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Fluoxetine is most commonly used to treat depression, obsessive-compulsive disorders, panic disorder, and bulimia (binge eating and purging). Fluoxetine is also used to treat premenstrual dysphoric disorder (PMDD), symptoms of which occur in the week or two before a woman's menstrual period and commonly include irritability, mood swings, and tension as well as the physical symptoms of bloating and breast tenderness. Fluoxetine may also be used for purposes other than those here.

The antidepressant, antiobsessive-compulsive, and antibulimic actions of fluoxetine (Prozac) are presumed to be linked to its inhibition of CNS neuronal uptake of serotonin. Studies at clinically relevant doses in man have demonstrated that fluoxetine blocks the uptake of serotonin into human platelets. Studies in animals also suggest that fluoxetine is a much more potent uptake inhibitor of serotonin than of norepinephrine.

In humans, following a single oral 40 mg dose, peak plasma concentrations of fluoxetine from 15 to 55 ng/ mL are observed after 6 to 8 hours.

Sometimes fluoxetine must be taken for up to 4 weeks or longer before you begin to feel better. Your doctor should check your progress at regular visits during this time.

Prozac is indicated for the treatment of depression.

Prozac is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD).

Bulimia Nervosa -- Prozac is indicated for the treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa.

Fluoxetine (Prozac) is contraindicated in patients known to be hypersensitive to it.

Monoamine Oxidase Inhibitors: There have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) in patients receiving fluoxetine in combination with a monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued fluoxetine and are then started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Fluoxetine (Prozac) should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI.

In addition, at least 5 weeks, perhaps longer, should be allowed after stopping Fluoxetine (Prozac) before starting an MAOI.

As with all drugs, the potential for interaction by a variety of mechanisms (eg, pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc) is a possibility.

Do not use fluoxetine and MAO inhibitors at the same time.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes cyproheptadine, lithium, dextromethorphan, selegiline, and medicines used to treat high blood pressure, seizures, and depression. Using these medicines in combination with Prozac can produce an adverse reaction.

Five patients receiving fluoxetine in combination with tryptophan experienced adverse reactions, including agitation, restlessness and gastrointestinal distress.

Inform your doctor of any other medical conditions, including kidney or liver disease, allergies, pregnancy, or breast-feeding.

Characterized as less common- Chills or fever; joint or muscle pain; skin rash, hives, or itching; trouble in breathing.

Characterized as rare- Burning or tingling in fingers, hands, or arms; convulsions (seizures); signs of low blood sugar, including anxiety or nervousness, cold sweats, confusion, cool pale skin, difficulty in concentration, drowsiness, excessive hunger, fast heartbeat, headache, shakiness or unsteady walk, or unusual tiredness or weakness; swelling of feet or lower legs; swollen glands; talking, feeling, and acting with excitement and activity you cannot control.

Side Effects That Usually Do Not Require Immediate Medical Attention

In clinical trials, the most commonly observed adverse events associated with the use of fluoxetine include nervousness, trouble sleeping, headache, drowsiness, fatigue, nausea, vomiting, diarrhea, loss of appetite, dry mouth, sweating, dizziness, lightheadedness, muscle spasms, or changes in sexual function. If they continue or are bothersome, check with your doctor.

Other less common side effects- Abnormal dreams; change in taste; changes in vision; chest pain; constipation; cough; decrease in concentration; fast or irregular heartbeat; feeling of warmth or heat; flushing or redness of skin, especially on face and neck; frequent urination; increased appetite; menstrual pain; stomach cramps, gas, or pain; stuffy nose; tiredness or weakness; tremor.

If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Fluoxetine (Prozac) is not a controlled substance. Since introduction, reports of death attributed to overdose of fluoxetine alone have been rare.

Symptoms of overdose of Fluoxetine (Prozac) may include nausea, vomiting, seizures, and restlessness.

Treatment

If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.

Establish and maintain an airway; ensure adequate oxygenation and ventilation. Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage, and should be considered in treating overdose. Cardiac and vital signs monitoring is recommended, along with general symptomatic and supportive measures. There are no specific antidotes for Prozac.

In managing overdosage, consider the possibility of multiple drug involvement.

Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

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