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About Prozac

This is a summary of the most important information about Prozac. For details, talk to your healthcare professional.

Usage

Prozac is in a class of medicines called selective serotonin reuptake inhibitors (SSRIs). Prozac is used to treat Depression, Obsessive-Compulsive Disorder (OCD), Bulemia Nervosa, and Panic Disorder.

Precautions

Never take Prozac if you are taking another drug used to treat depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking Prozac close in time to an MAOI can result in serious, sometimes fatal, reactions, including:

  • High body temperature

  • Coma

  • Seizures (convulsions)

Do not take a MAOI within 5 weeks of stopping Prozac.

MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), and other brands.

Never take Prozac if you are taking Mellaril (thioridazine), used to treat schizophrenia. Also, do not take Mellaril within 5 weeks of stopping Prozac. Taking Prozac close in time to Mellaril can result in serious heart beat problems.

Side Effects

  • Suicidal thoughts or actions: See FDA Alert.

  • Stopping Prozac: Do not stop taking Prozac suddenly because you could get side effects. Your healthcare professional will slowly decrease your dose.

  • Rash and possible allergic reactions: Prozac may cause serious skin, lung and allergic-type reactions. Contact your healthcare professional right away if you get a skin rash or hives, have problems breathing, or get swelling of your tongue, lips, or throat.

  • Bleeding problems: Prozac may cause bleeding problems, especially if taken with aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen), or other drugs that affect bleeding.

  • Mania: You may become hyperactive, excitable or elated.

  • Seizures: You may experience a seizure (convulsion), even if you are not taking Prozac close in time with a MAOI.

  • Weight loss: Prozac can cause weight loss. Children who take it for a long time should have their growth and body weight measured regularly.

  • Pregnancy : Tell your healthcare professional if you are or may be pregnant because babies delivered to mothers taking Prozac late in pregnancy have developed problems, such as difficulty breathing and feeding.

  • Sexual problems: You may have problems with impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire).

  • Other side effects include nausea, difficulty sleeping, anxiety, nervousness, and sleepiness.

  • Tell your healthcare professional about all your medical conditions, especially if you have liver or heart disease, or diabetes. Tell your healthcare professional if you are breast-feeding or plan to breast-feed your baby.

Drug Interaction

  • Do not take Prozac with Sarafem (fluoxetine hydrochloride), a drug used to treat PreMenstrual Dysphoric Disorder (PMDD), because they are very similar and you could get an overdose.

  • Prozac may interact with medicines other than the ones already mentioned in this information sheet, causing serious side effects. Tell your healthcare professional about all medicines, vitamins, and herbal supplements you take, especially:

    • Those that affect bleeding

    • Those used to treat diabetes, seizures, anxiety, mental illness, or depression

  • If you plan to drink alcohol, talk to your healthcare professional.

Directions

  • Prozac is taken by mouth, with or without food, exactly as prescribed by your healthcare professional.

  • Take the weekly version of Prozac only once a week. Do not start until 7 days after you’ve taken the last dose of the daily Prozac.

FDA ALERT [07/2005] – Suicidal Thoughts or Actions in Children and Adults

Patients with depression or other mental illnesses often think about or attempt suicide. Closely watch anyone taking antidepressants, especially early in treatment or when the dose is changed. Patients who become irritable or anxious, or have new or increased thoughts of suicide or other changes in mood or behavior (or their care givers) should contact their healthcare professional right away.

Children

Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger. FDA has approved Prozac for treating children who have depression or obsessive-compulsive disorder.

Adults

Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, FDA began a complete review of all available data to determine whether there is an increased risk of suicidal thinking or behavior in adults being treated with antidepressant medications.

It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that adults being treated with antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information.

Reference Prozac Article

U.S. Food and Drug Administration

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