ROZAMIN

Strengths

Rozamin 5/10, Rozamin 10/10, Rozamin 20/10

Dosage Form

Tablets

Composition

Rozamin 5/10
Each tablet contains:
Rosuvastatin 5 mg
Ezetimibe 10 mg

Rozamin 10/10
Each tablet contains:
Rosuvastatin 10 mg
Ezetimibe 10 mg

Rozamin 20/10
Each tablet contains:
Rosuvastatin 20 mg
Ezetimibe 10 mg

Packaging

Rozamin 5/10: 30 tablets
Rozamin 10/10: 30 tablets
Rozamin 20/10: 30 tablets

Indications

- As an adjunct to diet to patients with primary hypercholesterolemia (heterozygous familial and non-familial) where use of a combination product is appropriate in those patients:
• not appropriately controlled with rosuvastatin or ezetimibe alone; or
• already treated with rosuvastatin and ezetimibe.
 - Homozygous Familial Hypercholesterolemia (HoFH).
Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Dosage and Administration

This combination product is not indicated for first-line use.
The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with the product.
The product can be administered within the dosage range of 10 mg + 5 mg to 10 mg + 20 mg as a single daily dose. The recommended starting dose is 10 mg + 5 mg or 10 mg + 10 mg once per day.
The product can be administered at any time of the day, with or without food.
Therapy should be individualized according to the target lipid levels, the recommended goal of therapy and the patient's response.
The dose should also take into account the potential risk of adverse reactions.
A dose adjustment can be made after 4 weeks of therapy where necessary. The usual maximum dose of rosuvastatin is 20 mg once per day.