Generic Name : fluoxetine hydrochloride
Brand Name: Apo-Fluoxetine (CAN), Co-Fluoxetine (CAN), Novo-Fluoxetine (CAN), PMS-Fluoxetine (CAN), Prozac, Prozac Pulvules, Prozac Weekly, ratio-Fluoxetine (CAN), Sarafem
Pregnancy Category C
Dosage & Route
Available forms : Tablets—10, 20 mg; capsules—10, 20, 40 mg; liquid—20 mg/5 mL; DR capsules—90 mg
Dosages : Individualize dosage; same for oral or IV routes because of rapid and almost complete absorption.
- Antidepressant: The full antidepressant effect may not be seen for up to 4–6 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.
- OCD: Initially, 20 mg/day PO. If no clinical improvement is seen, increase dose after several weeks. Usual dosage range, 20–60 mg/day PO; 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 before 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 8–18 YR
- Major depressive disorder: 10 mg/day PO; may be increased to 20 mg/day after several weeks.
PEDIATRIC PATIENTS 7–17 YR
- OCD: Initially, 10 mg/day PO. After 2 wk increase to 20 mg/day. Suggested range, 20–60 mg/day PO.
PEDIATRIC PATIENTS < 7 YR
- Safety and efficacy not established.
GERIATRIC PATIENTS OR PATIENTS WITH HEPATIC OR RENAL IMPAIRMENT
- Give a lower or less frequent dose. Monitor response to guide dosage.
- 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.
- Treatment of depression; most effective in patients with major depressive disorder
- Treatment of OCD
- Treatment of bulimia
- Treatment of PMDD (Sarafem)
- Treatment of panic disorder with or without agoraphobia
- Unlabeled use: Treatment of obesity, alcoholism, numerous psychiatric disorders, chronic pain, various neuropathies
- Nervousness, insomnia, anxiety, headache, tremor, drowsiness, dry mouth, nausea, vomiting, sweating, diarrhoea. Seizures, mania, hypomania or mixed manic states reported. Hyponatraemia; elevation of hepatic enzymes.
- 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.
- Severe renal or hepatic failure; hypersensitivity; lactation; concomitant MAOIs or within 2 wk of MAOI withdrawal.
CLINICAL ALERT! Name confusion has occurred between Sarafem (fluoxetine) and Serophene (clomiphene); use caution.
- 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, LFTs, renal function tests
- Arrange for lower or less frequent doses in elderly patients and patients with hepatic or renal impairment.
- BLACK BOX WARNING: Establish suicide precautions for severely depressed patients. Limit quantity of capsules dispensed; high risk in children and adolescents.
- Administer drug in the morning.
- 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.
- It may take up to 4 weeks before the full effect occurs. Take in the morning. If you feel sleepy or tired, you may take it at night. 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 your health care provider.
- Keep this drug, and all medications, out of the reach of children.
- You may experience these side effects: Dizziness, drowsiness, nervousness, insomnia (avoid driving or performing hazardous tasks); nausea, vomiting, weight loss (eat small frequent meals; monitor your weight loss); sexual dysfunction; flulike symptoms.
- Report rash, mania, seizures, severe weight loss.