Livazo 1 coated tablets 1 mg. №30

Description

Livazo 1 composition
active substance: calcium pitavastatin;
1 film-coated tablet contains 1,045 mg of pitavastatin calcium equivalent to 1 mg of pitavastatin;
Excipients: lactose monohydrate, low-substituted hydroxypropylcellulose, hypromellose, magnesium-aluminum silicate, magnesium stearate, titanium dioxide (E 171), triethyl citrate, colloidal anhydrous silica.

Dosage form
Film-coated tablets.

Pharmacological properties
Pitavastatin competitively inhibits HMG CoA reductase, limiting the rate of action of the enzyme in cholesterol biosynthesis, and inhibits cholesterol synthesis in the liver. As a result, the expression of LDL receptors in the liver increases, contributing to the capture of circulating LDL from the blood, lowering total cholesterol (cholesterol) and LDL cholesterol (LDL-C) in the blood. Its sustained inhibition of hepatic cholesterol synthesis reduces the secretion of LDL into the blood by lowering plasma triglyceride (TG) levels.

Indication
Livazo 1 is recommended for the reduction of elevated total cholesterol (CHC) and low-density lipoprotein cholesterol (LDL-C) in adult patients, adolescents, and children over 6 years of age with primary hypercholesterolemia, including heterozygous familial hypercholesterolemia and hypercholesterolemia. response to diet and other non-drug therapy is insufficient.

Contraindication:

• known hypersensitivity to pitavastatin or to any of the excipients or other statins;
• severe hepatic insufficiency, active liver disease, or persistent elevation of serum transaminases of unknown etiology (more than 3 times the upper limit of normal [VMN]);
• myopathy;
• concomitant cyclosporine therapy;
• pregnancy, breastfeeding.

Children
Treatment of children over 6 years of age with Livazo should be performed only under the supervision of a physician experienced in the treatment of hyperlipidemia, with constant monitoring of the patient’s condition.

Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy and breastfeeding.

Method of application and dosage
Doses
Patients should follow a low-cholesterol diet before starting treatment. It is important that patients continue to follow a diet during treatment.
Usually the initial dose is 1 mg once a day. Dose adjustment should be performed at intervals of 4 weeks or more. The dosage should be selected individually, according to the level of LDL-C, the regimen and the patient’s condition. The maximum daily dose is 4 mg.
Children from 6 years old
Treatment of children aged 6 years and adolescents should be performed only under the supervision of a physician experienced in the treatment of hyperlipidemia, with constant monitoring of the patient’s condition. For children over 6 years of age and adolescents with heterozygous familial hypercholesterolemia, the initial starting dose is usually 1 mg once daily. Dose adjustment should be performed at intervals of 4 weeks or more. Doses should be selected individually according to the level of LDL-C, the regimen and the patient’s condition. For children aged 6 to 9 years, the maximum daily dose is 2 mg. For children over 10 years, the maximum daily dose is 4 mg.
Application method
For oral use only, the tablet should be swallowed whole. Livazo tablets can be taken with or without food. It is desirable that the patient take the tablets at the same time each day. Statin therapy is usually more effective when used in the evening, due to the circadian rhythm of lipid metabolism.
If a child or adolescent cannot swallow the tablet whole, if necessary, the tablet can be dissolved in a glass of water, which should be drunk immediately.
To ensure the full dose, another volume of water should be used to rinse the glass and drink immediately. The tablets should not be dissolved in sour fruit juices or milk.

Overdose
In case of overdose, the symptoms of adverse reactions may increase. There is no special therapy in case of overdose. Treatment should be symptomatic, if necessary, maintenance therapy should be carried out. Liver function and QC levels should be monitored. Hemodialysis is ineffective. There is no antidote.

Side effects:

• Mental disorders: insomnia.
• From the nervous system: headache.
• Gastrointestinal disorders: constipation, diarrhea, dyspepsia, nausea.
• From the hepatobiliary system: increased activity of transaminases (aspartate aminotransferase, alanine aminotransferase).
• From the skin and subcutaneous tissue: itching, rash.
• From the musculoskeletal system, connective tissue and bones: myalgia, arthralgia.
  stems: pollakiuria.
• General disorders: asthenia, malaise, fatigue, peripheral edema.

Expiration date
5 years.

Storage conditions
To protect from light, store the blister in the package.
Store Livazo 1 at a temperature not exceeding 25 ° C.
Keep out of reach of children.