fluoxetine

Pronunciation

Generic Name: fluoxetine (floo OX e teen)
Brand Name: PROzac, PROzac Weekly, Rapiflux, Sarafem, Selfemra, PROzac Pulvules

What is fluoxetine?

Fluoxetine is a selective serotonin reuptake inhibitors (SSRI) antidepressant. Fluoxetine affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms.

Fluoxetine is used to treat major depressive disorder, bulimia nervosa (an eating disorder) obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder (PMDD).

Fluoxetine is sometimes used together with another medication called olanzapine (Zyprexa). to treat depression caused by bipolar disorder (manic depression). This combination is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

Fluoxetine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about fluoxetine?

Do not use fluoxetine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. You must wait at least 14 days after stopping an MAO inhibitor before you can take fluoxetine. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine or an MAOI.

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You should not use fluoxetine if you also take pimozide or thioridazine, or if you are being treated with methylene blue injection.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using fluoxetine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

If you also take olanzapine (Zyprexa), read the Zyprexa medication guide and all patient warnings and instructions provided with that medication.

What should I discuss with my healthcare provider before taking fluoxetine?

Do not use fluoxetine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. You must wait at least 14 days after stopping an MAO inhibitor before you can take fluoxetine. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine or an MAOI.

You should not use fluoxetine if you are allergic to it, if you also take pimozide or thioridazine, or if you are being treated with methylene blue injection.

If you also take olanzapine (Zyprexa), read the Zyprexa medication guide and all patient warnings and instructions provided with that medication.

Tell your doctor about all other antidepressants you take, especially Celexa, Cymbalta, Desyrel, Effexor, Lexapro, Luvox, Oleptro, Paxil, Pexeva, Symbyax, Viibryd, or Zoloft.

To make sure fluoxetine is safe for you, tell your doctor if you have:

  • cirrhosis of the liver;

  • kidney disease;

  • diabetes;

  • glaucoma;

  • seizures or epilepsy;

  • bipolar disorder (manic depression); or

  • a history of drug abuse or suicidal thoughts.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using fluoxetine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category C. Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant while taking fluoxetine. Do not start or stop taking this medicine during pregnancy without your doctor's advice.

Fluoxetine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old without medical advice.

How should I take fluoxetine?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Do not stop using fluoxetine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using fluoxetine.

To treat premenstrual dysphoric disorder, the usual dose of fluoxetine is once daily while you are having your period, or 14 days before you expect your period to start. Follow your doctor's instructions.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss a dose of Prozac Weekly, take the missed dose as soon as you remember and take the next dose 7 days later. However, if it is almost time for the next regularly scheduled weekly dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking fluoxetine?

Avoid taking tryptophan while you are taking fluoxetine.

Drinking alcohol can increase certain side effects of fluoxetine.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Fluoxetine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

  • agitation, hallucinations, overactive reflexes, nausea, vomiting, diarrhea;

  • headache, slurred speech, severe weakness, muscle cramps, loss of coordination, feeling unsteady, seizure (convulsions), shallow breathing (breathing may stop); or

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • drowsiness, yawning;

  • tremors, sweating, feeling anxious or nervous;

  • dry mouth, upset stomach, mild nausea;

  • sleep problems (insomnia), strange dreams;;

  • mild rash;

  • changes in weight or appetite;

  • decreased sex drive, impotence, or difficulty having an orgasm; or

  • cold symptoms such as stuffy nose, sinus pain, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Fluoxetine Dosing Information

Usual Adult Dose for Premenstrual Dysphoric Disorder:

Note: Only fluoxetine marketed as Sarafem (R) is approved by the FDA for the treatment of Premenstrual Dysphoric Disorder (PMDD). All other formulations of fluoxetine are not FDA approved for PMDD.

Initial dose: 20 mg orally once daily
Maintenance dose: 20 mg/day orally continuously or, alternatively, 20 mg orally daily during the luteal phase of the menstrual system (the 14 days prior to the anticipated start of menses). The 20 mg daily dosage has been shown to be effective for up to six months of treatment. A 60 mg daily dosage has also been studied, but has not been shown to be significantly more effective than 20 mg daily.
Maximum dose: 80 mg orally daily

Approved indication (for Sarafem (R) only): PMDD

Usual Adult Dose for Obsessive Compulsive Disorder:

Initial dose: 20 mg orally once daily in the morning.
Maintenance dose: 20 to 60 mg orally daily in 1 to 2 divided doses.
Maximum dose: 80 mg orally daily

Comments:
-A dose increase may be considered after several weeks if insufficient clinical improvement is observed.
-Doses above 20 mg/day may be administered on a once daily (morning) or twice daily schedule (i.e., morning and noon).
-The full effect may be delayed until 4 weeks of treatment or longer.
-Acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is the same as the dose needed to maintain and/or sustain euthymia is unknown.

Approved indication: For the acute and maintenance treatment of obsessions and compulsions

Usual Adult Dose for Bulimia:

Initial dose: 60 mg orally once daily in the morning. Some patients have started with lower doses. Doses greater than 60 mg daily have not been studied.

Approved indication: For the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa.

Usual Adult Dose for Depression:

Initial dose: 20 mg orally once a day in the morning
Maintenance dose: 20 to 60 mg/day in 1 to 2 divided doses
Maximum dose: 80 mg/day

Fluoxetine weekly: 90 mg orally once weekly

Comments:
-A dose increase may be considered after several weeks if insufficient clinical improvement is observed.
-Doses above 20 mg/day may be administered on a once daily (morning) or twice daily schedule (i.e., morning and noon).
-The full effect may be delayed until 4 weeks of treatment or longer.
-Acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is the same as the dose needed to maintain and/or sustain euthymia is unknown.
-Weekly dosing with fluoxetine weekly is recommended to be initiated 7 days after the last daily dose of fluoxetine 20 mg.

Approved indication: Major Depressive Disorder

Usual Adult Dose for Panic Disorder:

Initial dose: 10 mg orally once daily in the morning. After one week, the dose should be increased to 20 mg orally once daily in the morning.
Maintenance dose: 20 to 60 mg orally daily in 1 to 2 divided doses
Maximum dose: 80 mg orally daily

Comments:
-A dose increase may be considered after several weeks if no clinical improvement is observed.

Approved indication: For the acute treatment of Panic Disorder

Usual Pediatric Dose for Depression:

7 years or younger:
Safety and efficacy have not been established.

8 years to less than 18 years:
Initial dose: 10 to 20 mg orally once daily. After 1 week at 10 mg/day, the dose should be increased to 20 mg/day.

Lower weight children:
Due to higher plasma levels in lower weight children, the starting and dose in this group should generally be 10 mg/day. A dose increase to 20 mg/day may be considered after several weeks if clinical improvement is insufficient.

Approved indication: Major Depressive Disorder

Usual Pediatric Dose for Obsessive Compulsive Disorder:

6 years or younger:
Safety and efficacy have not been established.

7 years to less than 18 years:
Initial dose: 10 mg orally once daily

Adolescents and higher weight children:
Initial dose: 10 mg orally daily
After 2 weeks at 10 mg/day, the dose should be increased to 20 mg/day. Additional dose increases may be considered after several more weeks if clinical improvement is insufficient. A dose range of 20 to 60 mg/day is recommended.

Lower weight children:
Initial dose: 10 mg orally once daily
Additional dose increases may be considered after several weeks if clinical improvement is insufficient. A dose range of 20 to 30 mg/day is recommended. There is minimal experience with doses greater than 20 mg/day and none with doses greater than 60 mg/day.

Approved indication: For the acute and maintenance treatment of obsessions and compulsions

What other drugs will affect fluoxetine?

Taking fluoxetine with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking fluoxetine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with fluoxetine may cause you to bruise or bleed easily.

Many drugs can interact with fluoxetine. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with fluoxetine, especially:

  • any other antidepressant;

  • a blood thinner (warfarin, Coumadin);

  • St. John's Wort;

  • tryptophan (sometimes called L-tryptophan);

  • prescription pain medicine--fentanyl, tramadol; medicine to treat anxiety--alprazolam, buspirone, diazepam; medication to treat mental illness--clozapine, haloperidol, iloperidone, lithium, ziprasidone, and others; or

  • heart medication--amiodarone, digitoxin, procainamide, quinidine, sotalol, and others; migraine headache medicine--almotriptan, frovatriptan, sumatriptan, naratriptan, rizatriptan, zolmitriptan; seizure medication--carbamazepine, phenytoin.

This list is not complete and many other drugs can interact with fluoxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about fluoxetine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 23.02. Revision Date: 2013-08-22, 3:16:19 PM.

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