Sertraline is an antidepressant that belongs to a group of drugs called selective serotonin reuptake inhibitors (SSRIs). It is used to treat major depressive disorder, obsessive-compulsive disorder (OCD), panic disorder, social anxiety disorder (SAD), and post-traumatic stress disorder (PTSD).

Sertraline is also used to treat premenstrual dysphoric disorder.

You should not use sertraline if you also take pimozide, or if you are being treated with methylene blue injection.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Do not stop taking sertraline without your doctor's advice.

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.

Take sertraline 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.

Take sertraline with or without food, at the same time each day.

Sertraline liquid (oral concentrate) must be diluted with a liquid right before you take it. Read and carefully follow all mixing instructions provided with your medicine. Ask your doctor or pharmacist if you need help.

Measure the mixed medicine with the supplied syringe or the dose-measuring device (not a kitchen spoon).

Swallow the capsule whole and do not crush, chew, break, or open it.

Sertraline may cause false results on a drug-screening urine test. Tell the laboratory staff that you use this medicine.

Do not stop using sertraline suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings). Ask your doctor before stopping the medicine.

Store tightly closed at room temperature, away from moisture and heat.

Usual Adult Dose for Depression:

Initial dose: 50 mg orally once a day
Maintenance Dose: 50 to 200 mg orally once a day.

Usual Adult Dose for Obsessive Compulsive Disorder:

Initial dose: 50 mg orally once a day
Maintenance Dose: 50 to 200 mg orally once a day

Usual Adult Dose for Panic Disorder:

Initial dose: 25 mg orally once a day, increased after one week to 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day.

Usual Adult Dose for Post Traumatic Stress Disorder:

Initial dose: 25 mg orally once a day, increased after one week to 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day

Usual Adult Dose for Social Anxiety Disorder:

Initial dose: 25 mg orally once a day, increased after one week to 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day.

Usual Adult Dose for Premenstrual Dysphoric Disorder:

Continuous regimen:
-Initial dose: 50 mg orally once a day during the menstrual cycle
-Maintenance dose: 50 to 150 mg orally once a day during the menstrual cycle

Cyclic regimen:
-Initial dose: 50 mg orally once a day starting 14 days prior to the anticipated start of menstruation through to the first full day of menses, and repeated with each new cycle
-Maintenance dose: 50 to 100 mg orally once a day.

Usual Pediatric Dose for Obsessive Compulsive Disorder:

6 to 12 years:
-Initial dose: 25 mg orally once a day
-Maintenance dose: 25 to 200 mg orally once a day

13 to 17 years:
-Initial dose: 50 mg orally once a day
-Maintenance dose: 50 to 200 mg orally once a day.

You should not use sertraline if you are allergic to it, or if you also take pimozide. Do not use the liquid form of this medicine if you take disulfiram (Antabuse).

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, and tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take sertraline.

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 sertraline could cause a serious condition called serotonin syndrome.

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

• an allergy or sensitivity to aspirin or tartrazine (food dye) or latex (oral solution - the dropper dispenser contains natural rubber);

• bipolar disorder (manic depression);

• heart disease, high blood pressure, or a stroke;

• liver or kidney disease;

• seizures;

• glaucoma;

• bleeding problems, or if you take warfarin (Coumadin, Jantoven);

• long QT syndrome; or

• low levels of sodium in your blood.

Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Your doctor will need to check your progress on a regular basis. Your family or caregivers should also watch for sudden changes in your behavior.

Sertraline is approved for use in children at least 6 years old, only to treat obsessive-compulsive disorder but not depression.

Taking sertraline during pregnancy could harm the baby, but stopping the medicine may not be safe for you. Do not start or stop this medicine without asking your doctor.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of sertraline on the baby.

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.

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).

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

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.

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

Drinking alcohol with sertraline can cause side effects.

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 sertraline: skin rash or hives (with or without fever or joint pain); 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:

• unusual bleeding or bruising;

• a seizure;

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

• low blood sodium - headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or

• manic episodes - racing thoughts, increased energy, unusual risk-taking behavior, extreme happiness, being irritable or talkative.

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.

Sertraline can affect growth in children. Your child's height and weight may be checked often.

Common sertraline side effects may include:

• indigestion, nausea, diarrhea, loss of appetite;

• nose bleeds;

• increased sweating;

• tiredness, sleep problems, insomnia;

• anxiety;

• loss of bladder control;

• tremors or agitation; or

• sexual problems.

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.

Sertraline can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with sertraline may cause you to bruise or bleed easily.

Other drugs may interact with sertraline, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking sertraline.

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.