Lansoprazole Delayed Release Capsules USP 15mg Technical Specification:
| Product Name: | Lansoprazole Delayed Release Capsules USP 15mg |
| Brand Name: | Generic |
| Strength: | 15mg, 30mg |
| Dosage Form: | Gastro-resistant Capsules |
| Route of Administration: | Via Oral Route |
| Packing: | 10, 100, 28s |
| 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: | Proton Pump Inhibitor |
| Indication: | To treat indigestion, heartburn, acid reflux, gastroesophageal reflux disease and stomach ulcers |
| Storage: | Store below 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Lansoprazole Delayed Release Capsules USP 15mg
Lansoprazole Delayed Release Capsules USP 30mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Lansoprazole Delayed Release Capsules USP 15mg
Each Capsule Contains:
Lansoprazole USP……….15mg
(As Enteric Coated Pellets)
THERAPEUTIC INDICATIONS:
Lansoprazole is used to treat certain conditions where there is too much acid in the stomach. It is used to treat duodenal and gastric ulcers, gastric ulcers caused by use of NSAID, erosive esophagitis and gastroesophageal reflux disease (GERD).
CAUTION & WARNING:
Read the package leaflet before use.
Keep out of the sight and reach of children.
Swallow the capsule whole with a glass of water. Do not crush or chew.
STORAGE & DOSAGE:
STORAGE: Store at 20°C to 25°C (68°F to 77°F) excursion permitted between 15°C to 30°C (between 59°F to 86°F).
DOSAGE: As directed by the Physician.