سعر اتروزيمب 80/10مجم 30 قرص 2024

Atrozemb 80/10 mg, pack of 30 film-coated tablets (Liptis, Egypt): atorvastatin 80 mg + ezetimibe 10 mg, a fixed-dose combination of an HMG-CoA reductase inhibitor (statin) and an intestinal cholesterol absorption inhibitor for hypercholesterolaemia.

• Reduction of the risk of cardiovascular events in patients with coronary heart disease and a history of acute coronary syndrome, previously treated with a statin or not.Population: AdultsHealth Products Regulatory Authority (HPRA), Ireland
• Adjunct to diet in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where a combination product is appropriate: patients not appropriately controlled with a statin alone, or already treated with a statin and ezetimibe.Population: AdultsHealth Products Regulatory Authority (HPRA), Ireland
• Adjunct to diet in adults with homozygous familial hypercholesterolaemia (may also receive LDL apheresis).Population: AdultsHealth Products Regulatory Authority (HPRA), Ireland

• Common with the combination (or equivalent co-administration): diarrhoea and myalgia. Uncommon: influenza, depression, insomnia, dizziness, dysgeusia, headache, paraesthesia, sinus bradycardia, hot flush, dyspnoea, gastrointestinal discomfort, acne, urticaria, arthralgia, back pain, muscle spasms/weakness, asthenia, fatigue, raised ALT/AST, CPK and GGT, weight increase.International label, equivalent formulation · Health Products Regulatory Authority (HPRA), Ireland
• Clinically important consecutive transaminase elevations (>=3 x ULN) occurred in 0.6% of patients on the combination. Not known frequency: hypersensitivity/anaphylaxis, thrombocytopenia, hepatitis, cholelithiasis, pancreatitis, hepatic failure, myopathy/rhabdomyolysis, tendinopathy, immune-mediated necrotising myopathy, severe skin reactions (erythema multiforme, SJS/TEN).International label, equivalent formulation · Health Products Regulatory Authority (HPRA), Ireland
• US label: common adverse reactions (2% or more and greater than placebo): increased ALT, increased AST and musculoskeletal pain.International label, equivalent formulation · DailyMed (U.S. National Library of Medicine)

• Hypersensitivity to the active substances or excipients; 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.International label, equivalent formulation · Health Products Regulatory Authority (HPRA), Ireland
• US label: active liver disease or unexplained persistent hepatic transaminase elevations; hypersensitivity to any component; women who are pregnant or may become pregnant; nursing mothers.International label, equivalent formulation · DailyMed (U.S. National Library of Medicine)

• Myopathy/rhabdomyolysis: measure CPK before treatment in patients with predisposing factors (renal impairment, hypothyroidism, hereditary muscle disorders, previous statin/fibrate muscle toxicity, liver disease or heavy alcohol use, age over 70, interacting drugs); patients should report unexplained muscle pain, tenderness or weakness; stop if CPK is markedly elevated (>5 x ULN) or myopathy is suspected. Immune-mediated necrotising myopathy and new or worsened myasthenia have been reported rarely.International label, equivalent formulation · Health Products Regulatory Authority (HPRA), Ireland
• Do not co-administer with systemic fusidic acid or within 7 days of stopping it (rhabdomyolysis, including fatalities); caution with strong CYP3A4 inhibitors and daptomycin.International label, equivalent formulation · Health Products Regulatory Authority (HPRA), Ireland
• Liver: perform liver function tests before treatment and periodically; use with caution in patients who drink substantial alcohol or have a history of liver disease; not recommended in moderate or severe hepatic insufficiency. Co-administration with fibrates is not recommended; caution with ciclosporin (monitor ciclosporin levels); monitor INR if added to warfarin, another coumarin or fluindione.International label, equivalent formulation · Health Products Regulatory Authority (HPRA), Ireland

• Strong CYP3A4 or OATP1B1/BCRP inhibitors (e.g. ciclosporin, clarithromycin, itraconazole, HIV protease inhibitors, letermovir)Increase atorvastatin plasma concentrations and myopathy risk; avoid if possible or use lower doses with clinical monitoring.Health Products Regulatory Authority (HPRA), Ireland
• Glecaprevir/pibrentasvirContraindicated.Health Products Regulatory Authority (HPRA), Ireland
• Elbasvir/grazoprevirDo not exceed 10/20 mg/day (ezetimibe/atorvastatin).Health Products Regulatory Authority (HPRA), Ireland

• Contraindicated during pregnancy; no clinical data with the combination. Should not be used in women who are pregnant, trying to become pregnant or suspect pregnancy; suspend treatment for the duration of pregnancy. Rare congenital anomalies after intrauterine statin exposure have been reported. Women of childbearing potential must use appropriate contraception.International label, equivalent formulation · Health Products Regulatory Authority (HPRA), Ireland
• US label: contraindicated in women who are or may become pregnant; statins may cause fetal harm; give to women of childbearing age only when highly unlikely to conceive, and stop immediately if pregnancy occurs.International label, equivalent formulation · DailyMed (U.S. National Library of Medicine)
• Contraindicated during breast-feeding; ezetimibe is secreted into rat milk and atorvastatin milk levels in rats are similar to plasma; unknown in humans.International label, equivalent formulation · Health Products Regulatory Authority (HPRA), Ireland

• Atorvastatin: Inhibits HMG-CoA reductase and hepatic cholesterol synthesis and increases hepatic LDL receptors, enhancing LDL uptake and catabolism (US LYPQOZET label).
• Ezetimibe: Inhibits intestinal absorption of cholesterol and phytosterols by targeting the sterol transporter NPC1L1 at the small-intestinal brush border (US LYPQOZET label).