| Product Name: | Rosuvastatin and Ezetimibe Tablets IP |
| Brand Name: | Generics |
| Strength: | 5mg + 10mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 40s, 90s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antihyperlipidemic, Cardiology |
| Indication: | Rosuvastatin and ezetimibe combination is used together with a proper diet to lower bad cholesterol (LDL) in the blood. It is also used alone or together with other medicines to treat homozygous familial hypercholesterolemia (HoFH). |
| Storage: | Store between 10˚C to 25˚C at a dry and dark place. |
Rosuvastatin and Ezetimibe Tablets IP Technical Specification:
GENERIC NAME OF THE MEDICINAL PRODUCT:
Rosuvastatin and Ezetimibe Tablets IP 5mg + 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Rosuvastatin and Ezetimibe Tablets IP 5mg + 10mg
Each Film coated Tablet contains:
Rosuvastatin Calcium IP
Eq. to Rosuvastatin…………………5mg
Ezetimibe IP……………………10mg
Excipients…………………………. q.s.
Colours: Ferric Oxide (RED) USP-NF
THERAPEUTIC INDICATIONS:
Rosuvastatin and ezetimibe combination is used together with a proper diet to lower bad cholesterol (LDL) in the blood. It is also used alone or together with other medicines to treat homozygous familial hypercholesterolemia (HoFH).
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Store between 10˚C to 25˚C at dry and dark place.
Dosage: As directed by the Physician.