Pantoprazole Sodium Delayed-Release Tablets USP 40mg Technical Specification:
| Product Name: | Pantoprazole Sodium Delayed-Release Tablets USP |
| Brand Name: | Generic |
| Strength: | 20mg, 40mg |
| Dosage Form: | Delayed-Release Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 7s, 28s, 30s, 90s |
| 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, Antiulcer |
| Indication: | To treat certain stomach and esophagus problems |
| Storage: | Store at 20° to 25°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Pantoprazole Gastro-resistant Tablets USP 20mg
Pantoprazole Sodium Delayed-Release Tablets USP 40mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Pantoprazole Sodium Delayed-Release Tablets USP 40mg
Each Delayed-Release Tablet Contains:
Pantoprazole Sodium USP
eq. to Pantoprazole……………………40 mg
Excipients……………………………………Q.S.
Colour: Ferric Oxide Yellow USP-NF
THERAPEUTIC INDICATIONS:
It is used to treat certain conditions in which there is too much acid in the stomach, to treat erosive esophagitis or “heartburn” caused by gastroesophageal reflux disease (GERD), a condition where the acid in the stomach washes back up into the esophagus and also used to treat Zollinger-Ellison syndrome, a condition where the stomach produces too much acid.
CAUTION & WARNING:
CAUTION:
Keep medicine out of reach of children.
Swallow the tablet whole. Do not chew or crush the tablet.
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.