| Product Name: | Metoclopramide Injection USP |
| Brand Name: | Generic |
| Strength: | 5mg/mL, 10mg/mL |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 2mL Amp & 2ml,10mL, 30mL single-use vial |
| Route of Administration: | For I.M./I.V. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | GI – Tract Prokinetic agents |
| Indication: | Metoclopramide injection is used to relieve symptoms caused by slow stomach emptying in people who have diabetes. These symptoms include nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness that lasts long after meals. |
| Storage: | Store at 20°C to 25°C. Protect from Light. See USP |
GENERIC NAME OF MEDICINAL PRODUCT:
- Metoclopramide Injection USP 5mg/mL
- Metoclopramide Injection USP 10mg/mL
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Metoclopramide Injection USP 5mg/mL
Each ml contains:
Metoclopramide Hydrochloride USP
Equivalent to Metoclopramide ………5mg
Sodium chloride USP……….8.5 mg
Water for injection USP…………q. s - Metoclopramide Injection USP 10mg/mL
Each ml contains:
Metoclopramide Hydrochloride USP
Equivalent to Metoclopramide ………10mg
Sodium chloride USP……….8.5 mg
Water for injection USP…………q. s
THERAPEUTIC INDICATION:
Metoclopramide injection is used to relieve symptoms caused by slow stomach emptying in people who have diabetes. These symptoms include nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness that lasts long after meals.
PACKING:
2mL Amp & 2ml,10mL, 30mL single-use vial
CAUTION AND WARNING:
CAUTION: Do not use it if the solution is not clear or has suspended matter.
KEEP OUT OF REACH OF CHILDREN.
NOT TO BE USED FOR NEWBORN BABIES & PREMATURE INFANTS.
SCHEDULE: SCHEDULE ‘H’ DRUG: Not to be sold by retail without the prescription of a registered Medical Practitioner.
STORAGE AND DOSAGE:
Storage: Store at 20°C to 25°C. Protect from Light.
Contains no preservatives.
Dosage: As directed by the Physician.