SERTRALINE [ ZOLOFT ]

What is sertraline?

Sertraline is an antidepressant in a group of drugs called . Sertraline affects chemicals in the brain that may be unbalanced in people with depression, panic, anxiety, or obsessive-compulsive symptoms.

Sertraline 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.

Warnings

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

Do not use sertraline if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some children and young adults 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.

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.

Before taking this medicine

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).

Do not use sertraline within 14 days before or 14 days after using an MAO inhibitor. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

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:

• 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 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.

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.

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

How should I take sertraline?

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 a dose-measuring device (not a kitchen spoon).

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.

Dosing information

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.

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking sertraline?

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.

Sertraline side effects

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:

• 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;
• sweating;
• tremors; 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.

What other drugs will affect sertraline?

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.