Fetzima 20mg Capsules

Levomilnacipran is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is the more pharmacologically active enantiomer of milnacipran. It potently inhibits the reuptake of both norepinephrine (NE) and serotonin (5-HT) in the central nervous system, with greater potency for NE reuptake inhibition than for 5-HT reuptake inhibition (approximately 2-fold greater in vitro). This dual reuptake inhibition is thought to potentiate the neurotransmitter activity in the CNS, leading to its antidepressant 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 immediately or seek emergency medical attention:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of bleeding: 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, or uncontrollable bleeding
Signs of low sodium levels: headache, difficulty focusing, memory problems, confusion, weakness, seizures, or balance disturbances
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Abnormal or rapid heartbeat
Seizures
Extreme fatigue or weakness
Urination difficulties
Sexual problems, including decreased libido, difficulty achieving orgasm, ejaculation issues, or erectile dysfunction (if you have concerns, discuss them with your doctor)

A rare but potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking other medications that interact with this drug. Seek immediate medical attention if you experience:
Agitation
Balance disturbances
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, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor:

Nausea or vomiting
Constipation
* Excessive sweating

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, 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.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions and circumstances to ensure safe treatment:

Any known allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
Presence of kidney disease, as this may affect the medication's dosage or administration.
Diagnosis or risk of narrow-angle glaucoma, a condition that affects the eyes.
Current or recent use of certain medications, including:
+ Linezolid or methylene blue, as these may interact with this medication.
+ Drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, taken within the last 14 days. Combining these medications can lead to very high blood pressure.
* Other health problems or medications, including prescription and over-the-counter drugs, natural products, and vitamins. This is not an exhaustive list, and it is crucial to disclose all relevant information.

To ensure your safety, consult your doctor and pharmacist about all your medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.

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.

To minimize the risk of side effects, do not abruptly stop taking this medication without first consulting your doctor. If you need to discontinue use, your doctor will provide guidance on how to gradually taper off the medication.

As directed by your doctor, regularly schedule blood work and other laboratory tests 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 the risk of bleeding, which can be life-threatening in some cases. Consult with your doctor to discuss this risk.

Certain individuals may have 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 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. Taking this medication during the third trimester of pregnancy may increase the risk of bleeding after delivery and potentially cause health problems in the newborn. Your doctor will help you weigh the benefits and risks of using this medication during pregnancy and breastfeeding.

• Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, selegiline, linezolid, methylene blue)
• Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's Wort) - concomitant use with MAOIs

• Serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, fentanyl, tramadol, lithium, 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
• Drugs that increase blood pressure or heart rate (e.g., stimulants, decongestants, other SNRIs) - additive effects
• Alcohol - may increase CNS effects and impair cognitive/motor skills

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil) - potential for increased levomilnacipran exposure
• Drugs that cause hyponatremia (e.g., diuretics) - increased risk of SIADH
• Drugs that affect urinary outflow (e.g., alpha-1 blockers) - potential for urinary retention

• Not specifically identified as minor interactions with clinical significance requiring dosage adjustment in package insert.

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, aggression, akathisia, hypomania, mania)
• Headache
• Nausea
• Constipation
• Dizziness
• Insomnia
• Hyperhidrosis (excessive sweating)
• Tachycardia
• Hypertension
• Urinary hesitancy/retention
• Sexual dysfunction
• Serotonin syndrome symptoms (e.g., agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, GI symptoms)
• Bleeding/bruising

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These complications can arise immediately upon delivery.

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 agitation, irritability, poor feeding, and poor weight gain.

Safety and effectiveness have not been established in pediatric patients. Fetzima is not approved for use in pediatric patients. A Black Box Warning regarding increased risk of suicidal thoughts and behavior in children, adolescents, and young adults is present.

No overall differences in safety or effectiveness were observed between elderly patients 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. Dose adjustments for renal impairment are more likely to be needed in elderly patients.

• Fetzima is an SNRI with a unique pharmacological profile, having greater potency for norepinephrine reuptake inhibition than serotonin reuptake inhibition, which differentiates it from other SNRIs like venlafaxine or duloxetine.
• It is dosed once daily due to its extended-release formulation and relatively long half-life.
• Patients should be advised not to crush, chew, or open the capsules, as this will alter the extended-release properties and could lead to increased side effects.
• Blood pressure and heart rate monitoring are crucial, especially during dose titration, due to the noradrenergic effects.
• Discontinuation syndrome can occur if Fetzima is stopped abruptly; a gradual dose reduction is recommended.
• Consider the risk of serotonin syndrome when co-administering with other serotonergic agents.
• Be vigilant for symptoms of mania/hypomania in patients with undiagnosed bipolar disorder.

• Other SNRIs (e.g., Venlafaxine, Duloxetine, Desvenlafaxine)
• SSRIs (e.g., Fluoxetine, Sertraline, Paroxetine, Citalopram, Escitalopram)
• Atypical antidepressants (e.g., Bupropion, Mirtazapine, Vortioxetine, Vilazodone)
• Tricyclic Antidepressants (TCAs)
• MAOIs (less common due to side effects and interactions)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
• Electroconvulsive Therapy (ECT) for severe or treatment-resistant depression

If your symptoms or health issues persist or worsen, it is 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, 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, 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. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.