Atorvast-Natrapharm

Atorvast-Natrapharm

atorvastatin

Manufacturer:

Natrapharm

Distributor:

Natrapharm
Concise Prescribing Info
Contents
Atorvastatin
Indications/Uses
Reduce LDL-cholesterol, apolipoprotein B & triglycerides. Increase HDL-cholesterol in the treatment of hyperlipidemia including hypercholesterolemia & combined (mixed) hyperlipidemia (type IIa & IIb hyperlipoproteinemia), hypertriglyceridemia (type IV) & dysbetalipoproteinemia (type III). Adjunctive therapy in patients w/ homozygous familial hypercholesterolemia who have LDL-receptor function.
Dosage/Direction for Use
Primary hypercholesterolemia & combined (mixed) dyslipidemia including familial combined hyperlipidemia Starting dose: 10 or 20 mg. Patients requiring large reduction in LDL-cholesterol (>45%) Start at 40 mg. Dose range: 10-80 mg. Adjust dose at intervals of 2-4 wk up to a max of 80 mg/day. Severe dyslipidemia including homozygous & heterozygous familial hypercholesterolemia & dysbetalipoproteinemia (type III) Up to 80 mg/day. Heterozygous familial hypercholesterolemia Childn 10-17 yr Starting dose: 10 mg. Max: 20 mg/day. Adjust dose at intervals of ≥4 wk. Primary prevention of MI 10 mg. Secondary prevention of MI 10-80 mg. All doses to be taken once daily.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Active liver disease or unexplained persistent elevations of serum transaminases >3x ULN. Pregnancy & lactation.
Special Precautions
Monitor lipid levels periodically. Discontinue use if markedly elevated creatine kinase levels & hypersensitivity occurs, if myopathy is diagnosed or suspected, during fusidic acid therapy & having risk factor predisposing to development of renal failure secondary to rhabdomyolysis. Patients w/ predisposing factors for myopathy/rhabdomyolysis. Concomitant use w/ CYP3A4 inhibitors; digoxin; drugs that may decrease endogenous steroid hormone levels (eg, ketoconazole, spironolactone, cimetidine). Consider risk of hemorrhagic stroke prior to treatment in patients w/ recent (1-6 mth) stroke or transient ischemic attack. Decrease in myocardial ubiquinone (CoQ10) levels may lead to impaired cardiac function in CHF patients. Severe renal impairment. Perform liver function test prior to treatment & periodically thereafter. Ped patients except childn 10-17 yr w/ heterozygous familial hypercholesterolemia. Elderly ≥70 yr.
Adverse Reactions
Diarrhea, dyspepsia, nausea, constipation, flatulence; asthenia; nasopharyngitis; abnormal liver function test, increased blood creatine phosphokinase, hyperglycemia; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; headache; pharyngolaryngeal pain, epistaxis.
Drug Interactions
CYP3A4 inhibitors eg, grapefruit juice, fibric acid derivatives (gemfibrozil, fenofibrate, other fibrates, niacin), macrolides (erythromycin, clarithromycin), immunosuppressants (cyclosporine), azole antifungals (itraconazole, ketoconazole), PIs (nelfinavir, lopinavir, ritonavir, saquinavir), antidepressants, nefazodone; CYP3A4 inducers eg, efavirenz, rifampin; colestipol; digoxin; OCs & hormone replacement therapy eg, norethindone, ethinylestradiol; Al- & Mg-containing antacids; diltiazem; fusidic acid.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Atorvast-Natrapharm FC tab 80 mg
Packing/Price
100's;10's
Form
Atorvast-Natrapharm FC tab 20 mg
Packing/Price
100's;10's
Form
Atorvast-Natrapharm FC tab 40 mg
Packing/Price
100's;10's
Form
Atorvast-Natrapharm FC tab 10 mg
Packing/Price
100's;10's
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