SERTRALINE - ORAL (SER-truh-leen)
COMMON BRAND NAME(S): Zoloft
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Zoloft Indications
and Usage
Zoloft is indicated for the treatment of depression. Obsessive-Compulsive
Disorder: Zoloft is indicated for the treatment of
obsessions and compulsions in patients with
obsessive-compulsive disorder (OCD).
Zoloft is indicated for
the treatment of panic disorder, with or without
agoraphobia.
Zoloft Contraindications
Patients with known
hypersensitivity to Zoloft. Concomitant use in
patients taking monoamine oxidase inhibitors (MAOIs) is
contraindicated.
Zoloft Warnings
Cases of serious
sometimes fatal reactions have been reported in patients
receiving Zoloft,
a selective serotonin reuptake inhibitor (SSRI), in
combination with a monoamine oxidase inhibitor (MAOI).
Symptoms of a drug interaction between an SSRI and an MAOI
include: hyperthermia, rigidity, myoclonus, autonomic
instability with possible rapid fluctuations of vital signs,
mental status changes that include confusion, irritability,
and extreme agitation progressing to delirium and coma.
These reactions have also been reported in patients who have
recently discontinued an SSRI and have been started on an
MAOI. Some cases presented with features resembling
neuroleptic malignant syndrome. Therefore, Zoloft should not
be used in combination with an MAOI, or within 14 days of
discontinuing treatment with an MAOI. Similarly, at least 14
days should be allowed after stopping Zoloft before starting
an MAOI.
Zoloft Precautions
Activation of
Mania/Hypomania:
During premarketing testing, hypomania or
mania
occurred in approximately 0.4% of Zoloft
treated patients.
Weight Loss:
Significant weight loss may be an undesirable result of
treatment with Zoloft for some patients, but on average,
patients in controlled trials had minimal, 1 to 2 pound
weight loss, versus smaller changes on placebo. Only rarely
have Zoloft patients been discontinued for weight loss.
Seizure:
Zoloft has not been evaluated in patients with a seizure
disorder. These patients were excluded from clinical studies
during the product’s premarket testing. No seizures were
observed among approximately 3000 patients treated with
Zoloft in the development program for depression. However, 4
patients out of approximately 1800 (220 <18 years of age)
exposed during the development program for
obsessive-compulsive disorder experienced seizures,
representing a crude incidence of 0.2%. Accordingly, Zoloft
should be introduced with care in patients with a seizure
disorder.
Suicide:
The possibility of a
suicide attempt is
inherent in depression and may persist until significant
remission occurs. Close supervision of high risk patients
should accompany initial drug therapy. Prescriptions for
Zoloft should be written for the smallest quantity of
tablets consistent with good patient management, in order to
reduce the risk of overdose.
Because of the
well-established comorbidity between both OCD and depression
and panic disorder and depression, the same precautions
observed when treating patients with depression should be
observed when treating patients with OCD or panic disorder.
Hepatic Dysfunction:
Zoloft is extensively metabolized by the liver. The
pharmacokinetics and therapeutic efficacy of Zoloft have
not been studied in patients with significant hepatic
dysfunction. Accordingly, it should be used with caution in
such patients.
Renal Dysfunction:
Zoloft is
extensively metabolized and excretion of unchanged drug in
the urine is a minor route of elimination. The
pharmacokinetics of Zoloft have not been studied in
patients with renal impairment and, until adequate numbers
of patients with mild, moderate or severe renal impairment
have been evaluated during chronic treatment with Zoloft,
it should be used with caution in such patients.
Usage in Children:
The safety and effectiveness of Zoloft in children below
the age of 18 have not been established.
Pregnancy & Nursing:
The safety of Zoloft during pregnancy and nursing has
not been established and therefore, it should not be used in
women of childbearing potential or nursing mothers, unless,
in the opinion of the physician, the potential benefits to
the patient outweigh the possible hazards to the fetus.
Interference with
Cognitive or Motor Performance:
Any psychoactive drug may impair judgment, thinking, or
motor skills, and patients should be advised to avoid
driving a car or operating hazardous machinery until they
are reasonably certain that the drug treatment does not
affect them adversely.
Zoloft Drug
Interactions
Zoloft will add to the
effects of alcohol and other depressants. BEFORE USING THIS
MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all
prescription and over-the-counter medicine that you are
taking. This includes cyproheptadine, clozapine,
dexfenfluramine, fenfluramine, astemizole, terfenadine,
lithium, selegiline, tramadol, and medicines used to treat
depression. Inform your doctor of any other medical
conditions, allergies, pregnancy, or breast-feeding.
Zoloft Adverse
Reactions
Side Effects That
Should Be Reported To Your Doctor:
(Less common or rare) Fast talking and excited feelings or
actions that are out of control; fever; skin rash, hives, or
itching. Side effects, that may go
away during treatment, include nervousness, trouble
sleeping, headache, drowsiness, fatigue, nausea, vomiting,
diarrhea, loss of appetite, dry mouth, sweating, dizziness,
lightheadedness, muscle spasms, or changes in sexual
function. If they continue or are bothersome, check with
your doctor. If you notice other effects not listed above,
contact your doctor, nurse, or pharmacist.
Zoloft Overdose
Signs and Symptoms:
Symptoms of overdose may
include sleepiness, nausea, vomiting, fast heartbeat,
dilated pupils, and anxiety.
Treatment: If you or someone you
know may have used more than the recommended dose of this
medicine, contact your local poison control center or
emergency room immediately. Establish and maintain an
airway, insure adequate oxygenation and ventilation.
Activated charcoal, which may be used with sorbitol, may be
as or more effective than emesis or lavage, and should be
considered in treating overdose. Cardiac and vital signs
monitoring is recommended along with general symptomatic and
supportive measures. There are no specific
antidotes for Zoloft.
Zoloft Dosage
Several weeks may pass
before this medicine reaches its full effect. Do not stop
taking this medicine without checking with your doctor. Do not exceed the
recommended dosage or take this medicine for longer than
prescribed. Continue to take this medicine even if you feel
better. Do not miss any doses.
-
Follow the directions for using this medicine provided by your
doctor.
-
Store this medicine at room temperature, away from heat and light.
-
If you miss a dose of this medicine, contact your doctor or
pharmacist for instructions. Do not take 2 doses at once.
Additional
Information: Do
not share this medicine with others for whom it was not
prescribed. Do not use this medicine for other health
conditions. Keep this medicine out of the reach of children. IF USING THIS MEDICINE
FOR AN EXTENDED PERIOD OF TIME, obtain refills before your
supply runs out. The dose of Zoloft
will be different for different patients. 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 Zoloft. For oral dosage
forms (capsules or tablets): For mental depression or
obsessive-compulsive disorder:
Adults: To start, usually 50 milligrams (mg) once a day, taken either in the
morning or evening. Your doctor may gradually increase your
dose if needed. However, the dose is usually not more than
200 mg a day.
Elderly and
Debilitated Patients:
To start, usually 12.5 to 25 mg once a day, taken either in
the morning or evening. Your doctor may gradually increase
your dose if needed.
Children:
Not recommended for use in children.
For oral dosage
forms (capsules or tablets): For panic disorder:
Adults: To start, usually 25 mg once a day, taken either in the morning or
evening. Your doctor may gradually increase your dose if
needed. However, the dose is usually not more than 200 mg a
day.
Elderly and
Debilitated Patients:
To start, usually 12.5 to 25 mg once a day, taken either in
the morning or evening. Your doctor may gradually increase
your dose if needed.
Zoloft should be
administered with food once daily preferably with the
evening meal, or, if administration in the morining is
desired, with breakfast.
How
Zoloft is Supplied
50 mg: Each white and yellow capsule contains: Zoloft HCl 50 mg. Tartrazine-free.
White high density polyethylene botles of 100 and 250.
100 mg: Each orange capsule contains: Zoloft HCl 100 mg. Tartrazine-free.
White high density polyethylene bottles of 100.
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IMPORTANT NOTE: This information is intended to
supplement, not substitute for, the expertise and judgment of
your physician, pharmacist or other healthcare professional.
It should not be construed to indicate that use of the
drug is
safe, appropriate, or effective for you. Consult your
healthcare professional before using Zoloft.
