Justechol 10 mg 14 tablets
Composition
Each tablet contains
Rosuvastatin – 10 mg.
Excipients
microcrystalline cellulose, dibasic calcium phosphate, dry lactose, sodium croscarmellose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, titanium dioxide, purified talc.
Description of the product:
A synthetic hypolipidemic agent from the statin group, inhibitor of HMG-CoA reductase.
Inhibition of enzyme activity reduces intracellular cholesterol content, enhances LDL receptor activity, and accelerates the catabolism of low-density lipoprotein cholesterol.
Indications for use
Treatment of hypercholesterolemia in adults, adolescents, and children ≥10 years with primary hypercholesterolemia (type IIa, including heterozygous familial) or mixed hypercholesterolemia (type IIb) as an adjunct to diet.
Homozygous familial hypercholesterolemia as an adjunct to diet and other therapy.
Primary prevention of major cardiovascular complications (stroke, myocardial infarction) in adult patients at high risk but without clinical manifestations of coronary heart disease.
Method of Administration and Dosage
Before starting therapy, patients should follow a standard cholesterol-lowering diet.
The drug is taken orally once daily, regardless of food intake.
Dose range: 5–40 mg/day.
Initial dose: 5–10 mg/day; in severe hyperlipidemia – 20 mg/day.
Dose adjustment possible after ≥4 weeks.
Children 6–9 years: 5–10 mg/day; 10–17 years: 5–20 mg/day.
Maximum dose for children: 20 mg/day.
Homozygous familial hypercholesterolemia: initial dose – 20 mg/day.
For Asian patients and those with severe renal impairment, therapy should start at 5 mg/day; maximum dose – 10 mg/day.
Contraindications
Hypersensitivity to drug components.
Active liver disease, including persistent elevation of transaminases.
Pregnancy and breastfeeding.
Precautions
Use with caution in
Renal impairment;
Hypothyroidism;
Hereditary myopathies;
Muscle toxicity with other statins;
Chronic alcoholism;
Patients over 65 years;
Liver disease, sepsis, hypotension;
Surgical interventions, trauma;
Severe metabolic disorders, uncontrolled epilepsy;
Patients of Asian origin;
At 40 mg dose, renal function monitoring is recommended.
Liver function should be checked before therapy and 3 months after initiation.
If transaminases exceed 3× ULN, discontinue or reduce dose.
Side effects
Generally well tolerated.
Possible: headache, myalgia, asthenia, constipation, dizziness, nausea, abdominal pain, diabetes mellitus;
itching, rash, urticaria;
myopathy, hypersensitivity reactions, pancreatitis;
jaundice, hepatitis; arthralgia;
memory impairment.
Pregnancy and lactation
Contraindicated during pregnancy and breastfeeding.
Storage conditions
Store at temperatures not exceeding 30 °C, in the original packaging, protected from moisture, and out of reach of children.
Packaging
Cardboard box containing 2 blisters of 7 tablets each, plus instructions for use.