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Lipitor

Lipitor

atorvastatin

Manufacturer:

Viatris

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Crystalline atorvastatin
Indications/Uses
Adjunct to diet for patients w/ elevated total cholesterol (total-C) & LDL-C, Apo B & triglycerides (TG) & to increase HDL-C in patients w/ primary hypercholesterolemia (heterozygous familial & non-familial), combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum TG levels (Fredrickson type IV) & patients w/ dysbetalipoproteinemia (Fredrickson type III) who respond inadequately to diet. Reduction of total-C & LDL-C in patients w/ HoFH. Reduction of total-C & LDL-C & apo B levels in boys & postmenarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia if after adequate diet therapy, LDL-C remains ≥190 mg/dL or ≥160 mg/dL & w/ +ve family history of premature CV disease or ≥2 other CV disease risk factors. Prevention of CV disease w/o clinically evident CV disease but w/ multiple CHD risk factors eg, age, smoking, HTN, low HDL-C, or family history of early CHD to reduce risk of MI, stroke, revascularization procedures & angina. Type 2 diabetes w/o clinically evident CHD but w/ multiple risk factors eg, retinopathy, albuminuria, smoking or HTN to reduce risk of MI & stroke. Patients w/ clinically evident CHD to reduce risk of non-fatal MI, fatal & non-fatal stroke, revascularization procedures, hospitalization for CHF & angina.
Dosage/Direction for Use
Dose range: 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. HoFH Most patient responded to 80 mg daily. Heterozygous familial hypercholesterolemia in ped patient 10-17 yr Initially 10 mg daily, dose adjustments made at ≥4 wk intervals. Max: 20 mg daily. Severe dyslipidemia in ped patient ≥10 yr Initially 10 mg once daily, may be increased to 80 mg daily. Dose adjustments made at ≥4 wk intervals. Childn HoFH Up to 80 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevated serum transaminases >3 times ULN. Women of childbearing potential who are not using adequate contraceptive measures. Pregnancy & lactation.
Special Precautions
Discontinue use if markedly elevated creatine phosphokinase (CPK) levels occur; myopathy is diagnosed or suspected. Temporarily withheld or discontinue use if acute, serious condition suggestive of myopathy or risk factor predisposing to renal failure secondary to rhabdomyolysis development occur. Increased risk for recurrent hemorrhagic stroke; increased HbA1c & fasting serum glucose levels; immune-mediated necrotizing myopathy. Induce de novo or aggravate preexisting myasthenia gravis or ocular myasthenia. Substantial alcohol consumption &/or history of hepatic disease. Perform LFTs prior to initiation & periodically thereafter. Reduce dose or discontinue use if increased ALT or AST >3 times ULN persist. Not recommended to be used concurrently w/ fusidic acid. Avoid use w/ cyclosporine, HIV PIs, hepatitis C PIs. Concurrent use w/ fibric acid derivatives, erythromycin, immunosuppressives, azole antifungals, HCV NS5A/NS5B inhibitors, letermovir, niacin ≥1 g daily. Women of childbearing potential should use effective contraception.
Adverse Reactions
Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; diarrhoea, dyspepsia, nausea, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; abnormal LFT, increased blood CPK.
Drug Interactions
Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, niacin, erythromycin, azole antifungals. Increased plasma conc by CYP3A4 inhibitors, erythromycin or clarithromycin, PIs, diltiazem, grapefruit juice. Increased AUC w/ itraconazole. Increased exposure w/ OATP1B1, OATP1B3, MDR1, BCRP, P-gp, MRP2, OAT2 inhibitors. Reduced plasma conc by CYP3A4 inducers, Mg- & Al hydroxide-containing antacids, colestipol. Increased digoxin conc. Increased AUC values for norethindrone & ethinyl estradiol. Cases of myopathy w/ colchicine. Increased risk of rhabdomyolysis w/ fusidic acid. Severe myositis & myoglobinuria w/ fibrates.
MIMS Class
Dyslipidaemic Agents
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 10 mg
Packing/Price
30's
Form
Lipitor FC tab 20 mg
Packing/Price
30's
Form
Lipitor FC tab 40 mg
Packing/Price
30's
Form
Lipitor FC tab 80 mg
Packing/Price
30's
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