Apo-Atorvastatin

Raises HDL-C & lowers LDL/HDL & total cholesterol (TC)/HDL ratios. Adjunct to lifestyle changes including diet, for reduction of elevated TC, LDL-C, Apo B & triglycerides (TG) in adults, adolescents & childn ≥10 yr w/ primary & heterozygous familial hypercholesterolemia, combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum TG levels (Fredrickson type IV) & dysbetalipoproteinemia (Fredrickson type III) when response to diet & other non-pharmacological measures is inadequate. Adjunct to other lipid-lowering treatments (eg, LDL apheresis) or such treatments are unavailable in adults w/ homozygous familial hypercholesterolemia. Prevention of CV diseases in adult hypertensives w/o clinically evident CHD, but w/ at least 3 additional risk factors for CHD; adults w/ type 2 DM w/o clinically evident CHD, but w/ multiple risk factors for CHD, to reduce risk of MI & stroke; adults w/ clinically evident CHD to reduce risk of non-fatal MI, fatal & non-fatal stroke, revascularization procedures, hospitalization for CHF & angina.

Individualized dosage. Initially 10-20 mg once daily. Patient who requires large reduction in LDL-C (>45%) Initially 40 mg once daily. Dosage range: 10-80 mg once daily. Prevention of CV disease Primary prevention: 10 mg once daily. Secondary prevention: 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia 80 mg. Childn ≥10 yr Hypercholesterolaemia Initially 10 mg daily w/ titration up to 20 mg daily. Combination w/ other medicinal compd (eg, cyclosporine, telaprevir or tipranavir/ritonavir) Max dose: 10 mg. Concomitant use w/ elbasvir/grazoprevir Max dose: 20 mg daily.

May be taken with or without food: Avoid excessive grapefruit juice consumption (>1.2 L/day).

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3x ULN. Concomitant treatment w/ glecaprevir/pibrentasvir. Women of childbearing potential who are not using adequate contraceptive measures. Pregnancy & lactation.

Perform LFTs before treatment initiation & periodically thereafter; in patients who develop signs or symptoms suggesting liver injury. Possible elevation in transaminases; reduce dose or w/draw if increase in ALT or AST >3x ULN persists. Patients who consume substantial quantities of alcohol &/or have history of liver disease. Advise patients to promptly report unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever. Discontinue treatment if markedly elevated creatine phosphokinase (CPK) levels occur or myopathy is diagnosed/suspected. Concurrent administration w/ cyclosporine, fibric acid derivatives, erythromycin, niacin, azole antifungals, colchicine, telaprevir, or tipranavir/ritonavir. Temporarily suspend treatment during fusidic acid therapy. Rare cases of rhabdomyolysis w/ acute renal failure secondary to myoglobinuria. Temporarily w/hold or discontinue use in any patient w/ acute, serious condition suggestive of myopathy or having risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders & uncontrolled seizures). Possible increase in HbA1c & fasting serum glucose levels. Higher incidence of hemorrhagic stroke. May induce de novo or aggravate pre-existing myasthenia gravis or ocular myasthenia; discontinue use in case of aggravation of symptoms; reported recurrence when same or different statin was re-administered. Closely monitor for skeletal muscle effects in patients w/ history of renal impairment. Women of childbearing potential should use adequate contraceptive measures. Childn <10 yr.

Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; insomnia; headache; nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; asthenia; abnormal LFT, increased blood CPK.

Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, lipid-modifying doses of niacin, CYP3A4 inhibitors (eg, erythromycin & azole antifungals), colchicine. Increased plasma conc w/ CYP3A4 inhibitors (eg, erythromycin, diltiazem, grapefruit juice). Increased AUC w/ OATP1B1 inhibitors (eg, cyclosporine), clarithromycin, PIs (eg, ritonavir, saquinavir, lopinavir), itraconazole. Reduced plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin), oral antacid suspension containing Mg & Al hydroxides, colestipol. Increased conc of digoxin. Increased AUC values of OCs containing norethindrone & ethinyl estradiol. Severe muscle problems (eg, rhabdomyolysis) w/ fusidic acid. Increased exposure of glecaprevir/pibrentasvir, elbasvir/grazoprevir.

Dyslipidaemic Agents

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

POM