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floo-OX-e-teen
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) .
Oral routeTabletSuicidality 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 .
Commonly used brand name(s):
In the U.S.
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Therapeutic Class: Antidepressant
Pharmacologic Class: Serotonin Reuptake Inhibitor
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 is used with olanzapine to treat depression that is a part of bipolar disorder. It is also used to treat treatment resistant depression in patients who have been treated with other antidepressants that did not work well. fluoxetine may also 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.
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:
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:
Tell your doctor if you have ever had any unusual or allergic reaction to fluoxetine 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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluoxetine in children with depression. However, safety and efficacy have not been established in children below 8 years of age.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluoxetine in children with obsessive-compulsive disorder. However, safety and efficacy have not been established in children below 7 years of age.
Appropriate studies have not been performed on the relationship of age to the effects of fluoxetine in children with bulimia nervosa and panic disorder. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of olanzapine and fluoxetine combination in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluoxetine in the elderly. However, elderly patients may be more sensitive to the effects of fluoxetine than younger adults and are more likely to have liver problems, which may require caution and an adjustment in the dose for patients receiving fluoxetine.
| 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. |
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.
Using fluoxetine 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.
Using fluoxetine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using fluoxetine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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.
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:
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.
fluoxetine should come with a Medication Guide. Read and follow these instructions carefully. Talk with your doctor if you have any questions.
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.
If you are using 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.
The dose of fluoxetine 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 fluoxetine. 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.
If you miss a dose of fluoxetine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
It is important that your doctor check your progress at regular visits, to allow changes in your dose 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 stop suddenly taking fluoxetine without checking first with your doctor. 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 lightheadedness, a fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble with sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.
Do not take fluoxetine within 2 weeks of taking an monoamine oxidase (MAO) inhibitor (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). 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 (Mellaril®) while you are taking fluoxetine or less than 5 weeks after you have stopped taking fluoxetine. You should not use pimozide (Orap®) while you are taking fluoxetine. Using these medicines together can cause very serious heart problems.
You should not take other medicines that also contain fluoxetine. This includes Symbyax®, Sarafem®, or Prozac Weekly®. Using these medicines together may increase your chance for more serious side effects.
Make sure your doctor knows about all the other medicines you are using. Fluoxetine may cause serious conditions such as serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions when taken with certain medicines such as linezolid [Zyvox®], lithium, tryptophan, St. John's Wort, or some pain medicines (e.g., tramadol [Ultram®], sumatriptan [Imitrex®], zolmitriptan [Zomig®], or rizatriptan [Maxalt®]). Check with your doctor first before taking any other medicines.
Make sure your doctor knows if you are also using aspirin, NSAIDS (e.g., ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®), or a blood thinner (e.g., warfarin [Coumadin®]). Fluoxetine may increase your risk of having bleeding problems especially when taken together with these medicines.
Avoid drinking alcohol while you are taking fluoxetine.
Do not breastfeed while you are using fluoxetine.
For diabetic patients:
fluoxetine 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.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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 immediately if any of the following side effects occur:
More commonSome 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 commonAfter you stop using fluoxetine, 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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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