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Precautions

Seizures: Caution is recommended when the drug is administered to patients with a history of seizures. The drug should be discontinued in any patient who develops seizures.

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: There have been several reports of abnormal bleeding (mostly ecchymosis and purpura) associated with paroxetine treatment, including a report of impaired platelet aggregation. While a causal relationship to paroxetine is unclear, impaired platelet aggregation may result from platelet serotonin depletion and contribute to such occurrences.

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.

Cardiac Conditions: Paxil has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Clinical studies indicated Paxil (paroxetine hydrochloride) does not cause any clinically important changes in heart rate or blood pressure or any significant ECG abnormalities.

Usage in Children: Do not give to children under 18 years old.

Pregnancy & Nursing: The effect of paroxetine on labor and delivery in humans is unknown. Therefore, Paxil should be used in women who are or might become pregnant only if the clinical condition clearly justifies potential risk to the fetus.

Like many other drugs, paroxetine is secreted in human milk, and caution should be exercised when Paxil (paroxetine hydrochloride) is administered to a nursing woman.

Interference with Cognitive or Motor Performance: Any psychoactive drug may impair judgment, thinking or motor skills. Although in controlled studies Paxil has not been shown to impair psychomotor performance, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Paxil therapy does not affect their ability to engage in such activities.

 
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