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Cilostazol
Drug interactions
Short-term (<4 days) concomitant use of cilostazol and acetylsalicylic acid
leads to a 23-25% increase in blocking ADP-induced platelet aggregation in ex vivo conditions compared to acetylsalicylic acid monotherapy. There was no apparent trend toward an increase in hemorrhagic adverse events in patients receiving cilostazol and aspirin compared with patients receiving placebo and an equivalent dose of acetylsalicylic acid.
In a study in healthy volunteers, simultaneous use of cilostazol with clopidogrel
had no effect on platelet count, prothrombin time (PT) and aPTT. When clopidogrel was used either as monotherapy or in combination with cilostazol, bleeding time increased in healthy volunteers. Taking cilostazol did not lead to an additional significant prolongation of bleeding time. However, caution is recommended when cilostazol is used concomitantly with any drug that inhibits platelet aggregation. It is recommended to regularly monitor bleeding time. The use of cilostazol is contraindicated in patients receiving two or more antiplatelet and/or anticoagulant drugs simultaneously.
warfarin metabolism.
and had no effect on blood clotting parameters (PT, APTT, bleeding time). However, caution is recommended when cilostazol is used concomitantly with any anticoagulant drug. The use of cilostazol is contraindicated in patients receiving two or more antiplatelet and/or anticoagulant drugs simultaneously.
In the liver, cilostazol is mainly metabolized by cytochrome P450 enzymes, predominantly CYP3A4 and CYP2C19 and, to a lesser extent, CYP1A2. It is believed that dehydrocilostazol, which is 4-7 times superior to cilostazol in its ability to inhibit platelet aggregation, is formed mainly with the participation of CYP3A4. 4′-trans-hydroxycilostazol, which has five times less pronounced ability to inhibit platelet aggregation, is formed mainly under the influence of CYP2C19. Accordingly, drugs that inhibit CYP3A4 (eg, some macrolides [erythromycin, clarithromycin], azole antifungals [ketoconazole, itraconazole], protease inhibitors) and CYP2C19 (eg, proton pump inhibitors [omeprazole, esomeprazole])
increase the overall pharmacological activity of cilostazol and may enhance its undesirable effects. Accordingly, patients receiving strong inhibitors of CYP3A4 or CYP2C19 are recommended to be prescribed cilostazol at a dose of 50 mg 2 times a day.
When taking cilostazol concomitantly with erythromycin
(a strong inhibitor of CYP3A4), the AUC values of cilostazol, dehydrocilostazol and 4′-trans-hydroxycilostazol increased by 72%, 6% and 119%, respectively. Based on changes in AUC values, it was found that the overall pharmacological activity of cilostazol when used simultaneously with erythromycin increases by 34%. Based on these data, it is recommended to use cilostazol at a dose of 50 mg 2 times a day simultaneously with erythromycin or similar drugs (for example, clarithromycin).
When taking cilostazol concomitantly with ketoconazole
(potent inhibitor of CYP3A4) Cilostazol AUC increases by 117%, dehydrocilostazol AUC decreases by 15%, 4′-trans-hydroxycilostazol AUC increases by 87%. Based on changes in AUC values, it was found that the overall pharmacological activity of cilostazol when used simultaneously with ketoconazole increases by 35%. Based on these data, it is recommended to use cilostazol at a dose of 50 mg 2 times a day when taken simultaneously with kenoconazole or similar drugs (for example, itraconazole).
When taking cilostazol concomitantly with diltiazem
(weak inhibitor of CYP3A4) AUC of cilostazol, dehydrocilostazol and 4′-trans-hydroxycilostazol increased by 44%, 4% and 43%, respectively. Based on changes in AUC values, it was found that the overall pharmacological activity of cilostazol when used simultaneously with diltiazem increases by 19%. No dose adjustment of cilostazol is required when used concomitantly with diltiazem.
With a single dose of 100 mg of cilostazol simultaneously with 240 ml of grapefruit juice
(intestinal CYP3A4 inhibitor), no significant changes in the pharmacokinetic parameters of cilostazol were observed. No dose adjustment of cilostazol is required. However, taking larger amounts of grapefruit juice may affect the pharmacokinetics of cilostazol.
When taking cilostazol concomitantly with omeprazole
(potent inhibitor of CYP2C19) The AUC of cilostazol and dehydrocilostazol increased by 22% and 68%, respectively, while the AUC of 4′-trans-hydroxycilostazol decreased by 36%. Based on changes in AUC values, it was found that the overall pharmacological activity of cilostazol when used simultaneously with omeprazole increases by 47%. It is recommended to reduce the dose of cilostazol to 50 mg 2 times a day when used simultaneously with omeprazole.
Cilostazol increases the AUC of lovastatin
(CYP3A4 substrate) and its beta-hydroxyl metabolite by 70%.
Caution is recommended when using cilostozol concomitantly with HMG-CoA reductase inhibitors (statins) metabolized by CYP3A4 (simvastatin, atorvastatin and lovastatin).
Caution is recommended when coadministering cilostozol with CYP3A4 substrates that have a narrow therapeutic index (such as cisapride, halofantrine, pimozide, ergot alkaloids).
The effect on the pharmacokinetics of cilastazol of drugs that increase the activity of CYP3A4 and CYP2C19, such as carbamazepine, phenytoin, rifampicin, St. John's wort preparations
, has not been studied. With simultaneous use, it is theoretically possible to reduce the antiplatelet effect of cilostazol, so bleeding time should be regularly monitored.
Clinical studies have shown that smoking
(a factor that enhances the activity of CYP1A2) reduces the concentration of cilostazol in the blood plasma by 18%.
Caution must be exercised when co-administering cilostazol with antihypertensive drugs.
, as well as
any other drugs that potentially lower blood pressure (including nitrates and PDE 5 inhibitors),
since an additive hypotensive effect with the development of reflex tachycardia is possible.
An increase in heart rate and peripheral edema was noted with the simultaneous use of cilostazol and other vasodilating agents, for example, calcium channel blockers dihydropyridine derivatives.
Description of the drug PLESTAZOL
Short-term (<4 days) concomitant use of cilostazol and acetylsalicylic acid
leads to a 23-25% increase in blocking ADP-induced platelet aggregation in ex vivo conditions compared to acetylsalicylic acid monotherapy. There was no apparent trend toward an increase in hemorrhagic adverse events in patients receiving cilostazol and aspirin compared with patients receiving placebo and an equivalent dose of acetylsalicylic acid.
In a study in healthy volunteers, simultaneous use of cilostazol with clopidogrel
had no effect on platelet count, prothrombin time (PT) and aPTT. When clopidogrel was used either as monotherapy or in combination with cilostazol, bleeding time increased in healthy volunteers. Taking cilostazol did not lead to an additional significant prolongation of bleeding time. However, caution is recommended when cilostazol is used concomitantly with any drug that inhibits platelet aggregation. It is recommended to regularly monitor bleeding time. The use of cilostazol is contraindicated in patients receiving two or more antiplatelet and/or anticoagulant drugs simultaneously.
warfarin metabolism.
and had no effect on blood clotting parameters (PT, APTT, bleeding time). However, caution is recommended when cilostazol is used concomitantly with any anticoagulant drug. The use of cilostazol is contraindicated in patients receiving two or more antiplatelet and/or anticoagulant drugs simultaneously.
In the liver, cilostazol is mainly metabolized by cytochrome P450 enzymes, predominantly CYP3A4 and CYP2C19 and, to a lesser extent, CYP1A2. It is believed that dehydrocilostazol, which is 4-7 times superior to cilostazol in its ability to inhibit platelet aggregation, is formed mainly with the participation of CYP3A4. 4′-trans-hydroxycilostazol, which has five times less pronounced ability to inhibit platelet aggregation, is formed mainly under the influence of CYP2C19. Accordingly, drugs that inhibit CYP3A4 (eg, some macrolides [erythromycin, clarithromycin], azole antifungals [ketoconazole, itraconazole], protease inhibitors) and CYP2C19 (eg, proton pump inhibitors [omeprazole, esomeprazole])
increase the overall pharmacological activity of cilostazol and may enhance its undesirable effects. Accordingly, patients receiving strong inhibitors of CYP3A4 or CYP2C19 are recommended to be prescribed cilostazol at a dose of 50 mg 2 times a day.
When taking cilostazol concomitantly with erythromycin
(a strong inhibitor of CYP3A4), the AUC values of cilostazol, dehydrocilostazol and 4′-trans-hydroxycilostazol increased by 72%, 6% and 119%, respectively. Based on changes in AUC values, it was found that the overall pharmacological activity of cilostazol when used simultaneously with erythromycin increases by 34%. Based on these data, it is recommended to use cilostazol at a dose of 50 mg 2 times a day simultaneously with erythromycin or similar drugs (for example, clarithromycin).
When taking cilostazol concomitantly with ketoconazole
(potent inhibitor of CYP3A4) Cilostazol AUC increases by 117%, dehydrocilostazol AUC decreases by 15%, 4′-trans-hydroxycilostazol AUC increases by 87%. Based on changes in AUC values, it was found that the overall pharmacological activity of cilostazol when used simultaneously with ketoconazole increases by 35%. Based on these data, it is recommended to use cilostazol at a dose of 50 mg 2 times a day when taken simultaneously with kenoconazole or similar drugs (for example, itraconazole).
When taking cilostazol concomitantly with diltiazem
(weak inhibitor of CYP3A4) AUC of cilostazol, dehydrocilostazol and 4′-trans-hydroxycilostazol increased by 44%, 4% and 43%, respectively. Based on changes in AUC values, it was found that the overall pharmacological activity of cilostazol when used simultaneously with diltiazem increases by 19%. No dose adjustment of cilostazol is required when used concomitantly with diltiazem.
With a single dose of 100 mg of cilostazol simultaneously with 240 ml of grapefruit juice
(intestinal CYP3A4 inhibitor), no significant changes in the pharmacokinetic parameters of cilostazol were observed. No dose adjustment of cilostazol is required. However, taking larger amounts of grapefruit juice may affect the pharmacokinetics of cilostazol.
When taking cilostazol concomitantly with omeprazole
(potent inhibitor of CYP2C19) The AUC of cilostazol and dehydrocilostazol increased by 22% and 68%, respectively, while the AUC of 4′-trans-hydroxycilostazol decreased by 36%. Based on changes in AUC values, it was found that the overall pharmacological activity of cilostazol when used simultaneously with omeprazole increases by 47%. It is recommended to reduce the dose of cilostazol to 50 mg 2 times a day when used simultaneously with omeprazole.
Cilostazol increases the AUC of lovastatin
(CYP3A4 substrate) and its beta-hydroxyl metabolite by 70%.
Caution is recommended when using cilostozol concomitantly with HMG-CoA reductase inhibitors (statins) metabolized by CYP3A4 (simvastatin, atorvastatin and lovastatin).
Caution is recommended when coadministering cilostozol with CYP3A4 substrates that have a narrow therapeutic index (such as cisapride, halofantrine, pimozide, ergot alkaloids).
The effect on the pharmacokinetics of cilastazol of drugs that increase the activity of CYP3A4 and CYP2C19, such as carbamazepine, phenytoin, rifampicin, St. John's wort preparations
, has not been studied. With simultaneous use, it is theoretically possible to reduce the antiplatelet effect of cilostazol, so bleeding time should be regularly monitored.
Clinical studies have shown that smoking
(a factor that enhances the activity of CYP1A2) reduces the concentration of cilostazol in the blood plasma by 18%.
Caution must be exercised when co-administering cilostazol with antihypertensive drugs.
, as well as
any other drugs that potentially lower blood pressure (including nitrates and PDE 5 inhibitors),
since an additive hypotensive effect with the development of reflex tachycardia is possible.
An increase in heart rate and peripheral edema was noted with the simultaneous use of cilostazol and other vasodilating agents, for example, calcium channel blockers dihydropyridine derivatives.
