Fluoxetine 90mg Delayed Rel Caps
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
Category C
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), and premenstrual dysphoric disorder (PMDD). This specific form is a delayed-release capsule taken once a week. It works by helping to restore the balance of a natural substance in the brain called serotonin, 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. Continue taking it even if you feel well, unless your doctor or healthcare provider tells you to stop. Swallow the medication whole; do not chew, break, or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Make sure the lid is tightly closed. Keep 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 dose, skip the missed dose and resume your regular 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. Continue taking it even if you feel well, unless your doctor or healthcare provider tells you to stop. Swallow the medication whole; do not chew, break, or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Make sure the lid is tightly closed. Keep 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 dose, skip the missed dose and resume your regular 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 a week on the same day.
- Do not crush, chew, or open the capsule; swallow it whole.
- It may take several weeks to feel the full benefits. Do not stop taking it suddenly without talking to your doctor, as this can cause withdrawal symptoms.
- Avoid alcohol while taking this medication.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it may cause dizziness or drowsiness.
- Maintain regular follow-up appointments with your doctor to monitor your progress and side effects.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
90 mg orally once weekly
Dose Range:
90 - 90 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
90 mg orally once weekly, typically initiated 7 days after the last daily dose of fluoxetine 20 mg. For maintenance.
Obsessive-Compulsive Disorder (OCD):
90 mg orally once weekly, typically initiated 7 days after the last daily dose of fluoxetine 20 mg. For maintenance.
Premenstrual Dysphoric Disorder (PMDD):
90 mg orally once weekly, initiated 7 days after the last daily dose of fluoxetine 20 mg. Can be continuous or luteal phase.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for 90mg delayed-release formulation. Daily fluoxetine is used for pediatric MDD/OCD.
Adolescent:
Not established for 90mg delayed-release formulation. Daily fluoxetine is used for adolescent MDD/OCD.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment typically necessary.
Moderate:
No dosage adjustment typically necessary.
Severe:
Use with caution. Consider lower or less frequent dosing. Accumulation of fluoxetine and norfluoxetine may occur.
Dialysis:
Not well studied. Use with caution. Consider lower or less frequent dosing.
Hepatic Impairment:
Mild:
Consider lower or less frequent dosing (e.g., every other day or every third day for daily fluoxetine, which would translate to careful consideration for weekly dosing).
Moderate:
Consider lower or less frequent dosing (e.g., every other day or every third day for daily fluoxetine, which would translate to careful consideration for weekly dosing).
Severe:
Use with caution. Consider lower or less frequent dosing (e.g., every other day or every third day for daily fluoxetine, which would translate to careful consideration for weekly dosing). Half-life of fluoxetine and norfluoxetine may be prolonged.
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, beta-adrenergic, dopaminergic, histaminergic, muscarinic, GABAergic).
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly stated for DR, but well absorbed. Food does not significantly affect systemic bioavailability.
Tmax:
6-8 hours (for 90mg DR capsule, for fluoxetine). Norfluoxetine Tmax is longer.
FoodEffect:
Food does not significantly affect the systemic bioavailability of fluoxetine, but may delay absorption slightly.
Distribution:
Vd:
20-40 L/kg
ProteinBinding:
Approximately 94.5% (primarily to albumin and alpha-1-glycoprotein)
CnssPenetration:
Yes
Elimination:
HalfLife:
Fluoxetine: 4-6 days; Norfluoxetine: 4-16 days (due to enterohepatic recirculation and slow elimination)
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (approximately 60% as metabolites), Fecal (approximately 12%)
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:
Peak therapeutic effect typically observed after 4-6 weeks of consistent dosing.
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 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
Serious 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 medical attention immediately:
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 period
Increased 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
+ Trouble having an orgasm
+ Ejaculation problems
+ Difficulty getting or maintaining 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 Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
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
This is not an exhaustive list of potential side effects. If you have questions or concerns, contact 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 medical attention immediately:
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 period
Increased 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
+ Trouble having an orgasm
+ Ejaculation problems
+ Difficulty getting or maintaining 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 Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
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
This is not an exhaustive list of potential side effects. If you have questions or concerns, contact 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:
- New or worsening depression or anxiety
- Thoughts of harming yourself or others
- Extreme agitation, restlessness, or panic attacks
- Difficulty sleeping (insomnia)
- Unusual changes in behavior or mood
- Severe headache, confusion, rapid heart rate, sweating, muscle stiffness, tremors, or twitching (signs of serotonin syndrome)
- Unexplained bleeding or bruising
- Seizures
- Allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
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 symptoms 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
Natural products and vitamins you are using
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 symptoms 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
Natural products and vitamins you are using
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
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
Stopping the Medication
Do not suddenly stop taking this medication without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will instruct you on how to gradually discontinue it.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness, consult your doctor.
Monitoring Blood Sugar Levels
If you have diabetes (high blood sugar), closely monitor your blood sugar levels while taking this medication.
Delayed Effects
It may take several weeks to experience the full effects of this medication.
Bleeding Risks
This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.
Severe Reactions
Rarely, severe and potentially life-threatening reactions, including rash, lung, kidney, or liver problems, have occurred with this medication. Immediately contact your doctor if you experience any of the following symptoms:
- Changes in urine output
- Dark urine
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
- Shortness of breath
Eye Problems
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 any of the following symptoms, contact your doctor immediately:
- Eye pain
- Changes in vision
- Swelling or redness in or around the eye
Low Sodium Levels
This medication can cause low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or death.
Effects on Growth in Children and Teens
In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary. Discuss this risk with your doctor.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. Taking this medication in the third trimester of pregnancy may increase the risk of bleeding after delivery and potentially cause health problems in the newborn. Your doctor will discuss the benefits and risks of taking this medication during pregnancy and breastfeeding.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
Stopping the Medication
Do not suddenly stop taking this medication without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will instruct you on how to gradually discontinue it.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness, consult your doctor.
Monitoring Blood Sugar Levels
If you have diabetes (high blood sugar), closely monitor your blood sugar levels while taking this medication.
Delayed Effects
It may take several weeks to experience the full effects of this medication.
Bleeding Risks
This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.
Severe Reactions
Rarely, severe and potentially life-threatening reactions, including rash, lung, kidney, or liver problems, have occurred with this medication. Immediately contact your doctor if you experience any of the following symptoms:
- Changes in urine output
- Dark urine
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
- Shortness of breath
Eye Problems
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 any of the following symptoms, contact your doctor immediately:
- Eye pain
- Changes in vision
- Swelling or redness in or around the eye
Low Sodium Levels
This medication can cause low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or death.
Effects on Growth in Children and Teens
In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary. Discuss this risk with your doctor.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. Taking this medication in the third trimester of pregnancy may increase the risk of bleeding after delivery and potentially cause health problems in the newborn. Your doctor will discuss the benefits and risks of taking this medication during pregnancy and breastfeeding.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Seizures
- Tachycardia (fast heart rate)
- ECG changes (e.g., QT prolongation)
- Somnolence (drowsiness)
- Coma
What to Do:
Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention. There is no specific antidote; treatment is supportive.
Drug Interactions
Contraindicated Interactions
- MAOIs (e.g., phenelzine, tranylcypromine, selegiline, linezolid, methylene blue) - risk of serotonin syndrome
- Pimozide - risk of QT prolongation
- Thioridazine - risk of QT prolongation and sudden death
Major Interactions
- Tricyclic Antidepressants (TCAs) - increased TCA levels
- Antiarrhythmics (e.g., flecainide, propafenone) - increased levels
- Antipsychotics (e.g., clozapine, haloperidol) - increased levels
- Triptans (e.g., sumatriptan) - risk of serotonin syndrome
- Other serotonergic drugs (e.g., tramadol, fentanyl, lithium, St. John's Wort, other SSRIs/SNRIs) - risk of serotonin syndrome
- Warfarin - increased bleeding risk
- Drugs that prolong QT interval (e.g., quinidine, sotalol, certain antipsychotics) - additive QT prolongation risk
Moderate Interactions
- Benzodiazepines (e.g., alprazolam, diazepam) - increased benzodiazepine levels
- Carbamazepine - increased carbamazepine levels
- Phenytoin - increased phenytoin levels
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs) - increased bleeding risk
- Aspirin - increased bleeding risk
- Metoprolol - increased metoprolol levels
- Atomoxetine - increased atomoxetine levels
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Psychiatric evaluation (mood, anxiety, suicidal ideation)
Rationale: To establish baseline symptom severity and identify risk factors for suicidality.
Timing: Prior to initiation
Complete Blood Count (CBC)
Rationale: To assess for potential hematologic abnormalities, though rare.
Timing: Prior to initiation (optional, but good practice)
Electrolytes (Sodium)
Rationale: To assess for baseline hyponatremia risk, especially in elderly or those on diuretics.
Timing: Prior to initiation
Weight/BMI
Rationale: To monitor for weight changes, a common side effect.
Timing: Prior to initiation
ECG
Rationale: Consider for patients with pre-existing cardiac conditions or on other QT-prolonging drugs.
Timing: Prior to initiation (if indicated)
Routine Monitoring
Clinical response (symptom improvement)
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated
Target: Reduction in symptom severity scores (e.g., HAM-D, MADRS, Y-BOCS)
Action Threshold: Lack of improvement after 6-8 weeks, or worsening symptoms
Suicidal ideation/behavior
Frequency: Weekly for first few weeks, especially in young adults/adolescents, then monthly or as clinically indicated
Target: Absence of new or worsening suicidal thoughts/behaviors
Action Threshold: Any new or worsening suicidal ideation, agitation, or unusual behavior
Adverse effects (e.g., GI upset, insomnia, sexual dysfunction, anxiety, agitation)
Frequency: Weekly for first few weeks, then monthly or as clinically indicated
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects requiring dose adjustment or discontinuation
Weight/BMI
Frequency: Every 3-6 months
Target: Stable weight or within acceptable range
Action Threshold: Significant weight gain or loss
Electrolytes (Sodium)
Frequency: Periodically, especially in elderly or those at risk for hyponatremia
Target: 135-145 mEq/L
Action Threshold: Sodium < 130 mEq/L
Symptom Monitoring
- Worsening depression
- New or worsening anxiety
- Agitation
- Panic attacks
- Insomnia
- Irritability
- Hostility
- Impulsivity
- Akathisia (psychomotor restlessness)
- Hypomania/mania
- Unusual changes in behavior
- Suicidal ideation or attempts
- Signs of serotonin syndrome (e.g., agitation, hallucinations, rapid heart beat, fever, sweating, shivering, muscle rigidity, twitching, loss of coordination, nausea, vomiting, diarrhea)
- Signs of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls)
Special Patient Groups
Pregnancy
Use during pregnancy should be carefully considered, balancing potential risks and benefits. Category C. Some studies suggest a potential increased risk of persistent pulmonary hypertension of the newborn (PPHN) and withdrawal symptoms in neonates exposed late in the third trimester.
Trimester-Specific Risks:
First Trimester:
Limited data on major malformations; some studies suggest a small increased risk of cardiovascular malformations, but overall risk is low and inconsistent across studies.
Second Trimester:
Generally considered safer than first or third trimester, but continued monitoring for maternal mental health is crucial.
Third Trimester:
Increased risk of neonatal withdrawal symptoms (e.g., irritability, tremor, feeding difficulties, respiratory distress) and persistent pulmonary hypertension of the newborn (PPHN).
Lactation
Fluoxetine and its active metabolite norfluoxetine are excreted into breast milk. The American Academy of Pediatrics considers fluoxetine to be a drug for which the effect on a nursing infant is unknown but may be of concern. Monitor infants for drowsiness, poor feeding, and weight gain. L3 (Moderately Safe).
Infant Risk:
Moderate risk. Potential for infant drowsiness, irritability, poor feeding, and weight loss. Long half-life may lead to accumulation in infant.
Pediatric Use
The 90mg delayed-release formulation is not approved for pediatric use. Daily fluoxetine is approved for MDD in children 8 years and older and OCD in children 7 years and older. Close monitoring for suicidality is crucial, especially at treatment initiation or dose changes.
Geriatric Use
Use with caution. Elderly patients may be more sensitive to the effects of SSRIs, including hyponatremia and CNS effects (e.g., dizziness, falls). Lower starting doses and slower titration may be appropriate for daily fluoxetine, which would translate to careful consideration for weekly dosing. 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 is why the 90mg DR can be dosed weekly.
- The long half-life also means that a washout period of at least 5 weeks (or longer, up to 7 weeks, especially if high doses or liver impairment) is required before starting an MAOI to avoid serotonin syndrome.
- Fluoxetine is a potent inhibitor of CYP2D6, which can lead to significant drug interactions with medications metabolized by this enzyme.
- While the 90mg DR is convenient for maintenance, it is not typically used for initial treatment due to the need for slower titration and monitoring of response and tolerability.
- Patients should be educated about the potential for activation syndrome (anxiety, agitation, insomnia) early in treatment and the importance of not discontinuing abruptly.
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)
- MAOIs (e.g., phenelzine, tranylcypromine)
- Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200+ per 4 capsules (1 month supply)
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 for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, don't hesitate to consult with 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.