Atorvastatin Sandoz

Atorvastatin

Hypercholesterolaemia: Adjunct to diet for reduction of elevated total-cholesterol (total-C), LDL-C, Apo B & triglycerides (TG) in adults, adolescents & childn ≥10 yr w/ primary hypercholesterolemia, heterozygous familial hypercholesterolemia or combined (mixed) hyperlipidaemia (Fredrickson Types IIa & IIb), elevated serum TG levels (Fredrickson Type IV) & for patients w/ dysbetalipoproteinemia (Fredrickson Type III) when response to diet & other non-pharmacological measures are inadequate. Raises HDL-C; lowers LDL/HDL & total-C/HDL ratios. Reduction of total-C & LDL-C in adults w/ HoFH as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable. CV disease prevention: Reduction of MI risk in hypertensive adult w/o clinically evident CHD but w/ at least 3 additional risk factors for CHD (eg, age ≥55 yr, male, smoking, left ventricular hypertrophy, other specified ECG abnormalities, microalbuminuria or proteinuria, ratio of plasma total-C to HDL-C ≥6 or premature family history of CHD). Reduce risk of MI & stroke in adult w/ type 2 diabetes w/o clinically evident CHD but w/ multiple risk factors for CHD (eg, retinopathy, albuminuria, smoking or HTN). Reduce risk of non-fatal MI, fatal & non-fatal stroke, for revascularization procedures, hospitalization for CHF, & angina in adult w/ clinically evident CHD.

Individualized dose. Recommended starting dose: 10 or 20 mg once daily. Adjust dose accordingly & analyze lipid levels w/in 2-4 wk after initiation &/or upon titration. Prevention of CV disease Primary prevention: 10 mg once daily. Secondary prevention: 10-80 mg once daily. Primary hypercholesterolaemia & combined (mixed) hyperlipidemia 10 mg once daily. Therapeutic response is evident w/in 2 wk & max response is usually achieved w/in 4 wk. HoFH 80 mg once daily. Patient who requires a large LDL-C reduction (>45%) Starting dose: 40 mg once daily. Dosage range: 10-80 mg once daily. Use in combination w/ other medicinal compd Co-administration w/ cyclosporine, telaprevir or tipranavir/ritonavir: Max dose: 10 mg. Concomitant use w/ elbasvir/grazoprevir: Max daily dose: 20 mg. Childn ≥10 yr Hypercholesterolemia Starting dose: 10 mg daily. May be titrated up to 20 mg daily. Titrate according to the individual response & tolerability.

May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.

Hypersensitivity. Patients w/ active liver disease or unexplained persistent elevations of serum transaminases >3x ULN; concomitantly treated 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 any signs or symptoms suggestive of liver injury. Reduce dose or w/draw treatment if an increase in ALT or AST of >3x ULN persists. Patients who consume substantial quantities of alcohol &/or have a history of liver disease. Discontinue use if markedly elevated creatine phosphokinase (CPK) levels occur or if myopathy is diagnosed or suspected. Carefully monitor patients for any signs & symptoms of muscle pain, tenderness or weakness particularly during initiation & any periods of upward dosage titration. Consider periodic CPK determinations. Closely monitor skeletal muscle effects in patients w/ history of renal impairment for potential development of rhabdomyolysis. Temporarily w/hold or discontinue therapy in any patient w/ an acute, serious condition suggestive of a myopathy or w/ a 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). Consider potential risk of hemorrhagic stroke before initiating treatment in patients w/ recent (1-6 mth) stroke or transient ischemic attack. Possible increased HbA1C & fasting serum glucose levels; periodically monitor patients at high risk of DM. Advise patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Concomitant use w/ fibric acid derivatives, erythromycin, immunosuppressive drugs, azole antifungals, HIV/HCV PIs, HCV non-structural protein 5A/5B inhibitors, letermovir or lipid-modifying doses of niacin. Concurrent use w/ fusidic acid is not recommended; temporarily suspend atorvastatin use during fusidic acid therapy. Not recommended in patients taking letermovir co-administered w/ cyclosporine. Monitor patients taking digoxin appropriately when giving atorvastatin 80 mg daily. Counsel adolescent females & women of childbearing potential on appropriate contraceptive methods while on therapy. Not indicated for childn <10 yr.

Headache; abdominal pain; increased blood CPK. Adult: Nasopharyngitis; hyperglycaemia; pharyngolaryngeal pain, epistaxis; insomnia; nausea, diarrhea, dyspepsia, constipation, flatulence; arthralgia, pain in the extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; asthenia; abnormal LFT. Childn: Increased ALT.

Increased risk of myopathy during treatment w/ cyclosporine, fibric acid derivatives, lipid-modifying doses of niacin or CYP3A4/transporter inhibitors (eg, erythromycin & azole antifungals). Increased plasma conc w/ CYP3A4 inhibitors (eg, clarithromycin, erythromycin, PIs, diltiazem HCl, cimetidine, itraconazole & grapefruit juice). Increased exposure w/ cyclosporine, glecaprevir, pibrentasvir, letermovir, elbasvir & grazoprevir; amlodipine. Reduced plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin), oral antacids containing Mg & Al hydroxide & colestipol. Increased conc of digoxin when given w/ atorvastatin 80 mg daily. Increased AUC of OCs containing norethindrone & ethinyl estradiol. Possible risk of myopathy w/ colchicine. Increased risk of rhabdomyolysis w/ fusidic acid.

Dyslipidaemic Agents

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

POM