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Zoloft (Sertraline Hydrochloride)
Zoloft comes in tablets as well as an oral concentrate. Zoloft is
a selective serotonin reuptake inhibitor (SSRI). It is presumed
to be linked to it inhibition of central nervous system uptake of
serotonin (5HT). Clinical studies show that relevant doses block
serotonin uptake into the human platelets. It has very weak effects
on Norepinephine and Dopamine neuronal reuptake.
Bioavailability
Peak plasma concentrations of Zoloft are reached 4.5 to 8.4 hours
after dosing. The half-life is about 26 hours, and plasma levels
should be reached after approximately one week of daily dosing.
Pediatric Pharmacokinetics
In studies with children ages 6-12 year old, it was found that the
6-12 year olds had higher plasma levels, and they attribute this
to patients’ lower body weight weights. The meds were titrated
up to 200 mg./day. The data suggests that in pediatric patients,
Zoloft is metabolized with a little greater efficacy than adults.
It may be advisable to use lower doses when dealing with the pediatric
population.
In reviewing the literature, it is important to note that this
author has not found any suggestion of Zoloft being connected with
completed suicides in children.
Zoloft precautions and side-effects
Precautions: In pre-marketing studies with Zoloft, there was 0.4%
increase in hypomania and mania with treated patients. Weight loss:
There was more significant weight loss than weight gain. Individuals
treated with Zoloft had a 1-2 lb. weight loss vs. placebo. Zoloft
should be used with caution with individuals who have a seizure
disorder. Suicide precaution is as follows: Individuals being treated
for major depressive episodes with Zoloft have a higher incidence
of suicide anyway. The Zoloft does not appear to increase the Suicidal
tendencies, despite all the recent media attention, as well as the
FDA warnings. In studies, Zoloft did not cause increased sedation,
or interfere with any psychomotor performance. Zoloft is definitely
indicated with Mono Amine Oxidase Inhibitors (MAOI’s). Caution
should be used in prescribing Zoloft with Imitrex, as well as tricyclic
antidepressants and other hypoglycemic drugs.
Zoloft and alcohol
As per Pfizer, Zoloft did not increase cognitive or psychomotor
effects with alcohol. However, it is strongly advised that alcohol
is not recommended with the use of Zoloft.
Zoloft and pregnancy
Zoloft is a Category C medication. It should not be taken during
pregnancy, and should only be used if the potential benefit justifies
the risk to the fetus. Studies where pregnant female rats were given
4x the maximum recommended human dose of Zoloft did increase the
number of stillborns.
Zoloft and breastfeeding
Caution should be exercised when giving Zoloft to nursing mothers.
Many drugs are excreted into breast milk. It is not known to what
extent Zoloft, when metabolized, is excreted into breast milk. Subsequently,
it is not advised.
In treatment studies of major depression and panic disorder, the
following are some of the most common side effects that occur. Ejaculation
failure, dry mouth, somnolence, dizziness, fatigue, diarrhea, nausea
and insomnia are some of the more common side effects.
Zoloft dosage and administration
For major depressive disorder and obsessive-compulsive disorder,
it is advised to start at 50 mg., once daily, and monitored from
there. For panic disorder, post-traumatic stress disorder and social
anxiety, Pfizer recommends starting at 25 mg., once daily, and after
one week, the dose should be increased to 50 mg., once daily, depending
on the resolution of symptomatology.
Premenstrual dysphoric disorder
Initiation with 50 mg. a day is recommended daily throughout the
menstrual cycle, or limited to the luteal phase of the menstrual
cycle, depending on the assessment. Dosage for the pediatric population,
children and adolescents, for obsessive-compulsive disorder, it
is recommended that Zoloft be initiated with a dose of 25 mg., once
daily in children 6-12, and a dose of Dosage for the pediatric population,
children and adolescents, for obsessive-compulsive disorder, it
is recommended that Zoloft be initiated with a dose of 25 mg., once
daily in children 6-12, and a dose of 50 mg., once daily in adolescents
ranging in age from 13-17.
In conclusion, I have had numerous successes with Zoloft in children,
as well as adults. I always tell my patients that as with any medication,
if we are not successful with a medication after slowly titrating
it up over 1-2 months, we may have to switch, but it is best to
be patient and allow the medication time to work. In treating depression
with pharmacological intervention, there is always some degree of
trial and error, since there are many similarities between the SSRI’s.
Pfizer, Feb., 2003.
Paxil (Paroxetine)
Paxil CR comes in a 12.5 25 mg. and 37.5 mg. controlled release
tablets. It is indicated for panic disorder and social anxiety disorder,
as well as major depressive disorder. Paxil is not recommended for
children. Paxil dosage: It is advised to start out once daily, adjust
by 10 mg./day at one-week intervals. Panic disorder, initially 10
mg./day, up to 40 mg. maximum. Social anxiety disorder, begin at
20 mg./day and up to 60 mg./day. Obsessive-compulsive disorder,
initially start out at 20 mg./day, and usually can go up to 40 mg./day.
Maximum is 60 mg./day. Post-traumatic stress disorder is 20 mg./day,
maximum of 50 mg./day. Cautioned with the elderly and hepatic and
renal impairment. It is contraindicated to go beyond 40 mg./day
with these individuals.
Paxil precautions
If a patient has a history of seizures, Paxil should be discontinued
if a seizure occurs. Paxil does lower the seizure threshold. Be
aware of increased risk of manic behavior and hypomanic states,
along with narrow angle glaucoma. In pregnancy, Paxil is Category
C. It is not recommended for pregnancy or for nursing mothers.
Paxil interactions
Paxil is not recommend in adjunct to MAOI’s. It is recommended
that alcohol be avoided if taking Paxil, and there is potentiation
with other protein bound drugs. Caution should be used with nonsteroidal
anti-inflammatories, as well as Warfarin and Tagamet, and caution
used by any drugs that are metabolized by the CYP2D6, including
tricyclic anti-depressants and phenothiazines, you want to monitor
Lithium and Digozin, as well as Dilantin.
Paxil adverse reactions
Sweating, decreased appetite, insomnia or somnolence, decreased
libido, tremor, stomach upset, impotence, and abnormal bleeding.
Paxil and weight gain
This author has not seen individuals gain much weight over a year’s
time on Paxil. If anything, I have seen more decreased appetite
and weight loss. However, in head to head studies over a year’s
time, Paxil vs. Zoloft, there was more of a weight gain with the
Paxil patients than with Zoloft.
Comparative data with Paxil and Zoloft
In head to head studies, in depression, the efficacy and safety,
Zoloft vs. Paxil, showed no significant different in improvement
and resolution of depressive symptoms. The study was a 24-week comparison
with Zoloft averaging between 50-150 mg./day and Paxil, 20-40 mg./day.
Depression rating scales and quality of life questionnaires were
given. There was no statistically difference between the two in
terms of resolution of depression. There were more side effects,
in terms of anti-cholinergic affects such as
drowsiness, fatigue, and weight gain with Paxil than there was with
Zoloft. In assessing insomnia and sedation, Paxil vs. Zoloft, there
were no statistically significant differences found between the
two medications in terms of adverse events such as over sedation
or insomnia.
In a study by Kroenke et al. he comments that although SSRI’s
are equally effective on average, not all SSRI’s are equally
effective for individual patients. In addition, he goes on to state
intolerable side effects caused by one SSRI does not necessary predict
intolerable side effects from a similar medication. This reinforces
what this author of Peace & Healing has been stating; that is,
it is important to explain to patients that they may not experience
the effects they are wanting initially, in the first month or two,
but that doesn’t mean they shouldn’t attempt another
medication. Patients frequently become intolerant and do not want
any medication when they have a bad side effect, and it is very
important that we support and reassure the patient, and reinforce
the need for another trial.
There does appear to be more of a weight gain factor with Paxil
than with Zoloft. In a randomized double blind study, Fava et al.
assessed long-term effects of treatment with Zoloft and Paxil. Out
of 284 patients, after 16 weeks of the initial drug treatment, 25%
of the Paxil patients experienced a weight gain approximately 7%
greater than baseline, as opposed to Zoloft, in which approximately
4.2% of the patients experienced weight gain.
Zoloft and Paxil are both very effective with social anxiety disorder,
panic disorder, and post-traumatic stress disorder, as well as depression.
Zoloft (Sertraline page) insert
Paxil (Paroxetine Hydrochloride) package insert
Fava M., Hoog, S.L., Judge, R.A., et al., Acute Efficacy of Fluoxetine
vs. Sertraline and Paroxetine in Major Depressive Disorder, Including
Affects of Baseline Insomnia, Journal of Clinical Psychopharmacology,
2002; 22: 137-147.
Kroenke, K., West S.L., Swindle R., et al., Similar Effectiveness
of Paroxetine, Fluoxetine and Sertraline in Primary Care: A Randomized
Trial, JAMA, 2001; 286: 2947-2955.
Simon, G. Choosing a First Line Anti-Depressant: Equal on Average
Does Not Mean Equal for Everyone.
JAMA, 2001; 286: 3003-3004.
Fava, M., Judge, R., Hoog, S., et al. Fluoxetine vs. Sertraline
and Paroxetine in a Major Depressive Disorder: Changes in Weight
with Long-Term Treatment. General Clinical Psychiatry, 2000, 61:
863-867.
Zoloft and the Treatment of Panic Disorder
The first long-term study for Zoloft in the treatment of panic disorder
came out in 2001. The study was done in 1999. This study followed
398 patients diagnosed with panic disorder and treated for 52 weeks
on Zoloft. The study concluded that long-term Zoloft treatment was
very effective in prevent relapse of panic disorder, and was well
tolerated with minimal discontinuation of symptoms. The results
of the study showed that long-term treatment was very effective
in alleviating panic disorder. Also when Zoloft was abruptly stopped
after 50 weeks of treatment, there were minimal discontinuation
of symptoms. This definitely reinforced that Zoloft was safe in
treating panic disorder. The average dose was started at
25 mg. It was increased to 50 mg. at the end of the first week.
In those patients who failed to demonstrate a satisfactory response,
there was another increase of 50 mg., the highest dose being 200
mg.
Side-effects
Headache was the most common side effect, followed by generalized
fatigue and then insomnia.
This author has used Zoloft for treatment of panic disorder, and
has had good results with it. This study continues to support the
benefits of psychopharmacological intervention for certain disorders.
It has also been shown that there was a higher efficacy rate when
combining Zoloft and cognitive behavioral therapy in panic disorder
patients, with evidence demonstrating a more successful outcome.
Patients begin to see some success and responsibility for alleviating
their own symptoms, while tapering off the anti-depressant.
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