Activation of Mania/Hypomania:
During clinical testing in depressed patients,
hypomania or mania occurred in approximately 0.6% of sertraline-treated patients. Activation of mania/hypomania has also been
reported in a small proportion of patients with Major Affective Disorder treated with other marketed antidepressants.
Sertraline has not been evaluated in patients with seizure disorders.
These patients were excluded from clinical studies during the product's premarket testing. Accordingly, sertraline should
be introduced with care in epileptic patients.
The possibility of a suicide attempt is inherent in depression
and may persist until significant remission occurs. Therefore, high risk patients should be closely supervised throughout
therapy and consideration should be given to the possible need for hospitalization. In order to minimize the opportunity for
overdosage, prescriptions for sertraline should be written for the smallest quantity of drug consistent with good patient
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.
Patients with Concomitant Illness:
Clinical experience with sertraline
in patients with certain concomitant systemic illnesses is limited. Caution is advisable in using sertraline in patients with
diseases or conditions that could affect metabolism or hemodynamic responses.
Sertraline has not been evaluated or used to any
appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease.
The electrocardiograms of 598 patients who received sertraline were compared in a blinded fashion
to the electrocardiograms of 244 placebo patients and 206 amitriptyline patients. The data indicate that sertraline is not
associated with the development of significant ECG abnormalities.
Effect on Blood Pressure:
The frequency of clinically noticeable
changes (+/-15 to 20 mm Hg) in blood pressure in placebo controlled studies was similar for patients being treated with sertraline
or placebo (see Table I).
Sertraline is extensively metabolized by the
liver. The pharmacokinetics and therapeutic efficacy of sertraline have not been studied in patients with significant hepatic
dysfunction. Accordingly, it should be used with caution in such patients.
Sertraline is extensively
metabolized and excretion of unchanged drug in the urine is a minor route of elimination. The pharmacokinetics of sertraline
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 sertraline, it should be used with caution in such patients.
In carcinogenicity studies in CD-1 mice, sertraline
at doses up to 40 mg/kg produces a dose related increase in the incidence of liver adenomas in male mice. Liver adenomas have
a very variable rate of spontaneous occurrence in the CD-1 mouse. The clinical significance of these findings is unknown.
Pregnancy and Lactation:
The safety of sertraline during pregnancy
and lactation 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
The safety and effectiveness of sertraline in children
below the age of 18 have not been established.
462 elderly patients (>=65 years) have participated
in multiple dose therapeutic studies with sertraline. The pattern of adverse reactions in the elderly was comparable to that
in younger patients.
Co-Administration of Drugs Highly Bound to Plasma Proteins:
sertraline is highly bound to plasma proteins, the co-administration of other highly bound drugs such as warfarin or digitoxin
may cause a shift in plasma concentrations potentially resulting in adverse effects. At this time, the effect of sertraline
on the anticoagulant activity of warfarin is unknown. Accordingly, prothrombin time should be carefully monitored when sertraline
therapy is initiated or discontinued. Conversely, adverse effects may result from displacement of protein bound sertraline
by other tightly bound drugs.
CNS Active Drugs:
The risk of using sertraline in combination with
other CNS active drugs has not been systematically evaluated. Consequently, caution is advised if the concomitant administration
of sertraline and such drugs is required.
Co-administration with tryptophan may lead to a high incidence of serotonin-associated side
effects. There is no experience with the concomitant use of sertraline and tryptophan in depressed patients.
In placebo-controlled trials in normal volunteers, the combined administration of lithium and
sertraline did not alter the pharmacokinetics of sertraline. There is, however, no clinical experience with sertraline in
lithium treated patients. Therefore, it is recommended that plasma lithium levels be monitored following initiation of sertraline
therapy, so that appropriate adjustments to the lithium dose may be made if necessary. Co-administration with lithium may
lead to a high incidence of serotonin-associated side effects.
There are no clinical studies with the
combined use of electroconvulsive therapy (ECT) and sertraline.
Although sertraline did not potentiate the cognitive and
psychomotor effects of alcohol in experiments with normal subjects, the concomitant use of sertraline and alcohol in depressed
patients has not been studied and is not recommended.
HD Patients Personal Experiences:
Now! Let me tell you about my experience with Zoloft! I was realeased
from the psyc. ward yesterday afternoon after having some kind of extreme reaction to it. I was taking 25mg daily and did
so for three days. By that third day I was extremely aggitated, my hands and legs would not quite moving, my mind was racing
so fast I could not think straight and was crying constantly. That said, I have taken many anti-depressants in my time and
have suffered for a very long time with bouts of depression, but folks this was a whole new ball game!
For the first time I actually kept thinking to myself "My God! this
is what it is like to lose my mind". I really didn't think I would ever be the same again. I have never been so terrified
in my life!
After being held in the hospital on a 24 hour hold I was let go.
This is my second morning back in my home and slowly but surely am starting to feel like myself again. I keep having small
panic attacks just from what I had gone through, if my leg twitches I think its comming back or something. But I know it's
not, it's just going to take awhile to get it out of my system.
I am seeing a NEW Doctor this afternoon and hopefully she will help
me, because the orginal reason for going to the Dr. last week was for flu like symptoms, but he said I was depressed. And
gave me the Zoloft. I knew I wasn't depressed and should have spoken up so let that be a lesson to everyone PLEASE!
IF YOU DO NOT THINK THAT THEY ARE TREATING YOU FOR THE RIGHT THING...... SPEAK UP FOR GOD'S SAKE SPEAK UP!!!
Or you could very well wind up like I did or God forbid worse. I just thank God my husband wouldn't let me take anymore of
the Zoloft thinking that was what was going wrong!!!! T.L.
My medical Dr. gave me a combo of Vioxx and Zoloft to treat my TMJ.
Well the Zoloft made me very irritable and agitated and I lost a lot of weight very quickly. I stopped in on my own after
3 weeks (I was up to 50 mg/day). MY