Atorvastatin | Torvacard tablets 40 mg, 30 pcs.

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In stock
SKU
BID463632
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Latin name

TORVACARD
Latin name

TORVACARD

Release form

film-coated tablets

Packing

30 pcs

Indications of

in combination with a diet to reduce elevated levels of total Chs, Chs-LDL, apolipoprotein B and triglycerides and increase the levels of Chs-HDL in patients with primary hypercholesterolemia, heterozygous familial and non-familial hypercholesterolemia (mixed cholesterolemia) Fredrickson IIb)

in combination with a diet for the treatment of patients with elevated serum levels of triglycerides (Fredrickson type IV) and patients with dysbetalipoproteinemia (Fredrickson type III) who do not have dietary therapy gives an adequate effect of

to reduce the levels of total Chs and Chs-LDL in patients with homozygous familial hypercholesterolemia, when diet therapy and other non-pharmacological treatments are not effective enough.

Contraindications

active liver disease or increased serum transaminase activity (more than 3 times the upper limit of normal) unclear genesis

pregnancy

lactation period

children and adolescents under 18 years of age (efficacy and safety not established)

hypersensitivity to the components of the drug Torvakard.

Caution should be used in chronic alcoholism, a history of liver disease, severe electrolyte imbalance, endocrine and metabolic disorders, arterial hypotension, severe acute infections (sepsis), uncontrolled epilepsy, and extensive surgical interventions for injuries and skeletal muscle diseases.

Use during pregnancy and lactation

Atorvastatin is contraindicated in pregnancy and lactation (breastfeeding).

It is not known whether atorvastatin is excreted in breast milk. Given the possibility of adverse events in infants, if necessary, use of the drug during lactation should decide on the termination of breastfeeding. Women of reproductive age should use adequate methods of contraception during treatment. Atorvastatin can be prescribed to women of reproductive age only if their probability of pregnancy is very low, and the patient is informed about the possible risk of treatment for the fetus.

Composition of

1 tablet contains:

Active ingredient: atorvastatin (in the form of calcium salt) 40 mg

Excipients: heavy magnesium oxide, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxymethyl dihydrocellulose.

Shell composition: hypromellose 2910/5, macrogol 6000, titanium dioxide, talc.

Dosage and administration of

Before prescribing Torvacard, the patient should be advised of a standard lipid-lowering diet, which he must continue to follow throughout the duration of therapy.

The initial dose is an average of 10 mg 1 time / day. The dose varies from 10 to 80 mg 1 time / day. The drug can be taken at any time of the day with food or regardless of the meal time. The dose is selected taking into account the initial levels of LDL-C, the purpose of therapy and the individual effect. At the beginning of treatment and / or during an increase in the dose of Torvacard, it is necessary to monitor plasma lipid levels every 2-4 weeks and adjust the dose accordingly.

In primary hypercholesterolemia and mixed hyperlipidemia, in most cases, a dose of 10 mg of Torvacard 1 time / day is sufficient. A significant therapeutic effect is observed after 2 weeks, as a rule, and the maximum therapeutic effect is usually observed after 4 weeks. With prolonged treatment, this effect persists.

Side effects

Infectious and parasitic diseases: often - nasopharyngitis.

From the blood and lymphatic system: rarely - thrombocytopenia.

On the part of the immune system: often - allergic reactions are very rare - anaphylaxis.

From the side of metabolism and nutrition: often - hyperglycemia infrequently - hypoglycemia, weight gain, anorexia.

From the psyche: infrequently - sleep disturbances, including insomnia and nightmares.

From the nervous system: often - headache infrequently - dizziness, paresthesia, hypesthesia, taste perversion, loss or decrease in memory rarely - peripheral neuropathy.

From the side of the organ of vision: infrequently - decreased clarity of vision rarely - impaired vision.

On the part of the organ of hearing and labyrinthine disorders: infrequently - tinnitus is very rare - hearing loss.

From the respiratory system, chest and mediastinal organs: often - pain in the throat and trachea, nosebleeds.

From the digestive system: often - constipation, flatulence, dyspepsia, nausea, diarrhea infrequently - vomiting, pain in the upper and lower abdomen, belching, pancreatitis.

From the side of the liver and biliary tract: infrequently - hepatitis rarely - cholestasis very rarely - liver failure.

On the part of the skin and subcutaneous tissues: infrequently - urticaria, skin rash, itching, alopecia, rarely - angioedema, bullous dermatitis, including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.

From the side of musculoskeletal and connective tissue: often - myalgia, arthralgia, pain in the extremities, muscle cramps, swelling of the joints, back pain infrequently - neck pain, muscle weakness rarely - myopathy, myositis, rhabdomyolysis, tendopathy (sometimes complicated by rupture) tendons).

General disorders and disorders at the injection site: infrequently - malaise, asthenia, chest pain, peripheral edema, fatigue, fever.

Laboratory and instrumental data: often - an increase in the activity of hepatic transaminases, an increase in the activity of CPK infrequently - leukocyturia, an increase in the concentration of glycosylated hemoglobin.

Drug Interaction

The risk of myopathy during treatment with other drugs in this class increases with the concomitant use of cyclosporine, fibrates, erythromycin, antifungal drugs, related to azoles, and niacin.

Plasma concentrations of atorvastatin decreased by approximately 35% with the concomitant administration of atorvastatin and a suspension containing magnesium and aluminum hydroxides, but the extent of the decrease in the level of Xc-LDL did not change.

Atorvastatin does not affect the pharmacokinetics of antipyrine when used concomitantly, so interactions with other drugs metabolized by the same cytochrome isoenzymes are not expected.

With concomitant administration of colestipol, atorvastatin plasma concentrations decreased by approximately 25%. However, the hypolipidemic effect of the combination of atorvastatin and colestipol was superior to that of each drug individually.

At repeated administration of digoxin and atorvastatin at a dose of 10 mg, the equilibrium concentrations of digoxin in the blood plasma did not change. However, when using digoxin in combination with atorvastatin at a dose of 80 mg / day, the concentration of digoxin increased by about 20%. Patients receiving digoxin in combination with atorvastatin require observation.

Atorvastatin and erythromycin (500 mg 4 times / day) or clarithromycin (500 mg 2 times / day), which inhibit the CYP3A4 isoenzyme, were co-administered with plasma concentrations of atorvastatin.

Atorvastatin (10 mg 1 time / day) and azithromycin (500 mg 1 time / day) concomitant plasma concentrations of atorvastatin did not change.

Atorvastatin did not have a clinically relevant effect on the plasma concentrations of terfenadine, which is metabolized mainly by CYP3A4 involvement in this regard, it seems unlikely, that atorvastatin is able to significantly affect the pharmacokinetic parameters of other CYP3A4 substrates.

A significant increase of norethindrone and ethinylestradiol AUC by about 30% and 20%, respectively, was observed with atorvastatin and oral contraceptive containing norethindrone and ethinylestradiol. This effect should be considered when choosing an oral contraceptive for a woman receiving atorvastatin.

No evidence of a clinically relevant interaction was observed in the study of the interaction of atorvastatin with warfarin and cimetidine.

Atorvastatin 80 mg and amlodipine 10 mg atorvastatin pharmacokinetics did not change at steady state.

Co-administration of atorvastatin with protease inhibitors known as CYP3A4 isoenzyme inhibitors, was accompanied by an increase in the concentration of atorvastatin in the blood plasma.

No clinically relevant undesirable interaction of atorvastatin and antihypertensive agents, as well as with estrogens, was noted. No interaction studies were performed with all specific drugs.

Pharmaceutical incompatibility is unknown.

Overdose

Symptoms: Arterial hypotension possible.

Treatment: carrying out symptomatic therapy. There is no specific antidote. Hemodialysis is ineffective.

Storage conditions

The drug should be stored out of the reach of children at a temperature of 10 ° to 30 РC.

Expiration

2 years.

Active ingredient

Atorvastatin

dosage form

dosage form

tablets

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