Pronunciation:

floo-OX-e-teen

Brand Names:

• Prozac
• Prozac Weekly
• Rapiflux
• Sarafem
• Selfemra
• Phl-Fluoxetine

Dosage Forms:

• Syrup
• Capsule, Delayed Release
• Tablet
• Solution
• Capsule

Warnings:

Suicidality and Antidepressant Drugs - Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluoxetine hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Fluoxetine hydrochloride is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD) .

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PROZAC(R) is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD) .

Suicidality and Antidepressant Drugs - Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluoxetine hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Patients who are started on antidepressant therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SARAFEM(R) is not approved for use in pediatric patients.

Pooled analyses of short-term (4 to 16 weeks) placebo-contolled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials .

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SARAFEM(R) is not approved for use in pediatric patients .

Classifications:

Therapeutic—

Antidepressant

Pharmacologic—

Serotonin Reuptake Inhibitor

Uses of This Medicine:

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

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.

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

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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, teenagers, and young adults with depression. Studies have shown occurrences of children, teenagers, and young adults 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, teenagers, and young adults .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of fluoxetine in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, which may require caution in patients receiving fluoxetine.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Clorgyline
• Dihydroergotamine
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Furazolidone
• Iproniazid
• Isocarboxazid
• Levomethadyl
• Mesoridazine
• Methylergonovine
• Methysergide
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Pimozide
• Procarbazine
• Selegiline
• Terfenadine
• Thioridazine
• Toloxatone
• Tranylcypromine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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.

If you are taking the oral liquid form of fluoxetine, shake the bottle well before measuring each dose. Use a small measuring cup or a measuring spoon to measure each dose. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts .

Dosing—

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

The amount of medicine 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 using the medicine.

• For oral dosage forms (capsules or solution):
  • For depression:
    • 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 above 8 years of age—At first, usually 10 or 20 milligrams (mg) a day, taken as a single dose in the morning. Your doctor may increase the dose if needed.
    • Children below 8 years of age—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 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.
    • Children above 7 years of age—At first, usually 10 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 60 mg a day.
    • Children below 7 years of age—Use and dose must be determined by your doctor .
  • For panic disorder:
    • Adults—At first, 10 milligrams (mg) a day, taken as a single dose in the morning or evening for one week. Your doctor may increase your dose if needed. However, the dose is usually not more than 60 mg per 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, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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, your child, or your caregiver notice any of these unwanted effects, tell your doctor or your child's doctor right away .

Do not suddenly stop taking your fluoxetine. If you have been instructed to stop taking fluoxetine, ask your doctor 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], 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 seizures.

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.

Make sure your doctor knows about all the other medicines you are using. Fluoxetine may cause a serious condition called Serotonin Syndrome when taken with certain medicines such as linezolid [e.g., Zyvox], lithium, tryptophan, St. John's Wort, or some pain medicines (e.g., tramadol [e.g., Ultram], sumatriptan [e.g., Imitrex], zolmitriptan [e.g., Zomig], or rizatriptan [e.g., Maxalt]). Check with your doctor first before taking any other medicines .

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, or 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

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, or 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 shortness of breath or troubled breathing

sudden weakness in arms or legs

sudden, severe chest pain

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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

Actions that are out of control

agitation

anxiety

burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling

crying

depersonalization

dizziness

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

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

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