Rostab 5 mg Tab

Rostab 5 mg Tab

COMPOSITION

ROSTAB 5 : Each film-coated tablet contains Rosuvastatin Calcium INN equivalent to Rosuvastatin 5 mg.

ROSTAB 10 : Each film-coated tablet contains Rosuvastatin Calcium INN equivalent to Rosuvastatin 10 mg.

ROSTAB 20 : Each film-coated tablet contains Rosuvastatin Calcium INN equivalent to Rosuvastatin 20 mg.

INDICATION AND USE

Heterozygous Hypercholesterolemia (Familial and Nonfamilial)

Homozygous Hypercholesterolemia (Familial)

Mixed Dyslipidemia (Fredrickson Type IIa and IIb)

DOSAGE AND ADMINISTRATION

Heterozygous Hypercholesterolemia (Familial and Nonfamilial) and

Mixed Dyslipidemia (Fredrickson Type IIa and IIb)

The usual recommended starting dose of Rosuvastatin is 10 mg once daily. Initiation of therapy with 5 mg once daily may be considered for patients requiring less aggressive LDL-C reductions or who have

predisposing factor for myopathy. For patients with marked hypercholesterolemia (LDL-C 190 mg/dl) and aggressive lipid target a 20 mg starting dose may be considered .The 40 mg dose of

Rosuvastatin should be reserved for those patients who have not achieved goal LDL-C at 20 mg.

Homozygous Hypercholesterolemia (Familial)

The recommended starting dose of Rosuvastatin is 20 mg once daily in patients with homozygous FH. The maximum recommended dose of Rosuvastatin is 40 mg.

Rosuvastatin should be used in these patients as an adjunct to other lipid lowering treatments (eg. LDL apheresis) or if such treatments are unavailable. Patients with renal insufficiency No modification of dosage is necessary for patients with mild to moderate renal insufficiency.

For patients with severe renal impairment (CLcr 30 ml/min/1.73 m2) the dosing of Rosuvastatin should be started at 5 mg once daily and not to exceed 10 mg once daily.

OR AS DIRECTED BY THE PHYSICIAN.

SIDE EFFECTS

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were myalgia, constipation, asthenia, abdominal pain, and nausea.

CONTRAINDICATIONS

Rosuvastatin is contraindicated in patients with a known hypersensitivity to any component of this product. Rosuvastatin is contraindicated in patients with active liver disease or with unexplained persistent elevation of serum transaminase. Caution should be taken in patients with hypocalcemia and risk-benefit should be considered.

USE IN PREGNANCY AND LACTATION

Rosuvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive. If the patient becomes pregnant while taking this drug, therapy should be discontinued immediately. It is not known whether Rosuvastatin is excreted in human milk.

USE IN PEDIATRIC PATIENTS

The safety and effectiveness in pediatric patients have not been established.

SUPPLY

ROSTAB 5 : Each box contains 3 x 10 tablets in Alu-Alu blister strip.

ROSTAB 10 : Each box contains 2 x 10 tablets in Alu-Alu blister strip.

ROSTAB 20 : Each box contains 1 x 10 tablets in Alu-Alu blister strip.