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

Vortioxetine may also be used for purposes not listed in this medication guide.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take vortioxetine with or without food.

You may have withdrawal symptoms if you stop using vortioxetine 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 vortioxetine if you are allergic to it.

Do not use vortioxetine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

After you stop taking vortioxetine 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.

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.

Not approved for use by anyone younger than 18 years old.

Taking vortioxetine 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 vortioxetine without asking your doctor.

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

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

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

Get emergency medical help if you have signs of an allergic reaction: 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.

Vortioxetine may cause serious side effects. 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 side effects of vortioxetine 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 affect 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 affect vortioxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking vortioxetine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.