Stator

Stator

atorvastatin

Manufacturer:

Dexa Medica
Concise Prescribing Info
Contents
Atorvastatin Ca
Indications/Uses
Adjunct to diet for the reduction of elevated total- & LDL-cholesterol, apolipoprotein-B & triglycerides in patients w/ primary hypercholesterolemia, combined (mixed) hyperlipidemia & heterozygous & homozygous familial hypercholesterolemia when response to diet & other nonpharmacological measures are inadequate. Reduce the risk of fatal CHD & non-fatal MI, stroke & revascularization, angina pectoris in dyslipidemia & hypertensive patients ≥40 yr w/ at least 3 risk factors eg, LVH, ECG abnormalities, NIDDM, peripheral vascular disease, TIA, smoking & CAD. Childn 10-17 yr: Adjunct to diet for the reduction of total- & LDL-cholesterol, apo-B levels in boys & postmenarchal girls w/ heterozygous familial hypercholesterolemia if LDL-C remains ≥190 mg/dL or ≥160 mg/dL w/ positive family history of premature CV disease or ≥2 CVD risk factors.
Dosage/Direction for Use
10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia 80 mg once daily. Heterozygous familial hypercholesterolemia Childn 10-17 yr 10 mg/day. Max: 20 mg/day. Adjust dose at ≥4-wk intervals.
Administration
May be taken with or without food.
Contraindications
Active liver disease or unexplained persistent elevations of serum transaminases >3 times the upper limit of normal. Pregnancy, lactation & women of childbearing potential.
Special Precautions
Liver function tests should be performed before the initiation of treatment & at 12 wk following both the initiation therapy & any evaluation of dose & semiannually thereafter. Avoid alcohol consumption. Myalgia & myopathy. Discontinue use in presence of markedly elevated CPK levels or myopathy or development of renal failure secondary to rhabdomyolysis.
Adverse Reactions
GI disturbances, insomnia, headache, myalgia, asthenia, angioneurotic edema, muscle cramps, myositis, myopathy, cholestatic jaundice, hypo & hyperglycemia, anorexia, peripheral neuropathy, pruritus, impotence, angina.
Drug Interactions
Increased risk of myopathy w/ concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, niacin or azole antifungals. Decreased atorvastatin plasma conc w/ oral antacid susp containing Mg & Al hydroxides, & colestipol. Increased steady-state plasma digoxin conc. Increased atorvastatin plasma conc w/ erythromycin. Increased AUC values for norethindrone & ethinylestradiol.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Stator FC tab 10 mg
Packing/Price
3 × 10's (Rp13,200/film-coated tab, Rp396,000/boks)
Form
Stator FC tab 40 mg
Packing/Price
3 × 10's
Form
Stator FC tab 20 mg
Packing/Price
3 × 10's (Rp450,000/boks, Rp15,000/film-coated tab)
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