Consumer Drug Information

Sertraline

Generic Name: Sertraline Tablets (SER-tra-leen)
Brand Name: Zoloft

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Sertraline outweigh the risks.

Family and caregivers must closely watch patients who take Sertraline . It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Sertraline is used for:

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Treating depression or obsessive-compulsive disorder (OCD). It may be used to treat panic disorder or posttraumatic stress disorder (PTSD). It may also be used to treat premenstrual dysphoric disorder (PMDD; a severe form of premenstrual syndrome) or social anxiety disorder. It may also be used for other conditions as determined by your doctor.

Sertraline is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems.

Do NOT use Sertraline if:

you are allergic to any ingredient in Sertraline
you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), selegiline, or St. John's wort within the last 14 days
you are taking a fenfluramine derivative (eg, dexfenfluramine), an H₁ antagonist (eg, astemizole, terfenadine), nefazodone, pimozide, sibutramine, or thioridazine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sertraline :

Some medical conditions may interact with Sertraline . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
if you have a history of seizures, heart problems, liver problems, stomach or bowel bleeding, or metabolism problems
if you are dehydrated, have low blood sodium levels, or drink alcohol
if you will be having electroconvulsive therapy (ECT)

Some MEDICINES MAY INTERACT with Sertraline . Tell your health care provider if you are taking any other medicines, especially any of the following:

Anorexiants (eg, phentermine), fenfluramine derivatives (eg, dexfenfluramine), linezolid, MAOIs (eg, phenelzine), metoclopramide, nefazodone, selegiline, serotonin 5-HT₁ receptor agonists (eg, sumatriptan), sibutramine, St. John's wort, or trazodone because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma, may occur
Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased
Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of blood sodium levels may be increased
Tramadol because the risk of seizures may be increased
H₁ antagonists (eg, astemizole, terfenadine) or phenothiazines (eg, chlorpromazine, thioridazine) because severe heart problems, including irregular heartbeat, may occur
Carbamazepine or cyproheptadine because they may decrease Sertraline 's effectiveness
Aripiprazole, clozapine, digoxin, flecainide, lithium, phenytoin, pimozide, propafenone, risperidone, tricyclic antidepressants (eg, amitriptyline), or valproate (eg, valproic acid) because the risk of their side effects may be increased by Sertraline

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sertraline may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sertraline :

Use Sertraline as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Sertraline comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sertraline refilled.
Take Sertraline by mouth with or without food.
Taking Sertraline at the same time each day will help you remember to take it.
Continue to take Sertraline even if you feel well. Do not miss any doses.
Do not suddenly stop taking Sertraline without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Sertraline and whenever a change in dose is made.
If you miss a dose of Sertraline , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Sertraline .

Important safety information:

Sertraline may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Sertraline with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol while you are using Sertraline .
Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Sertraline ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or use Sertraline for longer than prescribed without checking with your doctor.
Children, teenagers, and young adults who take Sertraline may be at increased risk for suicidal thoughts or actions. Watch all patients who take Sertraline closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
If your doctor tells you to stop taking Sertraline , you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking Sertraline .
Sertraline may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
Serotonin syndrome is a possibly fatal syndrome that can be caused by Sertraline . Your risk may be greater if you take Sertraline with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
Caution is advised when using Sertraline in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
Caution is advised when using Sertraline in CHILDREN; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.
Sertraline should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
Sertraline may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Sertraline .
PREGNANCY and BREAST-FEEDING: Sertraline may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sertraline while you are pregnant. It is not known if Sertraline is found in breast milk. If you are or will be breast-feeding while you use Sertraline , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Sertraline :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; increased sweating; loss of appetite; nausea; nervousness; stomach upset; tiredness; trouble sleeping; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; decreased bladder control; exaggerated reflexes; fast or irregular heartbeat; fever; hallucinations; loss of coordination; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; vision changes; worsening of depression.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http: / / www.aapcc.org / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately. Symptoms may include coma; fainting; fast, slow, or irregular heartbeat; hair loss; hallucinations; seizures; severe or persistent dizziness, drowsiness, diarrhea, nausea, or vomiting; tremor.

Proper storage of Sertraline :

Store Sertraline at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sertraline out of the reach of children and away from pets.

General information:

If you have any questions about Sertraline , please talk with your doctor, pharmacist, or other health care provider.
Sertraline is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is summary only. It does not contain all information about Sertraline . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: August 6, 2008

Database Edition 08.3.1.002