| Product Name: | Prasugrel Hydrochloride Tablets |
| Brand Name: | Generic |
| Strength: | 5mg , 10mg |
| Dosage Form: | Tablets (film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Platelet |
| Indication: | Prasugrel is used to prevent strokes, heart attacks, or other serious problems with your heart or blood vessels. It is given to patients before they have a heart procedure called percutaneous coronary intervention (PCI). |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture. |
Prasugrel Hydrochloride Tablets 5mg Technical Specification:
GENERIC NAME OF THE MEDICINAL PRODUCT:
a)Prasugrel Hydrochloride Tablets USP 5mg
b)Prasugrel Hydrochloride Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a)Prasugrel Hydrochloride Tablets USP 5mg
Each film-coated tablet contains:
Prasugrel Hydrochloride USP
Equivalent to Prasugrel………… 5mg
Excipients………………………………..q.s
Colour: Titanium Dioxide IP
b)Prasugrel Hydrochloride Tablets USP 10mg
Each film-coated tablet contains:
Prasugrel Hydrochloride USP
Equivalent to Prasugrel………… 10mg
Excipients………………………………..q.s
Colour: Ferric Oxide RED USP-NF, Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Prasugrel is used to prevent strokes, heart attacks, or other serious problems with your heart or blood vessels. It is given to patients before they have a heart procedure called percutaneous coronary intervention (PCI). Prevents the risk of heart attack, stroke, angina or other circulatory problems.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A CARDIOLOGIST ONLY. STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in a dry place protected from light and moisture.
Dosage: As directed by the Cardiologist.