Fetzima 120mg Capsules

Levomilnacipran is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It potently 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. It has a higher selectivity for norepinephrine reuptake inhibition compared to serotonin reuptake inhibition (NE:5-HT reuptake ratio of approximately 1:2).

Urgent Side Effects: Seek Medical Attention Immediately

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 help right away:

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 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
+ 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

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
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach 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 contact your doctor or seek medical help if you notice any of the following:

Upset stomach or vomiting
Constipation
Excessive sweating

These are not all the possible side effects that may occur. 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. 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 of developing it.
If you are currently taking or have recently taken certain medications, including:
+ Linezolid or methylene blue, as these can interact with this medication.
+ Certain antidepressants or Parkinson's disease medications, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Combining these medications can lead to 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.

Remember to consult with your doctor and pharmacist before starting, stopping, or changing the dose of any medication to guarantee your safety while taking this drug.

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 have your blood work and other laboratory tests checked. Additionally, monitor 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, or any prescription or over-the-counter drugs 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 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 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, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the benefits and risks of taking this medication. 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. If you are breastfeeding, you and your doctor will need to discuss any potential risks to your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, selegiline, isocarboxazid)
• Linezolid
• Intravenous Methylene Blue

• Serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's Wort) - increased risk of serotonin syndrome
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - increased levomilnacipran exposure
• Drugs that increase blood pressure or heart rate (e.g., other SNRIs, stimulants, decongestants) - additive effects
• Anticoagulants/Antiplatelets (e.g., warfarin, aspirin, NSAIDs) - increased risk of bleeding

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil) - increased levomilnacipran exposure
• Alcohol - may enhance CNS effects

• Not available

• Worsening depression
• Suicidal thoughts or behavior (especially in young adults)
• Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
• Signs of serotonin syndrome (e.g., agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, GI symptoms)
• Signs of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls, severe and more acute symptoms include hallucinations, syncope, seizure, coma, respiratory arrest)
• New or worsening hypertension
• Urinary hesitation or retention
• Visual disturbances (e.g., blurred vision, eye pain, halos around lights) - risk of angle-closure glaucoma

Use during pregnancy should be avoided unless 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. Due to the potential for serious adverse reactions in breastfed infants, including agitation, irritability, and poor feeding, a 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. Fetzima is not approved for use in pediatric patients. Antidepressants carry a Black Box Warning for increased risk of suicidality in children, adolescents, and young adults.

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. Dose adjustments may be necessary for elderly patients with renal impairment.

• Levomilnacipran has a higher norepinephrine reuptake inhibition ratio compared to serotonin, which may differentiate its side effect profile and efficacy from other SNRIs.
• Always titrate the dose gradually to minimize side effects, especially blood pressure and heart rate increases.
• Monitor blood pressure and heart rate regularly, particularly in patients with pre-existing cardiovascular conditions.
• Counsel patients on the Black Box Warning regarding suicidality, especially young adults, and the importance of reporting any worsening mood or behavioral changes.
• Be vigilant for signs of serotonin syndrome, especially when co-administered with other serotonergic agents.
• Discontinuation syndrome can occur if the drug is stopped abruptly; taper the dose gradually over at least 1-2 weeks.
• The capsule shell may be excreted in the stool, which is normal and does not mean the medication was not absorbed.

• Other SNRIs (e.g., Venlafaxine, Desvenlafaxine, Duloxetine)
• SSRIs (e.g., Fluoxetine, Sertraline, Paroxetine, Citalopram, Escitalopram)
• Atypical antidepressants (e.g., Bupropion, Mirtazapine, Vortioxetine, Vilazodone)
• Tricyclic Antidepressants (TCAs)
• MAOIs (reserved for refractory cases)

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, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. 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. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.