WARNING

Trintellix (vortioxetine) is a medication used to treat major depressive disorder (MDD). Like any medication, it comes with potential risks and side effects. Some of the risks associated with taking Trintellix include:

• Suicidal Thoughts or Behavior: Antidepressants, including Trintellix, may increase the risk of suicidal thoughts or actions in some individuals, especially during the initial weeks of treatment or when the dosage is changed.
• Serotonin Syndrome: Trintellix can cause a potentially life-threatening condition called serotonin syndrome when taken with other medications that increase serotonin levels, leading to symptoms such as agitation, hallucinations, rapid heart rate, fever, excessive sweating, shivering, muscle stiffness, tremors, incoordination, nausea, vomiting, and diarrhea.
• Bleeding Risk: Trintellix may increase the risk of bleeding, especially if taken with other medications that also increase bleeding risk, such as blood thinners (anticoagulants) or nonsteroidal anti-inflammatory drugs (NSAIDs).
• Hyponatremia: Trintellix may cause low sodium levels in the blood (hyponatremia), which can lead to symptoms such as headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can be severe and may rarely result in unconsciousness or death.
• Activation of Mania or Hypomania: Trintellix may cause activation of mania or hypomania in individuals with bipolar disorder, leading to symptoms such as unusually elated mood, increased energy, racing thoughts, reckless behavior, or excessive irritability.
• Withdrawal Symptoms: Abrupt discontinuation of Trintellix may lead to withdrawal symptoms such as headache, nausea, dizziness, lethargy, irritability, insomnia, electric shock-like sensations, and anxiety.
• Other Common Side Effects: Other common side effects of Trintellix include nausea, constipation, and sexual side effects such as decreased libido and erectile dysfunction.

It’s important to discuss any concerns or potential risks with your healthcare provider before starting or changing any medication regimen. Your doctor can provide personalized advice based on your medical history and individual circumstances.

Why is this medication prescribed?

Trintellix (vortioxetine) is prescribed primarily for the treatment of major depressive disorder (MDD), a mental health condition characterized by persistent feelings of sadness, loss of interest or pleasure in activities, changes in appetite or weight, sleep disturbances, fatigue, feelings of worthlessness or guilt, difficulty concentrating, and thoughts of death or suicide.

Trintellix is an antidepressant medication that works by affecting the levels of certain neurotransmitters in the brain, including serotonin. It is believed to enhance serotonin activity in the brain, which can help alleviate depressive symptoms.

How should this medicine be used?

Trintellix (vortioxetine) is a prescription medication used to treat major depressive disorder (MDD) in adults. Here’s a general guide on how Trintellix should be used:

• Dosage: The typical starting dose of Trintellix is 10 milligrams (mg) taken orally once daily. Your healthcare provider may adjust the dose based on your individual response to treatment and any side effects experienced. The maximum recommended dose is 20 mg per day.
• Administration: Trintellix can be taken with or without food. It’s important to take it consistently at the same time each day to maintain a steady level of the medication in your bloodstream.
• Swallowing: Trintellix tablets should be swallowed whole with water and should not be crushed, chewed, or split.
• Duration: Continue taking Trintellix even if you start to feel better, unless otherwise instructed by your healthcare provider. It may take several weeks for the full therapeutic effect to be realized.
• Monitoring: Your healthcare provider may periodically monitor your response to Trintellix and adjust the dosage accordingly. It’s essential to attend all scheduled appointments and communicate any concerns or changes in symptoms to your healthcare provider.
• Discontinuation: Do not stop taking Trintellix abruptly without consulting your healthcare provider, as this may lead to withdrawal symptoms. Your healthcare provider may gradually reduce the dosage over time to safely discontinue the medication.
• Interactions: Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as they may interact with Trintellix. Avoid taking Trintellix with other medications that increase serotonin levels, as this may increase the risk of serotonin syndrome.
• Special Populations: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of Trintellix with your healthcare provider before starting or continuing treatment.

Always follow the instructions provided by your healthcare provider and pharmacist regarding the use of Trintellix. If you have any questions or concerns about how to use Trintellix, do not hesitate to ask your healthcare provider or pharmacist for clarification.

Other uses for this medicine

While Trintellix is primarily indicated for the treatment of major depressive disorder, some off-label uses might include:

• Anxiety Disorders: Trintellix may be prescribed off-label for certain anxiety disorders, such as generalized anxiety disorder (GAD).
• Obsessive-Compulsive Disorder (OCD: There is some research suggesting that Trintellix may be beneficial in the treatment of OCD, although it’s not FDA-approved for this use.
• Fibromyalgia: Trintellix might be used off-label to help manage symptoms of fibromyalgia, such as pain and fatigue.

What special precautions should I follow?

Regarding special precautions for using Trintellix, here are some key points to consider:

• Suicidal Thoughts and Behavior: Like many antidepressants, Trintellix may increase the risk of suicidal thoughts or actions, especially in young adults under 25. Close monitoring is necessary during the early stages of treatment or when doses are adjusted.
• Serotonin Syndrome: Trintellix can cause serotonin syndrome, a potentially life-threatening condition characterized by agitation, hallucinations, rapid heart rate, fever, excessive sweating, and muscle stiffness. Caution is advised when combining Trintellix with other serotonergic medications.
• Bleeding Risk: Trintellix may increase the risk of bleeding, particularly when used with other medications that affect blood clotting. Careful monitoring is essential, especially in individuals taking anticoagulants or nonsteroidal anti-inflammatory drugs (NSAIDs).
• Hyponatremia: Trintellix can lead to low sodium levels in the blood (hyponatremia), which may cause symptoms like headache, confusion, weakness, and in severe cases, seizures or coma.
• Activation of Mania/Hypomania: Trintellix may trigger manic or hypomanic episodes in individuals with bipolar disorder. Close monitoring is necessary, and dosage adjustments may be required.
• Withdrawal Symptoms: Abrupt discontinuation of Trintellix may lead to withdrawal symptoms such as nausea, dizziness, insomnia, and irritability. Tapering off the medication under medical supervision is recommended.
• Pregnancy and Breastfeeding: The safety of Trintellix during pregnancy and breastfeeding is not well-established. The potential risks and benefits should be carefully weighed, and a healthcare provider should be consulted before use in these situations.
• Other Medical Conditions: Individuals with certain medical conditions such as liver or kidney impairment may require dose adjustments or closer monitoring while taking Trintellix.

Always inform your healthcare provider about all medications, supplements, and medical conditions you have before starting Trintellix. This allows for a comprehensive assessment of potential risks and benefits tailored to your individual needs.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Trintellix. However, maintaining a healthy and balanced diet may complement your overall mental health and well-being.

What should I do if I forget a dose?

If you forget to take a dose of Trintellix:

• Take It When You Remember: If it is within a few hours of your usual dosing time, take the missed dose as soon as you remember.
• Skip the Missed Dose if It’s Almost Time for the Next Dose: If it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.
• Set Reminders: To avoid missing doses in the future, consider setting alarms or reminders on your phone or using a pill organizer to keep track of your medication schedule.
• Contact Your Healthcare Provider if Unsure: If you are unsure about what to do or if you frequently forget doses, consult your healthcare provider for guidance. They may adjust your dosing schedule or provide additional support to help you stay on track with your medication regimen.

What side effects can this medication cause?

Trintellix (vortioxetine) can cause various side effects, though not everyone experiences them. Common side effects of Trintellix include:

• Nausea: Feeling queasy or having an upset stomach is one of the most common side effects of Trintellix, particularly when starting treatment. Taking Trintellix with food may help alleviate this symptom.
• Headache: Some individuals may experience headaches while taking Trintellix. These headaches are typically mild to moderate in intensity.
• Constipation: Trintellix can cause constipation in some people. Maintaining a healthy diet with plenty of fiber, fluids, and regular exercise may help alleviate this side effect.
• Sexual Dysfunction: Trintellix may cause sexual side effects such as decreased libido, difficulty achieving orgasm, or erectile dysfunction in some individuals. These side effects can impact both men and women.
• Insomnia or Sleep Changes: Trintellix may affect sleep patterns, leading to difficulty falling asleep or staying asleep (insomnia) or other sleep disturbances.
• Dizziness or Vertigo: Some people may experience dizziness or a sensation of spinning (vertigo) while taking Trintellix, especially when standing up quickly.
• Fatigue or Sleepiness: Trintellix may cause feelings of fatigue or drowsiness in some individuals, particularly when first starting treatment.
• Dry Mouth: Trintellix may lead to a dry mouth sensation, which can be bothersome for some individuals.
• Sweating: Increased sweating, including night sweats, is a potential side effect of Trintellix.
• Diarrhea: Some individuals may experience diarrhea as a side effect of Trintellix, particularly during the initial stages of treatment.
• Weight Changes: Trintellix may cause weight changes, either weight gain or weight loss, although these changes are less common compared to some other antidepressant medications.

It’s essential to note that not everyone will experience these side effects, and some individuals may experience side effects not listed here. Additionally, side effects may vary in severity from person to person. If you experience any concerning or persistent side effects while taking Trintellix, it’s important to inform your healthcare provider. They can offer guidance on managing side effects or adjusting your treatment regimen if necessary.

What should I know about storage and disposal of this medication?

Storage and Disposal:

• Storage: Store Trintellix tablets at room temperature away from light and moisture. Avoid storing it in the bathroom. Keep the medication out of reach of children and pets.
• Disposal: Dispose of unused or expired Trintellix tablets properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist or local waste disposal company for proper disposal instructions, such as using a drug take-back program.

In case of emergency/overdose

• In Case of Emergency: If you or someone else may have overdosed on Trintellix and is experiencing severe symptoms such as difficulty breathing, loss of consciousness, seizures, or severe dizziness, call emergency services immediately (such as 911 in the United States).
• Overdose Symptoms: Symptoms of Trintellix overdose may include nausea, vomiting, rapid heartbeat, dizziness, drowsiness, sweating, tremors, and confusion. Contact a poison control center or seek emergency medical attention if you suspect an overdose.

What other information should I know?

• Follow Healthcare Provider’s Instructions: Always take Trintellix exactly as prescribed by your healthcare provider. Do not adjust your dosage or stop taking the medication without consulting your doctor first.
• Regular Monitoring: Attend scheduled follow-up appointments with your healthcare provider to monitor your response to Trintellix and assess any side effects or changes in your condition.
• Avoid Alcohol: Limit or avoid alcohol consumption while taking Trintellix, as alcohol can interact with the medication and increase the risk of side effects.
• Inform Healthcare Providers: Inform all healthcare providers involved in your care, including dentists and specialists, that you are taking Trintellix. This can help prevent potential drug interactions or complications during medical procedures.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of Trintellix with your healthcare provider before starting or continuing treatment.
• Driving and Operating Machinery: Trintellix may cause drowsiness or dizziness in some individuals. Avoid driving, operating heavy machinery, or engaging in activities that require alertness until you know how Trintellix affects you.
• Medication Compliance: Take Trintellix regularly and as prescribed to maximize its effectiveness in managing your condition. If you have difficulty remembering to take your medication, consider using a pill organizer or setting reminders.

Always consult your healthcare provider or pharmacist if you have any questions or concerns about the storage, disposal, emergency management, or other aspects of taking Trintellix. They can provide personalized guidance based on your individual circumstances.