Fluoxetine 20mg/5ml Liquid
WARNING: Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.This drug is not approved for use in all children. Talk with the doctor to be sure that this drug is right for your child. @ COMMON USES: It is used to treat depression.It is used to treat obsessive-compulsive problems.It is used to treat eating problems.It is used to treat panic attacks.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antidepressant
Pharmacologic Class
Selective Serotonin Reuptake Inhibitor (SSRI)
Pregnancy Category
Not available
FDA Approved
Dec 1987
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluoxetine is a medication used to treat depression, obsessive-compulsive disorder, panic attacks, and certain eating disorders. It works by helping to restore the balance of a natural substance (serotonin) in the brain, which can improve mood, sleep, appetite, and energy levels.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, as directed. Continue taking it as prescribed by your doctor or healthcare provider, even if you start to feel better.
When taking a liquid dose, measure it carefully using the device that comes with the medication. If no device is provided, ask your pharmacist for a measuring tool to ensure accurate dosing.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep the lid tightly closed and store all medications in a safe location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, as directed. Continue taking it as prescribed by your doctor or healthcare provider, even if you start to feel better.
When taking a liquid dose, measure it carefully using the device that comes with the medication. If no device is provided, ask your pharmacist for a measuring tool to ensure accurate dosing.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep the lid tightly closed and store all medications in a safe location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take fluoxetine exactly as prescribed, usually once daily in the morning.
- Do not stop taking fluoxetine suddenly without talking to your doctor, as this can cause withdrawal symptoms.
- Avoid alcohol while taking fluoxetine, as it can worsen side effects.
- Be cautious when driving or operating machinery until you know how fluoxetine affects you, as it may cause dizziness or drowsiness.
- Report any new or worsening symptoms, especially changes in mood, behavior, or thoughts of self-harm, to your doctor immediately.
- Maintain regular follow-up appointments with your doctor to monitor your progress and side effects.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg orally once daily (for MDD)
Dose Range:
10 - 80 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial: 20 mg/day orally in the morning. May increase after several weeks if no clinical improvement. Max: 80 mg/day.
Obsessive-Compulsive Disorder (OCD):
Initial: 20 mg/day orally in the morning. May increase after several weeks. Max: 80 mg/day.
Panic Disorder:
Initial: 10 mg/day orally in the morning for 1 week, then increase to 20 mg/day. Max: 60 mg/day.
Bulimia Nervosa:
60 mg/day orally in the morning.
Premenstrual Dysphoric Disorder (PMDD):
Continuous dosing: 20 mg/day orally. Intermittent dosing: 20 mg/day orally starting 14 days prior to menstruation through the first full day of menses, or 20 mg/day orally starting 7 days prior to menstruation through the first full day of menses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
MDD (8-17 years): Initial 10-20 mg/day orally. OCD (7-17 years): Initial 10 mg/day orally, may increase to 20 mg/day after 2 weeks. Max: 60 mg/day for MDD, 60 mg/day for OCD.
Adolescent:
MDD (8-17 years): Initial 10-20 mg/day orally. OCD (7-17 years): Initial 10 mg/day orally, may increase to 20 mg/day after 2 weeks. Max: 60 mg/day for MDD, 60 mg/day for OCD.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment generally needed.
Moderate:
No dosage adjustment generally needed.
Severe:
Use with caution. Consider lower doses or less frequent dosing.
Dialysis:
Not well studied, use with caution. Consider lower doses or less frequent dosing.
Hepatic Impairment:
Mild:
Consider lower doses or less frequent dosing (e.g., 10 mg/day or 20 mg every other day).
Moderate:
Consider lower doses or less frequent dosing (e.g., 10 mg/day or 20 mg every other day).
Severe:
Consider lower doses or less frequent dosing (e.g., 10 mg/day or 20 mg every other day). Half-life may be prolonged significantly.
Pharmacology
Mechanism of Action
Fluoxetine selectively inhibits the reuptake of serotonin (5-HT) by neurons in the central nervous system. This leads to an increase in the concentration of serotonin in the synaptic cleft, enhancing serotonergic neurotransmission. Fluoxetine has little to no affinity for other neurotransmitter receptors (e.g., alpha-adrenergic, beta-adrenergic, dopaminergic, histaminergic, muscarinic, GABAergic receptors).
Pharmacokinetics
Absorption:
Bioavailability:
Well absorbed, approximately 72%
Tmax:
6-8 hours (fluoxetine), 6-10 hours (norfluoxetine)
FoodEffect:
Food does not significantly affect absorption, but may delay Tmax slightly.
Distribution:
Vd:
20-45 L/kg
ProteinBinding:
Approximately 94.5% (primarily to albumin and alpha-1-glycoprotein)
CnssPenetration:
Yes
Elimination:
HalfLife:
Fluoxetine: 2-4 days; Norfluoxetine: 7-15 days
Clearance:
Not readily available, but primarily hepatic metabolism and renal excretion.
ExcretionRoute:
Renal (approximately 60% as metabolites), Fecal (approximately 15%)
Unchanged:
<10% (fluoxetine), <10% (norfluoxetine)
Pharmacodynamics
OnsetOfAction:
Initial antidepressant effects may be seen within 1-2 weeks, but full therapeutic effects may take 4-6 weeks or longer.
PeakEffect:
4-6 weeks for full therapeutic effect.
DurationOfAction:
Due to the long half-life of fluoxetine and its active metabolite norfluoxetine, effects persist for several weeks after discontinuation.
Safety & Warnings
BLACK BOX WARNING
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 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 is not approved for use in pediatric patients less than 8 years of age.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Difficulty focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Sudden and significant weight gain or loss
Seizures
Dizziness
Slow heartbeat
Unexplained bruising or bleeding
Anxiety
Unusual thirst
Changes in menstrual period
Frequent urination
Trouble controlling body movements
Joint pain
Swollen glands
Painful erection (lasting more than 4 hours) or prolonged erection
Sex problems, such as:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or maintaining an erection
If you experience any of these symptoms, consult your doctor. Additionally, be aware of the risk of serotonin syndrome, a potentially life-threatening condition that may occur, especially when taking certain other medications. Seek immediate medical attention if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache
Another rare but serious side effect is an abnormal heartbeat (prolonged QT interval), which may lead to a potentially life-threatening arrhythmia (torsades de pointes). If you experience a fast or abnormal heartbeat or pass out, seek medical help immediately.
Other Possible Side Effects
Most people taking this medication do not experience significant side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
Constipation
Diarrhea
Upset stomach
Vomiting
Decreased appetite
Dry mouth
Drowsiness
Vivid or unusual dreams
Sleep disturbances
Fatigue or weakness
Flu-like symptoms
Yawning
Hot flashes
Nervousness or excitability
Shakiness
Excessive sweating
Headache
* Nose or throat irritation
This is not an exhaustive list of possible side effects. If you have concerns or questions, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Difficulty focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Sudden and significant weight gain or loss
Seizures
Dizziness
Slow heartbeat
Unexplained bruising or bleeding
Anxiety
Unusual thirst
Changes in menstrual period
Frequent urination
Trouble controlling body movements
Joint pain
Swollen glands
Painful erection (lasting more than 4 hours) or prolonged erection
Sex problems, such as:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or maintaining an erection
If you experience any of these symptoms, consult your doctor. Additionally, be aware of the risk of serotonin syndrome, a potentially life-threatening condition that may occur, especially when taking certain other medications. Seek immediate medical attention if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache
Another rare but serious side effect is an abnormal heartbeat (prolonged QT interval), which may lead to a potentially life-threatening arrhythmia (torsades de pointes). If you experience a fast or abnormal heartbeat or pass out, seek medical help immediately.
Other Possible Side Effects
Most people taking this medication do not experience significant side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
Constipation
Diarrhea
Upset stomach
Vomiting
Decreased appetite
Dry mouth
Drowsiness
Vivid or unusual dreams
Sleep disturbances
Fatigue or weakness
Flu-like symptoms
Yawning
Hot flashes
Nervousness or excitability
Shakiness
Excessive sweating
Headache
* Nose or throat irritation
This is not an exhaustive list of possible side effects. If you have concerns or questions, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening depression or anxiety
- Thoughts of harming yourself
- Feeling agitated, restless, or irritable
- Panic attacks
- Difficulty sleeping (insomnia)
- Unusual excitement or energy (mania/hypomania)
- Severe headache, confusion, problems with memory or concentration, weakness, unsteadiness (signs of low sodium)
- Fast or irregular heartbeat, dizziness, fainting (signs of heart problems)
- Muscle stiffness, twitching, fever, sweating, confusion, hallucinations (signs of serotonin syndrome)
- Unexplained bruising or bleeding
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking or have recently taken (within the last 14 days) certain medications, such as:
+ Linezolid, methylene blue, pimozide, or thioridazine
+ Medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as they may cause very high blood pressure
If you are taking any medications that can cause abnormal heart rhythms (prolonged QT interval). There are many medications that can have this effect, so it is crucial to consult with your doctor or pharmacist if you are unsure.
All your current medications, including prescription and over-the-counter drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Remember, this list is not exhaustive, and it is your responsibility to verify the safety of taking this medication with all your existing medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking or have recently taken (within the last 14 days) certain medications, such as:
+ Linezolid, methylene blue, pimozide, or thioridazine
+ Medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as they may cause very high blood pressure
If you are taking any medications that can cause abnormal heart rhythms (prolonged QT interval). There are many medications that can have this effect, so it is crucial to consult with your doctor or pharmacist if you are unsure.
All your current medications, including prescription and over-the-counter drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Remember, this list is not exhaustive, and it is your responsibility to verify the safety of taking this medication with all your existing medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.
Until you know how this medication affects you, avoid driving and other activities that require alertness. If you need to stop taking this medication, do not do so abruptly without consulting your doctor, as this may increase your risk of side effects. Instead, your doctor will guide you on how to gradually stop taking it.
While taking this medication, avoid consuming alcohol, and consult your doctor before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness.
If you have diabetes, it is crucial to closely monitor your blood sugar levels. You may not experience the full effects of this medication for several weeks.
Be aware that this medication may increase your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor. Rarely, severe and potentially fatal reactions, including lung, kidney, or liver problems, have occurred with this medication. Seek immediate medical attention if you experience any of the following symptoms: changes in urine output, dark urine, decreased appetite, stomach pain or upset, light-colored stools, vomiting, yellow skin or eyes, or shortness of breath.
Some individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess this risk. If you experience eye pain, changes in vision, or swelling and redness around the eye, contact your doctor promptly.
This medication can cause low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or death.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary, and you should discuss this with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Taking this medication during the third trimester of pregnancy may increase your risk of bleeding after delivery and potentially cause health problems in the newborn. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy and breastfeeding.
Until you know how this medication affects you, avoid driving and other activities that require alertness. If you need to stop taking this medication, do not do so abruptly without consulting your doctor, as this may increase your risk of side effects. Instead, your doctor will guide you on how to gradually stop taking it.
While taking this medication, avoid consuming alcohol, and consult your doctor before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness.
If you have diabetes, it is crucial to closely monitor your blood sugar levels. You may not experience the full effects of this medication for several weeks.
Be aware that this medication may increase your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor. Rarely, severe and potentially fatal reactions, including lung, kidney, or liver problems, have occurred with this medication. Seek immediate medical attention if you experience any of the following symptoms: changes in urine output, dark urine, decreased appetite, stomach pain or upset, light-colored stools, vomiting, yellow skin or eyes, or shortness of breath.
Some individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess this risk. If you experience eye pain, changes in vision, or swelling and redness around the eye, contact your doctor promptly.
This medication can cause low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or death.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary, and you should discuss this with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Taking this medication during the third trimester of pregnancy may increase your risk of bleeding after delivery and potentially cause health problems in the newborn. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy and breastfeeding.
Overdose Information
Overdose Symptoms:
- Seizures
- Drowsiness
- Nausea
- Vomiting
- Tachycardia (fast heart rate)
- Tremor
- Agitation
- Coma
- QT prolongation
- Ventricular arrhythmias
What to Do:
Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
- Thioridazine (risk of QT prolongation, ventricular arrhythmias, sudden death)
- Pimozide (risk of QT prolongation, ventricular arrhythmias)
- Linezolid (MAOI activity, risk of serotonin syndrome)
- Methylene blue (MAOI activity, risk of serotonin syndrome)
Major Interactions
- Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's Wort, tryptophan) (risk of serotonin syndrome)
- Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics) (additive QT prolongation)
- Drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants, atomoxetine, risperidone, metoprolol, flecainide, propafenone) (increased levels of CYP2D6 substrates)
- Warfarin (increased bleeding risk)
- NSAIDs, Aspirin (increased bleeding risk)
- Phenytoin (increased phenytoin levels)
- Benzodiazepines (e.g., alprazolam, diazepam) (altered metabolism, increased levels)
Moderate Interactions
- Alcohol (additive CNS depression, though not contraindicated)
- Drugs that lower seizure threshold (e.g., bupropion, tramadol)
- Hypoglycemic agents (potential for altered glucose control)
- Diuretics (increased risk of hyponatremia)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Psychiatric evaluation (mood, anxiety, suicidality)
Rationale: To establish baseline symptom severity and assess risk factors for suicidality.
Timing: Prior to initiation
Complete blood count (CBC)
Rationale: To assess for any pre-existing hematologic abnormalities.
Timing: Prior to initiation (optional, but good practice)
Electrolytes (especially sodium)
Rationale: To assess for baseline hyponatremia risk, especially in elderly or those on diuretics.
Timing: Prior to initiation (optional, but good practice)
Weight and Height (especially in pediatric patients)
Rationale: To monitor for growth suppression or significant weight changes.
Timing: Prior to initiation
ECG
Rationale: Consider in patients with pre-existing cardiac conditions or on other QT-prolonging drugs.
Timing: Prior to initiation (if indicated)
Routine Monitoring
Clinical response and symptom severity
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated.
Target: Reduction in target symptoms (e.g., HAM-D, MADRS scores)
Action Threshold: Lack of improvement or worsening of symptoms may require dose adjustment or alternative therapy.
Emergence of suicidal ideation or behavior
Frequency: Weekly for first 4 weeks, then every 2 weeks for next 4 weeks, then at 12 weeks, and periodically thereafter.
Target: Absence of new or worsening suicidal thoughts/behaviors.
Action Threshold: Immediate clinical assessment, consider dose adjustment or discontinuation, increased monitoring, or hospitalization.
Adverse effects (e.g., nausea, insomnia, anxiety, sexual dysfunction, weight changes)
Frequency: At each visit, especially during titration.
Target: Tolerable side effect profile.
Action Threshold: Intolerable side effects may require dose reduction, switching medication, or symptomatic treatment.
Weight (especially in pediatric patients)
Frequency: Periodically, e.g., every 3-6 months.
Target: Stable weight or appropriate growth trajectory.
Action Threshold: Significant weight gain/loss or growth suppression may require intervention.
Serum sodium
Frequency: Periodically, especially in elderly, volume-depleted, or those on diuretics.
Target: 135-145 mEq/L
Action Threshold: Hyponatremia (<135 mEq/L) requires investigation and management.
Blood pressure and heart rate
Frequency: Periodically.
Target: Within normal limits.
Action Threshold: Significant changes may require investigation.
Symptom Monitoring
- Worsening depression
- New or worsening anxiety
- Agitation
- Panic attacks
- Insomnia
- Irritability
- Hostility
- Impulsivity
- Akathisia (psychomotor restlessness)
- Hypomania or mania
- Unusual changes in behavior
- Suicidal ideation or attempts
- Signs of serotonin syndrome (e.g., agitation, hallucinations, rapid heart beat, fever, sweating, shivering, muscle stiffness/twitching, loss of coordination, nausea, vomiting, diarrhea)
- Signs of hyponatremia (e.g., headache, confusion, weakness, unsteadiness, seizures)
Special Patient Groups
Pregnancy
Use during pregnancy should be carefully considered, balancing potential risks to the fetus with the risks of untreated maternal depression. While older classification was Category C, current understanding suggests potential for persistent pulmonary hypertension of the newborn (PPHN) and withdrawal symptoms in neonates if used in late pregnancy. Data are conflicting regarding other malformations.
Trimester-Specific Risks:
First Trimester:
Some studies suggest a possible, but small, increased risk of cardiovascular malformations, particularly septal defects. Overall risk appears low.
Second Trimester:
Generally considered safer than first or third trimester, but continued monitoring for maternal and fetal well-being is important.
Third Trimester:
Increased risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., irritability, tremor, feeding difficulties, respiratory distress) if exposed late in pregnancy.
Lactation
Fluoxetine and its active metabolite norfluoxetine are excreted into breast milk. While some infants may experience no adverse effects, others may experience irritability, poor feeding, or drowsiness. Monitor the infant for side effects. Consider alternative antidepressants with lower milk levels or shorter half-lives if possible, especially in preterm or unstable infants.
Infant Risk:
Moderate concern (L3). Monitor for irritability, poor feeding, drowsiness, and weight gain.
Pediatric Use
Fluoxetine is approved for MDD in children 8 years and older, and for OCD in children 7 years and older. A Black Box Warning exists regarding increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Close monitoring is essential. Growth and weight should be monitored.
Geriatric Use
Use with caution in elderly patients. They may be more sensitive to the effects of fluoxetine, including hyponatremia and CNS side effects (e.g., dizziness, falls). Lower starting doses and slower titration may be appropriate. The half-life of fluoxetine and norfluoxetine may be prolonged in elderly patients with reduced hepatic or renal function.
Clinical Information
Clinical Pearls
- Fluoxetine has a very long half-life (especially its active metabolite norfluoxetine), which means it takes a long time to reach steady state and a long time to be eliminated from the body. This can be beneficial for adherence (less severe withdrawal if a dose is missed) but also means side effects can persist for weeks after discontinuation.
- Due to its long half-life, a 'washout' period of at least 5 weeks (or longer, up to 7 weeks, especially if high doses or hepatic impairment) is required before starting an MAOI to prevent serotonin syndrome.
- Fluoxetine is a potent inhibitor of CYP2D6, which can significantly increase the levels of other drugs metabolized by this enzyme.
- The liquid formulation (20mg/5ml) is useful for patients who have difficulty swallowing pills or require precise dose adjustments.
- Fluoxetine is one of the few SSRIs approved for pediatric depression and OCD.
- Weight changes (gain or loss) can occur with fluoxetine, though it is often associated with less weight gain than some other antidepressants.
- Sexual dysfunction (decreased libido, delayed orgasm/ejaculation) is a common side effect of SSRIs, including fluoxetine, and can be persistent even after discontinuation (PSSD).
Alternative Therapies
- Other SSRIs (e.g., Sertraline, Escitalopram, Citalopram, Paroxetine, Fluvoxamine)
- SNRIs (e.g., Venlafaxine, Duloxetine, Desvenlafaxine)
- Atypical antidepressants (e.g., Bupropion, Mirtazapine, Vortioxetine, Vilazodone)
- Tricyclic Antidepressants (TCAs)
- Monoamine Oxidase Inhibitors (MAOIs)
- Psychotherapy (e.g., Cognitive Behavioral Therapy, Interpersonal Therapy)
Cost & Coverage
Average Cost:
$20 - $100 per 120 mL of 20mg/5ml liquid
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.