Rosuvastatin and Ezetimibe Tablets IP 20mg + 10mg
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Rosuvastatin and Ezetimibe Tablets IP 20mg + 10mg Technical Specification:

Product Name: Rosuvastatin and Ezetimibe Tablets IP 20mg + 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)
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 dry and dark place.

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

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 the 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.

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) 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

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

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

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

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

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.