Simrovas

Simrovas

rosuvastatin

Manufacturer:

Simex
Concise Prescribing Info
Contents
Rosuvastatin
Indications/Uses
Primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) as an adjunct to diet & physical exercise. Reduction of elevated LDL-C, total cholesterol, triglycerides, ApoB, & to increase HDL-C. Homozygous familial hypercholesterolemia as adjunct to diet & other lipid-lowering treatment.
Dosage/Direction for Use
Initially 5 or 10 mg once daily in both statin-naive patients or patients switched from another HMG-CoA reductase inhibitor. May be adjusted to the next dose level after 4 wk, if needed. Severe hypercholesterolemia w/ high risk of CV especially familial hypercholesterolemia Max: 40 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease including undiagnosed persistent serum transaminase elevation, myopathy. Concomitant use w/ cyclosporine. Pregnancy & lactation.
Special Precautions
Monitor kidney function. Patients w/ kidney disorders, hypothyroid, muscle disorders, history of toxicity on the muscle, alcohol abuse. Concomitant use w/ fibrate. History of liver disease. May increase HbA1C & serum glucose level.
Adverse Reactions
Hypersensitivity reactions including angioedema, DM, headache, dizziness, constipation, nausea, abdominal pain, pancreatitis, pruritus, skin redness, urticaria, myalgia, myopathy including myositis, rhabdomyolysis, asthenia, proteinuria.
Drug Interactions
Cyclosporine, several PI including combined ritonavir w/ atazanavir, lopinavir &/or tipranavir, Al- & Mg hydroxide-containing antacids, erythromycin, vit K antagonist eg, warfarin, OC.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Simrovas FC tab 10 mg
Packing/Price
2 × 10's (Rp220,000/boks)
Form
Simrovas FC tab 20 mg
Packing/Price
2 × 10's (Rp240,000/boks)
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