Rosuvastatin and Aspirin Gastro-resistant Capsules Technical Specification:
| Product Name: | Rosuvastatin and Aspirin Gastro-resistant Capsules |
| Brand Name: | Generic |
| Strength: | 5mg + 75mg, 10mg + 75mg, 10mg + 150mg, 20mg + 75mg, 20mg + 150mg |
| Dosage Form: | Hard Gelatin Capsule |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 15s, 100s, 150s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Lipid-lowering and Anti-platelet |
| Indication: | Used for prevention of heart attack and stroke. |
| Storage: | Store below 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Rosuvastatin and Aspirin Gastro-resistant Capsules 5mg + 75mg
Rosuvastatin and Aspirin Gastro-resistant Capsules 10mg + 75mg
Rosuvastatin and Aspirin Gastro-resistant Capsules 10mg + 150mg
Rosuvastatin and Aspirin Gastro-resistant Capsules 20mg + 75mg
Rosuvastatin and Aspirin Gastro-resistant Capsules 20mg + 150mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Rosuvastatin and Aspirin Gastro-resistant Capsules 10mg + 150mg
Each Hard Gelatin Capsule Contains:
Rosuvastatin Calcium IP
Eq. to Rosuvastatin.………….10mg
(As Granules)
Aspirin IP ……………………….…150mg
(As Two Gastro-resistant Tablets)
Excipients……………………….…Q.S.
Colour: Quinoline Yellow Lake, Titanium Dioxide IP & Erythrosine Lake
Approved colours used in empty capsule shells.
THERAPEUTIC INDICATIONS:
It is used to prevent myocardial infarction (heart attack), stroke or peripheral vascular disease. It is also used to lower abnormally elevated cholesterol or fat levels (hyperlipidemia or dyslipidemia) in the body.
CAUTION & SCHEDULE:
CAUTION:
Keep this medicine out of reach of children.
Capsules not to be chewed or crushed. To be swallowed whole.
Do not take this product during the last 2 months of pregnancy unless directed by a physician. Aspirin taken near the time of delivery may cause bleeding problems to both mother & child.
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 30°C.
Protect from direct sunlight, heat & moisture.
Dosage: As directed by the Physician.