In the U.S.—

In Canada—

• Antianxiety
• antidepressant
• antiobsessional agent
• antipanic agent
• posttraumatic stress disorder therapy agent
• premenstrual dysphoric disorder (PMDD) therapy agent

Sertraline ( SER-tra-leen) is used to treat mental depression, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disorder, posttraumatic stress disorder, and social anxiety disorder.

Sertraline belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of the chemical serotonin in the brain.

ZOLOFT is available only with your doctor's prescription, in the following dosage forms:

Oral
• Capsules (Canada)
• Tablets (U.S.)
• Oral Concentrate (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sertraline, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to sertraline. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, dyes, or latex. The dispenser dropper for sertraline oral concentrate contains dry natural rubber.

Pregnancy—Sertraline has not been studied in pregnant women. However, side effects have been reported in babies exposed by their mother during pregnancy. Before taking ZOLOFT, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Sertraline passes into breast milk. Side effects have been reported in a baby exposed during nursing. Before taking ZOLOFT, make sure your doctor knows if you are nursing your baby.

Children—Sertraline has been tested in children 6 to 17 years of age with obsessive-compulsive disorder. In effective doses, ZOLOFT has not been shown to cause different side effects or problems than it does in adults. However, sertraline can cause a decrease in appetite and children who take ZOLOFT for a long time should have their growth and body weight measured by the doctor at regular visits.

Sertraline must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for ZOLOFT. More study is needed to be sure sertraline is safe and effective in children.

Older adults—In studies done to date that have included elderly people, sertraline did not cause different side effects or problems in older people than it did in younger adults. However, ZOLOFT may be removed from the body more slowly in older adults. An older adult may receive a lower dose of sertraline than a younger adult, especially when first starting treatment.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking sertraline, it is especially important that your health care professional know if you are taking any of the following:

• Astemizole (e.g., Hismanal)—Taking ZOLOFT while you are taking sertraline may lead to a serious change in the rhythm of your heartbeat

• Flecainide (e.g., Tambocor) or
• Propafenone (e.g., Rythmol)—Higher blood levels of these medicines may occur, which may increase the chance of developing unwanted effects. Your doctor may change the dose of these medicines.

• Buspirone (e.g., BuSpar) or
• Bromocriptine (e.g., Parlodel) or
• Dextromethorphan (cough medicine) or
• Levodopa (e.g., Sinemet) or
• Lithium (e.g., Eskalith) or
• Meperidine (e.g., Demerol) or
• Nefazodone (e.g., Serzone) or
• Pentazocine (e.g., Talwin) or
• Selective serotonin reuptake inhibitors, other (citalopram [e.g., Celexa], fluoxetine [e.g., Prozac], fluvoxamine [e.g., Luvox], paroxetine [e.g., Paxil]) or
• Street drugs (LSD, MDMA [e.g., ecstasy], marijuana) or
• Sumatriptan (e.g., Imitrex) or
• Tramadol (e.g., Ultram) or
• Trazodone (e.g., Desyrel) or
• Tryptophan or
• Venlafaxine (e.g., Effexor)—Using these medicines with sertraline may increase the chance of developing a rare, but very serious, unwanted effect known as the serotonin syndrome. This syndrome may cause confusion, diarrhea, fever, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, or twitching. If you develop these symptoms, contact your doctor as soon as possible

• Digitoxin (e.g., Crystodigin) or
• Warfarin (e.g., Coumadin)—Higher or lower blood levels of these medicines or sertraline may occur, which may increase the chance of having unwanted effects. Your doctor may need to change the dose of either these medicines or sertraline

• Disulfiram (e.g., Antabuse)—Disulfiram will react with the alcohol in sertraline oral concentrate and may cause serious problems

• Moclobemide (e.g., Manerex)—The risk of developing serious unwanted effects, including the serotonin syndrome, is increased. Use of moclobemide with sertraline is not recommended. Also, it is recommended that 3 to 7 days be allowed between stopping treatment with moclobemide and starting treatment with sertraline, and it is recommended that 2 weeks be allowed between stopping treatment with sertraline and starting treatment with moclobemide

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])— Do not take sertraline while you are taking or within 2 weeks of taking an MAO inhibitor. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, severe convulsions, or the serotonin syndrome. At least 14 days should be allowed between stopping treatment with one medicine (sertraline or the MAO inhibitor) and starting treatment with the other

• Pimozide (e.g., ORAP)—ZOLOFT should not be taken together with sertraline; tell your doctor if you are taking pimozide

• St. John's wort (Hypericum perforatum)—Use of ZOLOFT with sertraline may increase your chance of getting serious side effects.

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Higher blood levels of these medicines may occur, which may increase the chance of developing unwanted effects. Your doctor may check the blood level of the tricyclic antidepressant, and may change the dose of either these medicines or sertraline. Also, taking sertraline with amitriptyline, clomipramine, or imipramine may increase the chance of developing the serotonin syndrome

• Bleeding problems, abnormal or
• Purpura, or history of (purplish or brownish-red discoloration of skin)—Sertraline may make these problems worse.

• Brain disease or damage or
• Mental retardation or
• Seizure disorders (history of)—The risk of seizures may be increased

• Dehydration or
• Hyponatremia (condition in which your body has too little sodium)—Sertraline may make these problems worse, especially in older adults.

• Heart attack, recent or
• Heart disease, unstable—The medicine has not been studied in patients with these medical problems.

• Kidney disease—It is not known whether the chance of side effects will be increased

• Liver disease—Higher blood levels of sertraline may occur, increasing the chance of side effects. Your doctor may want you to take a lower dose or to take your doses less often than a person without liver disease

• Mania (history of)—May be activated

• Weight loss—Sertraline may cause weight loss. This weight loss is usually small, but if a large weight loss occurs, it may be harmful in some patients

Take ZOLOFT only as directed by your doctor, to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Sertraline may be taken with or without food on a full or empty stomach. ZOLOFT should be taken once a day in the morning or at night. If your doctor tells you to take it a certain way, follow your doctor's instructions.

If you are taking the oral concentrate, mix it with 4 ounces of water, ginger ale, lemon-lime soda, lemonade or orange juice. Take it right away after mixing.

You may have to take sertraline for 4 weeks or longer before you begin to feel better. Your doctor should check your progress at regular visits during this time. Also, if you are taking ZOLOFT for depression, you may need to keep taking it for 6 months or longer to help prevent the return of the depression.

Dosing—

The dose of sertraline will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of sertraline. If your dose is different, do not change it unless your doctor tells you to do so.

Also, the number of capsules or tablets that you take depends on the strength of the medicine and the medical problem for which you are taking sertraline.

• For oral dosage forms (capsules, oral solution or tablets):
  • Adults:
    • For mental depression or obsessive-compulsive disorder: To start, usually 50 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may increase your dose gradually if needed. However, the dose usually is not more than 200 mg a day.
    • For panic disorder, posttraumatic stress disorder, or social anxiety disorder: To start, usually 25 mg once a day, taken either in the morning or evening. Your doctor may increase your dose gradually if needed. However, the dose usually is not more than 200 mg a day.
    • For premenstrual dysphoric disorder: To start, 50 mg once a day throughout your menstrual cycle or just during the premenstrual time. Your doctor may increase your dose if needed. However, the dose usually is not more than 150 mg a day throughout your menstrual cycle or 100 mg a day if you are only taking it during your premenstrual time.
  • Children:
    • For mental depression, posttraumatic stress disorder, or panic disorder: Use and dose must be determined by the doctor.
    • For obsessive-compulsive disorder:
      • Children younger than 6 years old: Use and dose must be determined by the doctor.
      • Children 6 to 12 years old: To start, usually 25 mg once a day, taken either in the morning or evening. Your doctor may increase your dose gradually if needed. However, the dose usually is not more than 200 mg a day.
      • Children 13 to 17 years old: To start, usually 50 mg once a day, taken either in the morning or evening. Your doctor may increase your dose gradually if needed. However, the dose usually is not more than 200 mg a day.
  • Older adults:
    • For mental depression, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, or social anxiety disorder (using capsules or tablets): To start, usually 12.5 to 25 mg once a day, taken either in the morning or evening. Your doctor may increase your dose gradually if needed.

Missed dose—

Because sertraline may be given to different patients at different times of the day, you and your doctor should discuss what to do about any missed doses.

Storage—

To store ZOLOFT:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.