COMPOSITION:

Each film coated tablet contains:

• For Rosuvastatin 10 mg Film Coated Tablets:
Rosuvastatin calcium ………………… 10.416 mg (Equivalent to Rosuvastatin 10 mg)

Rosuvastatin calcium ………………… 20.832 mg (Equivalent to Rosuvastatin 20 mg)

 

PHARMACOLOGICAL ACTION:
Rosuvastatin calcium is a synthetic, enantiomerically pure lipid-lowering agent.
It is a selective, potent and competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyses the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in cholesterol biosynthesis.

INDICATIONS AND CLINICAL USE:

• Treatment of hypercholesterolemia:

o Adults, adolescents and children aged 10 years or older with primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other no pharmacological treatments is inadequate.
o Homozygous familial hypercholesterolemia as an adjunct to diet and other lipid lowering treatments.
• Prevention of Cardiovascular Events:
Prevention of major cardiovascular events in patients, who are estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors.

DOSAGE & ADMINISTRATION:

Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment. The dose should be individualized according to the goal of therapy and patient response, using current consensus guidelines.
Rosuvastatin F.C.Tablets may be given at any time of day, with or without food.
• Treatment of hypercholesterolemia:
The recommended start dose is 10 mg orally once daily in both statin naïve and patients switched from another HMGCoA reductase inhibitor.
The choice of start dose should take into account the individual patients cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions.
A dose adjustment to the next dose level can be made after 4 weeks, if necessary.
The maximum dose of 40 mg should be considered in patients with severe hypercholesterolemia at high cardiovascular risk who do not achieve their treatment goal on 20 mg
• Prevention of cardiovascular events:
In the cardiovascular events risk reduction study, the dose used was 20 mg daily.

CONTRA-INDICATIONS:

Rosuvastatin F.C.Tablets is contraindicated:
– In patients with hypersensitivity to rosuvastatin.
– In patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 x the upper limit of normal (ULN).
– In patients with severe renal impairment (creatinine clearance – In patients with myopathy.
– In patients receiving concomitant cyclosporine.
– During pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measures.

PRECAUTIONS & WARNINGS:

Endocrine Effects
Caution should be exercised if an HMG-CoA reductase inhibitor or other agent used to lower cholesterol levels is administered to patients receiving other drugs (e.g. ketoconazole, spironolactone or cimetidine) that may decrease the levels of endogenous steroid hormones.
Increases in fasting glucose and HbA1c levels have been reported with inhibitors of HMG-CoA reductase as a class. The benefit of treatment continues to outweigh the small increased risk. Periodic monitoring of these patients is recommended.
Hepatic Effects
Rosuvastatin is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal. Rosuvastatin should be discontinued or the dose reduced if the level of transaminases is greater than 3 times the upper limit of normal.
Muscle Effects
Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with rosuvastatin and with other HMG-CoA reductase inhibitors.

PACKAGE & STORAGE:

Rosuvastatin 10 mg Film Coated Tablets:
Carton box containing (transparent PVC/Alu) blister of 10 film coated tablets.

Rosuvastatin 20 mg Film Coated Tablets:
Carton box containing (transparent PVC/Alu) blister of 14 film coated tablets.

– Store at a temperature not exceeding 30 °C, in a dry place.
– Store in the original package in order to protect from moisture.
– Not to be used except under doctor supervision.

RELATED PRODUCTS: (Cardiovascular Products)
Borgavix 75
Borgastatin 10-40
Betaxolol 10- 40

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