Starez

Starez

rosuvastatin

Manufacturer:

Stellapharm

Distributor:

Stadpharm
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Reduction of LDL-C, Apo B & increase HDL-C in the management of hyperlipidemias including primary hypercholesterolemia (type IIa), mixed dyslipidemia (type IIb).
Dosage/Direction for Use
Adult Initially 10 mg once daily. Patient requiring less aggressive LDL-C reductions, w/ predisposing factors to myopathy & Asian patient Initially 5 mg once daily. Patient w/ marked hypercholesterolemia & aggressive lipid targets Initially 20 mg once daily, may be increased to max: 40 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ cyclosporine. Active liver disease or unexplained, persistent increased serum aminotransferase conc; severe renal impairment. Pregnancy & lactation.
Special Precautions
Myopathy. Perform LFTs prior to, 12 wk after initiation of therapy & semiannually thereafter. Asian patients. Not recommended in combination w/ gemfibrozil. Concomitant use w/ fibrates, niacin; drugs increasing plasma conc eg, certain PIs including combinations of ritonavir w/ atazanavir, lopinavir &/or tipanavir. Not to be used during pregnancy & lactation.
Adverse Reactions
Myalgia, constipation, asthenia, abdominal pain, nausea; pharyngitis, headache, diarrhea, dyspepsia, back pain, flu syndrome, UTI, rhinitis, sinusitis.
Drug Interactions
Severe myositis & myoglobinuria w/ fibrates. Increased risk of myopathy w/ gemfibrozil; ritonavir w/ atazanavir, lopinavir &/or tipanavir. Monitor INR w/ coumarin anticoagulants. Enhanced risk of skeletal muscle effects w/ niacin. Not to be used w/ cyclosporine.
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
Starez FC tab 10 mg
Packing/Price
30's
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