Activation of Mania/Hypomania: Paxil may trigger
hypomania or mania episodes in unipolar and bipolar individuals. As with all
antidepressants, Paxil should be used cautiously in patients with a history of
mania.
Suicide: The possibility of a suicide attempt is
inherent in depression and may persist until remission occurs. Therefore, high
risk patients should be closely supervised throughout therapy and consideration
should be given to the possible need for hospitalization. In order to minimize
the opportunity for overdosage, prescriptions for paroxetine should be written
for the smallest quantity of drug consistent with good patient management.
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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