Atorvin 10/Atorvin 20/Atorvin 40

Atorvastatin Ca

Adjunct to diet for reduction of elevated total-C, LDL-C, apo B & triglycerides in adults, adolescents & childn ≥10 yr w/ primary hypercholesterolemia (including heterozygous familial hypercholesterolemia) or combined (mixed) hyperlipidemia (Types IIa & IIb of the Fredrickson classification) when response to diet & other non-pharmacological measures is inadequate. Adjunct to other lipid-lowering treatments (eg, LDL apheresis), or if such treatments are unavailable, for reduction of total-C & LDL-C in adults w/ HoFH. Adjunct to correction of other risk factors for prevention of CV events in adults w/ high risk for a 1st CV event.

Individualize dose according to baseline LDL-C levels, goal of therapy, & patient response. Initially 10 mg once daily, adjust at intervals of ≥4 wk. Max: 80 mg once daily. Adult Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Heterozygous familial hypercholesterolemia Initially 10 mg daily, adjust every 4 wk to 40 mg daily. May increase dose to max 80 mg daily, or may combine 40 mg once daily w/ a bile acid sequestrant. HoFH 10-80 mg daily. Prevention of CV disease 10 mg daily. Childn ≥10 yr Heterozygous familial hypercholesterolemia Initially 10 mg daily, may be increased to 80 mg daily according to response & tolerability. Adjust at intervals of ≥4 wk. Patient taking hepatitis C antivirals (elbasvir/grazoprevir or letermovir) Max: 20 mg daily.

May be taken with or without food: Swallow whole, do not chew/crush/divide.

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases (>3 x ULN). Treatment w/ hepatitis C antivirals (glecaprevir/pibrentasvir). Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.

Perform LFTs before treatment initiation, & thereafter when clinically indicated. Consider potential risk of hemorrhagic stroke before initiating treatment. Risk of skeletal muscle effects eg, myalgia, myositis, myopathy (may progress to rhabdomyolysis), immune-mediated necrotizing myopathy. Measure creatine kinase (CK) level before starting treatment in patients w/ renal impairment; patients w/ hypothyroidism; patients w/ personal or familial history of hereditary muscular disorders; patients w/ previous history of muscular toxicity w/ a statin or fibrate; patients w/ previous history of liver disease &/or consumption of substantial quantities of alcohol; elderly >70 yr; situations where an increase in plasma levels may occur. Promptly report muscle pain, cramps, or weakness especially if accompanied by malaise or fever while on treatment. Discontinue treatment if clinically significant elevation of CK levels (>10 x ULN) occur, or if rhabdomyolysis is diagnosed or suspected. Reports of ILD, especially w/ long-term therapy; increases in HbA1c & fasting serum glucose levels. Concomitant use w/ potent CYP3A4 inhibitors or transport proteins; gemfibrozil & other fibric acid derivates, HCV antivirals (boceprevir, telaprevir, elbasvir/grazoprevir), erythromycin, niacin, ezetimibe. Avoid co-administration w/ strong CYP3A4 inhibitors. Avoid concomitant use w/ telaprevir. Do not co-administer w/ systemic fusidic acid or w/in 7 days of stopping fusidic acid treatment. Not recommended in patients taking letermovir co-administered w/ ciclosporin. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Patients w/ hepatic impairment. Not indicated in childn <10 yr.

Nasopharyngitis; allergic reactions; hyperglycemia; headache; pharyngolaryngeal pain, epistaxis; constipation, flatulence, dyspepsia, nausea, diarrhea; myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain; abnormal LFT, increased blood creatine kinase.

Increased plasma conc w/ potent CYP3A4 inhibitors (eg, ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole), some HCV antivirals (eg, elbasvir/grazoprevir), & HIV PIs including ritonavir, lopinavir, atazanavir, indinavir, darunavir; moderate CYP3A4 inhibitors (eg, erythromycin, diltiazem, verapamil, fluconazole). Increased risk of myopathy w/ erythromycin. Co-administration w/ amiodarone & verapamil may result in increased exposure to atorvastatin. Reduced plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin, St. John's wort). Increased systemic exposure w/ transport protein inhibitors (eg, ciclosporin, letermovir). Increased risk of muscle-related events including rhabdomyolysis w/ gemfibrozil/fibric acid derivatives & ezetimibe. Lower plasma conc of atorvastatin & its active metabolites w/ colestipol co-administration. Increased risk of myopathy including rhabdomyolysis w/ systemic fusidic acid. Reports of myopathy w/ colchicine. Slightly increased steady-state conc of digoxin. Increased plasma conc of norethindrone & ethinyl estradiol. Small decrease in prothrombin time w/ warfarin.

Dyslipidaemic Agents

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

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