Generic Name and Formulations:
Fluoxetine (as HCl) 10mg, 15mg, 20mg; tabs.
Indications for SARAFEM:
Premenstrual dysphoric disorder.
Give daily throughout menstrual cycle or intermittently (start 14 days before expected menses onset through first full day of menses). Initially 20mg/day; max 80mg/day. Hepatic dysfunction: reduce dose.
During or within 14 days of MAOIs; do not start an MAOI during or within 5 weeks of fluoxetine. Concomitant pimozide, thioridazine, linezolid, IV methylene blue.
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes. Monitor for serotonin syndrome or neuroleptic malignant syndrome-like symptoms; discontinue if occurs. Discontinue if unexplained allergic reaction (eg, rash) occurs. History of seizures. ECT. Screen for bipolar disorder; may activate mania/hypomania; monitor. Volume depletion. Conditions that affect metabolism or hemodynamic response. Cardiac disease. Diabetes. Angle-closure glaucoma. Monitor for weight changes. Write ℞ for smallest practical amount. Reevaluate periodically. Avoid abrupt cessation. Labor & delivery. Pregnancy (Cat.C; avoid 3rd trimester; see full labeling for effects on neonate). Nursing mothers: not recommended.
See Contraindications. Do not start with concomitant linezolid or IV methylene blue; if treatment is necessary, discontinue fluoxetine before starting; monitor for serotonin syndrome for 5 weeks or until 24hrs after last dose of linezolid or IV methylene blue, whichever comes first. Do not start thioridazine within at least 5 weeks of discontinuing fluoxetine. Concomitant SSRIs, SNRIs, tryptophan: not recommended. Increased risk of serotonin syndrome with other serotonergic drugs (eg, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). May potentiate protein-bound drugs (eg, warfarin, digoxin) and those metabolized by CYP2D6 (eg, tricyclics, vinblastine, flecainide). May potentiate carbamazepine, phenytoin. Monitor lithium, phenytoin, warfarin, tricyclics. Caution with benzodiazepines (eg, diazepam, alprazolam), antipsychotics (eg, clozapine, haloperidol), other CNS drugs, antiplatelets. Increased risk of bleeding with NSAIDs, aspirin, warfarin, and others that affect coagulation. Hyponatremia with diuretics.
Headache, asthenia, pain, accidental injury, infection, flu syndrome, nausea, diarrhea, insomnia, dizziness, nervousness, abnormal thinking, decreased libido, rhinitis, pharyngitis; rash (may be serious), hyponatremia (esp. elderly).
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