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Zoloft®
(sertaline
hydrochloride)
Tablets and Oral
Concentrate
Also see:
Celexa
Elavil Effexor Fluoxetine
Lexapro Paxil
Paxil CR Prozac
Remeron
Cymbalta
Drug Uses
Zoloft is a prescription medicine used to
treat depression, panic disorder, obsessive-compulsive disorder (also called OCD)
and posttraumatic stress disorder (also called PTSD) in adults. Zoloft is also
used to treat OCD in children (ages 6-12) and adolescents (ages 12-17).
How Taken
Zoloft comes as a tablet to take it
orally. It is usually taken once daily and may be taken with or without food.
Take Zoloft exactly as directed. Do not take more or less of it or take it more
often than prescribed by your doctor. Continue to take Zoloft even if you feel
well. Do not stop taking Zoloft without talking to your doctor, especially if
you have taken large doses for a long time. Your doctor probably will want to
decrease your dose gradually. This drug must be taken regularly for a few weeks
before its full effect is felt.
Warnings/Precautions
Before taking Zoloft, tell your doctor if
you have liver disease; kidney disease; suffer from seizures; or suffer from
mania or have suicidal thoughts. You may not be able to take Zoloft, or you may
need a dosage adjustment or special monitoring during treatment if you have any
of the conditions listed above. Zoloft is in the FDA pregnancy category C. This
means that it is unknown whether it will be harmful to an unborn baby. Do not
take Zoloft without first talking to your doctor if you are pregnant or could
become pregnant during treatment. It is not known whether Zoloft passes into
breast milk. Do not take Zoloft without first talking to your doctor if you are
breast-feeding a baby.
Missed Dose
If you take Zoloft once a day in the
morning, take the missed dose as soon as you remember it. However, if it is
almost time for the next dose, skip the missed dose and continue your regular
dosing schedule. If you take Zoloft once a day at bedtime and do not remember to
take it until the next morning, skip the missed dose. Do not take a double dose
to make up for a missed one.
Possible Side Effects
If you experience any of the following
serious side effects, stop taking Zoloft and contact your doctor immediately or
seek emergency medical treatment: an allergic reaction (difficulty breathing;
closing of the throat; swelling of the lips, tongue, or face; or hives); an
irregular heartbeat or pulse; low blood pressure (dizziness, weakness); high
blood pressure (severe headache, blurred vision); or chills or fever. If you
experience any of the following less serious side effects, continue taking
Zoloft and talk to your doctor: headache; tremor, nervousness, or anxiety;
nausea, diarrhea, dry mouth, or changes in appetite or weight; sleepiness or
insomnia; or decreased sex drive, impotence, or difficulty having an orgasm.
Side effects other than those listed here may also occur. Talk to your doctor
about any side effect that seems unusual or that is especially bothersome.
Storage
Store at 25°C (77°F); excursions permitted
to 15° - 30°C (59° - 86°F).
Overdose
Seek emergency medical attention. Symptoms
of a Zoloft overdose include nausea, vomiting, tremor, seizures, agitation,
drowsiness, hyperactivity, and enlarged pupils.
More Information
Use caution when driving, operating
machinery, or performing other hazardous activities. Zoloft may cause dizziness
or drowsiness. If you experience dizziness or drowsiness, avoid these
activities. Use alcohol cautiously. Alcohol may increase drowsiness or dizziness
while taking Zoloft.
Sertraline hydrochloride is a selective serotonin
reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of
342.7. Sertraline hydrochloride has the following chemical name:
(1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine
hydrochloride.
The empirical formula C17H17NCl2•HCl is represented by the
following structural formula:
Sertraline hydrochloride is a white crystalline powder that is slightly soluble
in water and isopropyl alcohol, and sparingly soluble in ethanol.
Sertraline hydrochloride is supplied for oral administration as scored tablets
equivalent to 25, 50 and 100 mg of sertraline and the following inactive
ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake
(in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red
#40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg
tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch
glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide.
Sertraline hydrochloride oral concentrate is available in a multidose 60 mL
bottle. Each mL of solution contains sertraline hydrochloride equivalent to 20
mg of sertraline. The solution contains the following inactive ingredients:
glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral
concentrate must be diluted prior to administration (see PRECAUTIONS,
INFORMATION FOR PATIENTS and DOSAGE AND ADMINISTRATION).
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and
behavior (suicidality) in children, adolescents, and young adults in short-term
studies of major depressive disorder (MDD) and other psychiatric disorders.
Anyone considering the use of Zoloft or any other antidepressant in a child,
adolescent, or young adult must balance this risk with the clinical need.
Short-term studies did not show an increase in the risk of suicidality with
antidepressants compared to placebo in adults beyond age 24; there was a
reduction in risk with antidepressants compared to placebo in adults aged 65 and
older. Depression and certain other psychiatric disorders are themselves
associated with increases in the risk of suicide. Patients of all ages who are
started on antidepressant therapy should be monitored appropriately and observed
closely for clinical worsening, suicidality, or unusual changes in behavior.
Families and caregivers should be advised of the need for close observation and
communication with the prescriber. Zoloft is not approved for use in pediatric
patients except for patients with obsessive compulsive disorder (OCD). (See
WARNINGS: Clinical worsening and suicide risk, PRECAUTIONS: Information for patients and precautions: Pediatric Use)
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