Avamax

Adjunct to diet to decrease elevated total-C, LDL-C, Apo B, & triglyceride levels & to increase HDL-C in patients w/ primary hypercholesterolemia (heterozygous familial & nonfamilial) or mixed dyslipidemia (Fredrickson types IIa & IIb); for the treatment of patients w/ elevated serum triglyceride levels (Fredrickson type IV); for the treatment of patients w/ dysbetalipoproteinemia (Fredrickson type III). Increase of HDL-C & decrease of LDL-C/HDL-C & total-C/HDL-C ratios. Adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable to decrease total-C & LDL-C in patients w/ HoFH. Adjunct to diet to decrease total-C, LDL-C, & Apo B levels in boys & postmenarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia. Prevention of CV disease in adults w/o clinical evidence of CHD but w/ multiple risk factors for CHD; patients w/ type 2 diabetes w/o clinical evidence of CHD but w/ multiple risk factors for CHD; patients w/ clinical evidence of CHD.

Hyperlipidemia (heterozygous familial & nonfamilial) & mixed dyslipidemia Initially 10 mg or 20 mg once daily. Dose range: 10-80 mg once daily. Patient requiring large LDL-C reduction (>45%) May be started at 40 mg once daily. HoFH 10-80 mg once daily. Heterozygous familial hypercholesterolemia Adult Initially 10 mg once daily, adjusted every 4 wk to 40 mg once daily. Dose may be increased to max of 80 mg once daily or a bile acid sequestrant may be combined w/ 40 mg once daily. Childn 10-17 yr Initially 10 mg once daily, may be adjusted at ≥4 wk interval. Max dose: 20 mg daily. Hypertriglyceridemia & dysbetalipoproteinemia 10-80 mg once daily as single dose, may be adjusted after 4 wk. Concomitant use w/ clarithromycin, itraconazole, or patient w/ HIV taking combination of saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir or fosamprenavir + ritonavir Not to exceed 20 mg once daily, HIV (eg, nelfinavir) or HCV (boceprevir) PI Not to exceed 40 mg once daily.

May be taken with or without food.

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases >3 x ULN. Women who are or may become pregnant. Lactation.

Discontinue use if markedly elevated CK levels occur or myopathy is diagnosed or suspected; ILD is suspected or developed. Temporarily discontinue use in any patient w/ acute, serious condition suggestive of myopathy or having a risk factor predisposing to development of renal failure secondary to rhabdomyolysis eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, & uncontrolled seizures. Rhabdomyolysis w/ acute renal failure secondary to myoglobinuria (rare); persistent elevations (>3 x ULN occurring on ≥2 occasions) in serum transaminases; increases in HbA1c & fasting serum glucose levels; potential risk of hemorrhagic stroke in patients w/ recent stroke or TIA. Patients who consume substantial quantities of alcohol &/or have a history of liver disease. Obtain liver enzyme tests prior to initiating therapy & repeat as clinically indicated. Concomitant use w/ ciclosporin, fibric acid derivatives, erythromycin, clarithromycin, niacin, azole antifungals, HCV PI telaprevir, fosamprenavir, & combinations of HIV PIs including saquinavir + ritonavir, lopinavir + ritonavir, tipranavir + ritonavir, darunavir + ritonavir, & fosamprenavir + ritonavir; other drugs that may decrease levels or activity of endogenous steroid hormones eg, ketoconazole, spironolactone, cimetidine. Hepatic insufficiency. Women of childbearing age. Pre-pubertal patients or childn <10 yr. Elderly ≥65 yr.

Nasopharyngitis, arthralgia, diarrhea, pain in extremity, UTI, dyspepsia, nausea, musculoskeletal & pharyngolaryngeal pain, muscle spasms, myalgia, insomnia.

Increased risk of myopathy w/ CYP3A4 inhibitors eg, ciclosporin, erythromycin, clarithromycin, HIV PIs, azole antifungals. Increased exposure w/ amiodarone, verapamil. Increased AUC w/ diltiazem. May increase risk of myopathy w/ ezetimibe; fusidic acid. Increased risk of myopathy/rhabdomyolysis w/ gemfibrozil; other fibrates. May enhance risk of skeletal muscle effects w/ niacin. Increased plasma conc w/ grapefruit juice. May result in decreased plasma conc w/ CYP3A4 inducers eg, efavirenz, rifampicin, St. John's wort. Decreased plasma conc w/ Mg- & Al-containing antacids; colestipol. Increased steady-state plasma conc of digoxin. Increased AUC of norethisterone & ethinyl estradiol; amlodipine. Cases of myopathy including rhabdomyolysis w/ colchicine.

Dyslipidaemic Agents

C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

Rx