Universal reference book for medicines
Name of the drug: CARDIOSTATIN В® (CARDIOSTATIN)

Active substance: lovastatin

Type: Lipid-lowering drug

Manufacturer: NIZHFARM (Russia) manufactured by MAKIZ-PHARMA (Russia)
Composition, form of production and packaging
Tablets are
flat-cylindrical, white or almost white, with a facet and a risk.

1 tab.

lovastatin 20 mg

- "- 40 mg

Excipients: lactose, potato pregelatinized starch, microcrystalline cellulose, croscarmellose sodium, butyloxyanisole, calcium stearate.

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
30 pcs.
- packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

Lipid-lowering drug.
Inhibitor of endogenous cholesterol synthesis. It breaks the early stages of cholesterol synthesis in the liver.
In the body, lovastatin forms a free ОІ-hydroxy acid, which competitively inhibits the HMC-CoA reductase and breaks its transformation into mevalonate, resulting in decreased cholesterol synthesis and increased catabolism.

Reduces the content of triglycerides, LDL, VLDL in the blood plasma, moderately increases the content of HDL.
Significantly reduces the amount of apoprotein B, which is part of LDL, and other circulating components of LDL.
The expressed therapeutic effect of the drug is observed within 2 weeks of treatment, the maximum is achieved in 4-6 weeks from the start of treatment.

Cardiostatin is effective in primary hypercholesterolemia in patients with uncomplicated type 1 and type 2 diabetes mellitus.

PHARMACOKINETICS

Suction

From the gastrointestinal tract is absorbed slowly and not completely - about 30% of the dose taken, taking an empty stomach reduces absorption by 30%.
C max in the blood plasma is observed after 2-4 hours, then the level in the blood plasma rapidly decreases, making after 24 hours 10% of the maximum.
Distribution

Binding to blood plasma proteins - 95%.
The clearance of lovastatin and its active metabolites with a single appointment for the night is achieved on the 2-3 day of therapy and 1.5 times higher than after a single dose. It penetrates the GEB and the placental barrier.
Distribution

It is subjected to intensive metabolism during the "first passage" through the liver, is oxidized to beta-hydroxy acid, its 6-hydroxy derivative and other metabolites, some of which are pharmacologically active (blocking 3-hydroxy-3-methylglutaryl coenzyme A-reductase).

Excretion

T 1/2 - 3 hours. It is excreted through the intestine - 83%, kidney 10%.

INDICATIONS

- Primary hypercholesterolemia (type IIa and IIb) with high LDL (not corrected by special diet and exercise);

- combined hypercholesterolemia and hypertriglyceridemia;

- Coronary atherosclerosis in patients with IHD (in order to slow its progression).

DOSING MODE

The initial dose for hypercholesterolemia is 10-20 mg 1 time / day, in the evening;
atherosclerosis - 20-40 mg / day. If necessary, increase the dose every 4 weeks. The maximum daily dose is 80 mg in 1 or 2 doses (during breakfast and dinner).
If the total cholesterol concentration in the plasma is reduced to 140 mg / dL (3.6 mmol / L) or LDL to 75 mg / dL (1.94 mmol / L), the dose of cardiostatin should be reduced.
For patients who are simultaneously receiving immunosuppressants, fibrates, nicotinamide, the daily dose should not exceed 20 mg.
Patients with chronic renal insufficiency of severe degree (CK less than 30 ml / min) should not be prescribed a drug in a dose exceeding 20 mg / day.

The drug is taken orally during a meal.
If the next dose is missed, the drug should be taken as soon as possible. If it's time for the next appointment, do not increase the dose.
SIDE EFFECT

On the part of the digestive system: heartburn, nausea, diarrhea, constipation, flatulence, abdominal pain, dry mouth, taste disorder, anorexia, gastralgia, cholestatic jaundice, hepatitis, acute pancreatitis, increased activity of hepatic transaminases, alkaline phosphatase, increased bilirubin level.

From the central nervous system and peripheral nervous system: dizziness, headache, general weakness, insomnia, convulsions, paresthesia, mental disorders.

From the side of the organ of vision: "fog" before the eyes, clouding of the lens, cataracts, atrophy of the optic nerve.

From the musculoskeletal system: myalgia, myositis, myopathy, rhabdomyolysis (with simultaneous use with cyclosporine, gemfibrozil or nicotinic acid), arthralgia, increased activity of CK.

On the part of laboratory indicators: eosinophilia, increased ESR, positive analysis for antinuclear antibodies.

Allergic reactions: urticaria, Quincke's edema, toxic epidermal necrolysis, skin rash, itching.

Other: decreased potency, acute renal failure (due to rhabdomyolysis), chest pain, palpitations.

CONTRAINDICATIONS

- liver disease in the acute phase;

-increase in activity of hepatic transaminases of unclear etiology;

-the general severe condition of the patient;

-pregnancy;

-period of lactation (breastfeeding);

-Children and adolescents under 18;

-increased sensitivity to the components of the drug.

With caution appoint a drug for liver diseases (in the anamnesis), with chronic alcoholism, organ transplantation, concomitant immunosuppressive therapy, chronic renal failure, during urgent surgical procedures (including dental), while taking gemfibrozil and other fibrates, nicotinamide (more than 1 g / day) because of the risk of developing myopathy.

PREGNANCY AND LACTATION

The drug is contraindicated for use in pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution appoint a drug for chronic kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution appoint a drug for liver diseases (including in the history).
The use of the drug is contraindicated in liver disease in the acute phase, with an increase in the activity of hepatic transaminases of unknown etiology

SPECIAL INSTRUCTIONS

Patients should be warned that if there is unexplained muscle pain, muscle weakness, especially accompanied by fever, the doctor should be informed immediately.

In the case of a persistent increase in the activity of transaminases and / or CPA, the drug should be discontinued.

If the patient's general serious condition is due to a disease, discontinue therapy for a long time or cancel the drug.

During the treatment, patients should follow a standard diet with low cholesterol.

Control of laboratory indicators

With prolonged therapy, biochemical control of liver function is indicated.
The activity of hepatic transaminases is determined before the start of therapy, every 8 weeks during the first year of therapy, then - at least 1 time in six months. Patients who have a daily dose of 80 mg should be examined once every 3 months. When the activity of transaminases increases, the study should be repeated and subsequently carried out more often. Therapy should be discontinued if the activity of AST and / or ALT is 3 times higher than UGN.
Use in Pediatrics

Safety and effectiveness of the drug in patients under the age of 18 years are not established.

OVERDOSE

Data on cases of overdose of the drug Cardiostatin is currently not available.

DRUG INTERACTION

Simultaneous reception of immunosuppressants, gemfibrozil, nicotinic acid, cyclosporine, erythromycin, antifungal drugs from the azole group increases the risk of myopathy with rhabdomyolysis and acute renal failure.

Simultaneous reception of cardiostatin increases the anticoagulant effect of indirect anticoagulants and the risk of bleeding.
In the case of joint intake, regular monitoring of prothrombin time is necessary.
Kolestyramin and colestipol reduce the bioavailability of lovastatin (the use of cardiostatin is possible 4 hours after the administration of these drugs, with an additive effect noted).

Cyclosporine with simultaneous application increases the plasma level of lovastatin metabolites.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored in a dry, cool, protected from light and out of reach of children.
Shelf life - 2 years.
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