Rosulin

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Rosulin Product Information Leaflets
Brand Name:
Rosulin
Generic Name:
Rosuvastatin

DESCRIPTION:

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor for cholesterol.

COMPOSITION:

ROSULIN 5mg, ROSULIN 10mg and ROSULIN 20mg film-coated tablets contain Rosuvastatin 5mg, Rosuvastatin 10mg and Rosuvastatin 20mg respectively.

INDICATIONS:

ROSULIN is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, non HDL-C, ApoB and triglycerides levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Hyperlipoproteinaemias/Fredrickson Types lIa and IIb). As an adjunct to diet for the treatment of patients with elevated serum TG levels (Hypertriglyceridaemia/ Fredrickson Type IV). To reduce total-C, LDL-C and ApoB in patients with homozygous familial hypercholesterolemia as an adjunct to diet and other non-pharmacological or lipid lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable or are inadequate.

DOSAGE & ADMINISTRATION:

The patient should be placed on a standard cholesterol-lowering diet before receiving ROSULIN and should continue on this diet during treatment with ROSULIN. ROSULIN can be administered as a single dose at any time of day, with or without food.

CONTRAINDICATIONS:

Rosuvastatin is contraindicated in- patients allergic to any component of the product. In patients with active liver disease including unexplained persistent elevations of serum transaminases and any serum transaminases elevation exceeding 3x the upper limit of normal (ULN). During pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measures. In patients with severe renal impairment (Creatinine clearance <30mL/min.). In patients with myopathy & in patients receiving concomitant cyclosporine.

UNDESIRABLE EFFECTS:

Myalgia, constipation, asthenia, abdominal pain & nausea are most frequent adverse events.

PRESENTATION:

Available in 5mg, 10mg, 20mg all strengths are in Alu-Alu Blister Pack of 10’s.

PREGNANCY & LACTATION:

The administration of Rosuvastatin is not recommended during pregnancy and lactation. Patients should consult with their physician before taking any medicine.

Patients should consult with their physician before taking any medicine.