Drug Profiles:
sertraltine HCl
Zoloft®

CAUTION: Federal law prohibits dispensing without prescription.

Oral

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

Before Using This Medicine
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-
One study looked at the babies of 147 women who took sertraline either at the beginning of pregnancy or through the entire pregnancy. This study found no harmful effects of sertraline on the babies. However, more study is needed to be sure that sertraline is safe to use during pregnancy. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant. FDA Pregnancy Category C.

Breast-feeding-
Sertraline passes into breast milk. No problems have been reported in nursing babies, but the long-term effects are not known.

Children-
Sertraline has been tested in children 6 to 17 years of age with obsessive-compulsive disorder. In effective doses, this medicine 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 this medicine for a long time should have their growth and body weight measured by the doctor at regular visits.

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, this medicine 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)
• Terfenadine (e.g., Seldane)—Taking these medicines while you are taking sertraline may lead to a serious change in the rhythm of your heartbeat
• Buspirone (e.g., BuSpar)
• Bromocriptine (e.g., Parlodel)
• Dextromethorphan (cough medicine)
• Levodopa (e.g., Sinemet)
• Lithium (e.g., Eskalith)
• Meperidine (e.g., Demerol)
• Nefazodone (e.g., Serzone)
• Pentazocine (e.g., Talwin)
• Selective serotonin reuptake inhibitors, other (citalopram [e.g., Celexa], fluoxetine [e.g., Prozac], fluvoxamine [e.g., Luvox], paroxetine [e.g., Paxil])
• Street drugs (LSD, MDMA [e.g., ecstasy], marijuana)
• Sumatriptan (e.g., Imitrex, Amerge, Maxalt, Zomig, Axert, Frova)
• Tramadol (e.g., Ultram)
• Trazodone (e.g., Desyrel)
• Tryptophan
• 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)
• 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) inhibitors (furazolidone [e.g., Furoxone], 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
• 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

Other medical problems-
The presence of other medical problems may affect the use of fluoxetine. Make sure you tell your doctor if you have any other medical problems, especially:

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

Proper Use of This Medicine
Take this medicine only as directed by your doctor

• Sertraline may be taken with or without food on a full or empty stomach. 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.

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 or posttraumatic stress 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.
• 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, or posttraumatic stress 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 this medicine:

• 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.

Precautions While Using This Medicine

• It is important that your doctor check your progress at regular visits, to allow for changes in your dose and to help reduce any side effects.
• Do not take sertraline with or within 14 days of taking an MAO inhibitor (furazolidone, phenelzine, procarbazine, selegiline, tranylcypromine). Do not take an MAO inhibitor within 14 days of taking sertraline
• Avoid drinking alcoholic beverages while taking sertraline.
• This medicine may cause some people to become drowsy, to have trouble thinking, or to have problems with movement. Make sure you know how you react to sertraline before you drive, use machines, or do anything else that could be dangerous if you are not alert or well-coordinated.
• Do not stop taking this medicine without first checking with your doctor.

Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. One rare, but very serious, effect that may occur is the serotonin syndrome. This syndrome (group of symptoms) is more likely to occur shortly after an increase in sertraline dose.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common: Decreased sexual desire or ability
• Less common or rare: Breast tenderness or enlargement; fast or irregular heartbeat; fast talking and excited feelings or actions that are out of control; fever ; inability to sit still; low blood sodium (confusion, convulsions [seizures], drowsiness, dryness of mouth, increased thirst, lack of energy); nose bleeds ; red or purple spots on skin; restlessness; serotonin syndrome (diarrhea, fever, increased sweating, mood or behavior changes, overactive reflexes, racing heartbeat, restlessness, shivering or shaking); skin rash, hives, or itching; unusual or sudden body or facial movements or postures; unusual secretion of milk (in females)

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common: Decreased appetite or weight loss; diarrhea or loose stools; dizziness; drowsiness; dryness of mouth; headache; increased sweating; nausea; stomach or abdominal cramps, gas, or pain; tiredness or weakness; trembling or shaking; trouble in sleeping
• Less common: Agitation, anxiety, or nervousness; changes in vision, including blurred vision; constipation; flushing or redness of skin, with feeling of warmth or heat; increased appetite; vomiting

After you stop taking sertraline, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time, check with your doctor if you notice any of the following side effects:

• Agitation; anxiety; dizziness; feeling of constant movement of self or surroundings; headache ; increased sweating; nausea; trembling or shaking; trouble in sleeping; trouble in walking; unusual tiredness

Brand Names-

U.S. and Canada: Zoloft