Lansoprazole Delayed-Release Orally Disintegrating Tablets 15mg Technical Specification:
| Product Name: | Lansoprazole Delayed-Release Orally Disintegrating Tablets |
| Brand Name: | Generic |
| Strength: | 15mg, 30mg |
| Dosage Form: | Delayed-Release Orally Disintegrating Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10, 30s, 100s |
| 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 between 20°-25°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15mg
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Lansoprazole Delayed-Release Orally Disintegrating Tablets 15mg
Each Orally Disintegrating Tablet Contains:
Lansoprazole USP……….15mg
(As Delayed-Release 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:
Keep this and all drugs out of reach of children.
Tablet should not be chewed.
Tablet should be taken before eating.
Place the tablet on the tongue & allow it to disintegrate, with or without water, until the particles can be swallowed.
STORAGE & DOSAGE:
STORAGE: Store at 20°C to 25°C (68°F to 77°F)
DOSAGE: As directed by the Physician.