Fluoxetine 10mg Capsules
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 (OCD), panic disorder, bulimia nervosa, and premenstrual dysphoric disorder (PMDD). 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 as directed, with or without food, and continue taking it even if you feel well. It's essential to adhere to your doctor's or healthcare provider's advice to ensure the medication works effectively.
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 the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue taking it even if you feel well. It's essential to adhere to your doctor's or healthcare provider's advice to ensure the medication works effectively.
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 the missed one.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning. Do not stop taking it suddenly without consulting your doctor, as this can cause withdrawal symptoms.
- It may take several weeks (4-6 weeks) to feel the full benefits of the medication.
- Avoid alcohol while taking fluoxetine, as it can worsen side effects like drowsiness.
- Be cautious when driving or operating machinery until you know how this medication affects you.
- Maintain regular follow-up appointments with your doctor to monitor your progress and side effects.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 10-20 mg once daily, typically in the morning. May increase after several weeks.
Dose Range:
10 - 80 mg
Condition-Specific Dosing:
Major Depressive Disorder:
Initial 20 mg once daily; may increase to 20-60 mg/day. Max 80 mg/day.
Obsessive-Compulsive Disorder (OCD):
Initial 20 mg once daily; may increase to 20-60 mg/day. Max 80 mg/day.
Bulimia Nervosa:
60 mg once daily.
Panic Disorder:
Initial 10 mg once daily; may increase to 20-60 mg/day.
Premenstrual Dysphoric Disorder (PMDD):
Continuous dosing: 20 mg once daily. Intermittent dosing: 20 mg once daily starting 14 days prior to menstruation through the first full day of menses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Major Depressive Disorder (8-17 years): Initial 10-20 mg once daily. OCD (7-17 years): Initial 10 mg once daily, may increase to 20 mg after 2 weeks, then up to 60 mg/day.
Adolescent:
Major Depressive Disorder (8-17 years): Initial 10-20 mg once daily. OCD (7-17 years): Initial 10 mg once daily, may increase to 20 mg after 2 weeks, then up to 60 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment typically needed.
Moderate:
No dosage adjustment typically needed.
Severe:
Use with caution. Consider lower doses or less frequent dosing (e.g., every other day) due to accumulation of fluoxetine and norfluoxetine.
Dialysis:
Use with caution. Not significantly removed by dialysis. Consider lower doses or less frequent dosing.
Hepatic Impairment:
Mild:
No specific adjustment, but monitor closely.
Moderate:
Consider a lower dose or less frequent dosing (e.g., 10 mg every other day or 20 mg every other day) due to prolonged half-life.
Severe:
Consider a lower dose or less frequent dosing (e.g., 10 mg every other day or 20 mg every other day) due to significantly prolonged half-life.
Pharmacology
Mechanism of Action
Fluoxetine is a selective serotonin reuptake inhibitor (SSRI). It potently and selectively inhibits the reuptake of serotonin (5-HT) into the presynaptic neuron, thereby increasing the concentration of serotonin in the synaptic cleft and enhancing serotonergic neurotransmission. It has minimal affinity for other neurotransmitter receptors (e.g., alpha-adrenergic, histamine, muscarinic, dopamine, GABA).
Pharmacokinetics
Absorption:
Bioavailability:
Well absorbed (not precisely quantified, but high)
Tmax:
Fluoxetine: 6-8 hours; Norfluoxetine: 6-10 hours
FoodEffect:
Food does not significantly affect the absorption of fluoxetine, but may delay Tmax slightly.
Distribution:
Vd:
20-45 L/kg (large volume of distribution)
ProteinBinding:
~94% (primarily to albumin and alpha-1-glycoprotein)
CnssPenetration:
Yes
Elimination:
HalfLife:
Fluoxetine: 2-4 days; Norfluoxetine: 7-16 days
Clearance:
Not readily available as a single rate, but primarily hepatic metabolism followed by renal excretion.
ExcretionRoute:
Renal (approximately 60% as metabolites, 10% as unchanged drug and norfluoxetine)
Unchanged:
Less than 10% (fluoxetine and norfluoxetine combined)
Pharmacodynamics
OnsetOfAction:
Initial antidepressant effects may be seen within 1-2 weeks, but full therapeutic effects may take 4-6 weeks or longer.
PeakEffect:
Typically 4-6 weeks for full therapeutic effect.
DurationOfAction:
Due to long half-lives of fluoxetine and 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 older than 24 years; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 years 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
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Sudden and significant weight gain or loss
Seizures
Dizziness
Slow heartbeat
Unexplained bruising or bleeding
Anxiety
Unusual thirst
Changes in menstrual periods
Increased urination
Trouble controlling body movements
Joint pain
Swollen glands
Painful erection (lasting longer than 4 hours) or prolonged erection
Sex problems, such as:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or keeping an erection
If you have any questions or concerns, discuss them with your doctor.
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek medical help immediately 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
Abnormal Heartbeat: A Rare but Serious Side Effect
This medication may cause a type of abnormal heartbeat (prolonged QT interval), which can lead to another type of unsafe abnormal heartbeat (torsades de pointes). Seek medical help immediately if you experience:
Fast or abnormal heartbeat
Fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:
Constipation
Diarrhea
Upset stomach
Vomiting
Decreased appetite
Dry mouth
Drowsiness
Strange or vivid dreams
Sleep disturbances
Fatigue or weakness
Flu-like symptoms
Yawning
Hot flashes
Feeling nervous or excitable
Shakiness
Excessive sweating
Headache
* Nose or throat irritation
Reporting Side Effects
If you have questions about side effects or want to report any, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects 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
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Sudden and significant weight gain or loss
Seizures
Dizziness
Slow heartbeat
Unexplained bruising or bleeding
Anxiety
Unusual thirst
Changes in menstrual periods
Increased urination
Trouble controlling body movements
Joint pain
Swollen glands
Painful erection (lasting longer than 4 hours) or prolonged erection
Sex problems, such as:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or keeping an erection
If you have any questions or concerns, discuss them with your doctor.
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek medical help immediately 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
Abnormal Heartbeat: A Rare but Serious Side Effect
This medication may cause a type of abnormal heartbeat (prolonged QT interval), which can lead to another type of unsafe abnormal heartbeat (torsades de pointes). Seek medical help immediately if you experience:
Fast or abnormal heartbeat
Fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:
Constipation
Diarrhea
Upset stomach
Vomiting
Decreased appetite
Dry mouth
Drowsiness
Strange or vivid dreams
Sleep disturbances
Fatigue or weakness
Flu-like symptoms
Yawning
Hot flashes
Feeling nervous or excitable
Shakiness
Excessive sweating
Headache
* Nose or throat irritation
Reporting Side Effects
If you have questions about side effects or want to report any, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening depression or thoughts about harming yourself (especially at the beginning of treatment or after a dose change)
- New or worsening anxiety, panic attacks, agitation, restlessness, irritability, aggression, or unusual changes in behavior
- Symptoms of serotonin syndrome: fast heartbeat, sweating, muscle stiffness or spasms, fever, confusion, severe diarrhea, agitation, hallucinations
- Unusual bleeding or bruising
- Symptoms of an allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing
- Symptoms of hyponatremia: headache, confusion, weakness, unsteadiness, memory problems, seizures
- Eye pain, vision changes (especially around lights), or eye swelling (may indicate angle-closure glaucoma)
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 you experienced.
If you are currently taking or have recently taken certain medications, such as:
+ Linezolid
+ Methylene blue
+ Pimozide
+ Thioridazine
+ Medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days, as this may increase the risk of 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.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting 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 you experienced.
If you are currently taking or have recently taken certain medications, such as:
+ Linezolid
+ Methylene blue
+ Pimozide
+ Thioridazine
+ Medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days, as this may increase the risk of 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.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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 any potential interactions with other treatments.
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. This is crucial to prevent accidents and ensure your safety.
Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue the medication, your doctor will guide you on how to gradually stop taking it to minimize potential risks.
While taking this medication, it is recommended that you avoid consuming alcohol, as it may interact with the medication and increase the risk of side effects.
Before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness, consult your doctor to discuss potential risks and interactions.
If you have diabetes, it is crucial to closely monitor your blood sugar levels, as this medication may affect them.
It may take several weeks to experience the full effects of this medication. Be patient and follow your doctor's instructions.
This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor and report any unusual bleeding or bruising.
In rare cases, this medication can cause severe and potentially life-threatening reactions, including lung, kidney, or liver problems. Seek immediate medical attention if you experience any of the following symptoms: changes in urine output, dark urine, decreased appetite, stomach pain, 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 your risk. If you experience eye pain, changes in vision, or swelling and redness in or 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 to monitor any potential effects. 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, planning to become pregnant, or breastfeeding, as this medication may pose risks to you and your baby. Taking this medication during the third trimester of pregnancy may increase the risk of bleeding after delivery and cause health problems in the newborn. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy or breastfeeding.
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. This is crucial to prevent accidents and ensure your safety.
Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue the medication, your doctor will guide you on how to gradually stop taking it to minimize potential risks.
While taking this medication, it is recommended that you avoid consuming alcohol, as it may interact with the medication and increase the risk of side effects.
Before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness, consult your doctor to discuss potential risks and interactions.
If you have diabetes, it is crucial to closely monitor your blood sugar levels, as this medication may affect them.
It may take several weeks to experience the full effects of this medication. Be patient and follow your doctor's instructions.
This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor and report any unusual bleeding or bruising.
In rare cases, this medication can cause severe and potentially life-threatening reactions, including lung, kidney, or liver problems. Seek immediate medical attention if you experience any of the following symptoms: changes in urine output, dark urine, decreased appetite, stomach pain, 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 your risk. If you experience eye pain, changes in vision, or swelling and redness in or 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 to monitor any potential effects. 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, planning to become pregnant, or breastfeeding, as this medication may pose risks to you and your baby. Taking this medication during the third trimester of pregnancy may increase the risk of bleeding after delivery and cause health problems in the newborn. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy or breastfeeding.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Seizures
- Tachycardia (fast heart rate)
- Somnolence (drowsiness)
- Coma
- QT prolongation
- Ventricular arrhythmias
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. Ensure adequate airway, breathing, and circulation. Activated charcoal may be considered if ingested recently. Monitor cardiac rhythm and vital signs.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
- Thioridazine (risk of QT prolongation and sudden death)
- Pimozide (risk of QT prolongation)
Major Interactions
- Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
- Drugs metabolized by CYP2D6 (e.g., TCAs, antipsychotics like haloperidol, risperidone, antiarrhythmics like flecainide, propafenone) - increased plasma concentrations of co-administered drug.
- Warfarin and other anticoagulants/antiplatelets (e.g., NSAIDs, aspirin) - increased risk of bleeding.
- Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics) - additive QT prolongation risk.
Moderate Interactions
- Benzodiazepines (e.g., alprazolam, diazepam) - potential for increased benzodiazepine levels.
- Phenytoin - potential for increased phenytoin levels and toxicity.
- Carbamazepine - potential for increased carbamazepine levels and toxicity.
- Lithium - potential for increased lithium levels and neurotoxicity.
- Tryptophan - increased risk of serotonin syndrome.
Minor Interactions
- Alcohol - generally advised to avoid due to CNS depressant effects, though no specific pharmacokinetic interaction.
Monitoring
Baseline Monitoring
Psychiatric evaluation (mood, anxiety, suicidal ideation)
Rationale: To establish baseline severity of symptoms and assess risk of suicidality.
Timing: Prior to initiation
Weight and Height (especially in pediatric patients)
Rationale: To monitor for potential weight changes, which can occur with SSRIs.
Timing: Prior to initiation
Liver function tests (LFTs)
Rationale: Fluoxetine is extensively metabolized by the liver; baseline assessment is prudent, especially in patients with known hepatic impairment.
Timing: Prior to initiation (if clinically indicated)
Renal function tests (creatinine, BUN)
Rationale: Although primarily metabolized by liver, metabolites are renally excreted; baseline assessment is prudent, especially in patients with known renal impairment.
Timing: Prior to initiation (if clinically indicated)
Routine Monitoring
Clinical response to therapy (mood, anxiety, functional status)
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated.
Target: Improvement in target symptoms, remission of disorder.
Action Threshold: Lack of improvement after adequate trial, worsening symptoms, or emergence of new symptoms.
Suicidal ideation and behavior
Frequency: Closely monitor, especially during initial treatment and dose changes (first few months).
Target: Absence of suicidal thoughts or plans.
Action Threshold: Any emergence or worsening of suicidal thoughts or behaviors; requires immediate clinical assessment and intervention.
Adverse effects (e.g., GI upset, insomnia, anxiety, sexual dysfunction, hyponatremia)
Frequency: Regularly, especially during initial treatment and dose changes.
Target: Tolerable side effect profile.
Action Threshold: Intolerable side effects, requiring dose adjustment or discontinuation.
Weight (especially in pediatric patients)
Frequency: Periodically, e.g., every 3-6 months.
Target: Stable weight or appropriate growth trajectory.
Action Threshold: Significant or concerning weight gain/loss.
Serum Sodium (Na+)
Frequency: Periodically, especially in elderly, those on diuretics, or with risk factors for hyponatremia.
Target: 135-145 mEq/L
Action Threshold: <135 mEq/L (hyponatremia); requires investigation and management.
Symptom Monitoring
- Worsening depression
- Emergence of suicidal thoughts or behavior
- Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
- Symptoms of serotonin syndrome (e.g., agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
- Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls, severe and recurrent seizures)
- Unexplained bleeding or bruising
Special Patient Groups
Pregnancy
Fluoxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Exposure during the third trimester has been associated with complications in neonates, including persistent pulmonary hypertension of the newborn (PPHN) and withdrawal symptoms (e.g., respiratory distress, feeding difficulties, irritability).
Trimester-Specific Risks:
First Trimester:
Some studies suggest a possible, but small, increased risk of cardiovascular malformations, particularly septal defects. However, data are conflicting and overall risk appears low.
Second Trimester:
Generally considered lower risk for major malformations compared to first trimester, but continued exposure may contribute to third-trimester risks.
Third Trimester:
Increased risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, constant crying).
Lactation
Fluoxetine and its active metabolite, norfluoxetine, are excreted into breast milk. While some infants may experience no adverse effects, monitor breastfed infants for sedation, poor feeding, irritability, and poor weight gain. Use with caution, especially in neonates or preterm infants.
Infant Risk:
L3 (Moderately Safe) - Monitor infant for adverse effects. Consider alternative if infant is very young or has health issues.
Pediatric Use
Fluoxetine is approved for MDD in children 8 years and older and OCD in children 7 years and older. A Black Box Warning exists regarding increased risk of suicidal thinking and behavior in children, adolescents, and young adults. Close monitoring is essential.
Geriatric Use
Use with caution. Start with lower doses and titrate slowly. Elderly patients may be more sensitive to the effects of SSRIs, including an increased risk of hyponatremia (SIADH) and falls. Monitor for adverse effects and drug interactions.
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 compliance (e.g., if a dose is missed) but requires a long washout period (at least 5 weeks) before starting an MAOI or other serotonergic drugs.
- It can be more activating than other SSRIs, which may be beneficial for patients with significant fatigue or psychomotor retardation, but may worsen anxiety or insomnia in some individuals, especially at the start of treatment. Taking it in the morning is often recommended.
- Fluoxetine is a potent inhibitor of CYP2D6, which can lead to significant drug-drug interactions with medications metabolized by this enzyme.
- The 90 mg weekly formulation (Prozac Weekly) is available for maintenance therapy after patients have been stabilized on a daily dose.
- Consider the risk of serotonin syndrome when co-prescribing with other serotonergic agents. Educate patients on symptoms.
Alternative Therapies
- Other Selective Serotonin Reuptake Inhibitors (SSRIs): Sertraline, Paroxetine, Citalopram, Escitalopram, Fluvoxamine
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine, Duloxetine, Desvenlafaxine
- Atypical Antidepressants: Bupropion, Mirtazapine, Trazodone, Vortioxetine, Vilazodone
- Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline, Imipramine
- Monoamine Oxidase Inhibitors (MAOIs): Phenelzine, Tranylcypromine (reserved for refractory cases)
- Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
- Electroconvulsive Therapy (ECT) for severe or refractory depression
Cost & Coverage
Average Cost:
Varies widely per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred, to facilitate prompt and appropriate treatment.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred, to facilitate prompt and appropriate treatment.