Rosuvastatin STELLA 10 mg

Rx

Indications:

• The management of hyperlipidaemias, including primary hypercholesterolaemia (type IIa), mixed dyslipidaemia (type IIb), and hypertriglycericaemia (type IV).
• The treatment for homozygous familial hypercholesterolaemia.

Dosage:

• Continue on diet during treatment. The usual initial dose is 5 – 10 mg once daily, increased dose at intervals of 4 weeks, if necessary, maximum 20 mg once daily.
• Severe hypercholesterolaemia: 40 mg once daily.
• The elderly patients, Asians, and those at risk of myopathy: The initial dose of 5 mg.
• Patients receiving ciclosporin: Maximum of 5 mg once daily.
• Patients receiving gemfibrozil or ritonavir-boosted lopinavir: Maximum of 10 mg once daily.
• The patients with marked hypercholesterolaemia, such as those with homozygous familial hypercholesterolaemia: Start with 20 mg once daily.
• Renal impairment (ClCr 30 – 60 mL/ minute): 5 mg once daily, maximum 20 mg once daily.
• Concomitant with atazanavir, atazanavir/ ritonavir and lopinavir/ ritonavir: Maximum 10 mg once daily.

Usage:

Rosuvastatin STELLA 10 mg is administered orally as a single dose at any time of day, with or without food.

• Hypersensitivity to any of the components of the product.
• Active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 times the upper limit of normal.
• Severe renal impairment (ClCr < 30 mL/minute).
• Myopathy
• During pregnancy and lactation and women of childbearing potential not using appropriate contraceptive measures.

Diabetes mellitus, increased blood sugar, increases in glycosylated hemoglobin (HbA1c). Headache, dizziness. Constipation, nausea, abdominal pain. Myalgia. Asthenia, cognitive impairment.

• Caution in patients with: renal impairment; hypothyroidism; personal/familial history of hereditary muscular disorders; previous history of muscular toxicity with a statin/fibrate, previous history of liver disease and/or where substantial quantities of alcohol are consumed; in elderly > 70 years with the presence of other predisposing factors for rhabdomyolysis.
• If serum creatine kinase concentrations become markedly elevated or if myopathy is diagnosed/suspected: discontinue rosuvastatin.
• Dosage reduction for patients receiving 40 mg of rosuvastatin daily who have unexplained persistent proteinuria.
• Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Patients should be aware of how they react to drug before driving or operating machinery.