| Product Name: | Rosuvastatin Calcium Tablets USP |
| Brand Name: | Rosutaj |
| Strength: | 5mg, 10mg, 20mg, 40mg |
| Dosage Form: | Tablet (Film-coated) |
| Route of administration: | Via oral route |
| Packing: | 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: | Antihyperlipidemic, Cardiology, Cardiovascular System |
| Indication: | Rosuvastatin is used in adult adolescents and children 6 years or older to treat high cholesterol. |
| Storage: | Store at a controlled room temperature of 20-25°C. Store all of your medicines in a cool, dry place. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Rosuvastatin Calcium Tablets USP 5mg (Rosutaj)
- Rosuvastatin Calcium Tablets USP 10mg (Rosutaj)
- Rosuvastatin Calcium Tablets USP 20mg (Rosutaj)
- Rosuvastatin Calcium Tablets USP 40mg (Rosutaj)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Rosuvastatin Calcium Tablets USP 5mg
Each film-coated tablet contains:
Rosuvastatin calcium
Equivalent to Rosuvastatin USP…….……….5mg
Excipients……………………………………q. s
Color: Indigo Blue - Rosuvastatin Calcium Tablets USP 10mg
Each film-coated tablet contains:
Rosuvastatin calcium
Equivalent to Rosuvastatin USP…….…………10mg
Excipients………………………………….…. q. s.
Color: Titanium Dioxide. - Rosuvastatin Calcium Tablets USP 20mg
Each film-coated tablet contains:
Rosuvastatin calcium
Equivalent to Rosuvastatin USP……………….20mg
Excipients………………………………….…. q. s.
Color: Iron oxide Red - Rosuvastatin Calcium Tablets USP 40mg
Each film-coated tablet contains:
Rosuvastatin calcium
Equivalent to Rosuvastatin USP………………40mg
Excipients……………………………………q. s.
Color: Iron Oxide Yellow.
THERAPEUTIC INDICATIONS:
Adults, adolescents, and children aged 6 years or older with primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) as an adjunct to diet when the response to diet and other non-pharmacological treatments (e.g., exercise, weight reduction) is inadequate.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at a controlled room temperature, 20-25°C.
Blister pack: Store in the original blister packs to protect from moisture.
Container pack: Keep the plastic container tightly closed to protect it from moisture.
Dosage: As directed by the Physician.