OVERDOSE
Human Experience
Overdose with immediate-release paroxetine HCl (up to
2000 mg) alone and in combination with other drugs has
been reported. Signs and symptoms of overdose with immediate-release
paroxetine HCl include nausea, vomiting, sedation, dizziness,
sweating, and facial flush. There are no reports of coma
or convulsions following overdosage with immediate-release
paroxetine alone. A fatal outcome has been reported rarely
when immediate-release paroxetine HCl was taken in combination
with other agents, or when taken alone.
Overdosage Management
Treatment should consist of those general measures employed
in the management of overdosage with any antidepressant.
A specific caution involves patients who are taking or
have recently taken paroxetine who might ingest excessive
quantities of a tricyclic antidepressant. In such a case,
accumulation of the parent tricyclic and/or an active
metabolite may increase the possibility of clinically
significant sequelae and extend the time needed for close
medical observation (see DRUG INTERACTIONS, Drugs Metabolized
by Cytochrome P450IID6).
In managing overdosage, consider the possibility of multiple-drug
involvement. The physician should consider contacting
a poison control center for additional information on
the treatment of any overdose.
Additional Information for Immediate-Release
Tablets and Oral Suspension: Ensure an adequate
airway, oxygenation, and ventilation. Monitor cardiac
rhythm and vital signs. General supportive and symptomatic
measures are also recommended. Induction of emesis is
not recommended. Gastric lavage with a large-bore orogastric
tube with appropriate airway protection, if needed, may
be indicated if performed soon after ingestion, or in
symptomatic patients.
Activated charcoal should be administered. Due to the
large volume of distribution of this drug, forced diuresis,
dialysis, hemoperfusion, and exchange transfusion are
unlikely to be of benefit. No specific antidotes for paroxetine
are known.
Additional Information for Controlled-Release
Tablets: Ensure an adequate airway, oxygenation,
and ventilation. Monitor cardiac rhythm and vital signs.
General supportive and symptomatic measures are also recommended.
Induction of emesis is not recommended. Gastric lavage
with a large-bore orogastric tube with appropriate airway
protection, if needed, may be indicated if performed soon
after ingestion, or in symptomatic patients.
Activated charcoal should be administered. Due to the
large volume of distribution of this drug, forced diuresis,
dialysis, hemoperfusion, and exchange transfusion are
unlikely to be of benefit. No specific antidotes for paroxetine
are known.
CONTRAINDICATIONS
Concomitant use in patients taking monoamine oxidase
inhibitors (MAOIs) is contraindicated (see WARNINGS and
PRECAUTIONS).
Paroxetine HCl is contraindicated in patients with a
hypersensitivity to paroxetine or to any of the inactive
ingredients in paroxetine HCl formulations.
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