Esomeprazole (Enteric coated) & Itopride (Sustained Release) Capsules 40mg + 150mg Technical Specification:
| Product Name: | Esomeprazole (Enteric coated) & Itopride (Sustained Release) Capsules |
| Brand Name: | Generic |
| Strength: | 40mg + 150mg |
| Dosage Form: | SR Capsules |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 100s, |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-ulcer, Proton Pump Inhibitor, gastroprokinetic agent |
| Indication: | To treat gastroesophageal reflux disease (acid reflux) and peptic ulcer disease |
| Storage: | Store below 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Esomeprazole (Enteric coated) & Itopride (Sustained Release) Capsules 40mg + 150mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Esomeprazole (Enteric coated) & Itopride (Sustained Release) Capsules 40mg + 150mg
Each Hard Gelatin Capsule Contains:
Esomeprazole Magnesium Trihydrate IP
Eq. to Esomeprazole …………………………40mg
(As enteric coated pellets)
Itopride Hydrochloride IP………………….150mg
(As sustained release pellets)
Excipients……………………………………………Q.S.
Colour: Ponceau 4R & Titanium Dioxide IP
Approved colours used in capsule Shells.
THERAPEUTIC INDICATIONS:
This medication is used in the treatment of gastroesophageal reflux disease (acid reflux), Heart burns and peptic ulcer disease.
CAUTION & SCHEDULE:
CAUTION:
Keep medicine out of reach of children.
SR Capsules should be swallowed whole; not to be opened, chewed or crushed.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG: WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A registered medical practitioner ONLY.
STORAGE & DOSAGE:
Storage: Must be stored in a cool, dry & dark place below 25°C.
Protect from direct sunlight, heat & moisture.
Dosage: As directed by the Physician.