Other Warnings/Precautions

✽ Add or initiate other antidepressants with caution for up to 5 weeks after discontinuing fluoxetine

• Use with caution in patients with history of seizure

• Use with caution in patients with bipolar disorder unless treated with concomitant mood-stabilizing agent

• When treating children, carefully weigh the risks and benefits of pharmacological treatment against the risks and benefits of nontreatment with antidepressants and make sure to document this in the patient’s chart

• Distribute the brochures provided by the FDA and the drug companies

• Warn patients and their caregivers about the possibility of activating side effects and advise them to report such symptoms immediately

• Monitor patients for activation of suicidal ideation, especially children and adolescents

Do Not Use

• If patient is taking an MAO inhibitor

• If patient is taking thioridazine

• If patient is taking pimozide

• If patient is taking tamoxifen

• If there is a proven allergy to fluoxetine

FLUOXETINE: SPECIAL POPULATIONS

Renal Impairment

• No dose adjustment

• Not removed by hemodialysis

Hepatic Impairment

• Lower dose or give less frequently, perhaps by half

Cardiac Impairment

• Preliminary research suggests that fluoxetine is safe in these patients

• Treating depression with SSRIs in patients with acute angina or following myocardial infarction may reduce cardiac events and improve survival as well as mood

Elderly

• Some patients may tolerate lower doses better

• Reduction in the risk of suicidality with antidepressants compared to placebo in adults age 65 and older

Children and Adolescents

• Carefully weigh the risks and benefits of pharmacological treatment against the risks and benefits of nontreatment with antidepressants and make sure to document this in the patient’s chart

• Monitor patients face-to-face regularly, particularly during the first several weeks of treatment

• Use with caution, observing for activation of known or unknown bipolar disorder and/or suicidal ideation, and inform parents or guardians of this risk so they can help observe child or adolescent patients

• Approved for OCD and depression

• Adolescents often receive adult dose, but doses slightly lower for children

• Children taking fluoxetine may have slower growth; long-term effects are unknown

Pregnancy

• Risk Category C [some animal studies show adverse effects; no controlled studies in humans]

• Not generally recommended for use during pregnancy, especially during first trimester

• Nonetheless, continuous treatment during pregnancy may be necessary and has not been proven to be harmful to the fetus

• Current patient registries of children whose mothers took fluoxetine during pregnancy do not show adverse consequences

• At delivery there may be more bleeding in the mother and transient irritability or sedation in the newborn

• Must weigh the risk of treatment (first trimester fetal development, third trimester newborn delivery) to the child against the risk of no treatment (recurrence of depression, maternal health, infant bonding) to the mother and child

• For many patients this may mean continuing treatment during pregnancy

• Exposure to SSRIs early in pregnancy may be associated with increased risk of septal heart defects (absolute risk is small)

• SSRI use beyond the 20th week of pregnancy may be associated with increased risk of pulmonary hypertension in newborns, although this is not proven

• Exposure to SSRIs late in pregnancy may be associated with increased risk of gestational hypertension and preeclampsia

• Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding; reported symptoms are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome, and include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying