Brand name: SERTRALINE
Pronounced: ZOE-loft
Generic name: Sertraline
Why is SERTRALINE prescribed?

SERTRALINE is prescribed for major depression--a persistently low mood that interferes with everyday living. Symptoms may include loss of interest in your usual activities, disturbed sleep, change in appetite, constant fidgeting or lethargic movement, fatigue, feelings of worthlessness or guilt, difficulty thinking or concentrating, and recurrent thoughts of suicide.

SERTRALINE is also used to treat the following:

* Premenstrual dysphoric disorder (PMDD), a condition marked by a depressed mood, anxiety or tension, emotional instability, and anger or irritability in the two weeks preceding menstruation.
* Obsessive-compulsive disorder (unwanted thoughts that won't go away and an irresistible urge to keep repeating certain actions, such as hand-washing or counting).
* Panic disorder (unexpected attacks of overwhelming anxiety, accompanied by fear of their return).
* Social anxiety disorder (extreme shyness in social situations that interferes with an individual's work and social life).
* Post-traumatic stress disorder (re-experiencing a dangerous or life-threatening event through intrusive thoughts, flashbacks, and intense psychological distress).

SERTRALINE belongs to a class of drugs called selective serotonin re-uptake inhibitors (SSRIs). Serotonin is one of the chemical messengers believed to govern moods. Ordinarily, it is quickly reabsorbed after its release at the junctures between nerves. Re-uptake inhibitors such as SERTRALINE slow this process, thereby boosting the levels of serotonin available in the brain.
Most important fact about SERTRALINE

Do not take SERTRALINE within 2 weeks of taking any drug classified as an MAO inhibitor. Drugs in this category include the antidepressants Marplan, Nardil, and Parnate. When serotonin boosters such as SERTRALINE are combined with MAO inhibitors, serious and sometimes fatal reactions can occur. In addition, you should not combine SERTRALINE with the drug pimozide (Orap).
How should you take SERTRALINE ?

Take SERTRALINE exactly as prescribed: once a day, in either the morning or the evening.

SERTRALINE is available in capsule and oral concentrate forms. To prepare SERTRALINE oral concentrate, use the dropper provided. Measure out the amount of concentrate prescribed by your doctor and mix it with 4 ounces of water, ginger ale, lemon/lime soda, lemonade, or orange juice. (Do not mix the concentrate with any other type of beverage.) Drink the mixture immediately; do not prepare it in advance for later use. At times, a slight haze may appear after mixing, but this is normal.

Improvement with SERTRALINE may not be seen for several days to a few weeks. You should expect to keep taking it for at least several months.

SERTRALINE may make your mouth dry. For temporary relief suck a hard candy, chew gum, or melt bits of ice in your mouth.

If you miss a dose...

Take the forgotten dose as soon as you remember. If several hours have passed, skip the dose. Never try to "catch up" by doubling the dose.

Storage instructions...

Store at room temperature.
SERTRALINE side effects

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking SERTRALINE .

* Side effects may include:
Abdominal pain, agitation, anxiety, constipation, decreased sex drive, diarrhea or loose stools, difficulty with ejaculation, dizziness, dry mouth, fatigue, gas, headache, decreased appetite, increased sweating, indigestion, insomnia, nausea, nervousness, pain, rash, sleepiness, sore throat, tingling or pins and needles, tremor, vision problems, vomiting

Many people lose a pound or two of body weight while taking SERTRALINE . This usually poses no problem but may be a concern if your depression has already caused you to lose a great deal of weight.

In a few people, SERTRALINE may trigger the grandiose, inappropriate, out-of-control behavior called mania or the similar, but less dramatic, "hyper" state called hypomania.
Why should SERTRALINE not be prescribed?

Do not use SERTRALINE while taking an MAO inhibitor or the drug pimozide (Orap) (see "Most important fact about SERTRALINE "). Avoid SERTRALINE if it causes an allergic-type reaction.
Special warnings about SERTRALINE

In clinical studies, antidepressants increased the risk of suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders. Anyone considering the use of SERTRALINE or any other antidepressant in a child or adolescent must balance this risk with the clinical need. SERTRALINE is only approved for treating obsessive-compulsive disorder in children 6 years and older.

Additionally, the progression of major depression is associated with a worsening of symptoms and/or the emergence of suicidal thinking or behavior in both adults and children, whether or not they are taking antidepressants. Individuals being treated with SERTRALINE and their caregivers should watch for any change in symptoms or any new symptoms that appear suddenly--especially agitation, anxiety, hostility, panic, restlessness, extreme hyperactivity, and suicidal thinking or behavior--and report them to the doctor immediately. Be especially observant at the beginning of treatment or whenever there is a change in dose.

Use SERTRALINE cautiously and under close medical supervision if you have a history of kidney or liver disorders, heart disease, seizures, or bleeding problems. Your doctor may limit your dosage if you have one of these conditions.

SERTRALINE could cause weight loss in children. The manufacturer recommends regular monitoring of weight and growth during long-term treatment in children.

SSRI antidepressants could potentially cause stomach bleeding, especially when combined with nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and ketoprofen (Orudis KT). Consult your doctor before combining SERTRALINE with NSAIDs or blood-thinning medications.

Like all antidepressants, SERTRALINE could trigger a manic episode. Let the doctor know if you've ever had this problem.

SERTRALINE has not been found to impair the ability to drive or operate machinery. Nevertheless, the manufacturer recommends caution until you know how the drug affects you.

If you are sensitive to latex, use caution when handling the dropper provided with the oral concentrate.
Possible food and drug interactions when taking SERTRALINE

Remember that SERTRALINE must never be combined with pimozide (Orap) or an MAO inhibitor (see "Most important fact about SERTRALINE ").

You should not drink alcoholic beverages while taking SERTRALINE . Use over-the-counter remedies with caution. Although none is known to interact with SERTRALINE , interactions remain a possibility.

If SERTRALINE is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining SERTRALINE with the following:

Antidepressants that boost serotonin such as Paxil and Prozac
Other antidepressants, including tricyclics such as Elavil and Pamelor
Cimetidine (Tagamet)
Diazepam (Valium)
Digitoxin (Crystodigin)
Flecainide (Tambocor)
Lithium (Eskalith, Lithobid)
Over-the-counter drugs such as cold remedies
Propafenone (Rythmol)
Sumatriptan (Imitrex)
Tolbutamide (Orinase)
Warfarin (Coumadin)

If you are using the oral concentrate form of SERTRALINE , do not take disulfiram (Antabuse)
Special information if you are pregnant or breastfeeding

The effects of SERTRALINE during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. SERTRALINE should be taken during pregnancy only if it is clearly needed. It is not known whether SERTRALINE appears in breast milk. Caution is advised when using SERTRALINE during breastfeeding.
Recommended dosage for SERTRALINE

ADULTS
Overdosage

Any medication taken in excess can have serious consequences. An overdose of SERTRALINE can be fatal. If you suspect an overdose, seek medical attention immediately.

* Common symptoms of SERTRALINE overdose include:
Agitation, dizziness, nausea, rapid heartbeat, sleepiness, tremor, vomiting

Other possible symptoms include coma, stupor, fainting, convulsions, delirium, hallucinations, mania, high or low blood pressure, and slow, rapid, or irregular heartbeat