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ZOLOFT
ZOLOFT ONLINE
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.
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.
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 this
medicine. 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, 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) or
| Terfenadine (e.g., Seldane)—Taking these medicines while
you are taking sertraline may lead to a serious change in the
rhythm of your heartbeat |
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| 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 |
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| 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 |
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| 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 |
| 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 |
Proper Use of This Medicine
Take this medicine 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. 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 this medicine 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 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. |
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| 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. |
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| 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. |
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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. |
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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. If you do, you may develop extremely high
blood pressure or convulsions (seizures).
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. Your doctor may want you to reduce
gradually the amount you are taking before stopping completely.
This is to decrease the chance of having discontinuation symptoms
such as agitation, anxiety, dizziness, feeling of constant
movement of self or surroundings, headache, increased sweating,
nausea, trembling or shaking, trouble in sleeping or walking, or
unusual tiredness.
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 |
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| 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) |
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| Symptoms of overdose--may be more severe than side
effects occurring at regular doses or several may occur
together
| Anxiety ; drowsiness; nausea;
serotonin syndrome (diarrhea, fever, increased sweating,
mood or behavior changes, overactive reflexes, racing
heartbeat, restlessness, shivering or shaking);
unusually fast heartbeat; unusually large pupils;
vomiting |
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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 |
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| 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 |
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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 |
Other side effects not listed above may also occur in some
patients. If you notice any other effects, check with your doctor.
Additional Information
Once a medicine has been approved for marketing for a certain
use, experience may show that it is also useful for other medical
problems. Although these uses are not included in product
labeling, sertraline is used in certain patients with the
following medical conditions:
| Premature ejaculation |
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