Learn About Paxil Dosage and Administration
Courtesy of the FDA
The following is information on Dosage and Administration, according to the
Food and Drug Administration:
Major Depressive
Disorder
Usual Initial Dosage: PAXIL should be administered as a
single daily dose with or without food, usually in the morning. The recommended
initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in
the clinical trials demonstrating the effectiveness of PAXIL in the treatment of
major depressive disorder. As with all drugs effective in the treatment of major
depressive disorder, the full effect may be delayed. Some patients not
responding to a 20-mg dose may benefit from dose increases, in 10-mg/day
increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals
of at least 1 week.
Maintenance Therapy: There is no body of
evidence available to answer the question of how long the patient treated with
PAXIL should remain on it. It is generally agreed that acute episodes of major
depressive disorder require several months or longer of sustained pharmacologic
therapy. Whether the dose needed to induce remission is identical to the dose
needed to maintain and/or sustain euthymia is unknown.
Systematic
evaluation of the efficacy of PAXIL has shown that efficacy is maintained for
periods of up to 1 year with doses that averaged about 30
mg.
Obsessive Compulsive Disorder:
Usual Initial Dosage:
PAXIL should be administered as a single daily dose with or without food,
usually in the morning. The recommended dose of PAXIL in the treatment of OCD is
40 mg daily. Patients should be started on 20 mg/day and the dose can be
increased in 10-mg/day increments. Dose changes should occur at intervals of at
least 1 week. Patients were dosed in a range of 20 to 60 mg/day in the clinical
trials demonstrating the effectiveness of PAXIL in the treatment of OCD. The
maximum dosage should not exceed 60 mg/day.
Maintenance Therapy:
Long-term maintenance of efficacy was demonstrated in a 6-month relapse
prevention trial. In this trial, patients with OCD assigned to paroxetine
demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL
PHARMACOLOGY—Clinical Trials). OCD is a chronic condition, and it is reasonable
to consider continuation for a responding patient. Dosage adjustments should be
made to maintain the patient on the lowest effective dosage, and patients should
be periodically reassessed to determine the need for continued
treatment.
Panic Disorder
Usual Initial Dosage: PAXIL
should be administered as a single daily dose with or without food, usually in
the morning. The target dose of PAXIL in the treatment of panic disorder is 40
mg/day. Patients should be started on 10 mg/day. Dose changes should occur in
10-mg/day increments and at intervals of at least 1 week. Patients were dosed in
a range of 10 to 60 mg/day in the clinical trials demonstrating the
effectiveness of PAXIL. The maximum dosage should not exceed 60
mg/day.
Maintenance Therapy: Long-term maintenance of efficacy was
demonstrated in a 3-month relapse prevention trial. In this trial, patients with
panic disorder assigned to paroxetine demonstrated a lower relapse rate compared
to patients on placebo (see CLINICAL PHARMACOLOGY—Clinical Trials). Panic
disorder is a chronic condition, and it is reasonable to consider continuation
for a responding patient. Dosage adjustments should be made to maintain the
patient on the lowest effective dosage, and patients should be periodically
reassessed to determine the need for continued treatment.
Social
Anxiety Disorder:
Usual Initial Dosage: PAXIL should be
administered as a single daily dose with or without food, usually in the
morning. The recommended and initial dosage is 20 mg/day. In clinical trials the
effectiveness of PAXIL was demonstrated in patients dosed in a range of 20 to 60
mg/day. While the safety of PAXIL has been evaluated in patients with social
anxiety disorder at doses up to 60 mg/day, available information does not
suggest any additional benefit for doses above 20 mg/day (see CLINICAL
PHARMACOLOGY—Clinical Trials).
Maintenance Therapy: There is no
body of evidence available to answer the question of how long the patient
treated with PAXIL should remain on it. Although the efficacy of PAXIL beyond 12
weeks of dosing has not been demonstrated in controlled clinical trials, social
anxiety disorder is recognized as a chronic condition, and it is reasonable to
consider continuation of treatment for a responding patient. Dosage adjustments
should be made to maintain the patient on the lowest effective dosage, and
patients should be periodically reassessed to determine the need for continued
treatment.
Generalized Anxiety Disorder:
Usual Initial
Dosage:PAXIL should be administered as a single daily dose with or without
food, usually in the morning. In clinical trials the effectiveness of PAXIL was
demonstrated in patients dosed in a range of 20 to 50 mg/day. The recommended
starting dosage and the established effective dosage is 20 mg/day. There is not
sufficient evidence to suggest a greater benefit to doses higher than 20 mg/day.
Dose changes should occur in 10 mg/day increments and at intervals of at least 1
week.
Maintenance Therapy: Systematic evaluation of continuing
PAXIL for periods of up to 24 weeks in patients with Generalized Anxiety
Disorder who had responded while taking PAXIL during an 8-week acute treatment
phase has demonstrated a benefit of such maintenance (see CLINICAL
PHARMACOLOGY—Clinical Trials). Nevertheless, patients should be periodically
reassessed to determine the need for maintenance
treatment.
Posttraumatic Stress Disorder:
Usual Initial
Dosage: PAXIL should be administered as a single daily dose with or without
food, usually in the morning. The recommended starting dosage and the
established effective dosage is 20 mg/day. In 1 clinical trial, the
effectiveness of PAXIL was demonstrated in patients dosed in a range of 20 to 50
mg/day. However, in a fixed dose study, there was not sufficient evidence to
suggest a greater benefit for a dose of 40 mg/day compared to 20 mg/day. Dose
changes, if indicated, should occur in 10 mg/day increments and at intervals of
at least 1 week.
Maintenance Therapy: There is no body of evidence
available to answer the question of how long the patient treated with PAXIL
should remain on it. Although the efficacy of PAXIL beyond 12 weeks of dosing
has not been demonstrated in controlled clinical trials, PTSD is recognized as a
chronic condition, and it is reasonable to consider continuation of treatment
for a responding patient. Dosage adjustments should be made to maintain the
patient on the lowest effective dosage, and patients should be periodically
reassessed to determine the need for continued treatment.
Special
Populations
Treatment of Pregnant Women During the Third
Trimester: Neonates exposed to PAXIL and other SSRIs or SNRIs, late in the
third trimester have developed complications requiring prolonged
hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When
treating pregnant women with paroxetine during the third trimester, the
physician should carefully consider the potential risks and benefits of
treatment. The physician may consider tapering paroxetine in the third
trimester.
Dosage for Elderly or Debilitated Patients, and Patients
With Severe Renal or Hepatic Impairment: The recommended initial dose is 10
mg/day for elderly patients, debilitated patients, and/or patients with severe
renal or hepatic impairment. Increases may be made if indicated. Dosage should
not exceed 40 mg/day.
Switching Patients to or From a Monoamine
Oxidase Inhibitor:
At least 14 days should elapse between discontinuation
of an MAOI and initiation of therapy with PAXIL. Similarly, at least 14 days
should be allowed after stopping PAXIL before starting an
MAOI.
Discontinuation of Treatment With PAXIL:
Symptoms
associated with discontinuation of PAXIL have been reported (see PRECAUTIONS).
Patients should be monitored for these symptoms when discontinuing treatment,
regardless of the indication for which PAXIL is being prescribed. A gradual
reduction in the dose rather than abrupt cessation is recommended whenever
possible. If intolerable symptoms occur following a decrease in the dose or upon
discontinuation of treatment, then resuming the previously prescribed dose may
be considered. Subsequently, the physician may continue decreasing the dose but
at a more gradual rate.
NOTE: SHAKE SUSPENSION WELL BEFORE
USING.
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see also:
Dosage
The dosage and administration for the drug PaxilImportant information regarding Paxil dosage and administration
Indication and Use
Information on Paxil Indication and Use from the FDAFind out about Paxil use from the Food and Drug Administration
