Fetzima 80mg Capsules

Manufacturer ACTAVIS Active Ingredient Levomilnacipran(lee voe mil NA si pran) Pronunciation lee-voe-mil-NA-si-pran
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 children. Talk with the doctor. @ COMMON USES: It is used to treat depression.
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Drug Class
Antidepressant
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Pharmacologic Class
Serotonin and Norepinephrine Reuptake Inhibitor (SNRI)
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Pregnancy Category
Not available
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FDA Approved
Jul 2013
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Fetzima is a medication used to treat depression. It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain, which can improve mood and feelings of well-being. It's a type of antidepressant called an SNRI.
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How to Use This Medicine

Taking Your Medication

To get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at the same time every day.
You can take your medication with or without food.
Swallow the medication whole - do not chew, open, or crush it.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

To ensure your medication remains effective and safe:

Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider.
Check with your pharmacist for guidance on the best way to dispose of your medication, or look into local drug take-back programs.

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take the missed dose as soon as you remember.
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 a missed dose.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily with or without food.
  • Do not crush, chew, or open the capsule; swallow whole.
  • Avoid abrupt discontinuation; gradually reduce dose under medical supervision to prevent withdrawal symptoms.
  • Avoid alcohol consumption, as it may worsen side effects.
  • Be cautious when driving or operating machinery until you know how the medication affects you, as it may cause dizziness or drowsiness.
  • Monitor blood pressure regularly as advised by your doctor.
  • Report any unusual changes in mood, behavior, or thoughts, especially suicidal thoughts, to your doctor immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial 20 mg once daily for 2 days, then 40 mg once daily. May increase to 80 mg or 120 mg once daily based on clinical response and tolerability.
Dose Range: 20 - 120 mg

Condition-Specific Dosing:

majorDepressiveDisorder: Initial 20 mg once daily for 2 days, then 40 mg once daily. May increase in 40 mg increments at intervals of 2 or more days up to a maximum of 120 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: CrCl 60-89 mL/min: No dosage adjustment needed.
Moderate: CrCl 30-59 mL/min: Maximum recommended dose is 80 mg once daily.
Severe: CrCl 15-29 mL/min: Maximum recommended dose is 40 mg once daily.
Dialysis: CrCl <15 mL/min or ESRD: Not recommended.

Hepatic Impairment:

Mild: Child-Pugh A: No dosage adjustment needed.
Moderate: Child-Pugh B: No dosage adjustment needed.
Severe: Child-Pugh C: Maximum recommended dose is 80 mg once daily.

Pharmacology

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Mechanism of Action

Levomilnacipran is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is the more pharmacologically active enantiomer of milnacipran. It selectively inhibits the reuptake of both serotonin (5-HT) and norepinephrine (NE) into presynaptic neurons, thereby increasing the concentrations of these neurotransmitters in the synaptic cleft. This action is thought to modulate mood and behavior, contributing to its antidepressant effects.
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Pharmacokinetics

Absorption:

Bioavailability: 92%
Tmax: 6-8 hours
FoodEffect: No clinically significant effect of food on absorption.

Distribution:

Vd: 460 L
ProteinBinding: 22%
CnssPenetration: Yes

Elimination:

HalfLife: 12 hours
Clearance: Not available
ExcretionRoute: Renal (primarily), also fecal.
Unchanged: 57% (renal)
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Pharmacodynamics

OnsetOfAction: Typically 1-2 weeks for initial therapeutic effects; full antidepressant effect may take 4-6 weeks.
PeakEffect: 4-6 weeks for maximal antidepressant effect.
DurationOfAction: 24 hours (due to once-daily dosing and half-life).

Safety & Warnings

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BLACK BOX WARNING

Antidepressants increased the risk compared to placebo of suicidal thoughts and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. This risk must be balanced 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. Fetzima is not approved for use in pediatric patients.
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Side Effects

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention right away:

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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Signs of low sodium levels, such as:
+ Headache
+ Difficulty focusing
+ Memory problems
+ Confusion
+ Weakness
+ Seizures
+ Changes in balance
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Fainting or loss of consciousness
+ Changes in vision
Abnormal or rapid heartbeat
Seizures
Feeling extremely tired or weak
Difficulty urinating
Sexual problems, such as:
+ Decreased interest in sex
+ Difficulty achieving orgasm
+ Ejaculation problems
+ Trouble 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 attention immediately if you experience:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Abnormal or rapid heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

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 is essential to report any bothersome or persistent side effects to your doctor. These may include:

Upset stomach or vomiting
Constipation
Excessive sweating

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor.

Reporting Side Effects

To report side effects, you can:

Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
Visit the FDA's MedWatch website at https://www.fda.gov/medwatch
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Seek Immediate Medical Attention If You Experience:

  • Worsening depression or anxiety
  • New or worsening suicidal thoughts or behavior
  • Panic attacks
  • Agitation, restlessness, irritability
  • Aggressiveness, violence
  • Unusual excitement or mania
  • Severe headache, confusion, rapid heartbeat, sweating, muscle stiffness, tremors, or twitching (signs of serotonin syndrome)
  • New or worsening high blood pressure
  • Difficulty urinating
  • Unusual bleeding or bruising
  • Seizures
  • Allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have kidney disease, as this may affect how your body processes the medication.
If you have narrow angle glaucoma or are at risk for developing this condition.
If you are currently taking or have recently taken certain medications, including:
+ Linezolid or methylene blue, as these can interact with this medication.
+ Certain drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications together can increase the risk of very high blood pressure.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Your doctor and pharmacist need to be aware of all your medications and health conditions to ensure it is safe for you to take this medication. Never start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before engaging in activities that require your full attention, such as driving, wait until you understand how this medication affects you.

Do not abruptly stop taking this medication without first consulting your doctor, as this may increase your risk of experiencing side effects. If you need to discontinue this medication, your doctor will provide guidance on how to gradually stop taking it to minimize potential risks.

As directed by your doctor, regularly undergo blood tests and other laboratory examinations to monitor your condition. Additionally, check your blood pressure and heart rate as instructed by your doctor.

While taking this medication, it is recommended that you avoid consuming alcohol. Before using marijuana, cannabis products, or prescription and over-the-counter medications that may cause drowsiness, consult with your doctor to discuss potential interactions.

Be aware that this medication may increase your risk of bleeding, which can be life-threatening in some cases. Consult your doctor to discuss this risk.

Some individuals may have a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye examination to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor immediately.

This medication can cause low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or death.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy and breastfeeding. Taking this medication during the third trimester may increase your risk of bleeding after delivery and potentially cause health problems in the newborn. If you are breastfeeding, your doctor will help you weigh the risks and benefits to your baby.
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Overdose Information

Overdose Symptoms:

  • Tachycardia
  • Hypertension
  • Somnolence
  • Nausea
  • Vomiting
  • Dizziness
  • Seizures
  • Serotonin syndrome

What to Do:

Seek immediate medical attention or call 911. Contact a poison control center (1-800-222-1222). Management is symptomatic and supportive. There is no specific antidote.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOI or starting MAOI after levomilnacipran)
  • Linezolid (reversible non-selective MAOI)
  • Methylene blue (reversible non-selective MAOI)
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - increased levomilnacipran exposure.
  • Anticoagulants/Antiplatelets (e.g., warfarin, aspirin, NSAIDs) - increased risk of bleeding.
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Moderate Interactions

  • Drugs that increase blood pressure (e.g., decongestants, certain stimulants) - additive pressor effects.
  • Alcohol - may exacerbate CNS effects.

Monitoring

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Baseline Monitoring

Depression severity (e.g., PHQ-9, HAM-D)

Rationale: To establish baseline and monitor treatment efficacy.

Timing: Prior to initiation

Suicidal ideation/behavior

Rationale: To assess risk, especially in young adults.

Timing: Prior to initiation

Blood pressure and heart rate

Rationale: SNRIs can cause dose-dependent increases in blood pressure and heart rate.

Timing: Prior to initiation

Electrolytes (especially sodium)

Rationale: To assess for baseline hyponatremia risk, particularly in elderly or those on diuretics.

Timing: Prior to initiation (consider)

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Routine Monitoring

Depression severity and clinical response

Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated.

Target: Reduction in symptom scores, improved mood/function.

Action Threshold: Lack of improvement or worsening symptoms may require dose adjustment or alternative therapy.

Suicidal ideation/behavior

Frequency: Weekly for first 4 weeks, then every 2 weeks for next 4 weeks, then monthly for 12 weeks, and as clinically indicated.

Target: Absence of suicidal thoughts/behaviors.

Action Threshold: Emergence or worsening of suicidal thoughts/behaviors requires immediate assessment and intervention.

Blood pressure and heart rate

Frequency: Regularly, especially during dose titration and periodically thereafter.

Target: Within patient's normal range or controlled with antihypertensives.

Action Threshold: Sustained clinically significant increases may require dose reduction or discontinuation.

Emergence of adverse effects (e.g., nausea, constipation, sweating, sexual dysfunction, urinary hesitancy)

Frequency: At each visit, especially during initial treatment.

Target: Tolerable side effect profile.

Action Threshold: Intolerable side effects may require dose adjustment or discontinuation.

Symptoms of serotonin syndrome (e.g., agitation, hallucinations, tachycardia, fever, hyperreflexia, incoordination)

Frequency: At each visit, especially if co-administered with other serotonergic drugs.

Target: Absence of symptoms.

Action Threshold: Immediate medical attention required if suspected.

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Symptom Monitoring

  • Worsening depression
  • Suicidal thoughts or behavior
  • Unusual changes in behavior or mood (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, aggression, mania/hypomania)
  • Serotonin syndrome symptoms (e.g., confusion, hallucinations, sweating, muscle rigidity, tremor, rapid heart rate, high blood pressure, nausea, vomiting, diarrhea)
  • Increased blood pressure or heart rate
  • Urinary hesitancy or retention
  • Excessive sweating
  • Sexual dysfunction
  • Nausea, constipation, dry mouth
  • Dizziness, headache

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Exposure to SNRIs in late pregnancy may increase the risk of persistent pulmonary hypertension of the newborn (PPHN) and withdrawal symptoms in the neonate.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations.
Second Trimester: Limited data.
Third Trimester: Increased risk of PPHN and neonatal withdrawal syndrome (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia) if exposed late in the third trimester.
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Lactation

Levomilnacipran is excreted into human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Fetzima, and any potential adverse effects on the breastfed infant from Fetzima or from the underlying maternal condition. Monitor infants for sedation, poor feeding, and poor weight gain.

Infant Risk: Moderate risk (L3) due to excretion into milk and potential for adverse effects.
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients. Fetzima is not approved for use in pediatric patients. Antidepressants increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults.

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Geriatric Use

No overall differences in safety or effectiveness were observed between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for hyponatremia and falls. Use with caution, generally starting at the lower end of the dosing range.

Clinical Information

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Clinical Pearls

  • Fetzima is an SNRI with a higher norepinephrine reuptake inhibition potency compared to serotonin, which may be beneficial for patients with prominent fatigue or anhedonia.
  • Capsules must be swallowed whole; do not open, chew, or crush, as this will alter the extended-release properties.
  • Monitor blood pressure and heart rate regularly, especially during dose titration, due to potential for dose-dependent increases.
  • Gradual tapering is essential upon discontinuation to minimize withdrawal symptoms (e.g., dizziness, nausea, headache, paresthesia, anxiety, insomnia).
  • Caution with concomitant use of other serotonergic agents due to the risk of serotonin syndrome.
  • Not recommended for patients with end-stage renal disease (CrCl <15 mL/min).
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Alternative Therapies

  • Other SNRIs (e.g., venlafaxine, desvenlafaxine, duloxetine)
  • SSRIs (e.g., fluoxetine, sertraline, escitalopram, citalopram, paroxetine)
  • Atypical antidepressants (e.g., bupropion, mirtazapine, vortioxetine, vilazodone)
  • Tricyclic antidepressants (TCAs)
  • MAOIs (less common due to side effects and interactions)
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Cost & Coverage

Average Cost: Varies widely, typically $300-$600+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand, or generic equivalent)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe and effective use. 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, do not 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 detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred.