"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Human Experience with Overdosage
There is limited clinical experience with BRISDELLE overdosage in humans, as there were no overdoses reported in the clinical studies.
Spontaneous cases of deliberate or accidental overdosage during paroxetine treatment have been reported; some of these cases were fatal and some of the fatalities appeared to involve paroxetine alone. Of nonfatal cases with known outcome, most recovered without sequelae. The largest known ingestion involved 2000 mg of paroxetine (267 times the maximum recommended daily dose) in a patient who recovered.
Commonly reported adverse reactions associated with paroxetine overdosage include somnolence, coma, nausea, tremor, tachycardia, confusion, vomiting, and dizziness. Other notable signs and symptoms observed with overdoses involving paroxetine (alone or with other substances) include mydriasis, convulsions (including status epilepticus), ventricular dysrhythmias (including torsades de pointes), hypertension, aggressive reactions, syncope, hypotension, stupor, bradycardia, dystonia, rhabdomyolysis, symptoms of hepatic dysfunction (including hepatic failure, hepatic necrosis, jaundice, hepatitis, and hepatic steatosis), serotonin syndrome, manic reactions, myoclonus, acute renal failure, and urinary retention.
Management of Overdosage
Treatment should consist of those general measures employed in the management of overdosage with any SSRI. Consult with a certified poison control center for up-to-date guidance and advice on treatment of overdosage.
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. In managing overdosage, consider the possibility of multiple drug involvement.
Monoamine Oxidase Inhibitors
Concomitant use of an MAOI with BRISDELLE or within 14 days of stopping treatment with BRISDELLE is contraindicated because of an increased risk of serotonin syndrome. The use of BRISDELLE within 14 days of stopping an MAOI is also contraindicated [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
Starting BRISDELLE in a patient who is being treated with linezolid or intravenous methylene blue, both of which inhibit monoamine oxidase, is also contraindicated because of an increased risk of serotonin syndrome [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
Concomitant use of BRISDELLE with thioridazine is contraindicated, because thioridazine prolongs the QT interval, and paroxetine can increase thioridazine levels [see DRUG INTERACTIONS].
Concomitant use of BRISDELLE with pimozide is contraindicated because pimozide prolongs the QT interval, and paroxetine increases pimozide levels [see DRUG INTERACTIONS].
Hypersensitivity to any Ingredient in BRISDELLE
BRISDELLE is contraindicated in patients with a history of hypersensitivity to paroxetine or any of the other ingredients in BRISDELLE.
Menopausal VMS does not occur during pregnancy and BRISDELLE may cause fetal harm [see Use In Specific Populations].
Last reviewed on RxList: 7/12/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Brisdelle Information
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