Justechol 10 mg 14 tablets

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.