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Torvacard, 90 pcs., 20 mg, film-coated tablets

Effect of drugs on atorvastatin when used simultaneously

Atorvastatin is metabolized by the cytochrome P450 isoenzyme CYP3A4 and is a substrate for transport proteins, such as the hepatic uptake transporter OATP1B1. Concomitant use of drugs that are inhibitors of the CYP3A4 isoenzyme or transport proteins may lead to an increase in the concentration of atorvastatin in the blood plasma and an increased risk of myopathy. The risk may also be increased when atorvastatin is used concomitantly with other drugs that can cause myopathy, such as fibric acid derivatives and ezetimibe.

Inhibitors of the CYP3A4 isoenzyme. It has been shown that potent inhibitors of the CYP3A4 isoenzyme lead to a significant increase in plasma concentrations of atorvastatin. If possible, avoid the simultaneous use of strong inhibitors of the CYP3A4 isoenzyme (for example, cyclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors, including ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.) . In cases where concomitant use of these drugs and atorvastatin cannot be avoided, lower initial and maximum doses of atorvastatin are recommended. When using a daily dose of Torvacard® more than 40 mg, it is recommended to conduct careful clinical monitoring of the patient's condition.

Moderate inhibitors of the CYP3A4 isoenzyme (for example, erythromycin, diltiazem, verapamil and fluconazole) may increase the plasma concentration of atorvastatin. An increased risk of myopathy is observed when erythromycin is used in combination with HMG-CoA reductase inhibitors (statins).

Drug interaction studies evaluating the effect of amiodarone or verapamil on atorvastatin have not been conducted. Both amiodarone and verapamil are known to inhibit CYP3A4 activity, and coadministration with atorvastatin may result in increased plasma concentrations of atorvastatin. Therefore, a lower maximum dose of atorvastatin should be prescribed and appropriate clinical monitoring of the patient's condition should be carried out when used concomitantly with moderate inhibitors of the CYP3A4 isoenzyme. Close clinical monitoring is recommended after initiation of therapy or during dose titration of the inhibitor.

Grapefruit juice. Contains 1 or more components that inhibit the CYP3A4 isoenzyme and may increase the plasma concentration of drugs metabolized by the CYP3A4 isoenzyme. Drinking one glass of grapefruit juice (240 ml) also resulted in a 20.4% reduction in AUC for the active orthohydroxy metabolite. Large volumes of grapefruit juice (more than 1.2 L per day for 5 days) increased the AUC of atorvastatin by 2.5 times and the AUC of active (atorvastatin and metabolites). The combined use of large volumes of grapefruit juice and Torvacard® is not recommended.

Inducers of the CYP3A4 isoenzyme. Concomitant use of atorvastatin with inducers of the cytochrome P450 isoenzyme CYP3A4 (for example, efavirenz, rifampicin, St. John's wort) can lead to various decreases in the concentration of atorvastatin in the blood plasma. Due to the dual mechanism of interaction of rifampicin (induction of the CYP3A4 isoenzyme and inhibition of the hepatic uptake transporter OATP1B1), simultaneous administration of atorvastatin and rifampicin is recommended, since delayed administration of atorvastatin after administration of rifampicin was accompanied by a significant decrease in the concentration of atorvastatin in the blood plasma. There are no data yet on the effect of rifampicin on the concentration of atorvastatin in hepatocytes, and if concomitant therapy cannot be avoided, the patient should be carefully monitored to monitor the effectiveness of the drug.

Transport protein inhibitors. Transport protein inhibitors (eg, cyclosporine) may increase the systemic exposure of atorvastatin. The effect of inhibition of hepatic uptake transport proteins on atorvastatin concentrations in hepatocytes is unknown. If concomitant therapy cannot be avoided, the dose of atorvastatin should be reduced and the patient's condition should be closely monitored to achieve the therapeutic goal.

Gemfibrozil/fibric acid derivatives. Monotherapy with fibrates is sometimes accompanied by the occurrence of adverse effects from skeletal muscles, incl. rhabdomyolysis. The risk of these effects may therefore be increased when fibric acid derivatives are combined with atorvastatin. If concomitant therapy cannot be avoided, the lowest dose of atorvastatin should be used and the patient's condition should be closely monitored.

Ezetimibe. Monotherapy with ezetimibe is accompanied by the occurrence of adverse events from skeletal muscles, incl. rhabdomyolysis. The risk of these events may therefore be increased with concomitant therapy with ezetimibe and atorvastatin. If concomitant therapy cannot be avoided, the lowest dose of atorvastatin should be used and the patient's condition should be closely monitored.

Colestipol. Plasma concentrations of atorvastatin and its active metabolites were lower (by approximately 25%) when colestipol and atorvastatin were co-administered. However, the effect on lipids was greater with combination therapy with atorvastatin and colestipol than with either drug alone.

Fusidic acid. Drug interaction studies between atorvastatin and fusidic acid have not been conducted. As with other statins, skeletal muscle adverse events, including rhabdomyolysis, have been reported during post-marketing use of atorvastatin with fusidic acid. The mechanism of this interaction is unknown. Patients should be carefully monitored and, if possible, temporary discontinuation of co-treatment with these drugs should be considered.

The effect of atorvastatin on concomitant drug therapy

Digoxin. With repeated doses of digoxin and atorvastatin at a dose of 10 mg, Css of digoxin increased slightly. Patients taking digoxin should be under appropriate medical supervision.

Oral contraceptives. Concomitant use of atorvastatin and oral contraceptives led to increased plasma concentrations of norethisterone and ethinyl estradiol. This effect should be taken into account when choosing an oral contraceptive for women receiving Torvacard®.

Warfarin. In a clinical study conducted in patients receiving long-term warfarin, concomitant use of atorvastatin 80 mg daily and warfarin caused a slight decrease in PT (approximately 1.7 s) during the first 4 days of treatment, which returned to normal within 15 days of atorvastatin therapy.

Although clinically significant anticoagulant interactions have been very rarely reported, the PT should be determined in patients taking coumarin anticoagulants before initiating therapy and regularly during initiation of atorvastatin therapy to ensure that there is no significant change in PT. Once a stable PT value has been established, it can be monitored at standard intervals recommended for patients receiving coumarin anticoagulants. If the dose of atorvastatin is changed or discontinued, the same procedure should be repeated. Atorvastatin therapy was not associated with bleeding or changes in PT in patients not taking anticoagulants.

With the simultaneous use of atorvastatin and antacid drugs containing magnesium and aluminum hydroxides, the concentration of atorvastatin in the blood plasma decreased by approximately 35%, but the degree of reduction in the concentration of cholesterol/LDL did not change.

Effect of drugs on the pharmacokinetics of atorvastatin during concomitant use

Concomitantly used drugs and dosage regimen Atorvastatin Dose, mg Change in AUC* Clinical recommendations Tipranavir, 500 mg 2 times a day / Ritonavir, 200 mg 2 times a day, 8 days (14-21st) 40 mg on day 1, 10 mg on the 20th day ↑ 9.4 times In cases where simultaneous use with atorvastatin is necessary, do not exceed the daily dose of atorvastatin more than 10 mg. Clinical monitoring of these patients is recommended Cyclosporine, 5.2 mg/kg/day, stable dose 10 mg once daily for 28 days ↑ 8.7 times Lopinavir, 400 mg twice daily/Ritonavir, 100 mg twice daily day, 14 days 20 mg 1 time per day 2 for 4 days ↑ 5.9 times In cases where simultaneous use with atorvastatin is necessary, the use of the smallest maintenance doses of atorvastatin is recommended. At a dose above 20 mg, clinical monitoring of the condition of these patients is recommended Clarithromycin, 500 mg 2 times a day, 9 days 80 mg 1 time a day for 8 days ↑ 4.4 times Saquinavir, 400 mg 2 times a day / Ritonavir (300 mg 2 times per day, on days 5-7, increase to 400 mg 2 times a day on day 8), days 5-18 40 mg 1 time for 4 days ↑ 3.9 times In cases where simultaneous use with atorvastatin is necessary, the use of the lowest maintenance doses of atorvastatin is recommended.

30 minutes after taking atorvastatin

Darunavir 300 mg 2 times a day / Ritonavir 100 mg 2 times a day, 9 days 10 mg 1 time a day 4 days ↑ 3.3 times For doses above 40 mg, clinical monitoring of the condition of these patients is recommended Itraconazole 200 mg 1 time day, 4 days 40 mg once ↑ 3.3 times Fozamprenavir 700 mg 2 times a day/Ritonavir 100 mg 2 times a day, 14 days 10 mg 1 time a day 4 days ↑ 2.5 times Fosamprenavir 1400 mg 2 times per day, 14 days 10 mg once a day 4 days ↑ 2.3 times Nelfinavir 1250 mg 2 times a day, 14 days 10 mg once a day 28 days ↑ 1.7 times*** No special recommendations Grapefruit juice, 240 ml once a day** 40 mg once a day ↑ by 37% The combined use of large quantities of grapefruit juice and atorvastatin is not recommended Diltiazem 240 mg once a day, 28 days 40 mg once a day ↑ by 51% After initiation of treatment or dose adjustment diltiazem, appropriate clinical monitoring of these patients is recommended Erythromycin 500 mg 4 times a day, 7 days 10 mg once ↑ by 33%*** The use of the lowest maximum dose and clinical monitoring of these patients is recommended Amlodipine 10 mg, once 80 mg once ↑by 18% No special recommendations Cimetidine 300 4 times a day, 2 weeks 10 mg 1 time a day 4 weeks ↓ less than 1%*** No special recommendations Suspensions of antacids containing magnesium and aluminum hydroxides 30 ml 4 times a day, 2 weeks 10 mg once daily for 4 weeks ↓ by 35% No special recommendations Efavirenz 600 mg once daily for 14 days 10 mg once daily for 3 days ↓ by 41% No special recommendations Rifampicin 600 mg once daily for 7 days (simultaneous administration) 40 mg once a day ↑ by 30% If concomitant therapy cannot be avoided, simultaneous use of rifampicin with atorvastatin under clinical monitoring is recommended Rifampicin 600 mg once a day for 5 days (separate doses) 40 mg once a day ↓ by 80% Gemfibrozil 600 mg twice a day day, 7 days 40 mg once ↑ by 35% The use of the lowest initial dose and clinical monitoring of these patients is recommended Fenofibrate 160 mg once a day, 7 days 40 mg once ↑ by 3% The use of the lowest initial dose and clinical monitoring of these patients is recommended

*Data reported as fold change represent the simple ratio between concomitant use and atorvastatin monotherapy (ie, 1 time = no change). Data reported as percentage change reflect the percentage difference relative to atorvastatin monotherapy (ie, 0% = no change).

**Contains 1 or more components that inhibit the CYP3A4 isoenzyme and may increase the plasma concentration of drugs metabolized by the CYP3A4 isoenzyme. Drinking one glass of grapefruit juice (240 ml) also reduced the AUC of the active orthohydroxy metabolite by 20.4%. Large volumes of grapefruit juice (more than 1.2 L per day for 5 days) increased the AUC of atorvastatin by 2.5-fold and the AUC of active atorvastatin and metabolites.

***Total equivalent activity of atorvastatin. An increase is indicated as ↑, a decrease - ↓

Children. Drug interaction studies have been conducted in adults only. The extent of interaction in children is unknown. When treating children, the above interactions and precautions for adults should be taken into account.

Special instructions for the use of Torvacard

Treatment should be discontinued in acute conditions with a risk of renal collapse due to rhabdomyolysis, such as surgery, trauma, endocrine and electrolyte disturbances, hypotension, uncontrolled convulsions and acute infections. Effect on the liver As with other lipid-lowering substances of the same group, an increase in the level of liver transaminases was noted during treatment with atorvastatin (more than 3 times). Liver function must be determined before treatment and periodically throughout the course of treatment. If the activity of liver transaminases increases, patients should be monitored until the values normalize, and the dose of Torvacard should be reduced or treatment discontinued. It is not recommended to drink alcohol during treatment. The use of Torvacard does not affect the performance of work that requires increased attention, speed of mental and physical reactions (driving vehicles and machinery, working at height, etc.). Effect on the musculoskeletal system During treatment with Torvacard, myalgia may be noted. Patients should be warned about the possible occurrence of muscle pain, severe muscle weakness, sometimes with fever. In cases of increased creatinine phosphate kinase (CPK) levels, a definite or probable diagnosis of myopathy, treatment with Torvacard should be stopped immediately.

Indications for use of the drug Torvacard

Treatment of patients with elevated levels of cholesterol, LDL cholesterol, apolipoprotein B and TG; patients with primary hypercholesterolemia (heterozygous form of familial hypercholesterolemia and polygenic hypercholesterolemia) and mixed type (combined) hyperlipidemia corresponding to type IIa or type IIb according to Fredrickson, elevated TG levels (type IV according to Fredrickson) and patients with dysbetalipoproteinemia (type III according to Fredrickson), if the effect of following a special diet was insufficient. Therapy with the drug is carried out while continuing to follow a special diet. To reduce total cholesterol and LDL cholesterol in patients with homozygous hereditary hypercholesterolemia, if diet and other non-pharmacological therapeutic actions have not produced sufficient effect. For secondary prevention of myocardial infarction, reducing the risk of death or readmission for angina in patients with cardiovascular disease and/or dyslipidemia.

Contraindications to the use of Torvacard

Hypersensitivity to any component of the drug; acute liver disease; liver failure; increased level of liver transaminases in the blood serum (more than 3 times); During pregnancy and breastfeeding. Due to the lack of experience in treating children with atorvastatin, it should be prescribed only by specialists for the treatment of serious forms of hypercholesterolemia in children, as well as homozygous forms of hereditary hypercholesterolemia, especially in the presence of a high risk of developing early atherosclerosis and its clinical complications.

Side effects of the drug Torvacard

The most common side effects (1% or more) noted during treatment with Torvacard were: general: headache, asthenia, abdominal pain, allergic reactions, back pain, chest pain, general fatigue; Gastrointestinal tract: dyspepsia, nausea, vomiting, anorexia, hepatitis, pancreatitis, cholestatic jaundice, flatulence, constipation, diarrhea; CNS: myalgia, paresthesia, peripheral neuropathy, dizziness, amnesia; musculoskeletal system: myalgia, myositis, myopathy, arthralgia, rhabdomyolysis; skin and mucous membranes: itching, alopecia, vesicular rash, urticarial rash, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome; genitourinary system: erectile dysfunction; metabolic and nutritional disorders: hypoglycemia, hyperglycemia, peripheral edema/edema, weight gain; hematological and lymphatic systems: thrombocytopenia.