Ozalex (rosuvastatin) coated tablets 20 mg №28

Description

Ozalex composition and form of release
Main active ingredient: 1 tablet contains rosuvastatin 20 mg.
Excipients: lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, colloidal silicon dioxide, magnesium stearate, Opadry 03F84827 pink coating.

Pharmacological properties
The specified drug Ozalex refers to lipid-lowering drugs.
The active substance selectively and competitively inhibits HMG-CoA reductase. The target of the drug is liver cells. They reduce the cholesterol content. The agent stimulates the growth of the number of low density lipoprotein (LDL) receptors on the cell surface of hepatocytes. Against this background, there is an increase in the capture and catabolism of LDL, inhibition of the synthesis of very low density lipoproteins (VLDL) in the liver. The described mechanism of action leads to a decrease in the total amount of VLDL and LDL particles.
The active ingredient also causes a decrease in cholesterol and triglyceride levels. This drug is used as a metabolic drug.

Indications
Ozalex is prescribed in the following cases:

• primary hypercholesterolemia (type IIa, including those with heterozygous familial hypercholesterolemia);
• mixed dyslipidemia (type IІb) as an adjunct to diet, when dietary adherence and the use of other non-drug means (eg exercise, weight loss) are insufficient;
• homozygous familial hypercholesterolemia – in addition to diet and other lipid-lowering therapies (eg, LDL apheresis) or when such treatment is inappropriate.

Contraindications
The drug in question is contraindicated for use in cases where the patient has severe hypersensitivity (allergy) to the main or to one of the auxiliary components.
The drug is contraindicated in the following cases:

• liver disease in the active phase, including a persistent increase in serum transaminases of unknown etiology and any increase in serum transaminases, which is 3 times the upper limit of the norm;
• severe renal dysfunction (creatinine clearance <30 ml / min);
• myopathy;
• simultaneous use with cyclosporine;

Children
In pediatrics, the drug is used after 10 years.

Application during pregnancy and lactation
This drug is contraindicated for pregnant women – only under strict indications determined by the attending physician.
If you need to take the drug during breastfeeding, you should stop lactation.

Method of administration and dosage
The recommended initial dose of Ozalex is 5-10 mg 1 time per day for both patients who have not previously used statins and those who have been transferred to the drug from taking another HMG-CoA reductase inhibitor.
When choosing an initial dose, one should take into account the cholesterol level in each individual patient and the risk of cardiovascular disorders in the future, as well as the likelihood of developing adverse reactions.
If necessary, increase the dose to the next level after 4 weeks.

Overdose
When prescribing the drug, the liver condition should be monitored.

Side effects:

The drug is usually well tolerated when used in the recommended doses.
As side effects can be observed:

• cough, shortness of breath;
• constipation, nausea, abdominal pain;
• pancreatitis;
• diarrhea;
• increased levels of hepatic transaminases;
• hematuria;
• diabetes;
• headache, dizziness;
• polyneuropathy, memory loss;
• depression;
• thrombocytopenia;
• hypersensitivity reactions, including angioedema;
• itching, rash, urticaria;
• Stevens-Johnson syndrome;
• myalgia;
• myopathy (including myositis), rhabdomyolysis;
• arthralgia;
• disorders of the tendons, sometimes complicated by ruptures;
• immune-mediated necrotizing myopathy;
• gynecomastia;
• asthenia;
• edema.

Storage conditions and periods
Expiration date – up to 2 years from the production date indicated on the package. Storage periods should not be exceeded.
Storage temperature should not exceed 25 ° C. Temperature deviations can change the properties of the preparation, therefore it should always be stored in its original packaging.