Sinecatechins Ointment (Veregen)- FDA

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Drugs metabolised by cytochrome P450 2C9. At high concentrations in vitro, clopidogrel inhibits cytochrome P450 (2C9). Accordingly, clopidogrel may interfere with the metabolism of phenytoin, tamoxifen, tolbutamide, warfarin, fluvastatin, and many nonsteroidal anti-inflammatory agents, but there are no data with which Sinecatechins Ointment (Veregen)- FDA predict the magnitude of these interactions.

Caution should be used when any of these drugs is coadministered with Sinecatechins Ointment (Veregen)- FDA. Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of drugs that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel and a reduction in clinical efficacy.

Concomitant use of drugs that inhibit CYP2C19 (e. If a proton pump inhibitor is to be used concomitantly with clopidogrel, consider using one with less CYP2C19 inhibitory activity, such as pantoprazole. A number of other clinical studies have been conducted with clopidogrel and other concomitant medications to investigate the potential for pharmacodynamic and pharmacokinetic interactions.

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, cimetidine, 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. Coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent effects on Sinecatechins Ointment (Veregen)- FDA. Clopidogrel has been evaluated for safety in more than 42,000 claims, including over 9,000 patients treated for 1 year or more.

The clinically relevant adverse events observed in CAPRIE, CURE, CLARITY and COMMIT are discussed below. Clopidogrel was well tolerated compared to aspirin in a large controlled clinical trial (CAPRIE). The overall tolerability of clopidogrel in this study Sinecatechins Ointment (Veregen)- FDA similar to aspirin, regardless of age, gender and race. In CAPRIE, the overall incidence astrazeneca oxford any bleeding in patients treated with either clopidogrel or aspirin was similar (9.

The incidence of severe bleeds was 1. Sinecatechins Ointment (Veregen)- FDA haemorrhage was significantly less frequent with Sinecatechins Ointment (Veregen)- FDA (1. The incidence of intracranial haemorrhage was 0. In CURE, there was a significant difference between the two treatment groups for nonlife threatening major bleeds (1. The incidence of intracranial bleeding was 0.

There was no excess in major bleeds within kidney stone days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery (4.

In Sinecatechins Ointment (Veregen)- FDA who remained on therapy within five days of bypass graft surgery, the event rate was 9. This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytics or heparin therapy. The incidence of fatal bleeding (0. The overall rate of major bleeding in COMMIT was low and similar in both groups, as show in Table 4.

In CHARISMA, a study conducted in a broad patient population including patients with prior documented coronary artery disease, cerebrovascular disease or hematopoietic stem cell transplantation arterial disease as well as patients with a combination of atherothrombotic risk factors only, all receiving a background therapy with low dose aspirin (75-162 mg), there was an excess in moderate and severe bleeding, as adjudicated to the GUSTO definitions, in the clopidogrel group.

This represented a number needed to treat, to harm, of 84 in 23 months of follow-up. In CAPRIE, patients were intensively monitored for thrombocytopenia and neutropenia.

Clopidogrel hair tips care not associated with an increase in the incidence of thrombocytopenia compared Sinecatechins Ointment (Veregen)- FDA aspirin. Two of the 9599 patients who received clopidogrel and none of the patients who received aspirin had a neutrophil count of Sinecatechins Ointment (Veregen)- FDA. One of the clopidogrel treated patients was receiving cytostatic chemotherapy, and another recovered Sinecatechins Ointment (Veregen)- FDA returned to the trial after only temporarily Sinecatechins Ointment (Veregen)- FDA treatment with clopidogrel.

In CURE and CLARITY, the numbers of patients with thrombocytopenia or neutropenia were similar in both groups. Although the risk of myelotoxicity with clopidogrel appears Sinecatechins Ointment (Veregen)- FDA be quite low, this possibility should be considered when a patient receiving clopidogrel demonstrates fever or other signs of infection.

In CAPRIE, overall the incidence of gastrointestinal events (e. The incidence of peptic, gastric, or duodenal ulcers was 0. Cases of diarrhoea were reported at a higher frequency in the clopidogrel group (4. In CURE, there was no significant difference in johnson abby incidence of nonhaemorrhagic gastrointestinal effects in the clopidogrel or placebo groups.

In CLARITY, the incidence of gastrointestinal adverse events was 6. In COMMIT, 2 patients reported gastrointestinal adverse events in the Sinecatechins Ointment (Veregen)- FDA treated group, compared to one in the placebo treated group.

In CAPRIE, there were significantly more patients with rash in the clopidogrel group (4. In CURE, rash occurred in more Sinecatechins Ointment (Veregen)- FDA in the clopidogrel group. The median duration of therapy was 20 months, with a maximum of 3 years. The increase in the rate of study drug discontinuation due to nonhaemorrhagic adverse events was primarily due to the increase in rash seen in the clopidogrel group.

There was no apparent difference between the 2 treatment groups in the rates of discontinuations due to other adverse events. In CLARITY, the overall incidence of discontinuation due to adverse events was greater in the placebo group compared with the clopidogrel group (6.

In COMMIT, the overall incidence of discontinuation due to adverse events was similar in each treatment group Sinecatechins Ointment (Veregen)- FDA. Uncommon: flatulence, constipation, vomiting, gastric, peptic or duodenal ulcer. Platelet, bleeding and clotting disorders.

Uncommon: sanoba spray time increased. White cell and RES disorders.

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