Drugs Plavix - Clopidogrel 75mg

Pink, round, biconvex, engraved with 75 on one side and 1171 on the other side. For further information please refer to section 5. The optimal duration of treatment has not been formally established. Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5. For patients over 75 years of age clopidogrel should be initiated without a loading dose.

Plavix is a medicine that contains the active substance clopidogrel. It is available as pink tablets (round: 75 mg; oblong: 300 mg). Plavix is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Plavix can be given to the following groups of patients:patients who have recently had a myocardial infarction (heart attack). Plavix can be started between a few days and 35 days after the attack;patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).

Strokes occurred in 296 (7. Mean peak plasma levels of unchanged clopidogrel (approximately 2. The binding is nonsaturable in vitro over a wide concentration range. Clopidogrel is first metabolised to a 2oxoclopidogrel intermediate metabolite. Subsequent metabolism of the 2oxoclopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel.

Not all pack sizes may be marketed. Excipients: each filmcoated tablet contains 12 mg of lactose and 13. Pink, oblong, engraved with 300 on one side and 1332 on the other side. For patients over 75 years of age clopidogrel, should be initiated without a loading dose.

In poor metabolisers, active metabolite exposure was decreased by 6371% compared to extensive metabolisers. When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen. An appropriate dose regimen for this patient population has not been established in clinical outcome trials. None of these analyses were adequately sized to detect differences in outcome in poor metabolisers. In addition, clinical tolerance was good in all patients.

The active thiol metabolite which has been isolated in vitro , binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation. C max occurs approximately 30 to 60 minutes after dosing. After a single oral dose of 75 mg, clopidogrel has a halflife of approximately 6 hours. The elimination halflife of the main circulating (inactive) metabolite was 8 hours after single and repeated administration. A patient with poor metaboliser status will possess two lossoffunction alleles as defined above.

In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9. The incidence of major bleeding was similar between groups. This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy. Major bleeding was mostly of extracranial origin in both groups (5. There was no statistically significant difference in the rates of fatal bleeding (1.

Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery. The concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4. If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, clopidogrel should be discontinued 7 days prior to surgery. Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken. Clopidogrel prolongs bleeding time and should be used with caution in patients who have lesions with a propensity to bleed (particularly gastrointestinal and intraocular).

Fifteen percent (15. This benefit was consistent across all prespecified subgroups including patients age and gender, infarct location, and type of fibrinolytic or heparin used. The coprimary endpoints were death from any cause and the first occurrence of reinfarction, stroke or death. The population included 27. Clopidogrel significantly reduced the relative risk of death from any cause by 7% (p=0.

It is characterised by thrombocytopenia and microangiopathic haemolytic anaemia associated with either neurological findings, renal dysfunction or fever. The clinical relevance of this interaction is uncertain. Therefore clopidogrel should be used with caution in these patients (see section 4. Clopidogrel should therefore be used with caution in this population (see section 4. This medicinal product contains hydrogenated castor oil which may cause stomach upset and diarrhoea.

Apart from the specific medicinal product interaction information described above, interaction studies with clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5. Animal studies have shown excretion of clopidogrel in breast milk. In addition to clinical studies experience, adverse reactions have been spontaneously reported. Drugs plavix is the most common reaction reported both in clinical studies as well as in postmarketing experience where it was mostly reported during the first month of treatment.

Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks. In patients with atrial fibrillation, clopidogrel should be given as a drugs plavix daily dose of 75 mg. For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose. Severe hepatic impairment. Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.

There was also a reduction in the patients who had a stent inserted. Plavix should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients. It must not be used in patients who have severe liver disease or a disease that may cause bleeding. Excipients: each filmcoated tablet contains 3 mg of lactose and 3. For a full list of excipients, see section 6.

These results indicate that clopidogrel can be administered with pantoprazole. No clinically significant pharmacodynamic interactions were observed when clopidogrel was coadministered with atenolol, nifedipine, or both atenolol and nifedipine. Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the coadministration of phenobarbital or oestrogen. The pharmacokinetics of digoxin or theophylline were not modified by the coadministration of clopidogrel. Antacids did not modify the extent of clopidogrel absorption.

Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies, and showed no genotoxic activity. Clopidogrel was found to have no effect on the fertility of male and female rats and was not teratogenic in either rats or rabbits. When given to lactating rats, clopidogrel caused a slight delay in the development of the offspring. Specific pharmacokinetic studies performed with radiolabelled clopidogrel have shown that the parent compound or its metabolites are excreted in the milk. In all aluminium drugs plavix, this medicinal product does not require any special storage conditions.

The mean bleeding time prolongation was also similar in the two groups. These occurred at doses representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day and were a consequence of an effect on hepatic metabolising enzymes. No effect on hepatic metabolising enzymes was observed in humans receiving clopidogrel at the therapeutic dose. At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/or vomiting) of clopidogrel was also reported in rat and baboon. There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).

Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in the table below. Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Appropriate therapy should be considered if bleedings are observed. No antidote to the pharmacological activity of clopidogrel has been found. If prompt correction of prolonged bleeding time is required, platelet transfusion may reverse the effects of clopidogrel.

Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. Due to the irreversible binding, platelets exposed are affected for the remainder of their lifespan (approximately 710 days) and recovery of normal platelet function occurs at a rate consistent with platelet turnover. At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%. Platelet aggregation and bleeding time gradually returned to baseline values, generally within 5 days after treatment was discontinued. Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.

This stops the platelets becoming sticky, reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke. The main measure of effectiveness was how many patients experienced a new ischaemic event (heart attack, ischaemic stroke or death) over one to three years. In the studies of acute coronary syndrome, all of the patients also took aspirin and the main measure of effectiveness was the number of patients who experienced an event such as a blocked artery, another heart attack or death during the study. Plavix was more effective than aspirin at preventing new ischaemic events. This corresponds to a relative reduction in risk of 9% compared with aspirin.

In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients 75 years. Patients were treated for up to one year. Heparins were administered in more than 90% of the patients and the relative rate of bleeding between clopidogrel and placebo was not significantly affected by the concomitant heparin therapy. There was no observed effect on the rate of rehospitalisation for unstable angina. The results obtained in populations with different characteristics (e.

A pharmacodynamic interaction between clopidogrel and acetylsalicylic acid is possible, leading to increased risk of bleeding. Therefore, concomitant use should be undertaken with caution (see section 4. Heparin : in a clinical study conducted in healthy subjects, clopidogrel did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation. Coadministration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel. A pharmacodynamic interaction between clopidogrel and heparin is possible, leading to increased risk of bleeding.

Thrombolytics : the safety of the concomitant administration of clopidogrel, fibrin or nonfibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction. The decrease was associated with a 39% (loading dose) and 21% (maintenance dose) reduction of inhibition of platelet aggregation. Esomeprazole is expected to give a similar interaction with clopidogrel. As a precaution, concomitant use of omeprazole or esomeprazole should be discouraged (see section 4. Less pronounced reductions of metabolite exposure has been observed with pantoprazole or lansoprazole.

Moreover, the safety profile of clopidogrel in this subgroup of patients did not raise any particular concern. Thus, the results from this subset are in line with the overall trial results. The patients were followed for 30 days. The patient population included 19. A total of 99.

This benefit was consistent across age, gender and with or without fibrinolytics, and was observed as early as 24 hours. Patients were treated for up to 5 years. The patient population included 41. The mean age was 71 years, 41. A total of 23.

The medicine can only be obtained with a prescription. Plavix is converted into its active form in the body. The best dose to use in these patients has not yet been determined. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).

	Guest	#1 \| Posted: Tuesday, September 6, 2011
Pink, round, biconvex, engraved with 75 on one side and 1171 on the other side. For further information please refer to section 5. The optimal duration of treatment has not been formally established. Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5. For patients over 75 years of age clopidogrel should be initiated without a loading dose. Plavix is a medicine that contains the active substance clopidogrel. It is available as pink tablets (round: 75 mg; oblong: 300 mg). Plavix is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Plavix can be given to the following groups of patients:patients who have recently had a myocardial infarction (heart attack). Plavix can be started between a few days and 35 days after the attack;patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). Strokes occurred in 296 (7. Mean peak plasma levels of unchanged clopidogrel (approximately 2. The binding is nonsaturable in vitro over a wide concentration range. Clopidogrel is first metabolised to a 2oxoclopidogrel intermediate metabolite. Subsequent metabolism of the 2oxoclopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel. Not all pack sizes may be marketed. Excipients: each filmcoated tablet contains 12 mg of lactose and 13. Pink, oblong, engraved with 300 on one side and 1332 on the other side. For patients over 75 years of age clopidogrel, should be initiated without a loading dose. In poor metabolisers, active metabolite exposure was decreased by 6371% compared to extensive metabolisers. When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen. An appropriate dose regimen for this patient population has not been established in clinical outcome trials. None of these analyses were adequately sized to detect differences in outcome in poor metabolisers. In addition, clinical tolerance was good in all patients. The active thiol metabolite which has been isolated in vitro , binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation. C max occurs approximately 30 to 60 minutes after dosing. After a single oral dose of 75 mg, clopidogrel has a halflife of approximately 6 hours. The elimination halflife of the main circulating (inactive) metabolite was 8 hours after single and repeated administration. A patient with poor metaboliser status will possess two lossoffunction alleles as defined above. In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9. The incidence of major bleeding was similar between groups. This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy. Major bleeding was mostly of extracranial origin in both groups (5. There was no statistically significant difference in the rates of fatal bleeding (1. Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery. The concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4. If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, clopidogrel should be discontinued 7 days prior to surgery. Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken. Clopidogrel prolongs bleeding time and should be used with caution in patients who have lesions with a propensity to bleed (particularly gastrointestinal and intraocular). Fifteen percent (15. This benefit was consistent across all prespecified subgroups including patients age and gender, infarct location, and type of fibrinolytic or heparin used. The coprimary endpoints were death from any cause and the first occurrence of reinfarction, stroke or death. The population included 27. Clopidogrel significantly reduced the relative risk of death from any cause by 7% (p=0. It is characterised by thrombocytopenia and microangiopathic haemolytic anaemia associated with either neurological findings, renal dysfunction or fever. The clinical relevance of this interaction is uncertain. Therefore clopidogrel should be used with caution in these patients (see section 4. Clopidogrel should therefore be used with caution in this population (see section 4. This medicinal product contains hydrogenated castor oil which may cause stomach upset and diarrhoea. Apart from the specific medicinal product interaction information described above, interaction studies with clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5. Animal studies have shown excretion of clopidogrel in breast milk. In addition to clinical studies experience, adverse reactions have been spontaneously reported. Drugs plavix is the most common reaction reported both in clinical studies as well as in postmarketing experience where it was mostly reported during the first month of treatment. Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks. In patients with atrial fibrillation, clopidogrel should be given as a drugs plavix daily dose of 75 mg. For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose. Severe hepatic impairment. Active pathological bleeding such as peptic ulcer or intracranial haemorrhage. There was also a reduction in the patients who had a stent inserted. Plavix should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients. It must not be used in patients who have severe liver disease or a disease that may cause bleeding. Excipients: each filmcoated tablet contains 3 mg of lactose and 3. For a full list of excipients, see section 6. These results indicate that clopidogrel can be administered with pantoprazole. No clinically significant pharmacodynamic interactions were observed when clopidogrel was coadministered with atenolol, nifedipine, or both atenolol and nifedipine. Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the coadministration of phenobarbital or oestrogen. The pharmacokinetics of digoxin or theophylline were not modified by the coadministration of clopidogrel. Antacids did not modify the extent of clopidogrel absorption. Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies, and showed no genotoxic activity. Clopidogrel was found to have no effect on the fertility of male and female rats and was not teratogenic in either rats or rabbits. When given to lactating rats, clopidogrel caused a slight delay in the development of the offspring. Specific pharmacokinetic studies performed with radiolabelled clopidogrel have shown that the parent compound or its metabolites are excreted in the milk. In all aluminium drugs plavix, this medicinal product does not require any special storage conditions. The mean bleeding time prolongation was also similar in the two groups. These occurred at doses representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day and were a consequence of an effect on hepatic metabolising enzymes. No effect on hepatic metabolising enzymes was observed in humans receiving clopidogrel at the therapeutic dose. At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/or vomiting) of clopidogrel was also reported in rat and baboon. There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day). Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in the table below. Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Appropriate therapy should be considered if bleedings are observed. No antidote to the pharmacological activity of clopidogrel has been found. If prompt correction of prolonged bleeding time is required, platelet transfusion may reverse the effects of clopidogrel. Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. Due to the irreversible binding, platelets exposed are affected for the remainder of their lifespan (approximately 710 days) and recovery of normal platelet function occurs at a rate consistent with platelet turnover. At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%. Platelet aggregation and bleeding time gradually returned to baseline values, generally within 5 days after treatment was discontinued. Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5. This stops the platelets becoming sticky, reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke. The main measure of effectiveness was how many patients experienced a new ischaemic event (heart attack, ischaemic stroke or death) over one to three years. In the studies of acute coronary syndrome, all of the patients also took aspirin and the main measure of effectiveness was the number of patients who experienced an event such as a blocked artery, another heart attack or death during the study. Plavix was more effective than aspirin at preventing new ischaemic events. This corresponds to a relative reduction in risk of 9% compared with aspirin. In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients 75 years. Patients were treated for up to one year. Heparins were administered in more than 90% of the patients and the relative rate of bleeding between clopidogrel and placebo was not significantly affected by the concomitant heparin therapy. There was no observed effect on the rate of rehospitalisation for unstable angina. The results obtained in populations with different characteristics (e. A pharmacodynamic interaction between clopidogrel and acetylsalicylic acid is possible, leading to increased risk of bleeding. Therefore, concomitant use should be undertaken with caution (see section 4. Heparin : in a clinical study conducted in healthy subjects, clopidogrel did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation. Coadministration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel. A pharmacodynamic interaction between clopidogrel and heparin is possible, leading to increased risk of bleeding. Thrombolytics : the safety of the concomitant administration of clopidogrel, fibrin or nonfibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction. The decrease was associated with a 39% (loading dose) and 21% (maintenance dose) reduction of inhibition of platelet aggregation. Esomeprazole is expected to give a similar interaction with clopidogrel. As a precaution, concomitant use of omeprazole or esomeprazole should be discouraged (see section 4. Less pronounced reductions of metabolite exposure has been observed with pantoprazole or lansoprazole. Moreover, the safety profile of clopidogrel in this subgroup of patients did not raise any particular concern. Thus, the results from this subset are in line with the overall trial results. The patients were followed for 30 days. The patient population included 19. A total of 99. This benefit was consistent across age, gender and with or without fibrinolytics, and was observed as early as 24 hours. Patients were treated for up to 5 years. The patient population included 41. The mean age was 71 years, 41. A total of 23. The medicine can only be obtained with a prescription. Plavix is converted into its active form in the body. The best dose to use in these patients has not yet been determined. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).