Composition: Each film-coated tablet contains Loperamide Hydrochloride USP 2 mg.
Usage: Symptomatic treatment of selected types of diarrhea.
Category: Antidiarrheal drugs
Therapeutic category: Antidiarrheal / Antimotility Agent
SKU: Loperamide Tablets
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Loperamide Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Loperamide Hydrochloride is an antimotility antidiarrheal medicine used for symptomatic control of selected types of diarrhea. It slows intestinal movement and can reduce stool frequency, but does not treat the underlying infectious cause. Oral rehydration remains essential, particularly with acute diarrhea.
Manufacturer: Healthy Life Pharma Pvt. Ltd. (as supplied). Exporter: Healthy Inc (as supplied). Manufacturing, certification and export claims require supporting records.
| Product | Loperamide Tablets |
|---|---|
| Composition | Each film-coated tablet contains Loperamide Hydrochloride USP 2 mg |
| CAS number | 34552-83-5 (loperamide hydrochloride) |
| Dosage form | Film-coated tablet |
| Therapeutic category | Antidiarrheal / antimotility agent |
| SKU | Loperamide Tablets |
| Pharmacopoeial standard | USP specified for supplied ingredient; finished-product compliance requires verification |
| Shelf life and packaging | Subject to approved stability studies and pack documentation |
Manufacture of a low-dose 2 mg film-coated tablet requires controlled blending, compression, coating and validated content-uniformity testing. Suitable packaging and process controls are established through product-specific development and stability studies. Specific equipment, excipients and processing methods have not been independently confirmed.
Product-specific testing may include identification, assay, uniformity of dosage units, dissolution, related substances, microbial quality where applicable and packaging integrity. Acceptance criteria must follow approved pharmacopoeial and regulatory specifications; numerical limits are not asserted without a certificate of analysis.
Loperamide acts mainly on peripheral μ-opioid receptors in the intestinal wall, reducing intestinal motility and prolonging transit time. It may help manage uncomplicated acute diarrhea and, when prescribed, certain chronic diarrhea conditions or ileostomy output.
Important: It should not be used as primary treatment for bloody diarrhea, high fever, suspected invasive bacterial infection, acute ulcerative colitis or certain antibiotic-associated colitis. Medical assessment is important if symptoms persist or dehydration develops.
For bulk or export enquiries, confirm market authorization, manufacturing licence, product-specific GMP documentation, certificate of analysis, approved artwork, shelf-life evidence and any applicable CTD/ACTD dossier. COPP, FSC and WHO-GMP claims require documentary verification for the specific site and product.
What is the strength? The supplied composition is Loperamide Hydrochloride USP 2 mg per film-coated tablet.
Is it the same as Imodium? Both may contain loperamide, but equivalence and interchangeability depend on the particular approved formulation.
Can it treat bloody diarrhea? Do not self-treat bloody diarrhea or diarrhea accompanied by fever with loperamide; seek medical advice.
Is it safe at higher doses? No. Excessive doses can cause serious, potentially fatal heart-rhythm disturbances.
Use strictly according to the locally approved label and clinician or pharmacist advice. For adults, labeled dosing for acute diarrhea may begin with 4 mg followed by 2 mg after loose stools, but maximum daily doses vary by country, product and prescription status; do not assume 16 mg/day is an appropriate OTC limit. Stop and seek advice if diarrhea persists beyond 48 hours, or earlier if fever, blood in stool, abdominal swelling or dehydration occurs. Replace fluids and electrolytes with oral rehydration solution as appropriate.
Store in the original package according to the temperature and moisture instructions on the approved market-specific label. Keep out of sight and reach of children. A specific below-25°C claim requires confirmation from approved labeling.