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Paxil - Warnings & Precautions

[Paroxetine]



Additional epidemiological studies, both of the case-control and cohort design, have confirmed the association between use of psychotropic agents that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding. In both studies, concurrent use of a nonsteroidal anti-inflammatory drug (NSAID) or aspirin potentiated the risk of bleeding (see Drug Interactions). Although these studies focused on upper gastrointestinal bleeding, there is no reason to believe that bleeding at other sites would not be similarly potentiated. Patients should be cautioned regarding the risk of bleeding associated with the concomitant use of PAXIL with NSAIDs, aspirin, or other drugs that affect coagulation.

Use in Patients With Concomitant Illness:

Clinical experience with PAXIL in patients with certain concomitant systemic illness is limited. Caution is advisable in using PAXIL in patients with diseases or conditions that could affect metabolism or hemodynamic responses.

As with other SSRIs, mydriasis has been infrequently reported in premarketing studies with PAXIL. A few cases of acute angle closure glaucoma associated with paroxetine therapy have been reported in the literature. As mydriasis can cause acute angle closure in patients with narrow angle glaucoma, caution should be used when PAXIL is prescribed for patients with narrow angle glaucoma.

PAXIL has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from clinical studies during the product's premarket testing. Evaluation of electrocardiograms of 682 patients who received PAXIL in double-blind, placebo-controlled trials, however, did not indicate that PAXIL is associated with the development of significant ECG abnormalities. Similarly, PAXIL does not cause any clinically important changes in heart rate or blood pressure.
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