Vastrol

Vastrol

rosuvastatin

Manufacturer:

Pharos
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia or mixed dyslipidaemia type IIb) as an adjunct to diet & exercise. Reduction of elevated LDL- & total cholesterol, triglycerides & apo B; increase in HDL-cholesterol. Homozygous familial hypercholesterolemia as an adjunct to diet & other lipid-lowering treatment (eg, LDL apheresis).
Dosage/Direction for Use
Initially 5 or 10 mg once daily in both statin naive patient or patient switched from another HMG-CoA reductase inhibitor. May be increased to the next dose level after 4 wk, if necessary. Severe hypercholesterolaemia at high CV risk Max dose: 40 mg.
Administration
May be taken with or without food.
Special Precautions
Consider renal function assessment during routine follow-up in patients treated w/ 40-mg dose. Patients who consume excessive quantities of alcohol &/or have a history of liver disease; w/ secondary hypercholesterolemia caused by hypothyroidism or nephrotic syndrome; w/ predisposing factors for myopathy/rhabdomyolysis. Perform liver function tests prior to initiation of therapy & 3 mth later. Report promptly inexplicable muscle pain, weakness or cramps, particularly if associated w/ malaise or fever. Monitor marked creatinine kinase elevations. Hypothyroidism, history of hereditary muscular disorders, muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, concomitant use of fibrates. Additional neuromuscular & serologic testing may be necessary. Increased HbA1c, serum glucose & plasma level. Concomitant administration w/ products that interact w/ protein transporter (eg, OATP1B1 & BCRP). Patient known to have c.521CC or c.421AA genotype. May impair ability to drive or operate machinery. Renal impairment. Childn. Elderly >70 yr.
Adverse Reactions
DM, headache, dizziness; constipation, nausea, abdominal pain; myalgia, asthenia.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Vastrol tab 10 mg
Packing/Price
3 × 10's (Rp250,000.00/boks)
Form
Vastrol tab 20 mg
Packing/Price
3 × 10's (Rp325,000.00/boks)
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