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Etaria

Pharmacodynamic interaction

Oral anticoagulants (warfarin): In patients receiving warfarin, etoricoxib 120 mg daily was associated with an approximately 13% increase in International Normalized Ratio (INR) prothrombin time. In patients receiving warfarin or similar medicinal products, INR values should be monitored when starting or changing treatment with etoricoxib, especially in the first few days.

Diuretics, angiotensin converting enzyme (ACE) inhibitors: There are reports that non-selective NSAIDs and selective COX-2 inhibitors may reduce the hypotensive effect of ACE inhibitors. This interaction should be taken into account when treating patients taking etoricoxib concomitantly with ACE inhibitors. In patients with impaired renal function (for example, with dehydration or in old age), such a combination may aggravate renal failure.

Acetylsalicylic acid: Etoricoxib can be used concomitantly with acetylsalicylic acid in low doses intended for the prevention of cardiovascular diseases. However, simultaneous administration of low doses of acetylsalicylic acid and etoricoxib may lead to an increased incidence of gastrointestinal ulcers and other complications compared to taking etoricoxib alone. At steady state, etoricoxib 120 mg once daily has no effect on the antiplatelet activity of low-dose acetylsalicylic acid (81 mg daily). The drug does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

Cyclosporine and tacrolimus increase the risk of nephrotoxicity when taking the drug.

Pharmacokinetic interaction

Lithium There is evidence that non-selective NSAIDs and selective COX-2 inhibitors may increase plasma lithium concentrations. This interaction should be taken into account when treating patients taking etoricoxib concomitantly with lithium.

Methotrexate: Two studies examined the effects of 60 mg, 90 mg, and 120 mg once daily for seven days in patients receiving 7.5 to 20 mg once-weekly methotrexate for rheumatoid arthritis. Etoricoxib at doses of 60 mg and 90 mg had no effect on plasma concentrations (according to AUC) and renal clearance of methotrexate. In one study, etoricoxib 120 mg had no effect on plasma concentrations (AUC) or renal clearance of methotrexate. In another study, etoricoxib 120 mg increased plasma methotrexate concentrations by 28% (AUC) and decreased methotrexate renal clearance by 13%. When co-administering etoricoxib at doses above 90 mg per day and methotrexate, monitor for the possible occurrence of toxic effects of methotrexate.

Oral contraceptives: Taking etoricoxib 120 mg with oral contraceptives containing 35 mcg ethinyl estradiol (EE) and 0.5 to 1 mg norethindrone for 21 days, either simultaneously or 12 hours apart, increases the steady-state AUC0-24h for EE by 50 -60%. However, norethisterone concentrations usually do not increase to a clinically significant extent. This increase in EE concentrations should be taken into account when selecting the appropriate oral contraceptive for concomitant use with etoricoxib. This fact may lead to an increase in the frequency of thromboembolism due to increased exposure to EE.

Significant pharmacokinetic interaction with glucocorticosteroids

not detected.

Digoxin: etoricoxib does not affect the steady-state AUC0-24h or the elimination of digoxin. At the same time, etoricoxib increases Cmax (by an average of 33%), which may be important in the development of digoxin overdose.

Rifampicin: Concomitant use of etoricoxib and rifampicin, a potent inducer of hepatic metabolism, resulted in a 65% reduction in the plasma AUC of etoricoxib. This interaction should be considered when etoricoxib is coadministered with rifampicin.

Antacids and ketoconazole (a strong CYP3A4 inhibitor) do not have a clinically significant effect on the pharmacokinetics of etoricoxib.

Instructions for use ARCOXIA® (ARCOXIA)

Pharmacodynamic interactions

Oral anticoagulants.

In patients whose condition is stabilized on chronic warfarin, etoricoxib 120 mg/day is associated with an approximately 13% increase in the international normalized ratio (INR) prothrombin time. Therefore, patients receiving oral anticoagulants should have their prothrombin time (IHO) monitored frequently, especially during the first days of etoricoxib use or when its dose is changed.

Diuretics, angiotensin-converting enzyme (ACE) inhibitors and angiotensin II antagonists.

NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (eg, dehydrated patients or elderly patients with compromised renal function), concomitant use of an ACE inhibitor or angiotensin II antagonist and COX-inhibiting drugs may result in subsequent deterioration of renal function, including possible acute renal failure. , which is usually reversible. The possibility of such interactions should be kept in mind in patients who use etoricoxib concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, this combination should be prescribed with caution, especially in elderly patients. Adequate hydration should be provided and consideration should be given to monitoring renal function at the start of combination treatment and at regular intervals thereafter.

Acetylsalicylic acid.

In a study involving healthy volunteers, under steady state conditions, the use of etoricoxib at a dose of 120 mg 1 time/day did not affect the antiplatelet activity of acetylsalicylic acid (81 mg 1 time/day). Etoricoxib can be prescribed concomitantly with acetylsalicylic acid, used in doses for the prevention of cardiovascular complications (low doses). However, simultaneous use of low doses of acetylsalicylic acid and etoricoxib may lead to an increased incidence of gastrointestinal ulcers or other complications compared to etoricoxib monotherapy. The simultaneous use of etoricoxib with acetylsalicylic acid in doses exceeding those established for the prevention of cardiovascular complications, as well as with other NSAIDs, is not recommended.

Cyclosporine and tacrolimus.

Although the interaction of etoricoxib with these drugs has not been studied, concomitant use of NSAIDs with cyclosporines and tacrolimus may enhance the nephrotoxic effect of the latter. Monitor renal function when etoricoxib is used concomitantly with any of these drugs.

Pharmacokinetic interactions

Effect of etoricoxib on the pharmacokinetics of other drugs

Lithium.

NSAIDs reduce the renal excretion of lithium, thereby increasing plasma lithium levels. If necessary, frequently monitor lithium blood levels and adjust the dose of lithium while these drugs are being used concomitantly, as well as when NSAIDs are discontinued.

Methotrexate.

Two studies examined the effects of etoricoxib at doses of 60 mg, 90 mg, and 120 mg once daily for seven days in patients receiving once-weekly methotrexate 7.5 mg to 20 mg for rheumatoid arthritis. Etoricoxib 60 mg and 90 mg did not affect plasma concentrations or renal clearance of methotrexate. In one study, etoricoxib 120 mg had no effect on methotrexate levels, but in another study, methotrexate plasma concentrations increased by 28% and methotrexate renal clearance decreased by 13%. If etoricoxib is used concomitantly with methotrexate, appropriate monitoring for methotrexate toxicity should be performed.

Oral contraceptives.

Etoricoxib 60 mg, when coadministered with oral contraceptives containing 35 mcg ethinyl estradiol and 0.5-1 mg norethindrone for 21 days, resulted in a 37% increase in ethinyl estradiol AUC0-24. Etoricoxib at a dose of 120 mg, when used with the above oral contraceptives simultaneously or at intervals of 12 hours, increased the AUC0-24 value of ethinyl estradiol at steady state by 50-60%. This increase in ethinyl estradiod concentrations should be kept in mind when selecting an oral contraceptive to be used concomitantly with etoricoxib. Increased exposure to ethinyl estradiol may increase the incidence of adverse reactions associated with the use of oral contraceptives (for example, venous thromboembolism in women at risk).

Hormone replacement therapy. Taking 120 mg of etoricoxib with hormone replacement drugs including conjugated estrogens (Premarin™ 0.625 mg) for 28 days increased the average AUC0-24 at steady state of unconjugated estrone (by 41%), equilin (by 76%) and 17-β- estradiol (by 22%). The effects of etoricoxib doses recommended for long-term use (30, 60 and 90 mg) have not been studied.

Etoricoxib 120 mg reduced exposure (AUC0-24) to the estrogenic components of Premarin by less than half compared with Premarin monotherapy; the dose of the latter was increased from 0.625 to 1.25 mg. The clinical significance of these increases is unknown, and higher doses of Premarin in combination with etoricoxib have not been studied. These increases in estrogen concentrations should be taken into account when choosing a hormonal drug for postmenopausal use during concomitant use of etoricoxib, as increased estrogen exposure may increase the risk of adverse reactions during hormone replacement therapy.

Prednisone/prednisolone.

In drug interaction studies, etoricoxib did not have a clinically significant effect on the pharmacokinetics of prednisone/prednisolone.

Digoxin.

When etoricoxib was used at a dose of 120 mg 1 time / day for 10 days by healthy volunteers, there was no effect on AUC0-24 at steady state and on the excretion of digoxin by the kidneys. An increase in digoxin Cmax was observed (approximately 33%). This increase is usually not significant for most patients. However, patients at high risk for digoxin toxicity should be monitored when receiving etoricoxib and digoxin concomitantly.

Effect of etoricoxib on drugs metabolized by sulfotransferases

Etoricoxib is an inhibitor of human sulfotransferase activity, particularly SULT1E1, and may also increase serum ethinyl estradiol concentrations. Because there is currently limited data on the effects of various sulfotransferases and the clinical relevance for many drugs is still being studied, it is prudent to use caution when coadministering etoricoxib with other drugs that are metabolized primarily by human sulfotransferases (eg, oral salbutamol and minoxidil).

Effect of etoricoxib on drugs metabolized by CYP isoenzymes

Based on in vitro data, etoricoxib is not expected to inhibit cytochromes P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4. In a study of healthy volunteers, daily use of etoricoxib 120 mg had no effect on hepatic CYP3A4 activity as determined by the erythromycin breath test.

Effect of other drugs on the pharmacokinetics of etoricoxib

The main route of metabolism of etoricoxib is dependent on CYP enzymes. CYP3A4 contributes to the metabolism of etoricoxib in vivo. In vitro studies indicate that CYP2D6, CYP2C9, CYP1A2 and CYP2C19 can also catalyze the major metabolic pathway, but their quantitative characteristics have not been studied in vivo.

Ketoconazole.

Ketoconazole is a potent CYP3A4 inhibitor. When administered to healthy volunteers in doses of 400 mg once daily for 11 days, ketoconazole did not have a clinically significant effect on the pharmacokinetics of a single dose of etoricoxib 60 mg (43% increase in AUC).

Rifampicin.

Concomitant use of etbricoxib and rifampicin (a strong CYP enzyme inducer) resulted in a 65% decrease in etoricoxib plasma concentrations. This interaction may be accompanied by relapse of symptoms if etoricoxib is used concomitantly with rifampicin. While these data may indicate a need for dose escalation, it is not recommended to use etoricoxib in doses higher than those indicated for each indication as the combination use of rifampicin and etoricoxib at such doses has not been studied.

Antacids.

Antacids do not have a clinically significant effect on the pharmacokinetics of etoricoxib.

Etoricoxib-Alium

Pharmacodynamic interaction

Oral anticoagulants (warfarin). In patients receiving warfarin, etoricoxib 120 mg daily was associated with an approximately 13% increase in international normalized ratio (INR) prothrombin time. In patients receiving oral anticoagulants, prothrombin time and INR should be monitored when starting treatment or when changing treatment with etoricoxib, especially in the first few days.

Diuretics, angiotensin-converting enzyme (ACE) inhibitors and angiotensin II antagonists. NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (eg, dehydrated patients or elderly patients with compromised renal function), concomitant use of an ACE inhibitor or angiotensin II antagonist and drugs that inhibit cyclooxygenase may lead to further deterioration of renal function, including the possible development of acute renal disease. failure, which is usually reversible. The possibility of such interactions should be kept in mind in patients taking etoricoxib concomitantly with ACE inhibitors or angiotensin II antagonists.

This combination should be prescribed with caution, especially in elderly patients. At the beginning of combined treatment, as well as at certain intervals in the future, fluid deficiency should be replenished and the issue of monitoring renal function should be considered.

Acetylsalicylic acid. In a study in healthy volunteers, etoricoxib 120 mg daily at steady state did not affect the antiplatelet activity of acetylsalicylic acid (81 mg once daily).

Etoricoxib can be used simultaneously with acetylsalicylic acid in low doses intended for the prevention of cardiovascular diseases. However, simultaneous administration of low doses of acetylsalicylic acid and etoricoxib may lead to an increased incidence of gastrointestinal ulcers and other complications compared to taking etoricoxib alone. The simultaneous use of etoricoxib with acetylsalicylic acid in doses exceeding those recommended for the prevention of cardiovascular complications, as well as with other NSAIDs, is not recommended (see section “Pharmacological properties”, subsection “Pharmacodynamics”, as well as section “Special instructions”).

Cyclosporine and tacrolimus. The interaction of etoricoxib with these drugs has not been studied, however, the simultaneous use of NSAIDs with cyclosporine and tacrolimus may increase the nephrotoxic effect of these drugs. Monitor renal function when etoricoxib is used concomitantly with any of these drugs.

Pharmacokinetic interaction

Effect of etoricoxib on other drugs

Lithium. NSAIDs reduce the renal excretion of lithium and, therefore, increase the concentration of lithium in the blood plasma. If necessary, frequently monitor the concentration of lithium in the blood and adjust the dose of lithium during simultaneous use with NSAIDs, as well as when NSAIDs are discontinued.

Methotrexate. Two studies examined the effects of etoricoxib 60, 90, and 120 mg once daily for seven days in patients receiving 7.5 to 20 mg of methotrexate once weekly for rheumatoid arthritis. Etoricoxib at doses of 60 and 90 mg had no effect on plasma concentrations and renal clearance of methotrexate. In one study, etoricoxib 120 mg had no effect on the pharmacokinetics of methotrexate. In another study, plasma methotrexate concentrations increased by 28% and renal clearance of methotrexate decreased by 13%. If etoricoxib and methotrexate are co-administered, patients should be monitored for possible toxic effects of methotrexate.

Oral contraceptives. Taking etoricoxib 60 mg for 21 days with oral contraceptives containing 35 mcg ethinyl estradiol (EE) and 0.5 to 1 mg norethindrone increased the AUC0-24h for EE by 37%. Taking etoricoxib at a dose of 120 mg with the above oral contraceptives (simultaneously or with an interval of 12 hours) increases the steady-state AUC0-24h for EE by 50-60%. This increase in EE concentrations should be taken into account when selecting the appropriate oral contraceptive for concomitant use with etoricoxib. This fact may lead to an increase in the incidence of adverse events associated with the use of oral contraceptives (for example, venous thromboembolism in women at risk).

Hormone replacement therapy (HRT).

Administration of etoricoxib 120 mg concomitantly with hormone replacement therapy containing conjugated estrogens at a dose of 0.625 mg for 28 days increased the mean steady-state AUC0-24h of unconjugated estrone (41%), equilin (76%), and 17-β- estradiol (22%). The effects of etoricoxib doses recommended for long-term use (30, 60 and 90 mg) have not been studied. Etoricoxib at a dose of 120 mg changed the exposure (AUC0-24h) of these estrogenic components to less than half compared with monotherapy with a drug containing conjugated estrogens, when the dose of the latter was increased from 0.625 to 1.25 mg. The clinical significance of such increases is unknown. The combination of etoricoxib and a product containing higher doses of conjugated estrogens has not been studied. Increased estrogen concentrations should be taken into account when choosing a hormonal drug for postmenopausal use when coadministered with etoricoxib, since increased estrogen exposure may increase the risk of HRT-related adverse events.

Prednisone/prednisolone. In drug interaction studies, etoricoxib did not have a clinically significant effect on the pharmacokinetics of prednisone/prednisolone.

Digoxin. When etoricoxib was administered at a dose of 120 mg once daily for 10 days in healthy volunteers, there was no change in AUC0-24h at steady state or an effect on the renal excretion of digoxin. An increase in digoxin Cmax was noted (approximately 33%). This increase is usually not significant in most patients. However, when etoricoxib and digoxin are used concomitantly, patients at high risk for digoxin toxicity should be monitored.

Effect of etoricoxib on drugs metabolized by sulfotransferases. Etoricoxib is an inhibitor of human sulfotransferases (specifically SULT1E1) and may increase serum EE concentrations. Because there is currently limited data on the effects of various sulfotransferases, and their clinical relevance for the use of many drugs is still being studied, it is advisable to use caution when prescribing etoricoxib concomitantly with other drugs metabolized primarily by human sulfotransferases (for example, oral salbutamol and minoxidil ).

Effect of etoricoxib on drugs metabolized by isoenzymes of the cytochrome system. Based on the results of in vitro studies, etoricoxib is not expected to inhibit cytochrome P450 isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4. In a study of healthy volunteers, daily administration of etoricoxib 120 mg had no effect on hepatic CYP3A4 activity as measured by the erythromycin breath test. /

Effect of other drugs on the pharmacokinetics of etoricoxib

The main pathway of metabolism of etoricoxib depends on enzymes of the cytochrome system. The CYP3A4 isoenzyme promotes the metabolism of etoricoxib in vivo. In vitro studies suggest that the isoenzymes CYP2D6, CYP2C9, CYP1A2 and CYP2C19 can also catalyze the main metabolic pathway, but their quantitative characteristics in vivo have not been studied.

Ketoconazole. Ketoconazole is a potent inhibitor of the CYP3A4 isoenzyme. When ketoconazole was administered to healthy volunteers at a dose of 400 mg once daily for 11 days, it had no clinically significant effect on the pharmacokinetics of a single dose of etoricoxib 60 mg (43% increase in AUC).

Voriconazole and miconazole. Co-administration of strong CYP3A4 inhibitors (oral voriconazole or topical miconazole oral gel) and etoricoxib caused a slight increase in etoricoxib exposure, which was not considered clinically significant based on published data.

Rifampicin. The simultaneous administration of etoricoxib and rifampicin (a powerful inducer of the cytochrome system) led to a decrease in the concentration of etoricoxib in the blood plasma by 65%. This interaction may be accompanied by a relapse of symptoms when etoricoxib is co-administered with rifampicin. These data may indicate a need for dose escalation, but etoricoxib should not be used in doses that exceed those recommended for each indication (see Dosage and Administration) as the combined use of rifampicin and etoricoxib at such doses has not been studied.

Antacids. Antacids do not have a clinically significant effect on the pharmacokinetics of etoricoxib.