Vilazodone 40mg Tablets

Vilazodone is an antidepressant that acts as a selective serotonin reuptake inhibitor (SSRI) and a 5-HT1A receptor partial agonist. The combination of these two activities is thought to contribute to its antidepressant effects. It inhibits the reuptake of serotonin into presynaptic neurons, increasing serotonin concentrations in the synaptic cleft. Its partial agonism at 5-HT1A receptors may modulate serotonergic 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
+ 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
+ Change in balance
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that looks like coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that get bigger
+ Uncontrollable bleeding
Seizures
Sex problems, including:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or keeping an erection
Serotonin syndrome, a potentially life-threatening condition that may occur, especially when taking certain other medications. Call your doctor right away if you experience:
+ Agitation
+ Change 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

Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Trouble sleeping
Diarrhea
Stomach pain
Upset stomach or vomiting
Dry mouth
Dizziness or headache
* Feeling sleepy

Reporting Side Effects

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

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

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

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, including any symptoms that occurred.
If you have been diagnosed with glaucoma.
If you are currently taking or have recently taken certain medications, including:
+ Linezolid or methylene blue.
+ Certain antidepressant or Parkinson's disease medications, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications with this drug may lead to severely high blood pressure.
Other health problems or medications that may interact with this drug. This is not an exhaustive list, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, to your doctor and pharmacist.

To ensure your safety, it is vital to verify that it is safe to take this medication with all your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

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 alertness, such as driving, wait until you understand how this drug affects you. Additionally, avoid consuming alcohol while taking this medication.

Prior to using marijuana, other forms of cannabis, or prescription and over-the-counter (OTC) drugs that may impair your actions, consult with your doctor. Be aware that it may take several weeks to experience the full effects of this medication.

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

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 drug. 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.

Low blood sodium levels (hyponatremia) can occur with this medication, and in severe cases, this can be fatal. Consult with your doctor about this potential risk. 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 will need to discuss the benefits and risks of taking this medication during pregnancy, as it may increase the risk of bleeding after delivery and potentially cause health problems in the newborn, particularly if taken during the third trimester.

If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOI or starting MAOI after vilazodone)
• Pimozide (theoretical risk of QT prolongation, though not specifically studied with vilazodone)

• Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, tramadol, tryptophan, buspirone, St. John's Wort, linezolid, methylene blue) - increased risk of Serotonin Syndrome
• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - increased vilazodone exposure (requires dose reduction)
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) - decreased vilazodone exposure (requires dose increase)
• Anticoagulants (e.g., warfarin) and antiplatelet agents (e.g., aspirin, NSAIDs) - increased risk of bleeding

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem) - potential for increased vilazodone exposure
• Moderate CYP3A4 inducers (e.g., efavirenz) - potential for decreased vilazodone exposure

• Not available

• Worsening depression
• Suicidal thoughts or behavior
• Anxiety
• Agitation
• Panic attacks
• Insomnia
• Irritability
• Hostility
• Impulsivity
• Akathisia (psychomotor restlessness)
• Hypomania
• Mania
• Serotonin Syndrome symptoms (e.g., confusion, sweating, muscle rigidity, tremor, fever, seizures)
• Abnormal bleeding or bruising
• Nausea
• Diarrhea
• Dizziness
• Insomnia

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

Vilazodone is excreted into human milk. The decision to breastfeed during treatment should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Monitor breastfed infants for adverse reactions (e.g., sedation, poor feeding, poor weight gain).

Safety and efficacy have not been established in pediatric patients. Vilazodone is not approved for use in patients under 18 years of age. There is a Black Box Warning regarding increased risk of suicidality in children, adolescents, and young adults with antidepressant use.

No specific dose adjustment is recommended based on age alone. However, elderly patients may be more sensitive to the effects of antidepressants and may have a higher risk of hyponatremia. Monitor for adverse effects and adjust dose based on tolerability and clinical response.

• Vilazodone MUST be taken with food. Taking it without food significantly reduces its absorption and effectiveness, potentially leading to treatment failure.
• The titration schedule (10mg for 7 days, then 20mg for 7 days, then 40mg) is crucial for minimizing gastrointestinal side effects, particularly nausea and diarrhea.
• Patients should be educated about the risk of Serotonin Syndrome, especially if taking other serotonergic agents.
• Due to its long half-life, withdrawal symptoms can occur if discontinued abruptly. Tapering is recommended.
• Monitor for activation of mania/hypomania in patients with undiagnosed bipolar disorder.

• Other SSRIs (e.g., escitalopram, sertraline, fluoxetine, paroxetine, citalopram)
• SNRIs (e.g., venlafaxine, duloxetine, desvenlafaxine, levomilnacipran)
• Atypical antidepressants (e.g., bupropion, mirtazapine, vortioxetine)
• Tricyclic Antidepressants (TCAs)
• Monoamine Oxidase Inhibitors (MAOIs - generally reserved for refractory cases)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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. 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, consult your doctor, pharmacist, or other healthcare provider for clarification.

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, including the name of the medication taken, the quantity, and the time it occurred.