Loperamide Hydrochloride Tablets USP 2mg Technical Specification:
| Product Name: | Loperamide Hydrochloride Tablets USP 2mg |
| Brand Name: | Generic |
| Strength: | 2mg |
| Dosage Form: | Film Coated Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 12s, 24s, 60s, 100s, 300s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Anti-diarrheal |
| Indication: | To treat acute diarrhea |
| Storage: | Store at 20° to 25°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Loperamide Hydrochloride Tablets USP 2mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Loperamide Hydrochloride Tablets USP 2mg
Each Uncoated Tablet Contains:
Loperamide Hydrochloride USP…………….2 mg
Excipients…………………………………………..Q.S.
Not for pediatric use.
THERAPEUTIC INDICATIONS:
It is used to control and relieve the symptoms of acute diarrhea, chronic diarrhea in patients with inflammatory bowel disease. It stops diarrhea by slowing down the movements of the intestines. Loperamide is also used to decrease the amount of drainage in patients who have ileostomies.
CAUTION & WARNING:
CAUTION:
Keep medicine out of reach of children.
Taking more than directed dose can cause serious heart problems or death.
WARNING:
TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
STORAGE: Store at 20°-25°C (68° to 77°F); excursion permitted to 15° to 30°C (59-86°F).
DOSAGE: As directed by the Physician.