Rosuvastatin STELLA 20 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 is administered orally as a single dose at any time of day, with or without food.
• The patient should be placed on a standard cholesterol-lowering diet before receiving rosuvastatin and should continue on this diet during treatment.
• The dosage may be carefully adjusted according to individual requirements and response, increases should be made at intervals of at least 4 weeks. Adverse effects should be monitored closely, specially, muscle adverse reactions.

• Hypersensitivity to any of the ingrdients.
• 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.
• Rosuvastatin is contraindicated in pregnancy and lactation.
• Patients should be aware of how they react to drug before driving or operating machinery.