Rosuvastatin-Vertex, 10 mg 30 pcs

Rosuvastatin is a selective competitive inhibitor of HMG-CoA reductase, the enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonic acid, a precursor of cholesterol.

Indications

– Primary hypercholesterolemia according to the Fredrickson classification (type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (type IIb) as an adjunct to diet when diet and other non-drug treatments (eg, exercise, weight loss) are insufficient;

Pharmacological effect

Rosuvastatin is a selective competitive inhibitor of HMG-CoA reductase, an enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A into mevalonic acid, a cholesterol precursor.

Special instructions

Renal dysfunction. In patients receiving high doses of rosuvastatin (particularly 40 mg/day), tubular proteinuria was observed, which was detected using test strips and in most cases was intermittent or short-term. Such proteinuria does not indicate acute illness or progression of concomitant renal disease.

Active ingredient

Rosuvastatin

Composition

active ingredient:

Pregnancy

Rosuvastatin is contraindicated during pregnancy and lactation.

Contraindications

Daily dose up to 30 mg: hypersensitivity to rosuvastatin; liver diseases in the active phase (including a persistent increase in the activity of liver transaminases and an increase in the activity of liver transaminases in the blood serum by more than 3 times compared to ULN); severe renal failure (Cl creatinine <30 ml/min); myopathy; simultaneous use of cyclosporine; patients predisposed to the development of myotoxic complications; pregnancy, breastfeeding period; use in women of childbearing age who do not use adequate methods of contraception; age up to 18 years.

Side Effects

Side effects observed with the use of rosuvastatin are usually mild and go away on their own. As with other HMG-CoA reductase inhibitors, the incidence of side effects is mainly dose-dependent. WHO classification of the incidence of side effects:

Interaction

Transport protein inhibitors: rosuvastatin binds to some transport proteins, in particular OATP1B1 and BCRP. Concomitant use of drugs that are inhibitors of these transport proteins may be accompanied by an increase in the concentration of rosuvastatin in the blood plasma and an increased risk of developing myopathy.

Overdose

Symptoms: the clinical picture of overdose has not been described. When taking several daily doses at a time, the pharmacokinetic parameters of rosuvastatin do not change.

Recommendations for use

Inside, do not chew or crush the tablet, swallow it whole with water. The drug can be prescribed at any time of the day, regardless of meal time. Before starting therapy with Rosuvastatin, the patient should begin following a standard cholesterol-lowering diet and continue to follow it during treatment. The dose of the drug should be individualized depending on the goals of therapy and the therapeutic response to treatment, taking into account current recommendations for target lipid concentrations. The recommended initial dose for patients starting to take the drug, or for patients transferred from taking other HMG-CoA reductase inhibitors, should be 5 or 10 mg of Rosuvastatin 1 time / day. When choosing an initial dose, one should be guided by individual cholesterol levels and take into account the possible risk of cardiovascular complications, and the potential risk of side effects should be assessed. If necessary, the dose can be increased to a higher dose after 4 weeks (see section “Pharmacodynamics”). Due to the possible development of side effects when taking a dose of 40 mg, compared with lower doses of the drug (see section “Side effects”), increasing the dose to 40 mg, after an additional dose above the recommended initial dose for 4 weeks of therapy, can only be carried out in patients with severe hypercholesterolemia and at high risk of cardiovascular complications (especially in patients with familial hypercholesterolemia), who have not achieved the desired result of therapy when taking a dose of 20 mg, and which will be under the supervision of a specialist (see section “Special instructions”).

Manufacturer

Vertex, Russia