Sarafem

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FLUOXETINE (Systemic)

Some commonly used brand names are:

In the U.S.—

  • Prozac
  • Prozac Weekly
  • Sarafem

In Canada—

  • Prozac

Category

  • Antidepressant
  • antiobsessional agent
  • antibulimic agent

Description

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.

This medicine 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.)

Before Using This Medicine

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 this medicine.

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 this medicine had vomiting, watery stools, crying, and sleep problems. Be sure you have discussed the risks and benefits of this medicine with your doctor.

Children—This medicine 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 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 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. Thioridazine and fluoxetine should not be taken together and thioridazine should not be taken less than 5 weeks after you have stopped taking fluoxetine.

Other medical problems—The presence of other medical problems may affect the use of fluoxetine. Make sure you tell your doctor if you have any other medical problems, especially:

  • 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

Proper Use of This Medicine

Take this medicine 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 this medicine 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 this medicine 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 this medicine, 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 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 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.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits, to allow dosage adjustments and help reduce any side effects.

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

Fluoxetine may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any 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 healthcare professional how to slowly decrease the dose. This is to decrease the chance of having symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or light-headedness, fast heartbeat, headache, increased sweating, 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 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]) and do not take an MAO inhibitor for at least 5 weeks after taking fluoxetine . If you do, you may develop extremely high blood pressure or convulsions.

Do not take thioridazine (e.g., Mellaril) while you are 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 change in 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 think clearly, or to have poor muscle control. Make sure you know how you react to fluoxetine before you drive, use machines, or do anything else that could be dangerous if you are not alert and well able to control your movements .

Side Effects of This Medicine

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

Check with your doctor as soon as possible if 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; symptoms of 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, or unusual 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 acting with excitement and activity you cannot control; trouble in breathing; unusual or incomplete body or facial movements; unusual secretion of milk, in females

Incidence not known

Abdominal or stomach pain; agitation; back or leg pains; bleeding gums; 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 or lightheadedness; eye pain; fainting; fainting, fast, pounding, or irregular heartbeat 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 around the eyes, face, lips or tongue; hostility; increased hunger; indigestion; irregular or slow heart rate; irritability; itching; joint or muscle pain; 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 on skin; 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 white spots 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; swelling of 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; vomiting of blood; wheezing; yellow eyes or skin

Symptoms of overdose—May be more severe than side effects that may occur from 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 you cannot control; trembling or shaking

Other side effects may occur that usually do not need medical attention. These side effects may 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 are bothersome:

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

Incidence not known

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

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

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

Incidence not known

Cracks in skin; loss of heat from the body; painful or prolonged erection of the penis; red, swollen skin; scaly skin; swelling of the breasts or breast soreness in both females and males; unusual milk production

After you stop using fluoxetine, it may still produce some side effects that need attention. During this period of time, chek with your doctor immediately if you notice the following side effect:

Actions that are out of control; agitation; anxiety; burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling; crying; depersonalization; euphoria; feeling of distress; feeling that body or surroundings are turning; general feeling of discomfort or illness; headache; irritability; mental depression; mood or mental changes; nervousness; nausea; paranoia; quick to react or overreact emotionally; rapidly changing moods; sleeplessness; sweating; talking, feeling, and acting with excitement; trouble sleeping; unable to sleep; unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness; unusual tiredness or weakness; vaginal bleeding

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

Additional Information

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

  • Premature ejaculation

Revised: 02/01/2005

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