Rosuvastatin Calcium Tablets 20mg Technical Specification:

Product Name:
Rosuvastatin Calcium Tablets 20mg
Brand Name:Generic
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’s adolescents and children 6 years or older to treat high cholesterol.
Storage:Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Rosuvastatin Calcium Tablets 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Rosuvastatin Calcium Tablets 20mg
    Each film-coated tablet contains:
    Rosuvastatin calcium
    Equivalent to Rosuvastatin …….……….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 & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

Lipid metabolism regulator.

Take Rosuvastatin by mouth with or without food.

Read enclosed leaflet before use.

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:  Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

Dosage:  As directed by the Physician.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

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

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


D. Rosuvastatin Calcium Tablets USP 40mg
Each film-coated tablet contains:
Rosuvastatin calcium
Equivalent to Rosuvastatin ……………...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 & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Lipid metabolism regulator.
Take Rosuvastatin by mouth with or without food.
Read enclosed leaflet before use.
Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
KEEP MEDICINE OUT OF REACH OF CHILDREN.