Oleptro is an antidepressant medicine. It affects chemicals in the brain that may be unbalanced in people with depression.

Oleptro is used to treat major depressive disorder (MDD).

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

You should not use Oleptro if you are allergic to trazodone, or if you are being treated with methylene blue injection.

Do not use Oleptro if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using Oleptro. Your family or other caregivers should also be 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 this medicine to anyone younger than 18 years old without the advice of a doctor. Oleptro is not approved for use in children.

Take Oleptro exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your

Take Oleptro on an empty stomach at bedtime or late in the evening.

Do not crush, chew, or break an extended-release Oleptro tablet. Swallow the tablet whole. You may break the tablet in half along the score line if needed.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Do not stop using Oleptro suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light.

You should not use Oleptro if you are allergic to trazodone, or if you are being treated with methylene blue injection.

Do not use Oleptro if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking trazodone, you must wait at least 14 days before you start taking an MAOI.

To make sure Oleptro is safe for you, tell your doctor if you have:

• liver or kidney disease;

• heart disease;

• a bleeding or blood clotting disorder;

• seizures or epilepsy;

• narrow-angle glaucoma;

• bipolar disorder (manic depression);

• a history of Long QT syndrome;

• a history of drug abuse or suicidal thoughts; or

• if you have recently had a heart attack.

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

Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant while taking Oleptro. Do not start or stop taking this medicine during pregnancy without your doctor's advice.

It is not known whether trazodone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of trazodone can be fatal when it is taken with alcohol, barbiturates such as phenobarbital, or sedatives such as diazepam (Valium).

Overdose symptoms may include extreme drowsiness, vomiting, penis erection that is painful or prolonged, fast or pounding heartbeat, seizure (black-out or convulsions), or breathing that slows or stops.

Do not drink alcohol. Oleptro can increase the effects of alcohol, which could be dangerous.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Oleptro may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with Oleptro may cause you to bruise or bleed easily.

Stop taking Oleptro and call your doctor at once if you have a penis erection that is painful or lasts 6 hours or longer. This is a medical emergency and could lead to a serious condition that must be corrected with surgery.

Get emergency medical help if you have any signs of an allergic reaction to Oleptro: hives; difficulty 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:

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• chest pain or pressure, tight feeling in your neck or jaw, sweating, pain spreading to your arm or shoulder;

• high levels of serotonin in the body - agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

• low levels of sodium in the body - headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common Oleptro side effects may include:

• drowsiness, dizziness;

• vision changes;

• constipation; or

• dry mouth, altered sense of taste.

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.

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Oleptro with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with trazodone. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Oleptro, especially:

• any other antidepressant;

• anagrelide;

• droperidol;

• methadone;

• ondansetron;

• an antibiotic - azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine;

• cancer medicine - arsenic trioxide, vandetanib;

• anti-malaria medication - chloroquine, halofantrine;

• heart rhythm medicine - amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol; or

• medicine to treat a psychiatric disorder - chlorpromazine, haloperidol, pimozide, thioridazine.

This list is not complete and many other drugs can interact with trazodone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.