Ezenstatin: Medicine to treat hyperlipidemia

2021-07-04 05:48 PM

Ezenstatin prevents cardiovascular events in coronary artery disease patients with a history of acute coronary syndromes. Treatment of primary hypercholesterolemia or mixed dyslipidemia.

Ingredient

Ezenstatin 10/10 Each tablet: Ezetimibe 10 mg, atorvastatin 10 mg. Ezenstatin 10/20 Each tablet: Ezetimibe 10 mg, atorvastatin 20 mg.

Indications and uses

Prevention of cardiovascular events in coronary artery disease patients with a history of acute coronary syndromes. Treatment of primary hypercholesterolemia or mixed dyslipidemia when statin monotherapy is inadequately controlled or when statin and ezetimibe alone are treated. Treatment or adjunct to other lipid-lowering treatments (eg, LDL apheresis) for adult patients with homozygous familial hypercholesterolemia.

Dosage and instructions for use

Start with the lowest effective dose; then, according to need and response, increase the dose in increments of not less than 4 weeks until the desired LDL cholesterol concentration or maximum dose is reached; Adverse reactions should be monitored, especially with the muscular system. Adults: start at 10/10 mg/day or 10/20 mg/day, titrate after 2 weeks if necessary; maintenance 10/10 - 10/20 mg/day, increase dose if necessary, not to exceed 80 mg atorvastatin/day.

How to use

Swallow whole (do not crush, dissolve or chew), single dose, any time of day (evening increases potency), with meals or on an empty stomach.

Contraindications

Hypersensitivity to drug components. Active liver disease, unexplained persistent elevations in serum transaminases. Pregnant and lactating women.

Cautions

Patients with risk factors for muscle damage such as >65 years of age, uncontrolled hypothyroidism, kidney disease. Monitor CK (>5xULN: statin therapy should not be initiated) in cases of renal failure, hypothyroidism, personal/familial history of hereditary myopathy, history of myopathy due to previous statin/fibrates, history of liver disease and/or heavy alcohol consumption, >70 years. have risk factors for rhabdomyolysis, the possibility of drug interactions, some special patient populations. Use only in women of childbearing age when it is certain that they are not pregnant and have very high blood cholesterol that has not responded to other medications. Do not use in patients with severe renal impairment; galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.

Side Effects

Common: diarrhea, constipation, flatulence, abdominal pain, nausea; headache, dizziness, blurred vision, insomnia, weakness; muscle pain, joint pain.

Interactive

CYP3A4 inhibitors (eg, cyclosporin, erythromycin, gemfibrozil, itraconazole, ketoconazole), niacin >1g/day, colchicine, fibrates: possible myositis and rhabdomyolysis. Cholestyramine, colestipol: may significantly reduce the bioavailability of atorvastatin (should be administered at intervals of 2 hours). Other lipid-lowering agents: possibility of increased risk of myopathy. Diltiazem: increased concentration of atorvastatin; risk of muscle wasting, kidney failure. Antacids containing magnesium and aluminum hydroxide: decreased concentrations of atorvastatin. HIV and hepatitis C protease inhibitors: may increase risk of serious muscle damage, kidney failure leading to renal failure and possibly death (tipranavir+ritonavir, telaprevir: avoid; lopinavir+ritonavir: if necessary, use lowest dose of atorvastatin; darunavir+ritonavir, fosamprenavir, fosamprenavir+ritonavir, saquinavir+ritonavir: no more than 20 mg atorvastatin/day; nelfinavir: no more than 40 mg atorvastatin/day). May increase the effect of warfarin. Oral administration of atorvastatin after oral rifampin resulted in significant reductions in atorvastatin concentrations (co-administration if combined). Increased AUC of norethindrone and ethinyl estradiol.

Classification (US)/pregnancy

Grade X: Animal and human studies have shown fetal abnormalities; or there is evidence of fetal risk based on human experience; or both of these; and the risks of using the drug to pregnant women clearly outweigh any benefits. This drug is contraindicated in women who are pregnant or may become pregnant.

Presentation and packaging

Ezenstatin 10/10 Film-coated tablets: 4 × 7's.

Ezenstatin 10/20 Film-coated tablets: 4 × 7's.