fluoxetine hydrochloride

(floo ox' e teen)

Apo-Fluoxetine (CAN), Novo-Fluoxetine (CAN), PMS-Fluoxetine (CAN),
Prozac, Prozac Weekly, Sarafem

Pregnancy Category B

Drug classes
Antidepressant
SSRI

Therapeutic actions
Acts as an antidepressant by inhibiting CNS neuronal uptake of serotonin; blocks uptake
of serotonin with little effect on norepinephrine; little affinity for muscarinic,
histaminergic, and alpha1-adrenergic receptors.

Indications
• Treatment of depression; most effective in patients with major depressive disorder
• Treatment of obsessive-compulsive disorder
• Treatment of bulimia
• Sarafem: Treatment of PMDD (pre-menstrual dysphoric disorder)
• Prozac: Treatment of panic disorder with or without agoraphobia
• Unlabeled use: Treatment of obesity, alcoholism, numerous psychiatric disorders,
chronic pain, various neuropathies

Contraindications and cautions

• Contraindicated with hypersensitivity to fluoxetine, pregnancy.
• Use cautiously with impaired hepatic or renal function, diabetes mellitus,
lactation, seizures.

Available forms
Tablets—10, 20 mg; pulvules—10, 20, 40 mg; liquid—20 mg/5 mL; DR capsules—
90 mg

Dosages
ADULTS
• Antidepressant: The full antidepressant effect may not be seen for up to 4 wk.
Initially, 20 mg/day PO in the morning. If no clinical improvement is seen,
increase dose after several weeks. Administer doses > 20 mg/day on a bid
schedule. Do not exceed 80 mg/day. Once stabilized, may switch to 90-mg DR
capsules once a week.
• Obsessive-compulsive disorder: Initially, 20 mg/day PO. If no clinical
improvement is seen, increase dose after several weeks. Usual dosage range, 20–
60 mg/day; may require up to 5 wk for effectiveness. Do not exceed 80 mg/day.
• Bulimia: 60 mg/day PO in the morning.
 • PMDD (Sarafem): 20 mg/day PO or 20 mg/day PO starting 14 days prior to the
anticipated beginning of menses and continuing through the first full day of
menses, then no drug until 14 days before next menses; do not exceed 80 mg/day.
• Panic disorder (Prozac): 10 mg/day PO for the first week, increase to 20 mg/day
if needed. Maximum dose, 60 mg/day.
PEDIATRIC PATIENTS
< 7 yr: Safety and efficacy not established.
7–17 yr:
• Major depressive order: 10 mg/day PO; may be increased to 20 mg/day after
several weeks.
• Obsessive-compulsive disorder: Initially, 10 mg/day PO. After 2 wk increase to
20–60 mg/day.
GERIATRIC PATIENTS OR PATIENTS WITH HEPATIC OR RENAL IMPAIRMENT
Give a lower or less frequent dose. Monitor response to guide dosage.

Pharmacokinetics
Route Onset Peak
Oral Slow 6–8 hr

Metabolism: Hepatic; T1/2: 2–9 days

Distribution: Crosses placenta; enters breast milk
Excretion: Urine and feces

Adverse effects
• CNS: Headache, nervousness, insomnia, drowsiness, anxiety, tremor, dizziness,
light-headedness, agitation, sedation, abnormal gait, seizures
• CV: Hot flashes, palpitations
• Dermatologic: Sweating, rash, pruritus, acne, alopecia, contact dermatitis
• GI: Nausea, vomiting, diarrhea, dry mouth, anorexia, dyspepsia, constipation,
taste changes, flatulence, gastroenteritis, dysphagia, gingivitis
• GU: Painful menstruation, sexual dysfunction, frequency, cystitis, impotence,
urgency, vaginitis
• Respiratory: Upper respiratory infections, pharyngitis, cough, dyspnea,
bronchitis, rhinitis
• Other: Weight loss, asthenia, fever

Interactions
Drug-drug
• Increased therapeutic and toxic effects of TCAs
• Do not use with thioridazine (increased levels of thioridazine)
• Decreased effectiveness if taken while smoking
• Increased toxicity of lithium; avoid this combination
• Possible fatal reactions with MAOIs; do not administer together; 2-wk washout
period needed
 • Additive CNS effects if combined with benzodiazepines, alcohol; avoid these
combinations
• Avoid administration with other serotonergic drugs; may lead to serotonin
syndrome
Drug-alternative therapy
• Increased risk of severe reaction if combined with St. John's wort therapy.

Nursing considerations
CLINICAL ALERT!
Name confusion has been reported between Sarafem (fluoxetine) and
Serophene (clomiphene); use caution.

Assessment
• History: Hypersensitivity to fluoxetine, impaired hepatic or renal function,
diabetes mellitus, lactation, pregnancy, seizures
• Physical: Weight, T; skin rash, lesions; reflexes, affect; bowel sounds, liver
evaluation; P, peripheral perfusion; urinary output, renal and liver function tests,
CBC

Interventions
• Arrange for lower or less frequent doses in elderly patients and patients with
hepatic or renal impairment.
• Establish suicide precautions for severely depressed patients. Limit quantity of
capsules dispensed.
• Administer drug in the morning. If dose of > 20 mg/day is needed, administer in
divided doses.
• Monitor patient for response to therapy for up to 4 wk before increasing dose.
• Switch to once a week therapy by starting weekly dose 7 days after last
20 mg/day dose. If response is not satisfactory, reconsider daily dosing.

Teaching points
• It may take up to 4 wk before the full effect occurs. Take in the morning (or in
divided doses if necessary). If you are taking the once weekly capsule, mark
calendar with reminders of drug day.
• Do not take this drug during pregnancy. If you think that you are pregnant or wish
to become pregnant, consult with your physician.
• These side effects may occur: Dizziness, drowsiness, nervousness, insomnia
(avoid driving or performing hazardous tasks); nausea, vomiting, weight loss (eat
frequent small meals; monitor your weight loss); sexual dysfunction; flulike
symptoms.
• Report rash, mania, seizures, severe weight loss.
• Keep this drug, and all medications, out of the reach of children.

Adverse effects in Italic are most common; those in Bold are life-threatening.