OVERDOSE
Human Experience
Worldwide exposure to fluvoxamine maleate includes over
37,000 patients treated in clinical trials and an estimated
exposure of 4,500,000 patients treated during foreign
marketing experience (circa 1092). Of the 354 cases of
deliberate or accidental overdose involving fluvoxamine
maleate reported from this population, there were 19 deaths.
Of the 19 deaths, 2 were in patients taking fluvoxamine
maleate alone and the remaining 17 were in patients taking
fluvoxamine maleate along with other drugs. In the remaining
335 patients, 309 had complete recovery after gastric
lavage or symptomatic treatment. One patient had persistent
mydriasis after the event, and a second patient had a
bowel infraction requiring a hemicolectomy. In the remaining
24 patients the outcome was unknown . The highest reported
overdose of fluvoxamine maleate involved a non- lethal
ingestion of 10,000 mg (equivalent of 1-3 months' dosage).
The patient fully recovered with no sequelae. Commonly
observed adverse events associated with fluvoxamine maleate
overdose included drowsiness, vomiting, diarrhea, and
dizziness. Other notable signs and symptoms seen with
fluvoxamine maleate overdose (single or mixed drugs) included
coma, tachycardia, bradycardia, hypotension, ECG abnormalities,
liver function abnormalities, convulsions, and symptoms
such as aspiration pneumonitis, respiratory difficulties
or hypokalemia that may occur secondary to loss of consciousness
or vomiting.
Management of Overdose
1. An unobstructed airway should be established with
maintenance of respiration as required. Vital signs and
ECG should be monitored.
2. Administration of activated charcoal may be as effective
as emesis or lavage and should be considered in treating
overdose. Since absorption with overdose may be delayed,
measures to minimize absorption may be necessary for up
to 24 hours post-ingestion.
3. Maintain close observation as clinically indicated.
4. There are no specifics as for LUVOX Tablets.
5. In managing overdosage, consider the possibility of
multiple drug involvement. Physician should consider contacting
a poison control center for additional information on
the treatment of any overdosage.
CONTRAINDICATIONS
No information provided.
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