Description
Latin name
TORVACARD
Packaging
In a blister pack of 10 tablets. There are 9 blisters in a cardboard box.
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 hyperlipidemia (mixed cholesterol) and 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 normal range) of unknown origin
pregnancy
lactation period
children and adolescents under 18 years of age (efficacy and safety not established)
increased sensitivity to the components of the drug Torvakard.
Caution should be used for chronic alcoholism, a history of liver disease, severe electrolyte imbalance, endocrine and metabolic disorders, and arterial hypotension, severe acute infections (sepsis), uncontrolled epilepsy, with extensive surgical interventions, injuries, diseases of the skeletal muscles.
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 contraceptive methods 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
1 tablet contains:
Active ingredient: atorvastatin (in the form of calcium salt) 40 mg
Excipients: heavy magnesium oxide, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, low-substituted hydroxypropyl cellulose LH21, colloidal silicon dioxide, magnesium stearate.
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.
The following recommendations can be used to determine the goal of treatment.
Recommendations of the National Cholesterol Education Program (USA). Diagnosed vascular atherosclerosis * Cholesterol-LDL, mg / dL (mmol / L).
The goals of lipid-lowering therapy of the European Society of Atherosclerosis In patients with a confirmed diagnosis of coronary heart disease and other patients with a high risk of ischemic complications, the goal of treatment is to lower cholesterol – LDL less than 115 mg / dl (less than 3 mmol / l) and total cholesterol less than 190 mg / dl ( less than 5 mmol / l).
National treatment guidelines for homozygous familial hypercholesterolemia. In a study in adult patients with homozygous familial hypercholesterolemia, atorvastatin therapy at a dose of 80 mg in most cases led to a decrease in the level of LDL-C by more than 15% (18-45%). The use of the drug in patients with renal failure and kidney disease does not affect the level of atorvastatin in the blood plasma or the degree of decrease in cholesterol – LDL when it is used, therefore, changing the dose of the drug is not required. When using the drug in elderly patients, there were no differences in safety, efficacy, or achievement of the goals of lipid-lowering therapy in comparison with the general population.
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, increased fatigue, fever.
Laboratory and instrumental data: often – increased activity of hepatic transaminases, increased CPK activity infrequently – leukocyturia, increased concentration of glycosylated hemoglobin.
Drug Interaction
The risk of myopathy during treatment with other drugs in this class is increased with the concomitant use of cyclosporine, fibrates, erythromycin, antifungal agents, azole, and niacin.
When co-administered with atorvastatin and a suspension containing magnesium and aluminum hydroxides, the plasma concentrations of atorvastatin decreased by about 35%, but the degree of cholesterol reduction – 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, and it is therefore unlikely that atorvastatin is able to significantly affect the pharmacokinetic parameters of other CYP3A4 substrates.
Concomitant use of atorvastatin and oral contraceptive containing norethindrone and ethinylestradiol. With the concomitant use of atorvastatin and oral contraceptive containing norethindrone and ethinylestradiol, a significant increase in the AUC of norethindrone and ethinylestradiol was observed by about 30% and 20%, respectively. 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.
The concomitant use of atorvastatin with protease inhibitors known as CYP3A4 isoenzyme inhibitors was accompanied by an increase in the concentration of atorvastatin in 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.
Overdose
Symptoms: Arterial hypotension possible.
Treatment: conducting symptomatic therapy. There is no specific antidote. Hemodialysis is ineffective.
Storage conditions
Store at 10 ° to 30 ° C.
Expiration
2 years.
Deystvuyuschee substances
Atorvastatin
Pharmacy terms of sale
Prescription
Zentiva ks, Czech Republic
