Fluoxentine HCl (Prozac) Drug Study

Fluoxentine HCl (Prozac) 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.

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

Other Info: Pregnancy Category C

Drug class: Antidepressant, SSRI

Indications

• 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

Contraindications and cautions

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

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.

ADULTS

• 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.

Pharmacokinetics

Metabolism: Hepatic; T_1/2: 9 days

Distribution: Crosses placenta; enters breast milk

Excretion: Feces, urine

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: URIs, pharyngitis, cough, dyspnea, bronchitis, rhinitis
• Other: weight changes, asthenia, fever

Interactions

Drug-drug

• WARNING: Possible fatal reactions with MAOIs; do not administer together; 2-wk washout period needed.
• 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
• 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

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, LFTs, renal function tests

Interventions

• 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.

Teaching points

• 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.

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