In the U.S.—

In Canada—

• Antidepressant
• antiobsessional agent
• antibulimic agent

Fluoxetine (floo-OX-e-teen) is used to treat mental depression. It is also used to treat obsessive-compulsive disorder, bulimia nervosa, and premenstrual dysphoric disorder (PMDD).

Fluoxetine also may be used for other conditions as determined by your doctor.

Fluoxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of a chemical called serotonin in the brain.

FLUOXETINE is available only with your doctor's prescription, in the following dosage forms:

Oral
• Capsules (U.S. and Canada)
• Oral solution (U.S. and Canada)
• Tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fluoxetine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to fluoxetine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—One study of babies whose mothers had taken fluoxetine while they were pregnant found some problems in the babies, such as premature birth, jitteriness, and trouble in breathing or nursing. However, four other studies did not find any problems in babies or young children whose mothers had taken fluoxetine while they were pregnant. Tell your doctor if you are pregnant (especially if it is the third trimester) or if you may become pregnant while you are taking FLUOXETINE.

Breast-feeding—Fluoxetine passes into breast milk. A study of 11 breast-fed babies whose mothers were taking fluoxetine found no effect on the babies. However, another baby whose mother was taking FLUOXETINE had vomiting, watery stools, crying, and sleep problems. Be sure you have discussed the risks and benefits of FLUOXETINE with your doctor.

Children—FLUOXETINE has been tested in a limited number of children 7 to 18 years of age. These studies indicate that fluoxetine may help to treat depression and obsessive-compulsive disorder in children. However, unusual excitement, restlessness, irritability, and trouble in sleeping may be especially likely to occur in children, who seem to be more sensitive than adults to the effects of fluoxetine. Fluoxetine must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for FLUOXETINE. More study is needed to be sure fluoxetine is safe and effective in children.

Older adults—Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. In studies done to date that included elderly people, fluoxetine did not cause different side effects or problems in older people than it did in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fluoxetine, it is especially important that your health care professional know if you are taking any of the following:

• Alprazolam (e.g., Xanax)—Higher blood levels of alprazolam may occur and its effects may be increased

• Anticoagulants (blood thinners) (warfarin [e.g., Coumadin) or
• Digitalis glycosides (heart medicine)—Higher or lower blood levels of these medicines or fluoxetine may occur, increasing the chance of unwanted effects such as serious bleeding problems. Your doctor may need to see you more often, especially when you first start or when you stop taking fluoxetine. Your doctor also may need to change the dose of either medicine

• Aspirin or
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (celecoxib [e.g., Celebrex], diclofenac [e.g., Voltaren], diflunisal [e.g., Dolobid], etodolac [e.g., Lodine], fenoprofen [e.g., Nalfon], flurbiprofen [e.g., Ansaid], ibuprofen [e.g., Advil, Motrin, Nuprin], indomethacin [e.g., Indocin], ketoprofen [e.g., Orudis, Oruvail], ketorolac [e.g., Toradol], meclofenamate [e.g., Meclomen], mefenamic acid [e.g., Ponstel], meloxicam [e.g., Mobic], nabumatone [e.g., Relafen], naproxen [e.g., Aleve, Anaprox, Naprosyn], oxaprozin [e.g., Daypro], phenylbutazone, piroxicam [e.g., Feldene], rofecoxib [e.g., Vioxx], sulindac [e.g., Clinoril], tolmetin [e.g., Tolectin], valdecoxib [e.g., Bextra])—Taking any of these medicines with fluoxetine may cause bleeding problems.

• Astemizole (e.g., Hismanal)—Higher blood levels of astemizole may occur, which increases the chance of having a very serious change in the rhythm of your heartbeat

• Buspirone (e.g., BuSpar) or
• Bromocriptine (e.g., Parlodel) or
• Dextromethorphan (cough medicine) or
• Levodopa (e.g., Sinemet) or
• Lithium (e.g., Eskalith) or
• Meperidine (e.g., Demerol) or
• Nefazodone (e.g., Serzone) or
• Pentazocine (e.g., Talwin) or
• Selective serotonin reuptake inhibitors, other (citalopram [Celexa], fluvoxamine [e.g., Luvox], paroxetine [e.g., Paxil], sertraline [e.g., Zoloft]) or
• Street drugs (LSD, MDMA [e.g., ecstasy], marijuana) or
• Sumatriptan (e.g., Imitrex) or
• Tramadol (e.g., Ultram) or
• Trazodone (e.g., Desyrel) or
• Tryptophan or
• Venlafaxine (e.g., Effexor)—Using these medicines with fluoxetine or within 5 weeks of stopping fluoxetine may increase the chance of developing a rare, but very serious, unwanted effect known as the serotonin syndrome. This syndrome may cause confusion, diarrhea, fever, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, or twitching. If you develop these symptoms contact your doctor as soon as possible. Taking tramadol with fluoxetine increases the chance of having convulsions (seizures). Also, taking tryptophan with fluoxetine may result in increased agitation or restlessness and intestinal or stomach problems

• Moclobemide (e.g., Manerex)—The risk of developing serious unwanted effects, including the serotonin syndrome, is increased. Use of moclobemide with fluoxetine is not recommended. Also, it is recommended that 7 days be allowed between stopping treatment with moclobemide and starting treatment with fluoxetine, and it is recommended that 5 weeks be allowed between stopping treatment with fluoxetine and starting treatment with moclobemide

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])— Do not take fluoxetine while you are taking or within 2 weeks of taking an MAO inhibitor. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal problems, sudden high body temperature, extremely high blood pressure, and severe convulsions. At least 14 days should be allowed between stopping treatment with an MAO inhibitor and starting treatment with fluoxetine. If you have been taking fluoxetine, at least 5 weeks should be allowed between stopping treatment with fluoxetine and starting treatment with an MAO inhibitor

• Phenytoin (e.g., Dilantin) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Higher blood levels of these medicines may occur, which increases the chance of having serious side effects. Your doctor may want to see you more often and may need to change the doses of your medicines. Also, taking amitriptyline, clomipramine, or imipramine with fluoxetine may increase the chance of developing the serotonin syndrome

• Thioridazine (e.g., Mellaril)—Taking thioridazine with fluoxetine can cause serious heart problems.

• Bipolar disorder (mood disorder with alternating episodes of mania and depression) or risk of—May make condition worse. Your doctor will check you for this condition.

• Brain disease or mental retardation or
• Seizures, history of—The chance of having seizures may be increased

• Diabetes—The amount of insulin or oral antidiabetic medicine that you need to take may change

• Diseases that affect your body's metabolism—Caution should be used

• Kidney disease or
• Liver disease—Higher blood levels of fluoxetine may occur, increasing the chance of side effects

• Parkinson's disease—May become worse

• Weight loss—Fluoxetine may cause weight loss. This weight loss is usually small, but if a large weight loss occurs, it may be harmful in some patients

Take FLUOXETINE only as directed by your doctor, to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If FLUOXETINE upsets your stomach, it may be taken with food.

If you are taking fluoxetine for depression, it may take 4 weeks or longer before you begin to feel better. Also, you may need to keep taking FLUOXETINE for 6 months or longer to stop the depression from returning. If you are taking fluoxetine for obsessive-compulsive disorder, it may take 5 weeks or longer before you begin to get better. Your doctor should check your progress at regular visits during this time.

If you are taking fluoxetine for bulimia nervosa, you may begin to get better after 1 week. However, it may take 4 weeks or longer before you get better.

Dosing—

The dose of fluoxetine will be different for different patients and for different medical problems. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of fluoxetine. If your dose is different, do not change it unless your doctor tells you to do so:

The number of capsules or teaspoonfuls of solution that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking fluoxetine.

• For oral dosage forms (capsules or solution):
  • For depression or obsessive-compulsive disorder:
    • Adults—At first, usually 20 milligrams (mg) a day, taken as a single dose in the morning. Your doctor may increase the dose if needed. However, the dose usually is not more than 80 mg a day. Once your depression is under control, your doctor may wish to change you to a weekly dose. In this case, you will usually take a 90-mg capsule as a single dose one day per week.
    • Children—Use and dose must be determined by your doctor.
  • For bulimia nervosa:
    • Adults—Usually 60 milligrams (mg) a day, taken as a single dose in the morning. Your doctor may start with a lower dose and increase it gradually. The dose usually is not more than 80 mg a day.
    • Children—Use and dose must be determined by your doctor.
  • For premenstrual dysphoric disorder:
    • Adults—At first, usually 20 milligrams (mg) a day, taken as a single dose in the morning. Your doctor may have you take 20 mg every day of your menstrual cycle or for only 14 days out of your cycle. Your doctor will determine the use and dose that is right for you. Your doctor may increase the dose if needed. However, the dose usually is not more than 80 mg a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of FLUOXETINE, it is not necessary to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not double doses.

Storage—

To store FLUOXETINE:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the oral solution form of FLUOXETINE from freezing.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.