سعر اتوريزا 40/10مجم 28 قرص 2024

Atoreza film-coated tablets containing atorvastatin 40 mg and ezetimibe 10 mg, a fixed-dose lipid-lowering combination (HMG-CoA reductase inhibitor plus cholesterol absorption inhibitor) marketed in Egypt by Marcyrl co.; pack of 28 tablets.

• Prevention of cardiovascular events in patients with coronary heart disease and a history of acute coronary syndrome (previously on a statin or not)Population: AdultsEgyptian Drug Authority (EDA) e-services
• Primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed hyperlipidaemia, as an adjunct to diet, when a combination is appropriate: not controlled on a statin alone or already treated with a statin and ezetimibePopulation: AdultsEgyptian Drug Authority (EDA) e-services
• Homozygous familial hypercholesterolaemia, as an adjunct to diet; may also receive other lipid-lowering treatments such as LDL apheresisPopulation: AdultsEgyptian Drug Authority (EDA) e-services

• Common: diarrhoea, myalgia. Uncommon: influenza, depression, insomnia, dizziness, dysgeusia, headache, paraesthesia, sinus bradycardia, hot flush, dyspnoea, abdominal pain, abdominal distension, constipation, dyspepsia, flatulence, frequent bowel movements, gastritis, nausea, stomach discomfort, acne, urticaria, arthralgia, back pain, muscle fatigue, muscle spasms, muscular weakness, pain in extremity, asthenia, fatigue, malaise, oedema, raised ALT/AST/CK and GGT, weight increase. Serious effects reported with the components include rhabdomyolysis, hepatitis, hepatic failure, severe skin reactions and tendon rupture.Egyptian label · Egyptian Drug Authority (EDA) e-services

• Hypersensitivity to the active substances or any excipient; pregnancy, breast-feeding and women of child-bearing potential not using appropriate contraception; active liver disease or unexplained persistent serum transaminase elevations above 3 times ULN; concomitant glecaprevir/pibrentasvir.Egyptian label · Egyptian Drug Authority (EDA) e-services
• Active liver disease or unexplained persistent elevations of hepatic transaminases; hypersensitivity to any component; pregnancy or women who may become pregnant; nursing mothers.International label, same formulation · DailyMed (U.S. National Library of Medicine)

• Myopathy and rhabdomyolysis (atorvastatin; also reported with ezetimibe); immune-mediated necrotising myopathy very rarely; measure CK before treatment in patients with predisposing factors; do not start if baseline CK exceeds 5 times ULN; stop if CK exceeds 10 times ULN or rhabdomyolysis is suspected.Egyptian label · Egyptian Drug Authority (EDA) e-services
• Do not use with systemic fusidic acid or within 7 days of stopping it; avoid potent CYP3A4 inhibitors where possible; consider temporary suspension with daptomycin.Egyptian label · Egyptian Drug Authority (EDA) e-services
• Liver function tests before treatment and periodically thereafter; caution with substantial alcohol intake or a history of liver disease.Egyptian label · Egyptian Drug Authority (EDA) e-services

• Ciclosporin, tipranavir/ritonavirMarkedly increased atorvastatin exposure; do not exceed ezetimibe/atorvastatin 10/10 mg daily (ciclosporin also raises ezetimibe exposure; monitor ciclosporin levels).Egyptian Drug Authority (EDA) e-services
• Lopinavir/ritonavir, clarithromycinIncreased atorvastatin exposure; clinical monitoring recommended at doses above 10/20 mg.Egyptian Drug Authority (EDA) e-services
• Saquinavir/ritonavir, darunavir/ritonavir, fosamprenavir, itraconazoleIncreased atorvastatin exposure; clinical monitoring recommended at doses above 10/40 mg.Egyptian Drug Authority (EDA) e-services

• Contraindicated during pregnancy and in women of child-bearing potential not using appropriate contraception; safety of atorvastatin in pregnancy not established and no clinical data for ezetimibe in pregnancy; rare congenital anomalies reported after intrauterine exposure to HMG-CoA reductase inhibitors; stop treatment if pregnancy occurs.Egyptian label · Egyptian Drug Authority (EDA) e-services
• Contraindicated during breast-feeding; atorvastatin and ezetimibe are excreted in rat milk and excretion in human milk is unknown.Egyptian label · Egyptian Drug Authority (EDA) e-services

• Atorvastatin: Selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme of cholesterol synthesis; lowers plasma cholesterol and increases hepatic LDL receptors, enhancing LDL uptake and catabolism.
• Ezetimibe: Inhibits intestinal absorption of cholesterol and related plant sterols by targeting the sterol transporter Niemann-Pick C1-Like 1 (NPC1L1) at the small-intestinal brush border.

Store at or below 30 °C in a dry place.