Rosuvastatin and Ezetimibe Tablets 5mg+10mg
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Rosuvastatin and Ezetimibe Tablets 5mg+10mg Technical Specification:

Product Name:Rosuvastatin and Ezetimibe Tablets 5mg+10mg
Brand Name:Generics
Strength:(5mg+10mg), (10mg+10mg), (20mg+10mg), (40mg+10mg)
Dosage Form:Tablets (Film-coated)
Route of Administration:Via oral Route
Packing:40s, 90s, 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
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: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:

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Rosuvastatin and Ezetimibe Tablets 5mg+10mg
    Each Film coated Tablet contains:
    Rosuvastatin Calcium
    Eq. to Rosuvastatin…………………5.2mg
    Ezetimibe……………………10mg
    Excipients………………………….q.s.
    Colours: Ferric Oxide (RED) USP-NF
  • Rosuvastatin and Ezetimibe Tablets 10mg+10mg
    Each Film coated Tablet contains:
    Rosuvastatin Calcium
    Eq. to Rosuvastatin…………………10.4mg
    Ezetimibe……………………10mg
    Excipients…………………………. q.s.
    Colours: Titanium Dioxide
  • Rosuvastatin and Ezetimibe Tablets 20mg+10mg
    Each Film coated Tablet contains:
    Rosuvastatin Calcium
    Eq. to Rosuvastatin…………………20.8mg
    Ezetimibe……………………10mg
    Excipients…………………………. q.s.
    Colours: Ferric Oxide (Yellow) USP-NF
  • Rosuvastatin and Ezetimibe Tablets 40mg+10mg
    Each Film coated Tablet contains:
    Rosuvastatin Calcium
    Eq. to Rosuvastatin…………………41.7mg
    Ezetimibe……………………10mg
    Excipients………………………….q.s.
    Colours: Sunset Yellow

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 enclosed leaflet before use.

Keep 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:  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.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Rosuvastatin and Ezetimibe Tablets 5mg+10mg
B. Rosuvastatin and Ezetimibe Tablets 10mg+10mg
C. Rosuvastatin and Ezetimibe Tablets 20mg+10mg
D. Rosuvastatin and Ezetimibe Tablets 40mg+10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Rosuvastatin and Ezetimibe Tablets 5mg+10mg
Each Film coated Tablet contains:
Rosuvastatin Calcium
Eq. to Rosuvastatin…………………5.2mg
Ezetimibe……………………10mg
Excipients…………………………. q.s.
Colours: Ferric Oxide (RED) USP-NF

b) Rosuvastatin and Ezetimibe Tablets 10mg+10mg
Each Film coated Tablet contains:
Rosuvastatin Calcium
Eq. to Rosuvastatin…………………10.4mg
Ezetimibe……………………10mg
Excipients…………………………. q.s.
Colours: Titanium Dioxide

c) Rosuvastatin and Ezetimibe Tablets 20mg+10mg
Each Film coated Tablet contains:
Rosuvastatin Calcium
Eq. to Rosuvastatin…………………20.8mg
Ezetimibe……………………10mg
Excipients…………………………. q.s.
Colours: Ferric Oxide (Yellow) USP-NF

d) Rosuvastatin and Ezetimibe Tablets 40mg+10mg
Each Film coated Tablet contains:
Rosuvastatin Calcium
Eq. to Rosuvastatin…………………41.7mg
Ezetimibe……………………10mg
Excipients…………………………. q.s.
Colours: Sunset Yellow

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 enclosed leaflet before use.
KEEP 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: 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.