Viibryd 10mg Tablets

Vilazodone is an antidepressant that acts as a selective serotonin reuptake inhibitor (SSRI) and a 5-HT1A receptor partial agonist. The precise mechanism of the antidepressant action of vilazodone is unknown, but is believed to be related to its enhancement of serotonergic activity in the central nervous system through these dual actions.

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 immediate medical attention:

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Signs of bleeding, such as:
+ 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
Seizures
Sex problems, including:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems or trouble getting or maintaining an erection
Serotonin syndrome, a potentially life-threatening condition, which may be more likely if you take certain other medications. Call your doctor 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, stomach upset, or vomiting
+ Severe headache

Other Possible Side Effects

Most people do not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor:

Difficulty sleeping
Diarrhea, stomach pain, upset stomach, or vomiting
Dry mouth
Dizziness or headache
* Feeling sleepy

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. Be sure to describe the allergic reaction you experienced.
If you have been diagnosed with glaucoma.
If you are currently taking or have recently taken certain medications, including:
+ Linezolid or methylene blue.
+ Certain antidepressants or Parkinson's disease medications within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
Other health problems or medications that may interact with this drug, as this is not an exhaustive list.

To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help determine whether it is safe to take this medication with your other medications and health conditions. Never 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 drug affects you. Additionally, avoid consuming alcohol while on this medication.

Before using marijuana, other cannabis products, or prescription and over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor. It may take several weeks to experience the full effects of this medication.

Do not abruptly stop taking this medication without 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 your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor. Certain individuals may be more prone to 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.

Low blood sodium levels (hyponatremia) can occur with this medication, and in severe cases, this can be fatal. Discuss this risk with your doctor. 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 benefits and risks of taking this medication during pregnancy. 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, inform your doctor, and 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)

• Serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's Wort, other SSRIs/SNRIs) - increased risk of serotonin syndrome.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - may increase vilazodone exposure; reduce vilazodone dose by half.
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - may decrease vilazodone exposure; consider increasing vilazodone dose up to 80 mg/day if tolerated and needed.

• Drugs that interfere with hemostasis (e.g., NSAIDs, aspirin, warfarin) - increased risk of bleeding.
• Drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants, risperidone, atomoxetine) - vilazodone is a weak inhibitor of CYP2D6, potential for increased exposure of these drugs.

• Not specifically identified as minor, but caution with any CNS depressants.

• Worsening depression
• Suicidal thoughts or attempts
• Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, aggression, mania/hypomania)
• Serotonin Syndrome (agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
• Abnormal bleeding or bruising
• Hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls)
• Seizures
• Visual disturbances (e.g., angle-closure glaucoma)

Vilazodone is Pregnancy Category C. There are no adequate and well-controlled studies of vilazodone in pregnant women. Use during pregnancy only 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.

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

Safety and effectiveness in pediatric patients have not been established. Viibryd is not approved for use in pediatric patients. 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 subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment is recommended based on age alone, but caution is advised due to potential for comorbidities and polypharmacy. Start at the lower end of the dosing range and monitor closely.

• **Must be taken with food:** This is a critical instruction for vilazodone. Taking it without food significantly reduces its absorption and efficacy. Advise patients to take it with a meal or substantial snack.
• **Titration is essential:** Vilazodone requires a gradual dose titration (10 mg for 7 days, then 20 mg, potentially to 40 mg) to minimize gastrointestinal side effects like nausea and diarrhea.
• **GI side effects are common:** Nausea and diarrhea are frequently reported, especially during initiation. Taking with food helps, and these often subside with continued use.
• **Serotonin Syndrome risk:** Be vigilant for signs of serotonin syndrome, especially when co-prescribing with other serotonergic agents (e.g., triptans, other antidepressants, tramadol, St. John's Wort).
• **CYP3A4 interactions:** Dose adjustments are necessary when co-administering with strong CYP3A4 inhibitors (reduce vilazodone dose by half) or inducers (consider increasing vilazodone dose).
• **Black Box Warning:** Reinforce the importance of monitoring for worsening depression and suicidality, especially in young adults, and during initial treatment or dose changes.
• **Discontinuation Syndrome:** Advise patients not to stop abruptly. Tapering the dose gradually is recommended to avoid withdrawal symptoms.

• SSRIs (e.g., escitalopram, sertraline, fluoxetine, paroxetine, citalopram)
• SNRIs (e.g., venlafaxine, duloxetine, desvenlafaxine)
• Atypical antidepressants (e.g., bupropion, mirtazapine, vortioxetine, levomilnacipran)
• Tricyclic Antidepressants (TCAs)
• MAOIs (e.g., phenelzine, tranylcypromine, selegiline)

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, which is 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 guidance.

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 amount consumed, and the time it occurred.