Duvaztor-20/Duvaztor-40

Reduce LDL-C, Apo-B, triglycerides & increase HDL-C in the treatment of hyperlipidaemia including hypercholesterolaemia & combined (mixed) hyperlipidaemia (type IIa or IIb hyperlipoproteinemias), hypertriglyceridaemia (type IV) & dysbetalipoproteinemia (type III). Adjunct therapy in patients w/ homozygous familial hypercholesterolaemia who have some LDL-receptor function.

10-20 mg once daily. Patient who require large reduction in LDL-C Initially 40 mg once daily, may be adjusted up to max 80 mg daily at 4-wk interval. Childn & adolescent 10-17 yr Heterozygous familial hypercholesterolaemia Initially 10 mg once daily, adjusted according to response to max 20 mg once daily.

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

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

Risk of haemorrhagic stroke in patients w/ prior haemorrhagic stroke or lacunar infarct. May affect skeletal muscle & cause myalgia, myositis & myopathy that may progress to rhabdomyolysis. Before starting treatment, measure creatine kinase (CK) level in patients w/ predisposing factors to rhabdomyolysis eg, renal impairment; hypothyroidism; personal or familial history of hereditary muscular disorders; previous history of muscular toxicity w/ statin or fibrate; previous history of liver disease &/or where substantial quantities of alcohol are consumed; in elderly >70 yr; situations where an increase in plasma levels may occur. Discontinue treatment or do not start treatment if CK levels are significantly elevated >5 times ULN. Consider discontinuation of treatment if muscular symptoms are severe & cause daily discomfort (even w/ CK levels <5 times ULN). Discontinue use if clinically significant elevation of CK levels (>10 times ULN) occur, or rhabdomyolysis is diagnosed or suspected. Very rare reports of immune-mediated necrotizing myopathy during or after treatment w/ some statins. Concomitant use w/ medicinal products that may increase plasma conc of atorvastatin eg, potent inhibitors of CYP3A4 or transport proteins (eg, ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole & HIV PIs including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir); gemfibrozil & other fibric acid derivatives, antivirals for treatment of HCV (boceprevir, telaprevir, elbasvir/grazoprevir), erythromycin, niacin or ezetimibe. Do not co-administer w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid treatment. Perform LFTs before initiation of treatment & periodically thereafter, & in patients who develop any signs & symptoms suggestive of liver injury. Reduce dose or w/draw treatment if increase in transaminase of >3 times ULN persist.

Nasopharyngitis; allergic reactions; hyperglycaemia; headache; pharyngolaryngeal pain, epistaxis; constipation, flatulence, dyspepsia, nausea, diarrhoea; myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain.

Increased plasma conc w/ medicinal products that are CYP3A4 or transport proteins inhibitors; potent/moderate CYP3A4 inhibitors. Increased exposure w/ amiodarone & verapamil. Variable reductions in plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin, St. John's wort). Delayed administration of atorvastatin after administration of rifampin has been associated w/ significant reduction in atorvastatin plasma conc. Increased systemic exposure w/ transport proteins inhibitors (eg, ciclosporin). Increased risk of myopathy including rhabdomyolysis w/ gemfibrozil/fibric acid derivatives; ezetimibe; fusidic acid; colchicine. Lowered plasma conc of atorvastatin & its metabolites w/ colestipol.

Dyslipidaemic Agents

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

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