Livazo tablet 2mg #28

Form

tableti

Dosage mg

2

Pack

28

International Nonproprietary Name - pitavastatin One tablet contains: 1mg 2mg 4mg Active substance: Pitavastatin calcium 1.045mg 2.090mg 4.180mg (equivalent to pitavastatin) (1.000mg) (2.000mg) (4.000mg) Excipients: Lactose monohydrate 63.085mg 126.170mg 252.340mg Low-substituted hydroxypropyl cellulose 12.540mg 25.080mg 50.160mg Hypromellose 1.330mg 2.660mg 5.320mg Magnesium aluminometasilicate 1.600mg 3.200mg 6.400mg Magnesium stearate 0.400mg 0.800mg 1.600mg Coating: Opadry White 13.000mg 5.000mg 9.000mg Composition of White Opadry: Hypromellose 1.9800mg 3.3065mg 5.9520mg Titanium dioxide 0.8000mg 1.3380mg 2.4090mg Triethyl citrate 0.2000mg 0.3305mg 0.5940mg Colloidal silicon dioxide 0.0200mg 0.0250mg 0.0450mg Indications Primary hypercholesterolemia, including heterozygous familial hypercholesterolemia (Fredrickson type IIa hyperlipidemia) or mixed hypercholesterolemia (Fredrickson type IIb hyperlipidemia), hypertriglyceridemia (Fredrickson type IV hyperlipidemia) as an adjunct to diet when diet alone and other non-drug methods of treatment (e.g., physical exercise, weight reduction) are insufficient. Contraindications • Hypersensitivity to pitavastatin, excipients of the preparation, and other HMG-CoA reductase inhibitors (statins). • Severe liver failure (>9 points according to Child-Pugh scale) or Class C liver failure according to Child-Pugh classification, active liver disease, including elevated serum transaminase activity (more than 3 times the upper limit of normal). • Lactose intolerance, lactase deficiency, or glucose-galactose malabsorption. • Myopathy. • Concomitant use of cyclosporine. • Pregnancy, breastfeeding, absence of adequate contraception in women of childbearing potential. • Age under 18 years (efficacy and safety have not been established). Dosage and Administration Take orally, the tablet should be swallowed whole. It is advisable to take the tablets at the same time of day, preferably in the evening, in accordance with the circadian rhythm of lipid metabolism. Before starting and during treatment, the patient should follow a hypocholesterolemic diet. The initial dose of the preparation is 1mg once daily. If necessary, the dose of the preparation is increased up to 2mg daily at intervals of not less than 4 weeks. The dose is selected individually based on LDL-C concentrations, treatment goals, and patient's response to treatment. Most patients require a dose of 2mg. The maximum daily dose is 4mg. Patients with mild to moderate hepatic impairment: a maximum daily dose of 2mg is recommended. Patients with renal impairment: In case of mild renal impairment (it is advisable to objectively assess the severity of renal impairment based on creatinine clearance or glomerular filtration rate), the preparation Livazo should be taken with caution. Data on taking the maximum daily dose of 4mg in case of any degree of renal impairment are limited, therefore, the maximum daily dose of 4mg is prescribed only if renal function is carefully monitored after gradual dose increase. In case of severe renal impairment, administration of the maximum daily dose of 4mg is not recommended; in case of acute renal failure, it is advisable to limit the maximum dose to 2mg. Elderly patients: Dose adjustment is not required. Adverse Reactions In controlled clinical trials, less than 4% of patients treated with Livazo withdrew from the study due to adverse reactions at recommended doses. Myalgia was the most frequently reported.