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Drugs reference index «Sarafem»



Generic name: Fluoxetine hydrochlorideBrand names: Sarafem, Prozac Weekly, Prozac

Why is Sarafem prescribed?

Prozac is prescribed for the treatment of depression—that is, a continuing depression that interferes with daily functioning. The symptoms of major depression often include changes in appetite, sleep habits, and mind/body coordination; decreased sex drive; increased fatigue; feelings of guilt or worthlessness; difficulty concentrating; slowed thinking; and suicidal thoughts.

Prozac is also prescribed to treat obsessive-compulsive disorder. An obsession is a thought that won't go away; a compulsion is an action done over and over to relieve anxiety. The drug is also used in the treatment of bulimia (binge-eating followed by deliberate vomiting). It has also been used to treat other eating disorders and obesity.

In addition, Prozac is used to treat panic disorder, including panic associated with agoraphobia (a severe fear of being in crowds or public places). People with panic disorder usually suffer from panic attacks—feelings of intense fear that develop suddenly, often for no reason. Various symptoms occur during the attacks, including a rapid or pounding heartbeat, chest pain, sweating, trembling, and shortness of breath.

In children and adolescents, Prozac is used to treat major depression and obsessive-compulsive disorder.

Prozac Weekly is approved for treating major depression.

Under the brand name Sarafem, the active ingredient in Prozac is also prescribed for the treatment of premenstrual dysphoric disorder (PMDD), formerly known as premenstrual syndrome (PMS). Symptoms of PMDD include mood problems such as anxiety, depression, irritability or persistent anger, mood swings, and tension. Physical problems that accompany PMDD include bloating, breast tenderness, headache, and joint and muscle pain. Symptoms typically begin 1 to 2 weeks before a woman's menstrual period and are severe enough to interfere with day-to-day activities and relationships.

Prozac belongs to the class of drugs called selective serotonin re-uptake inhibitors (SSRIs). Serotonin is one of the chemical messengers believed to govern moods. Ordinarily, it is quickly reabsorbed after its release at the junctures between nerves. Re-uptake inhibitors such as Prozac slow this process, thereby boosting the levels of serotonin available in the brain.

Most important fact about Sarafem

Serious, sometimes fatal, reactions have been known to occur when Prozac is used in combination with other antidepressant drugs known as MAO inhibitors; and when Prozac is discontinued and an MAO inhibitor is started. Never take Prozac with one of these drugs or within at least 14 days of discontinuing therapy with one of them; and allow 5 weeks or more between stopping Prozac and starting an MAO inhibitor. Be especially cautious if you have been taking Prozac in high doses or for a long time.

In addition, Prozac should never be combined with thioridazine due to the risk of life-threatening drug interactions; and a minimum of 5 weeks should be allowed between stopping Prozac and starting Mellaril.

If you are taking any prescription or nonprescription drugs, notify your doctor before taking Prozac.

How should you take Sarafem?

Prozac should be taken exactly as prescribed by your doctor.

Prozac usually is taken once or twice a day. To be effective, it should be taken regularly. Make a habit of taking it at the same time you do some other daily activity.

It may be 4 weeks before you feel any relief from your depression, but the drug's effects should last about 9 months after a 3-month treatment regimen. For obsessive-compulsive disorder, the full effect may take 5 weeks to appear.

  • If you miss a dose...Take the forgotten dose as soon as you remember. If several hours have passed, skip the dose. Never try to "catch up" by doubling the dose.
  • Storage instructions...Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Prozac.

  • Side effects may include:Abnormal dreams, abnormal ejaculation, abnormal vision, anxiety, diarrhea, diminished sex drive, dizziness, dry mouth, flu-like symptoms, flushing, gas, headache, impotence, insomnia, itching, loss of appetite, nausea, nervousness, rash, sex-drive changes, sinusitis, sleepiness, sore throat, sweating, tremors, upset stomach, vomiting, weakness, yawning

Why should Sarafem not be prescribed?

If you are sensitive to or have ever had an allergic reaction to Prozac or similar drugs, you should not take Sarafem. Make sure that your doctor is aware of any drug reactions that you have experienced.

Do not take Sarafem while using an MAO inhibitor (see "Most important fact about Sarafem"). You should also not use Prozac if you are taking thioridazine. Likewise, do not start taking thioridazine within 5 weeks of stopping Prozac.

Special warnings about Sarafem

In clinical studies, antidepressants increased the risk of suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders. Anyone considering the use of Prozac or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Prozac is approved for treating major depression in children 8 years and older and for treating obsessive-compulsive disorder in children 7 years and older.

Additionally, the progression of major depression is associated with a worsening of symptoms and/or the emergence of suicidal thinking or behavior in both adults and children, whether or not they are taking antidepressants. Individuals being treated with Prozac and their caregivers should watch for any change in symptoms or any new symptoms that appear suddenly—especially agitation, anxiety, hostility, panic, restlessness, extreme hyperactivity, and suicidal thinking or behavior—and report them to the doctor immediately. Be especially observant at the beginning of treatment or whenever there is a change in dose.

Unless you are directed to do so by your doctor, do not take Sarafem if you are recovering from a heart attack or if you have liver disease or diabetes.

Prozac may cause you to become drowsy or less alert and may affect your judgment. Therefore, driving or operating dangerous machinery or participating in any hazardous activity that requires full mental alertness is not recommended.

While taking Sarafem, you may feel dizzy or light-headed or actually faint when getting up from a lying or sitting position. If getting up slowly doesn't help or if this problem continues, notify your doctor.

If you develop a skin rash or hives while taking Prozac, discontinue use of the medication and notify your doctor immediately.

Prozac should be used with caution if you have a history of mania or seizures. You should discuss all of your medical conditions with your doctor before taking Sarafem.

Prozac can occasionally cause decreased appetite and weight loss, especially in depressed people who are already underweight and in those with bulimia. If you notice changes in your weight or appetite, tell your doctor.

Antidepressants such as Prozac could potentially cause stomach bleeding, especially when combined with nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, naproxen, and ketoprofen. Consult your doctor before combining Prozac with NSAIDs or blood-thinning medications.

There have been rare reports of prolonged seizures in people who received electroconvulsive therapy (ECT) while taking Prozac. To date, there are no clinical studies establishing the benefit of combined treatment with Prozac and ECT.

As with other SSRIs, Prozac therapy should be slowly tapered instead of abruptly stopped. If abruptly discontinued, drowsiness, irritability, agitation, anxiety, headache, and insomnia may occur.

Possible food and drug interactions when taking Sarafem

Never take Prozac with MAO inhibitors or thioridazine (see "Most important fact about Sarafem").

Do not drink alcohol while taking Sarafem.

If Prozac is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Prozac with the following:

AlprazolamAny other antidepressantsAspirinCarbamazepineClozapineDiazepamDigitoxinDrugs that impair brain function, such as sleep aids and narcotic painkillersFlecainideHaloperidolLithiumNonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, naproxen, and ketoprofenPhenytoinPimozideSumatriptanTryptophanVinblastineWarfarin

Special information if you are pregnant or breastfeeding

The effects of Prozac during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. There have been reports of newborns experiencing complications such as respiratory problems, bluish coloring of the skin, irregular breathing, muscular problems, vomiting, and constant crying after exposure to Prozac late in the third trimester.

This medication appears in breast milk, and breastfeeding is not recommended while you are taking Prozac.

Recommended dosage for Sarafem


It may take 4 weeks before the full antidepressant effect of Prozac is seen.


The recommended starting dose is 20 milligrams a day, usually taken in the morning. If needed, the doctor may gradually increase the dose up to a maximum of 80 milligrams a day. The usual daily dose ranges from 20 to 60 milligrams. Daily doses above 20 milligrams should be taken in the morning or in two smaller doses taken in the morning and at noon.

Children 8 years and older

The usual starting dose is 10 or 20 milligrams a day. Children starting at 10 milligrams will have their dose increased to 20 milligrams a day after 1 week. Underweight children may need to remain at the 10-milligram dose.

Prozac Weekly

You need to wait at least 7 days after stopping your daily dose of Prozac before switching to the once-weekly formulation. One Prozac Weekly capsule contains 90 milligrams of medication.


It may take 5 weeks before the full effects of Prozac are seen.


The recommended starting dose is 20 milligrams a day, usually taken in the morning. If needed, the doctor may gradually increase the dose up to a maximum of 80 milligrams a day. The usual daily dose ranges from 20 to 60 milligrams. Daily doses above 20 milligrams should be taken in the morning or in two smaller doses taken in the morning and at noon.

Children 7 years and older

The recommended starting dose is 10 milligrams a day. After 2 weeks, the doctor will increase the dose to 20 milligrams. If needed, the doctor may further increase the dose up to a maximum of 60 milligrams a day. The recommended dosage range for underweight children is 10 to 30 milligrams a day



The recommended dose is 60 milligrams a day taken in the morning. The doctor may start you at a lower dose and gradually increase it over a period of several days.



The recommended starting dose is 10 milligrams a day. After 1 week, the doctor will increase the dose to 20 milligrams. If no improvement is seen after several weeks, the doctor may increase the dose to a maximum of 60 milligrams a day.



The usual dose of Sarafem is 20 milligrams a day. The doctor will instruct you to take the dose either every day of the month or only during the 2 weeks before menstruation begins (the luteal phase of your cycle). If there's no improvement after several weeks, the dose can be increased, usually to 60 milligrams a day. The maximum dose is 80 milligrams daily.


For all indications, the doctor may need to prescribe a lower dose if you are elderly, have liver disease, or are taking other medications.


Any medication taken in excess can have serious consequences. An overdose of Prozac can be fatal. In addition, combining Prozac with certain other drugs can cause symptoms of overdose. If you suspect an overdose, seek medical attention immediately.

  • Common symptoms of Prozac overdose include:Nausea, rapid heartbeat, seizures, sleepiness, vomiting
  • Other symptoms of Prozac overdose include:Coma, delirium, fainting, high fever, irregular heartbeat, low blood pressure, mania, rigid muscles, sweating, stupor
  • Sarafem Prescribing Information (FDA)
  • Sarafem MedFacts Consumer Leaflet (Wolters Kluwer)
  • Sarafem Advanced Consumer (Micromedex) - Includes Dosage Information
  • Fluoxetine MedFacts Consumer Leaflet (Wolters Kluwer)
  • Fluoxetine Prescribing Information (FDA)
  • Prozac Consumer Overview
  • Prozac Weekly Prescribing Information (FDA)
  • Prozac Weekly Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)
  • Selfemra Prescribing Information (FDA)

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