Zoloft (sertraline)
Zoloft is in a class of drugs called selective serotonin reuptake inhibitors. Zoloft affects chemicals in the brain that may become unbalanced and cause depression, panic or anxiety, or obsessive or compulsive symptoms.
Zoloft is indicated for the treatment of major depressive disorder, Obsessive-Compulsive
Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric
Disorder, Social Anxiety Disorder
Side Effects
Zoloft has numerous side effects on all the body systems
*Body as a Whole: Malaise(A vague feeling of bodily discomfort), fatigue,
pain
*Dermatologic: Rash
*Cardiovascular: Palpitation, Vasodilation (increase in the internal diameter
of a blood vessel causing increased blood flow)
*Gastrointestinal: Nausea, Dry Mouth, Decreased Appetite, Flatulence, vomiting,
diarrhea, dyspepsia (impairment of digestive function),Abdominal Pain, Constipation
*Nervous System: Ejaculation Failure, Dry Mouth, Increased Sweating, Somnolence(sleepiness),
tremor, dizziness
*Psychiatric Disorders: Agitation, Insomnia, decreased libido, Nervousness
*Special Senses: Abnormal vision
Precautions and drug interactions:
Zoloft has adverse interactions with many drugs. Zoloft should not be taken
with the following medications:
*Gastrointestinal drugs: Cimetidine(Tagamet)
*Anticonvulsants: phenytoin, Tegretol
*Antipsychotics: haloperidol, clozapine
*Benzodiazepines: Valium, Xanax
*Lithium
*Tryptophan:(please note that tryptophan is present in high quantities in
turkey and milk, so caution must be taken if ingesting these foods.)
*MAOI'S
*Other Antidepressants
*Warfarin and other blood thinners
*Sumatriptan(Imitrex)
*Alcohol
Other precautions
*Weight Loss: Significant weight loss may be an undesirable result of treatment
with sertraline for some patients
* Abnormal Bleeding: Published case reports have documented the occurrence
of bleeding episodes in patients treated with psychotropic drugs that interfere
with serotonin reuptake. Patients should be cautioned regarding the risk
of bleeding associated with the concomitant use of ZOLOFT with non-selective
NSAIDs such as aspirin, or other drugs that affect coagulation.
*Liver Impairment: The use of sertraline in patients with liver disease
must be approached with caution. If sertraline is administered to patients
with liver impairment, a lower or less frequent dose should be used
WARNING |
*Cases of serious, sometimes fatal reactions have been reported in patients
receiving ZOLOFT 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.
* Clinical Worsening and Suicide Risk: Patients with major depressive disorder,
both adult and pediatric, may experience worsening of their depression and/or
the emergence of suicidal ideation and behavior (suicidality). Patients
being treated with antidepressants should be observed closely for clinical
worsening and suicidality, especially at the beginning of a course of drug
therapy, or at the time of dose changes, either increases or decreases.
* Discontinuing Treatment: If the decision has been made to discontinue
treatment, medication should be tapered, as rapidly as is feasible, but
with recognition that abrupt discontinuation can be associated with certain
symptoms including the following: dysphoric mood, irritability, agitation,
dizziness, sensory disturbances (e.g. paresthesias(numbness and tingling
in the limbs) such as electric shock sensations), anxiety, confusion, headache,
lethargy, emotional lability, insomnia, and hypomania. While these events
are generally self-limiting, there have been reports of serious discontinuation
symptoms.
Pregnancy and Nursing Mothers
Zoloft is in pregnancy category C. Studies in rats have resulted in deaths
and damage to the fetus. There are no adequate and well-controlled studies
in pregnant women. Because animal reproduction studies are not always predictive
of human response, this drug should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
The effect of Zoloft on labor and delivery in humans is unknown. However,
because Zoloft crosses the placenta and because of the possibility that
Zoloft may have adverse effects on the newborn, Zoloft should be used during
labor and delivery only if the potential benefit justifies the potential
risk to the fetus.
Like many other drugs, Zoloft is secreted in human milk, and caution should
be exercised when ZOLOFT is administered to a nursing woman.
Pediatric Use
The risks, if any, that may be associated with ZOLOFT's use beyond 1 year
in children and adolescents with OCD or major depressive disorder have not
been systematically assessed. In particular, there are no studies that directly
evaluate the effects of long-term sertraline use on the growth, development,
and maturation of children and adolescents. Although there is no affirmative
finding to suggest that sertraline possesses a capacity to adversely affect
growth, development or maturation, the absence of such findings is not compelling
evidence of the absence of the potential of sertraline to have adverse effects
in chronic use.
Geriatric Use
No overall differences in safety or effectiveness were observed between
these subjects and younger subjects, and other reported clinical experience
has not identified differences in responses between the elderly and younger
patients, but greater sensitivity of some older individuals cannot be ruled
out. As with other SSRIs, Zoloft has been associated with cases of clinically
significant hyponatremia (low sodium levels) in elderly patients
Drug Abuse and Dependence
Zoloft is not a controlled substance.
Recommended Dosage
Recommended dosage differs depending upon the condition being treated.
* Major Depressive Disorder and Obsessive-Compulsive Disorder: ZOLOFT treatment
should be administered at a dose of 50 mg once daily.
* Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety Disorder:
ZOLOFT treatment should be initiated with a dose of 25 mg once daily. After
one week, the dose should be increased to 50 mg once daily.
* Premenstrual Dysphoric Disorder: ZOLOFT treatment should be initiated
with a dose of 50 mg/day, daily throughout the menstrual cycle
Dosage for Children and Adolescents
*Obsessive-Compulsive Disorder: ZOLOFT treatment should be initiated with
a dose of 25 mg once daily in children (ages 6-12) and at a dose of 50 mg
once daily in adolescents (ages 13-17).
Overdose
Of 1,027 cases of overdose involving sertraline hydrochloride worldwide,
alone or with other drugs, there were 72 deaths (circa 1999). The most common
signs and symptoms associated with non-fatal sertraline Zoloft overdosage
were somnolence(sleepiness), vomiting, tachycardia(rapid heartbeat), nausea,
dizziness, agitation and tremor.