Pantoprazole Gastro-resistant and Domperidone Prolonged-release (40mg + 30mg) Capsules Technical Specification:
| Product Name: | Pantoprazole Gastro-resistant and Domperidone Prolonged-release Capsules |
| Brand Name: | Generic |
| Strength: | 40mg + 30mg |
| Dosage Form: | Hard Gelatin Capsule |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 100s, 15s, 150s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Proton pump inhibitor, Anti-emetic |
| Indication: | To treat Gastroesophageal reflux disease & Peptic ulcer disease |
| Storage: | Store below 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Pantoprazole Gastro-resistant and Domperidone Prolonged-release Capsules 40mg + 30mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Pantoprazole Gastro-resistant and Domperidone Prolonged-release Capsules
Each Hard Gelatin Capsule Contains:
Pantoprazole Sodium IP
eq. to Pantoprazole ……………40mg
(As Gastro-resistant Pellets)
Domperidone IP…………………30mg
(As Prolonged-release Pellets)
Excipients……………………………Q.S.
Colour: Indigo Carmine, Sunset Yellow FCF & Titanium Dioxide IP
Approved colours used in capsule shells.
THERAPEUTIC INDICATIONS:
This combination is used to treat acidity, heartburn or Gastroesophageal Reflux Disease (GERD); a condition where the acid in the stomach flows back up into the esophagus.
CAUTION & SCHEDULE:
CAUTION:
Keep medicine out of reach of children.
Capsule not to be chewed or crushed. To be swallowed whole.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG: WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A registered medical practitioner ONLY.
STORAGE & DOSAGE:
STORAGE: Store protected from moisture at a temperature not exceeding 25°C.
DOSAGE: As directed by the Physician.