Fetzima 40mg Capsules

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) in the central nervous system, thereby increasing the synaptic concentrations of these neurotransmitters. The exact mechanism of action in major depressive disorder (MDD) is unknown but is presumed to be related to its potentiation of serotonergic and noradrenergic neurotransmission.

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 medical attention immediately:

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 or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Fainting or changes in vision
Fast or abnormal heartbeat
Seizures
Feeling extremely tired or weak
Difficulty urinating
Sexual problems, such as:
+ Decreased interest in sex
+ Trouble having an orgasm
+ Ejaculation problems
+ Difficulty getting or maintaining an erection
A potentially life-threatening condition called serotonin syndrome, which may be more likely if you take 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

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

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. 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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
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 of 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.
* Other health problems or medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins. This is not an exhaustive list, and it is crucial to discuss all your medications and health issues with your doctor to ensure safe treatment.

To ensure your safety, it is vital to consult with your doctor and pharmacist about all your medications and health problems before taking this medication. Do not start, stop, or change the dose of any medication without first consulting your doctor.

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 stop taking it.

As directed by your doctor, regularly schedule blood tests and other laboratory exams 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.

Be aware that this medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.

Certain 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 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 may be pregnant, inform your doctor. You and your doctor will need to discuss the potential benefits and risks to you and your baby. Taking this medication during the third trimester may increase the risk of bleeding after delivery and potentially cause health problems in the newborn.

If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOI, or starting MAOI within 7 days of stopping levomilnacipran)
• Linezolid (reversible MAOI)
• Methylene blue (reversible MAOI)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir, saquinavir, telithromycin, nefazodone) - may increase levomilnacipran exposure
• Serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's Wort) - increased risk of serotonin syndrome
• Drugs that affect hemostasis (e.g., NSAIDs, aspirin, warfarin) - increased risk of bleeding
• Other CNS depressants (e.g., alcohol, benzodiazepines, opioids) - additive CNS depression

• Moderate CYP3A4 inhibitors
• Drugs that increase heart rate or blood pressure (e.g., sympathomimetics, other SNRIs)

• Not specifically listed as minor, but general caution with drugs metabolized by minor CYP pathways.

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
• Serotonin syndrome (e.g., agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, gastrointestinal symptoms)
• Hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls)
• Increased blood pressure or heart rate
• Urinary hesitation or retention
• Sexual dysfunction
• Nausea, constipation, vomiting

Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Neonates exposed to SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.

Levomilnacipran is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, including central nervous system effects, the decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients (under 18 years of age). Antidepressants increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults.

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. Dosage adjustments may be needed based on renal function, which often declines with age.

• Levomilnacipran has a higher norepinephrine reuptake inhibition potency relative to serotonin compared to other SNRIs like venlafaxine or duloxetine, which may be beneficial for patients with prominent fatigue or low energy.
• Always titrate the dose slowly to minimize side effects, especially blood pressure and heart rate increases.
• Counsel patients on the importance of not abruptly discontinuing the medication to avoid withdrawal symptoms.
• Monitor blood pressure and heart rate regularly, especially in patients with pre-existing cardiovascular conditions.
• Be vigilant for signs of serotonin syndrome, particularly when co-prescribing with other serotonergic agents.
• Consider the renal impairment dosing adjustments carefully, as levomilnacipran is primarily renally eliminated.

• 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 effect profile and interactions)

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 amount, and the time it occurred.