Paxil - Warnings & Precautions

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Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which PAXIL is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate (see DOSAGE AND ADMINISTRATION).

Hyponatremia:

Several cases of hyponatremia have been reported. The hyponatremia appeared to be reversible when PAXIL was discontinued. The majority of these occurrences have been in elderly individuals, some in patients taking diuretics or who were otherwise volume depleted.

Abnormal Bleeding:

Published case reports have documented the occurrence of bleeding episodes in patients treated with psychotropic agents that interfere with serotonin reuptake.

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.