Lipitor

Lipitor

atorvastatin

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
Atorvastatin Ca (crystalline form)
Indications/Uses
Adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, apo-B & triglycerides in patients w/ primary hypercholesterolemia, combined (mixed) hyperlipidemia & heterozygous & homozygous familial hypercholesterolemia when response to diet & other nonpharmacological measures are inadequate. Prevention of CV complications, in hypertensive patient (≥40 yr) & dyslipidemia w/ at least 3 risk factor for future CV events eg, LVH, ECG abnormalities, NIDDM, peripheral vascular disease, post-history of cerebrovascular events including TIA ≥3 mth previously, microalbuminaria/proteinuria, smoking (regular smoker w/in the last year of 20 cigarettes or cigards/weel), TC/HDL-C ratio ≥6 & history of CAD event in a 1st degree relative before age 55 (male) or 60 (women). Reduce the risk of fatal CHD & non-fatal MI, stroke & revascularization procedures & angina pectoris. Childn 10-17 yr: Adjunct to diet to reduce total-cholesterol, LDL-cholesterol, apo-B levels in boys & postmenarchal girls, 10-17 yr of age, w/ heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL-C remains ≥190 mg/dL or ≥160 mg/dL & there is a positive family history of premature CV disease or ≥2 other CVD risk factors.
Dosage/Direction for Use
Recommended starting dose: 10 mg once daily. Usual dosage range: 10-80 mg once daily. Doses may be given any time of the day. Starting & maintenance dosage should be individualized. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia 80 mg. Heterozygous familial hypercholesterolemia in childn 10-17 yr Initially 10 mg daily. Max dose: 20 mg daily. Adjustments should be made at intervals ≥4 wk. Combination w/ cyclosporin, telaprevir, or the combination tipranavir/ritonavir: Dose should not exceed 10 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases >3 times the upper limit of normal. Pregnancy & lactation.
Special Precautions
Hepatic effects: Liver function tests should be performed prior to initiation of treatment, 12 wk following both the initiation therapy & any evaluation of dose & periodically thereafter. Monitor for creatine phosphokinase & transaminase elevations. Avoid alcohol consumption. Skeletal muscle effects: Myalgia. Increased risk of myopathy in concurrent administration w/ cyclosporine, fibric acid derivatives, erythromycin, niacin or azole antifungals. Temporary suspension of atorvastatin may be appropriate during fusidic acid therapy. Hemorrhagic stroke. Ensure appropriate diet, exercise & wt reduction in obese patients & treat underlying medical problems before atorvastatin therapy.
Adverse Reactions
Insomnia, headace, nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence, myalgia, arthralgia, asthenia, hypoglycemia, hyperglycemia, anorexia, peripheral neuropathy, paresthesia, tinnitus, pancreatitis, vomiting, hepatitis, cholestatic jaundice, alopecia, pruritus, rash, urticarial myopathy, myositis, muscle cramps, impotence, angioneurotic edema, malaise, angina.
Drug Interactions
Risk of myopathy increased w/ concurrent administration of cyclosporin, fibric acid derivatives, niacin or CYP450 3A4 inhibitors (eg, erythromycin, azole antifungals). Transporter inhibitors of the OATP1B1 (eg, cyclosporine) can increase the bioavailability of atorvastatin. Diltiazem HCl can increase plasma conc of atorvastatin. Cimetidine, CYP450 3A inducers: efavirenz, rifampin. Antipyrine, azithromycin, warfarin, amlodipine, fusidic acid, other concomitant therapy. Decreased atorvastatin plasma conc w/ oral antacid susp containing Mg & Al hydroxides, & colestipol. Increases plasma digoxin conc. Increased atorvastatin plasma conc w/ erythromycin/clarithromycin, PIs, grapefruit juice. Increases AUC values for norethindrone & ethinylestradiol, itraconazole.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Lipitor FC tab 20 mg
Packing/Price
30's (Rp810,992/pak)
Form
Lipitor FC tab 10 mg
Packing/Price
30's (Rp787,674/pak)
Form
Lipitor FC tab 80 mg
Packing/Price
1 × 30's (Rp921,099/boks)
Form
Lipitor FC tab 40 mg
Packing/Price
30's (Rp850,588/pak)
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