FLUOXETINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Prozac
• Prozac Weekly
• Sarafem

In Canada?

• Prozac

Category

• Antidepressant
• antiobsessionalagent
• antibulimic agent

Description

Fluoxetine (floo-OX-e-teen) is used to treat mentaldepression. It is also used to treat obsessive-compulsive disorder, bulimianervosa, and premenstrual dysphoric disorder (PMDD).

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

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

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

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

Before Using This Medicine

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

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

Pregnancy?One study of babies whose mothers had taken fluoxetinewhile they were pregnant found some problems in the babies, such as prematurebirth, jitteriness, and trouble in breathing or nursing. However, four otherstudies did not find any problems in babies or young children whose mothershad taken fluoxetine while they were pregnant. Tell your doctor if you arepregnant (especially if it is the third trimester) or if you may become pregnantwhile you are taking this medicine.

Breast-feeding?Fluoxetine passes into breast milk. A study of11 breast-fed babies whose mothers were taking fluoxetine found no effecton the babies. However, another baby whose mother was taking this medicinehad vomiting, watery stools, crying, and sleep problems. Be sure you havediscussed the risks and benefits of this medicine with your doctor.

Children?This medicine has been tested in a limited numberof children 7 to 18 years of age. These studies indicate that fluoxetine mayhelp to treat depression and obsessive-compulsive disorder in children. However,unusual excitement, restlessness, irritability, and trouble in sleeping maybe especially likely to occur in children, who seem to be more sensitive thanadults to the effects of fluoxetine. Fluoxetine must be used with cautionin children with depression. Studies have shown occurrences of children thinkingabout suicide or attempting suicide in clinical trials for this medicine.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 theydo in younger adults or if they cause different side effects or problems inolder people. In studies done to date that included elderly people, fluoxetinedid not cause different side effects or problems in older people than it didin younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingfluoxetine, it is especially important that your health care professionalknow if you are taking any of the following:

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

• Anticoagulants (blood thinners) (warfarin [e.g., Coumadin) or
• Digitalis glycosides (heart medicine)?Higher or lower bloodlevels of these medicines or fluoxetine may occur, increasing the chance ofunwanted effects such as serious bleeding problems. Your doctor may need tosee you more often, especially when you first start or when you stop takingfluoxetine. 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 ofthese medicines with fluoxetine may cause bleeding problems.

• Astemizole (e.g., Hismanal)?Higher blood levels of astemizolemay occur, which increases the chance of having a very serious change in therhythm 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 fluoxetineor within 5 weeks of stopping fluoxetine may increase the chance of developinga 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 contactyour doctor as soon as possible. Taking tramadol with fluoxetine increasesthe chance of having convulsions (seizures). Also, taking tryptophan withfluoxetine may result in increased agitation or restlessness and intestinalor stomach problems

• Moclobemide (e.g., Manerex)?The risk of developing seriousunwanted effects, including the serotonin syndrome, is increased. Use of moclobemidewith fluoxetine is not recommended. Also, it is recommended that 7 days beallowed between stopping treatment with moclobemide and starting treatmentwith fluoxetine, and it is recommended that 5 weeks be allowed between stoppingtreatment 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 anMAO inhibitor. If you do, you may develop confusion, agitation, restlessness,stomach or intestinal problems, sudden high body temperature, extremely highblood pressure, and severe convulsions. At least 14 days should be allowedbetween stopping treatment with an MAO inhibitor and starting treatment withfluoxetine. If you have been taking fluoxetine, at least 5 weeks should beallowed between stopping treatment with fluoxetine and starting treatmentwith 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])?Higherblood levels of these medicines may occur, which increases the chance of havingserious side effects. Your doctor may want to see you more often and may needto change the doses of your medicines. Also, taking amitriptyline, clomipramine,or imipramine with fluoxetine may increase the chance of developing the serotoninsyndrome

• Thioridazine (e.g., Mellaril)?Taking thioridazine with fluoxetinecan cause serious heart problems. Thioridazine andfluoxetine should not be taken together and thioridazine should not be takenless than 5 weeks after you have stopped taking fluoxetine.

Other medical problems?The presence of other medicalproblems may affect the use of fluoxetine. Make sure you tell your doctorif you have any other medical problems, especially:

• Bipolar disorder (mood disorder with alternating episodes of maniaand depression) or risk of?May make condition worse. Your doctor willcheck 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 medicinethat you need to take may change

• Diseases that affect your body's metabolism?Caution shouldbe 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 lossis usually small, but if a large weight loss occurs, it may be harmful insome patients

Proper Use of This Medicine

Take this medicine only as directed by your doctor, to benefit yourcondition as much as possible. Do not take more of it, do not take it moreoften, and do not take it for a longer time than your doctor ordered.

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

If you are taking fluoxetine for depression, it maytake 4 weeks or longer before you begin to feel better. Also, you may needto keep taking this medicine for 6 months or longer to stop the depressionfrom returning. If you are taking fluoxetine forobsessive-compulsive disorder, it may take 5 weeks or longer before you beginto get better. Your doctor should check your progress at regular visitsduring this time.

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

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

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

• For oral dosage forms (capsules or solution):
  • For depression or obsessive-compulsive disorder:
    • Adults?At first, usually 20 milligrams (mg) a day, taken asa 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 depressionis under control, your doctor may wish to change you to a weekly dose. Inthis case, you will usually take a 90-mg capsule as a single dose one dayper week.
    • Children?Use and dose must be determined by your doctor.
  • For bulimia nervosa:
    • Adults?Usually 60 milligrams (mg) a day, taken as a singledose in the morning. Your doctor may start with a lower dose and increaseit 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 asa single dose in the morning. Your doctor may have you take 20 mg every dayof your menstrual cycle or for only 14 days out of your cycle. Your doctorwill determine the use and dose that is right for you. Your doctor may increasethe 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 this medicine, it is notnecessary to make up the missed dose. Skip the missed dose and continue withyour next scheduled dose. Do not double doses.

Storage?To store this medicine:

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

Precautions While Using This Medicine

It isimportant that your doctor check your progress at regular visits, to allowdosage adjustments and help reduce any side effects.

If you develop a skin rash or hives, stop taking fluoxetineand check with your doctor as soon as possible.

Fluoxetine may cause some people to be agitated, irritable or display otherabnormal behaviors. It may also cause some people to have suicidal thoughtsand tendencies or to become more depressed. If you or your caregiver noticeany of these unwanted effects, tell your doctor right away.

Do not suddenly stop taking your fluoxetine.If you have been instructed to stop taking fluoxetine, ask you healthcareprofessional how to slowly decrease the dose. This is to decrease the chanceof having symptoms such as agitation, breathing problems, chest pain, confusion,diarrhea, dizziness or light-headedness, fast heartbeat, headache, increasedsweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping,trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

Do not take fluoxetine within 2 weeks of taking a monoamineoxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine[e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl],tranylcypromine [e.g., Parnate]) and do not take an MAO inhibitor for atleast 5 weeks after taking fluoxetine. If you do, you may develop extremelyhigh blood pressure or convulsions.

Do not take thioridazine (e.g., Mellaril) while youare taking fluoxetine or less than 5 weeks after you have stopped taking fluoxetine. Using these medicines together can cause very serious heart problems.

Avoid drinking alcohol while you are taking fluoxetine.

For diabetic patients:

• This medicine may affect blood sugar levels. If you notice a changein the results of your blood or urine sugar tests or if you have any questions,check with your doctor.

This medicine may cause some people to become drowsy or less able to thinkclearly, or to have poor muscle control. Make sure youknow how you react to fluoxetine before you drive, use machines, or do anythingelse that could be dangerous if you are not alert and well able to controlyour movements.

Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Although not all of these sideeffects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possibleif any of the following side effects occur:

More common

Decreased sexual drive or ability; inability to sit still; restlessness; skin rash, hives, or itching

Less common

Chills or fever; joint or muscle pain

Rare

Breast enlargement or pain; convulsions(seizures); fast or irregular heartbeat; purple or red spots on skin; symptomsof hypoglycemia (low blood sugar), including anxiety or nervousness, chills,cold sweats, confusion, cool pale skin, difficulty in concentration, drowsiness,excessive hunger, fast heartbeat, headache, shakiness or unsteady walk, orunusual tiredness or weakness; symptoms of hyponatremia(low blood sodium), including confusion, convulsions (seizures), drowsiness,dryness of mouth, increased thirst, lack of energy; symptoms of serotonin syndrome, including diarrhea, fever, increased sweating,mood or behavior changes, overactive reflexes, racing heartbeat, restlessness,shivering or shaking; talking, feeling, and actingwith excitement and activity you cannot control; trouble in breathing; unusual or incomplete bodyor facial movements; unusual secretion of milk, infemales

Incidence not known

Abdominal or stomach pain; agitation; back or leg pains; bleedinggums; blindness; blistering,peeling, loosening of skin; bloating; blood in urine or stools; bloody, black,or tarry stools; blue-yellow color blindness; blurred vision; changes in behavior; chest pain or discomfort; clay-colored stools; coma; constipation; continuing vomiting; cough/dry cough; dark urine; decreased urine output; decreased vision; depression; difficulty breathing; difficulty swallowing; dizziness orlightheadedness; eye pain; fainting; fainting, fast, pounding, or irregularheartbeat or pulse; fatigue; general body swelling; high fever; high or low blood pressure; hives or welts; hives, itching, puffiness or swelling of the eyelids or aroundthe eyes, face, lips or tongue; hostility; increased hunger; indigestion; irregular or slow heart rate; irritability; itching; joint or musclepain; large, hive-like swelling on face, eyelids,lips, tongue, throat, hands, legs, feet, sex organs; lethargy; light-colored stools; loss of appetite; loss of bladder control; muscle twitching; nausea; nightmares; no blood pressure or pulse; noisy breathing; nosebleeds; pain in ankles or knees; painful, red lumps under the skin, mostly on the legs; pains in stomach, side, or abdomen, possibly radiating to the back; palpitations; pinpoint red spots onskin; pounding heartbeat; rapid weight gain; red or irritated eyes; red skin lesions, often with a purple center; redness, tenderness, itching, burning, or peeling of skin; severe muscle stiffness; shortness of breath; skin rash; slurred speech; sore throat; sores, ulcers, or whitespots on lips or in mouth; stopping of heart; stupor; sudden, severe chest pain; sudden shortness of breath or troubled breathing; sudden weakness in arms or legs; swellingof face, ankles, or hands; swollen or painful glands; thoughts of killing oneself; tightness in chest; tiredness; twitching, twisting, uncontrolled repetitive movements of tongue, lips, face,arms, or legs; unconsciousness; unpleasant breath odor; unusual bleeding or bruising; unusually pale skin; use of extreme physical or emotional force; vomitingof blood; wheezing; yelloweyes or skin

Symptoms of overdose?May be more severe than side effects that may occurfrom regular doses, or several symptoms may occur together

Agitation and restlessness; convulsions(seizures); drowsiness; fast heartbeat; nausea and vomiting; talking, feeling, and acting with excitement and activity youcannot control; trembling or shaking

Other sideeffects may occur that usually do not need medical attention. These side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effects continue or arebothersome:

More common

Anxiety or nervousness; decreased appetite; diarrhea; drowsiness; headache; increased sweating; nausea; tiredness or weakness; trembling or shaking; trouble in sleeping

Less common or rare

Abnormal dreams; change in sense oftaste; changes in vision; chest pain; constipation; dizziness or light-headedness; dryness of mouth; feeling of warmth or heat; flushingor redness of skin, especially on face and neck; frequent urination; hair loss; increased appetite; increased sensitivity of skinto sunlight; menstrual pain; stomach cramps, gas, or pain; vomiting; weight loss; yawning

Incidence not known

Cracks in the skin; loss of heat fromthe body; painful or prolonged erections of penis; red, swollen skin; scalyskin

After you stop taking fluoxetine, your body may need time to adjust. Thelength of time this takes depends on the amount of medicine you were usingand how long you used it. During this period of time, check with your doctorif you notice any of the following side effects:

Anxiety; dizziness; feeling that body or surroundings are turning; generalfeeling of discomfort or illness; headache; nausea; sweating; unusual tiredness or weakness

Incidence not known

After you stop using fluoxetine, it maystill produce some side effects that need attention. During this period oftime, chek with your doctor immediately if younotice the following side effect:

Other side effects not listed above may alsooccur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketingfor a certain use, experience may show that it is also useful for other medicalproblems. Although these uses are not included in product labeling, fluoxetineis used in certain patients with the following medical conditions:

• Premature ejaculation