inhibits the release of acetylcholine and prostaglandins, which physically paralyzes the smooth muscle of the gut. By drastically slowing down intestinal motility (peristalsis), it increases the transit time of the fecal mass, allowing the intestines more time to reabsorb water and electrolytes, effectively hardening the stool.
- Sphincter Tone Enhancement: In addition to slowing the gut, Loperamide actively increases the tone of the anal sphincter, providing rapid relief from severe fecal urgency and incontinence.
- The “Brain-Safe” Opioid: Although it is technically an opioid, at standard therapeutic doses, Loperamide is heavily actively pumped out of the central nervous system by P-glycoprotein efflux pumps at the blood-brain barrier. It has virtually zero systemic CNS effects, meaning it causes no sedation, euphoria, or respiratory depression, making it perfectly safe for widespread OTC distribution.
Product Composition & Strength
We supply this product as a Hard Gelatin Capsule, packed in cost-effective, moisture-resistant Alu-PVC blister strips.
| Active Ingredient | Strength | Primary Clinical Use |
|---|---|---|
| Loperamide Hydrochloride USP/BP/Ph.Eur. | 2 mg | Standard Adult Dose for Acute & Chronic Diarrheal Management |
| Excipients | Lactose Monohydrate / Maize Starch / Magnesium Stearate | Diluent / Disintegrant / Lubricant (Ensures rapid gastric dispersion) |
*Pack Sizes: 10×10 Alu-PVC Blisters or Bulk Jars (Optimized for massive-volume retail and NGO dispensing).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Gastrointestinal Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances) |
| CAS Number | 34552-83-5 |
| Dosage Form | Hard Gelatin Capsule |
| Packaging | Alu-PVC Blisters. (The API is highly stable, making Alu-PVC the ideal, cost-effective packaging choice for high-volume tenders). |
| Storage | Store below 30°C in a dry place. Protect from Light. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Low-Dose Uniformity: Because the active ingredient is dosed very low (2 mg), our manufacturing utilizes advanced high-shear V-blenders to guarantee absolute content uniformity across every batch, preventing sub-therapeutic capsules and ensuring rapid, predictable cessation of diarrheal episodes.
- High-Capacity Output: As an essential OTC medicine, Loperamide demands massive volume fulfillment. Our automated encapsulation and blistering lines are scaled to meet the multi-million unit demands of national health ministries and global NGO procurement cycles rapidly.
Therapeutic Indications (Human Use)
Indicated for the rapid symptomatic control of hypermotility:
- Acute Diarrhea: Symptomatic control of acute, non-specific diarrhea, including traveler’s diarrhea.
- Chronic Diarrhea: Long-term management of chronic diarrhea associated with Inflammatory Bowel Disease (IBD) or short bowel syndrome.
- Ileostomy Management: Utilized to significantly reduce the volume and increase the viscosity of discharge from ileostomies.
Dosage & Administration
Recommended Dosage (Adults & Children over 12 years):
- Acute Diarrhea Protocol (CRITICAL): The initial dose is 4 mg (2 capsules) followed by 2 mg (1 capsule) after each subsequent unformed stool.
- Maximum Daily Dose: Do not exceed 16 mg (8 capsules) per day.
- Hydration Therapy: Loperamide only stops the motility; it does not replace lost fluids. It must ALWAYS be administered alongside abundant liquid intake or Oral Rehydration Salts (ORS).
Safety Warnings (CRITICAL):
- Infectious Dysentery (BLACK BOX EQUIVALENT CONTRAINDICATION): Loperamide is strictly contraindicated in patients presenting with high fever or bloody stools (dysentery) caused by invasive organisms like Salmonella, Shigella, or Campylobacter. Paralyzing the gut traps these destructive pathogens inside the bowel, massively increasing the risk of fatal Toxic Megacolon and bowel perforation.
- Cardiac Toxicity (Abuse Warning): Taking massively higher-than-recommended doses of Loperamide (often done by individuals attempting to achieve a central opioid high or manage opioid withdrawal) can cause severe, fatal cardiac arrhythmias, including QT prolongation, Torsades de Pointes, and cardiac arrest.
- Pediatric Restriction: Should not be used in infants or children under 2 years of age due to the risk of respiratory depression and severe paralytic ileus.
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 Essential Gastrointestinal Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable NGO Tender Supplier for global health 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.









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