Trintellix is a prescription medicine that affects chemicals in the brain that may be unbalanced.

Trintellix is an antidepressant that is used to treat major depressive disorder in adults.

Trintellix is supplied as an immediate-release tablet in 5mg, 10mg, and 20mg strengths.

In May 2016 Takeda Pharmaceuticals U.S.A., Inc. and Lundbeck announced that Brintellix will be marketed in the United States under the new name Trintellix effective June 2016. The change comes after receiving reports of name confusion in the marketplace between Brintellix and the anti-blood clotting therapy Brilinta (ticagrelor). The formulation, indication, dosage forms and strengths of Trintellix remain the same as Brintellix.

Do not use Trintellix if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, methylene blue injection, phenelzine, tranylcypromine, and others. After you stop taking Trintellix you must wait at least 21 days before you start taking an MAO inhibitor.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Do not give Trintellix to anyone younger than 18 years old without the advice of a doctor. This medicine is not approved for use in children.

Take Trintellix exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Trintellix with or without food.

You may have withdrawal symptoms if you stop using Trintellix suddenly. Ask your doctor before stopping the medicine.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Depression:

Initial dose: 10 mg orally once a day
Maintenance dose: 5 to 20 mg orally once a day
Maximum dose: 20 mg/day

Comments:
-Patients should be screened for bipolar disorder, mania, and hypomania prior to starting treatment.
-Patients who do not tolerate higher doses may be maintained on 5 mg orally once a day.

Use: Treatment of major depressive disorder (MDD)

Usual Adult Dose for Major Depressive Disorder:

Initial dose: 10 mg orally once a day
Maintenance dose: 5 to 20 mg orally once a day
Maximum dose: 20 mg/day

Comments:
-Patients should be screened for bipolar disorder, mania, and hypomania prior to starting treatment.
-Patients who do not tolerate higher doses may be maintained on 5 mg orally once a day.

Use: Treatment of major depressive disorder (MDD)

You should not use Trintellix if you are allergic to vortioxetine.

After you stop taking Trintellix you must wait at least 21 days before you start taking an MAO inhibitor.

Tell your doctor if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with vortioxetine could cause a serious condition called serotonin syndrome.

To make sure Trintellix is safe for you, tell your doctor if you have ever had:

• bipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts;

• glaucoma;

• seizures or epilepsy;

• bleeding problems; or

• low levels of sodium in your blood.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Trintellix is not approved for use by anyone younger than 18 years old.

Taking Trintellix in the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, serious lung problems, or other complications in the baby. However, stopping the medicine may not be safe for you. Do not start or stop Trintellix without asking your doctor.

Ask a doctor if it is safe to breastfeed while using this medicine.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction to Trintellix: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;

• vision changes, eye pain, eye redness or swelling;

• easy bruising, unusual bleeding, coughing up blood; or

• low sodium level (may be more likely to occur in older adults - confusion, memory problems, hallucinations, slurred speech, severe weakness, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Trintellix side effects may include:

• nausea;

• constipation; or

• vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines. Many drugs can interact with vortioxetine, especially:

• any other antidepressant;

• buspirone;

• fentanyl, tramadol;

• lithium;

• St. John's wort, tryptophan (sometimes called L-tryptophan);

• a blood thinner (warfarin, Coumadin, Jantoven);

• a diuretic or "water pill";

• migraine headache medicine (triptans);

• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

• seizure medicine - carbamazepine, phenytoin.

This list is not complete and many other drugs may interact with vortioxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.