Pronunciation
floo-OX-uh-teen

Trade Name(s)

• Prozac

• Prozac Weekly

• Sarafem

Pregnancy Category
Category B

Ther. class.
antidepressants

Pharm. class.
selective serotonin reuptake inhibitors ssris

• Various forms of depression

• OCD

• Bulimia nervosa

• Panic disorder

• Sarafem: Management of premenstrual dysphoric disorder (PMDD)

Unlabelled Use(s):
Anorexia nervosa

» ADHD

» Diabetic neuropathy

» Fibromyalgia

» Obesity

» Raynaud's phenomenon

» Social anxiety disorder (social phobia)

» Post traumactic stress disorder (PTSD)

Selectively inhibits the reuptake of serotonin in the CNS

Therapeutic Effect(s):

• Antidepressant action

• Decreased behaviors associated with

» panic disorder

» bulimia

• Decreased mood alterations associated with PMDD

Absorption: Well absorbed after oral administration

Distribution: Crosses the blood-brain barrier

Protein Binding: 94.5%

Metabolism and Excretion: Converted by the liver to norfluoxetine, another antidepressant compound; fluoxetine and norfluoxetine are mostly metabolized by the liver; 12% excreted by kidneys as unchanged fluoxetine, 7% as unchanged norfluoxetine

Half-life: 1–3 days (norfluoxetine 5–7 days)

TIME/ACTION PROFILE (antidepressant effect)

ROUTE	ONSET	PEAK	DURATION
PO	1–4 wk	unknown	2 wk

Contraindicated in:

• Hypersensitivity

• Concurrent use or use within 14 days of discontinuing MAO inhibitors (fluoxetine should be discontinued 5 weeks before MAO therapy is initiated)

Use Cautiously in:

• Severe hepatic or renal impairment (lower/less frequent dose may be necessary)

• History of seizures

• Debilitated patients (I risk of seizures)

• Diabetes mellitus

• Patients with concurrent chronic illness, or multiple drug therapy (dose adjustments may be necessary)

• Patients with impaired hepatic function (J doses/I dosing interval may be necessary)

• May I risk of suicide attempt/ideation especially during early treatment or dose adjustment

• OB: Use during third trimester may result in neonatal serotonin syndrome requiring prolonged hospitalization, respiratory and nutritional support. May cause sedation in infant

• Lactation: May cause sedation in infant; discontinue drug or bottle-feed

• Pedi: Risk of suicide ideation or attempt may be greater in children or adolescents (safe use in children <8 yr not established)

• Geri: Appears on Beers list. Geriatric patients are at increased risk for excessive CNS stimulation, sleep disturbances, and agitation

CNS: SEIZURES, anxiety, drowsiness, headache, insomnia, nervousness, abnormal dreams, dizziness, fatigue, hypomania, mania, weakness.

EENT: stuffy nose, visual disturbances.

Resp: cough.

CV: chest pain, palpitations.

GI: diarrhea, abdominal pain, abnormal taste, anorexia, constipation, dry mouth, dyspepsia, nausea, vomiting, weight loss.

GU: sexual dysfunction, urinary frequency.

Derm: excessive sweating, pruritus, erythema nodusum, flushing, rashes.

Endo: dysmenorrhea.

F and E: hyponatremia.

MS: arthralgia, back pain, myalgia.

Neuro: tremor.

Misc: allergic reactions, fever, flu-like syndrome, hot flashes, sensitivity reaction.

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Drug-Drug

• Discontinue use of MAO inhibitors for 14 days before fluoxetine therapy; combined therapy may result in confusion, agitation, seizures, hypertension, and hyperpyrexia (serotonin syndrome). Fluoxetine should be discontinued for at least 5 wk before MAO inhibitor therapy is initiated

• Inhibits the activity of cytochrome P450 2D6 enzyme in the liver and I effects of drugs metabolized by this enzyme system

• Medications that inhibit the P450 enzyme system (including ritonavir , saquinavir , and efavirenz ) may I risk of developing the serotonin syndrome). For concurrent use with ritonavir J fluoxetine dose by 70%; if initiating fluoxetine, start with 10 mg/day dose

• J metabolism and I effects of alprazolam (decrease alprazolam dose by 50%)

• I CNS depression with alcohol , antihistamines , other antidepressants , opioid analgesics , or sedative/hypnotics

• I risk of side effects and adverse reactions with other antidepressants , tryptophan , risperidone , or phenothiazines

• May I effectiveness/risk of toxicity from carbamazepine , clozapine , digoxin , haloperidol , phenytoin , lithium , or warfarin

• May J the effects of buspirone

• Cyproheptadine may J or reverse effects of fluoxetine

• May I sensitivity to adrenergics and increase the risk of serotonin syndrome

• May alter the activity of other drugs that are highly bound to plasma proteins

• I risk of serotonin syndrome with 5HT₁ agonists

• I risk of bleeding with NSAIDS , aspirin , clopidogrel , or warfarin

Drug-Natural Products
I risk of serotonin syndrome with St. John's wort and SAMe

• PO (Adults):
Depression, OCD—20 mg/day in the morning. After several weeks, may increase by 20 mg/day at weekly intervals. Doses greater than 20 mg/day should be given in 2 divided doses, in the morning and at noon (not to exceed 80 mg/day). Patients who have been stabilized on the 20 mg/day dose may be switched over to delayed-release capsules (Prozac Weekly) at dose of 90 mg weekly, initiated 7 days after the last 20 mg dose.
Panic disorder—10 mg/day initially, may increase after one week to 20 mg/day (usual dose is 20 mg, but may be increased as needed/tolerated up to 60 mg/day).
Bulimia nervosa—60 mg/day (may need to titrate up to dosage over several days).
PMDD—20 mg/day (not to exceed 80 mg/day)
or 20 mg/day starting 14 days prior to expected onset on menses, continued through first full day of menstruation, repeated with each cycle.

• PO (Geriatric Patients):
Depression—10 mg/day in the morning initially, may be increased (not to exceed 60 mg/day).

• PO (Children 7–17 yr):
adolescents and higher weight children—10 mg/day may be increased after 2 wk to 20 mg/day; additional increases may be made after several more weeks (range 20–60 mg/day);
lower-weight children—10 mg/day initially, may be increased after several more weeks (range 20–30 mg/day).

• Tablets: 10 mg, 20 mg

» Cost:
Generic: 10 mg $47.98/90, 20 mg $62.97/90.

• Capsules: 10 mg, 20 mg, 40 mg

» Cost:
Generic: 10 mg $48.97/90, 20 mg $26.99/90, 40 mg $119.97/90.

• Delayed-release capsules (Prozac Weekly): 90 mg

» Cost: $110.99/4.

• Oral solution (mint flavor): 20 mg/5 ml

» Cost:
Generic: $72.98/120 ml.

• In combination with: olanzapine (Symbyax; see combination drugs)

• Monitor mood changes. Inform health care professional if patient demonstrates significant increase in anxiety, nervousness, or insomnia

» Assess for suicidal tendencies, especially during early therapy. Restrict amount of drug available to patient. Risk may be increased in children, adolescents, and adults C24 yrs. After starting therapy, children, adolescents, and young adults should be seen by health care professional at least weekly for 4 wks, every 3 wks for next 4 wks, and on advice of health care professional thereafter

» Monitor appetite and nutritional intake. Weigh weekly. Notify health care professional of continued weight loss. Adjust diet as tolerated to support nutritional status

» Assess patient for sensitivity reaction (urticaria, fever, arthralgia, edema, carpal tunnel syndrome, rash, hives, lymphadenopathy, respiratory distress) and notify health care professional if present; symptoms usually resolve by stopping fluoxetine but may require administration of antihistamines or corticosteroids

• Assess for sexual side effects (erectile dysfunction; decreased libido)

OCD

• Assess patient for frequency of obsessive-compulsive behaviors. Note degree to which these thoughts and behaviors interfere with daily functioning

Bulimia Nervosa

• Assess frequency of binge eating and vomiting during therapy

PMDD

• Monitor patient's mood prior to and periodically during therapy

Lab Test Considerations

• Monitor CBC and differential periodically during therapy. Notify health care professional if leukopenia, anemia, thrombocytopenia, or increased bleeding time occurs

» Proteinuria and mild I in AST may occur during sensitivity reactions

» May cause I in serum alkaline phosphatase, ALT, BUN, creatine phosphokinase; hypouricemia, hypocalcemia, hypoglycemia or hyperglycemia, and hyponatremia

• Ineffective coping (Indications)

• Risk for injury (Side Effects)

• Sexual dysfunction (Side Effects)

• Do not confuse Sarafem (fluoxetine) with Serophene (clomiphene)

• PO: Administer as a single dose in the morning. Some patients may require increased amounts, in divided doses, with a 2nd dose at noon

» May be administered with food to minimize GI irritation

• Instruct patient to take fluoxetine as directed. If a dose is missed, omit and return to regular schedule. Do not double doses or discontinue without consulting health care professional; discontinuation may cause anxiety, insomnia, nervousness

• May cause drowsiness, dizziness, impaired judgment, and blurred vision. Caution patient to avoid driving and other activities requiring alertness until response to the drug is known

• Advise patient to avoid alcohol or other CNS depressant drugs during therapy and to consult health care professional before taking other medications or natural/herbal products with fluoxetine

• Caution patient to change positions slowly to minimize dizziness

• Inform patient that frequent mouth rinses, good oral hygiene, and sugarless gum or candy may minimize dry mouth. If dry mouth persists for more than 2 wk, consult health care professional regarding use of saliva substitute

• Instruct female patients to inform health care professional if pregnancy is planned or suspected

• Caution patient to wear protective clothing and use sunscreen to prevent photosensitivity reactions

• Inform patient that medication may cause decreased libido

• Advise patient to notify health care professional if symptoms of sensitivity reaction occur or if headache, nausea, anorexia, anxiety, or insomnia persists

• Emphasize the importance of follow-up exams to monitor progress. Encourage patient participation in psychotherapy to improve coping skills

• Increased sense of well-being

» Renewed interest in surroundings. May require 1–4 wk of therapy to obtain antidepressant effects

• Decrease in obsessive-compulsive behaviors

• Decrease in binge eating and vomiting in patients with bulimia nervosa

• Decreased incidence frequency of panic attacks

• Decreased mood alterations associated with PMDD