Generic Name

Fluoxetine

Precaution

Unstable epilepsy, liver and renal impairment, cardiac disease, diabetes, electroconvulsive therapy, bleeding disorders, closed-angle glaucoma; pregnancy. May impair performace of skilled tasks; withdraw gradually. Close monitoring of clinical worsening and behavioural changes during the 1st few mth of treatment or when there are dose changes. Lactation Excreted in milk; avoid (AAP states effect on nursing infants is unknown but may be of concern)

Indication

Panic disorder, Obsessive compulsive disorder, Trichotillomania, Premenstrual dysphoric disorder, Major depression, Post-traumatic stress disorder, Bulimia nervosa, Body dysmorphic disorder, Binge eating disorder

Contra Indication

Severe renal or hepatic failure; hypersensitivity; lactation; concomitant MAOIs or within 2 wk of MAOI withdrawal.

Dose

N/A

Side Effect

>10% Headache (20-25%),Nausea (12-29%),Insomnia (10-33%),Anorexia (4-17%),Anxiety (6-15%),Asthenia (10-15%),Diarrhea (8-18%),Nervousness (8-14%),Somnolence (5-17%),Tremor (3-13%),Weakness (7-21%) 1-10% Dizziness (9%),Dry mouth (6-10%),Dyspepsia (6-10%),Sweating (5-10%),Decreased libido (2-5%),Abnormal taste (>1%),Agitation (>1%),Chest pain (>1%),Chills (>1%),Confusion (>1%),Ear pain (>1%),Hypertension (>1%),Increased appetite (>1%),Palpitation (>1%),Sleep disorder (>1%),Tinnitus (>1%),Urinary frequency (>1%),Vomiting (>1%),Weight gain (>1%) Frequency Not Defined Dysglycemia in patients with DM Risk of seizure with concomitant electroconvulsive therapy (rare) Potentially Fatal: Rarely, systemic events possibly related to vasculitis have been reported in patients with rash but may be serious involving lungs, kidney and liver.

Pregnancy Category

Mode of Action

Fluoxetine is a potent and highly selective inhibitor of serotonin (5-HT) re-uptake. No affinity for adrenoceptors or histamine, GABA-B, or muscarinic receptors.

Interaction

May cause transient shift in plasma conc of tightly protein bound drugs e.g. warfarin and digoxin, resulting in adverse effects. T1/2 of diazepam is prolonged. Avoid concurrent use with clopidogrel. Potentially Fatal: Serious reactions when combined with MAOIs; at least 14 days should elapse after MAOIs withdrawal before starting fluoxetine treatment or at least 5 wk should elapse after fluoxetine treatment before starting MAOIs therapy. Two-fold increase in plasma levels of other antidepressants when combined with fluoxetine. Monitor lithium levels when combined.

Pregnancy Category Note

Pregnancy category: C Treatment of pregnant women during the first trimester: There are no adequate and well-controlled clinical studies on the use of fluoxetine in pregnant women, but 1 prospective cohort study conducted by the European Network of Teratology Information Services reported an increased risk of cardiovascular malformations in infants born to women (N = 253) exposed to fluoxetine during the first trimester of pregnancy, compared with infants of women (N = 1359) who were not exposed to fluoxetine Use late in the third trimester associated with complications in newborns and may require prolonged hospitalization, respiratory support, and tube feeding When treating a pregnant woman with fluoxetine, physician should carefully consider trimester both for the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant; the decision can only be made on a case by case basis Lactation Excreted in milk; avoid (AAP states effect on nursing infants is unknown but may be of concern)

Adult Dose

Oral Depression Adult: Initially, 20 mg once daily. May gradually increase up to max 80 mg daily in 2 divided doses, if no clinical response after several wk. Bulimia nervosa Adult: 60 mg daily as a single or in divided doses. Hepatic impairment: Reduce dose and/or dosing frequency. Obsessive compulsive disorder Adult: Initially, 20 mg once daily, increased up to 60 mg daily if no clinical response after several wk. Max: 80 mg daily in 2 divided doses. Premenstrual dysphoric disorder Adult: 20 mg daily continuously. Alternatively, 20 mg daily to be started 14 days before menstruation and continued until 1st day of menses; repeat w/ each cycle. Panic disorder Adult: Initially, 10 mg once daily, increase to 20 mg daily after a wk. May further increase to 60 mg daily, if no clinical response after several wk. Elderly: Max: 60 mg daily. Hepatic impairment: Reduce dose and/or dosing frequency.

Child Dose

Oral Depression Child: >8 yr Initially, 10 mg daily, may increase to 20 mg daily after 1-2 wk. Low wt childn: Initially, 10 mg daily, may increase to 20 mg daily after several wk, only if clinical response is insufficient. Obsessive compulsive disorder Child: >7 yr Initially, 10 mg daily, may increase to 20 mg daily after 2 wk; increase further up to 60 mg daily after several wk as necessary. Low-wt childn: Initially, 10 mg daily, may increase to 20-30 mg daily after several wk, if required.

Renal Dose

Renal impairment: Use caution; drug accumulation may occur with severe renal impairment

Administration

May be taken with or without food.