GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Rosuvastatin Calcium Tablets IP 5mg
B. Rosuvastatin Calcium Tablets IP 10mg
C. Rosuvastatin Calcium Tablets IP 20mg
D. Rosuvastatin Calcium Tablets IP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Rosuvastatin Calcium Tablets IP 5mg
Each film-coated tablet contains:
Rosuvastatin calcium
Equivalent to Rosuvastatin IP…….……….5mg
Excipients…………………………………...q. s
Colours: Indigo Blue

B. Rosuvastatin Calcium Tablets IP 10mg
Each film-coated tablet contains:
Rosuvastatin calcium
Equivalent to Rosuvastatin IP…….………...10mg
Excipients………………………………….…. q. s
Colours: Titanium Dioxide

C. Rosuvastatin Calcium Tablets IP 20mg
Each film-coated tablet contains:
Rosuvastatin calcium
Equivalent to Rosuvastatin IP……………….20mg
Excipients………………………………….…. q. s
Colours: Iron oxide Red


D. Rosuvastatin Calcium Tablets IP 40mg
Each film-coated tablet contains:
Rosuvastatin calcium
Equivalent to Rosuvastatin IP……………...40mg
Excipients……………………………………q. s
Colours: Iron Oxide Yellow

THERAPEUTIC INDICATIONS:

Rosuvastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
SCHEDULE “H” Prescription Drug Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 25˚C.
Do not freeze.
Dosage: As directed by the Physician.

Rosuvastatin Tablets IP 20mg Technical Specification:

Product Name:
Rosuvastatin Tablets IP 20mg
Brand Name:Rosutaj
Strength:5mg, 10mg, 20mg, 40mg
Dosage Form:Tablet (Film coated)
Route of Administration:Via oral Route
Packing:100s, 500s, 1000s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antihyperlipidemic, Cardiology, Cardiovascular System
Indication: Rosuvastatin is used in adult’s adolescents and children 6 years or older to treat high cholesterol.
Storage:Protect form moisture at a temperature not exceeding 25˚C.Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Rosuvastatin Calcium Tablets IP 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Rosuvastatin Calcium Tablets IP 20mg
    Each film-coated tablet contains:
    Rosuvastatin calcium
    Equivalent to Rosuvastatin IP…….……….20mg
    Excipients……………………………………q. s
    Colours: Iron oxide Red

THERAPEUTIC INDICATIONS:

Rosuvastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH

Read enclosed leaflet before use.

SCHEDULE “H” Prescription Drug Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage:  Protect form moisture at a temperature not exceeding 25˚C.Do not freeze.

Dosage:  As directed by the Physician.