ROSTATIN

Rosuvastatin INN

Composition : Rosuvastatin INN 10 mg

Indication : Rostatin is indicated for - 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 Rostatin is 10mg once daily. Initiation of therapy with 5mg once daily may be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy. For patients with marked hypercholesterolemia (LDL-C>190 mg/dL) and aggressive lipid targets, a 20mg starting dose may be considered.

Homozygous Hypercholesterolemia (Familial): The recommended starting dose of Rostatin is 20mg once daily in patients with Homozygous FH. The maximum recommended daily dose is 40mg.

Dosage in Patients with Renal Insufficiency: For patients with severe renal impairment (CLcr <30 ml/min/1.73m2) not on hemodialysis, dosing of Rostatin should be started at 5mg once daily and not to exceed 10mg once daily.

Pediatric patients : The safety and effectiveness in pediatric patients have not been established. Or, as directed by the registered physician.

Packing : Rostatin-10 : 2 X 10's tablets in blister pack.

PRESCRIBING DESCRIPTION

Composition : Rosuvastatin 5mg, 10mg & 20mg Tablet. Indications : Rostatin is indicated for - 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 Rostatin is 10mg once daily. Initiation of therapy with 5mg once daily may be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy. For patients with marked hypercholesterolemia (LDL-C>190 mg/dL) and aggressive lipid targets, a 20mg starting dose may be considered. Homozygous Hypercholesterolemia (Familial): The recommended starting dose of Rostatin is 20mg once daily in patients with Homozygous FH. The maximum recommended daily dose is 40mg. Dosage in Patients with Renal Insufficiency : For patients with severe renal impairment (CLcr<30 ml/min/1.73m2) not on hemodialysis, dosing of Rosatatin should be start at 5mg once daily and not to exceed 10mg once daily. Pediatric patients : The safety
Contraindications : Rostatin is contraindicated in patients with hypersensitivity to any component of this medications, active liver disease or unexplained persistent, elevations of serum transaminases. Side effects : Rostatin is generally well tolerated. The most common side effects are constipation, myalgia, asthenia, abdominal pain and nausea. Pregnancy and lactation : Pregnancy Category - X. Not for use in pregnancy. Drug interaction : The risk of myopathy during treatment with other drugs in this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, azole antifungal or niacin. This increases in risk may also occur when combining these drugs with Atorvastatin. Packing : Rostatin-10 : 2 X 10's tablets in blister pack.