INDICATIONS
Immediate-Release Tablets, Oral Suspension, and
Controlled-Release Tablets
Depression
Paroxetine HCl is indicated for the treatment of depression.
The efficacy of paroxetine HCl in the treatment of a
major depressive episode was established in 6-week controlled
trials (for the immediate-release and oral suspension)
and 12-week controlled trials (for the controlled-release
tablets) of outpatients whose diagnoses corresponded most
closely to the DSM-III category (for the immediate-release
and oral suspension) and DSM-IV category (for the controlled-release
tablets) of major depressive disorder (see CLINICAL PHARMACOLOGY).
The antidepressant action of paroxetine HCl in hospitalized
depressed patients has not been adequately studied.
Paroxetine HCl controlled-release tablets have not been
systematically evaluated beyond 12 weeks in controlled
clinical trials; however, the efficacy of immediate-release
paroxetine HCl in maintaining an antidepressant response
for up to 1 year was demonstrated in a placebo-controlled
trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician
who elects to use paroxetine HCl for extended periods
should periodically re-evaluate for long-term usefulness
of the drug for the individual patient.
Additional Information for Immediate-Release
Tablets and Oral Suspension: A major depressive
episode implies a prominent and relatively persistent
depressed or dysphoric mood that usually interferes with
daily functioning (nearly every day for at least 2 weeks);
it should include at least 4 of the following 8 symptoms:
change in appetite, change in sleep, psychomotor agitation
or retardation, loss of interest in usual activities or
decrease in sex drive, increased fatigue, feelings of
guilt or worthlessness, slowed thinking or impaired concentration,
and a suicide attempt or suicidal ideation.
The efficacy of paroxetine HCl in maintaining an antidepressant
response for up to 1 year was demonstrated in a placebo-controlled
trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician
who elects to use paroxetine HCl for extended periods
should periodically re-evaluate the long-term usefulness
of the drug for the individual patient.
Additional Information Controlled-Release
Tablets: A major depressive episode (DSM-IV)
implies a prominent and relatively persistent (nearly
every day for at least 2 weeks) depressed mood or loss
of interest or pleasure in nearly all activities, representing
a change from previous functioning, an includes the presence
of at least five of the following nine symptoms during
the same two week period: depressed mood, markedly diminished
interest or pleasure in usual activities, significant
change in weight and/or appetite, insomnia or hypersomnia,
psychomotor agitation or retardation, increased fatigue,
feelings of guilt or worthlessness, slowed thinking or
impaired concentration, a suicide attempt or suicidal
ideation.
Immediate-Release Tablets and Oral Suspension
Obsessive Compulsive Disorder
Paroxetine HCl is indicated for the treatment of obsessions
and compulsions in patients with obsessive compulsive
disorder (OCD) as defined in the DSM-IV. The obsessions
or compulsions cause marked distress, are time-consuming,
or significantly interfere with social or occupational
functioning.
The efficacy of paroxetine HCl was established in two
12-week trials with obsessive compulsive outpatients whose
diagnoses corresponded most closely to the DSM-IIIR category
of obsessive compulsive disorder (see CLINICAL STUDIES).
Obsessive compulsive disorder is characterized by recurrent
and persistent ideas, thoughts, impulses or images (obsessions)
that are ego-dystonic and/or repetitive, purposeful and
intentional behaviors (compulsions) that are recognized
by the person as excessive or unreasonable.
Long-term maintenance of efficacy was demonstrated in
a 6-month relapse prevention trial. In this trial, patients
assigned to paroxetine showed a lower relapse rate compared
to patients on placebo (see CLINICAL PHARMACOLOGY). Nevertheless,
the physician who elects to use paroxetine HCl for extended
periods should periodically re-evaluate the long-term
usefulness of the drug for the individual patient (see
DOSAGE AND ADMINISTRATION
).
Panic Disorder
Paroxetine HCl is indicated for the treatment of panic
disorder, with or without agoraphobia, as defined in DSM-IV.
Panic disorder is characterized by the occurrence of unexpected
panic attacks and associated concern about having additional
attacks, worry about the implications or consequences
of the attacks, and/or a significant change in behavior
related to the attacks.
The efficacy of paroxetine HCl was established in three
10- to 12-week trials in panic disorder patients whose
diagnoses corresponded to the DSM-IIIR category of panic
disorder (see CLINICAL STUDIES).
Panic disorder (DSM-IV) is characterized by recurrent
unexpected panic attacks i.e., a discrete period of intense
fear or discomfort in which 4 (or more) of the following
symptoms develop abruptly and reach a peak within 10 minutes:
(1) palpitations, pounding heart or accelerated heart
rate; (2) sweating; (3) trembling or shaking; (4) sensations
of shortness of breath or smothering; (5) feeling of choking;
(6) chest pain or discomfort; (7) nausea or abdominal
distress; (8) feeling dizzy, unsteady, lightheaded, or
faint; (9) derealization (feelings of unreality) or depersonalization
(being detached from oneself); (10) fear of losing control;
(11) fear of dying; (12) paresthesias (numbness or tingling
sensations); (13) chills or hot flushes.
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). Nevertheless, the physician who
prescribes paroxetine HCl for extended periods should
periodically re-evaluate the long-term usefulness of the
drug for the individual patient.
Social Anxiety Disorder
Paroxetine HCl is indicated for the treatment of social
anxiety disorder, also known as social phobia, as defined
in DSM-IV (300.23) Social anxiety disorder is characterized
by a marked and persistent fear of one or more social
or performance situations in which the person is exposed
to unfamiliar people or to possible scrutiny by others.
Exposure to the feared situation almost invariably provokes
anxiety, which may approach the intensity of a panic attack.
The feared situations are avoided or endured with intense
anxiety or distress. The avoidance, anxious anticipation,
or distress in the feared situation(s) interferes significantly
with the person's normal routine, occupational or academic
functioning, or social activities or relationships, or
there is marked distress about having the phobias. Lesser
degrees of performance anxiety or shyness generally do
not require psychopharmacological treatment.
The efficacy of paroxetine HCl was established in three
12-week trials in adult patients with social anxiety disorder
(DSM-IV). Paroxetine HCl has not been studied in children
or adolescents with social phobia (see CLINICAL STUDIES).
The effectiveness of paroxetine HCl in long-term treatment
of social anxiety disorder, i.e., for more than 12 weeks,
has not been systemically evaluated in adequate and well-controlled
trials. Therefore, the physician who elects to prescribe
paroxetine HCl for extended periods should periodically
re-evaluate the long-term usefulness of the drug for the
individual patient (see
DOSAGE AND ADMINISTRATION
).
DOSAGE AND ADMINISTRATION
Depression
Usual Initial Dosage: Immediate-Release
Tablets and Oral Suspension Only: Paroxetine HCl immediate-release
formulations 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 antidepressant effectiveness of paroxetine HCl. As
with all antidepressants, the full antidepressant 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. Controlled-Release Tablets:
Paroxetine HCl controlled-release tablets should be administered
as a single daily dose, usually in the morning, with or
without food. The recommended initial dose is 25 mg/day.
Patients were dosed in a range of 25 mg to 62.5 mg/day
in the clinical trials demonstrating the antidepressant
effectiveness of paroxetine HCl controlled-release tablets.
As with all antidepressants, the full antidepressant effect
may be delayed. Some patients not responding to a 25 mg
dose may benefit from dose increases, in 12.5 mg/day increments,
up to a maximum of 62.5 mg/day. Dose changes should occur
at intervals of at least 1 week.
Patients should be cautioned that the paroxetine HCl
controlled-release tablet should not be chewed or crushed,
and should be swallowed whole.
Maintenance Therapy: Immediate-Release
Tablets, Oral Suspension, and Controlled-Release Tablets:
There is no body of evidence available to answer the question
of how long the patient treated with paroxetine HCl should
remain on it. It is generally agreed that acute episodes
of depression require several months or longer of sustained
pharmacologic therapy. Whether the dose of an antidepressant
needed to induce remission is identical to the dose needed
to maintain and/or sustain euthymia is unknown.
Systematic evaluation of the efficacy of immediate-release
paroxetine HCl has shown that efficacy is maintained for
periods of up to 1 year with doses that averaged about
30 mg, which corresponds to a 37.5 mg dose of paroxetine
HCl controlled-release tablets, based on relative bioavailability
considerations (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
Obsessive Compulsive Disorder
Immediate-Release Tablets and Oral Suspension
Usual Initial Dosage: Paroxetine
HCl should be administered as a single daily dose, with
or without food, usually in the morning. The recommended
dose of paroxetine HCl 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 paroxetine HCl
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).
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
Immediate-Release Tablets and Oral Suspension
Usual Initial Dosage: Paroxetine
HCl should be administered as a single daily dose with
or without food, usually in the morning. The target dose
of paroxetine HCl 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 paroxetine HCl. 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). 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
Immediate-Release Tablets and Oral Suspension
Usual Initial Dosage: Paroxetine
HCl 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 paroxetine HCl was demonstrated in patients
dosed in a range of 20 to 60 mg/day. While the safety
of paroxetine HCl 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).
Maintenance Therapy: There
is no body of evidence available to answer the question
of how long the patient treated with paroxetine HCl should
remain on it. Although the efficacy of paroxetine HCl
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.
Immediate-Release Tablets, Oral Suspension,
and Controlled-Release Tablets
Dosage for Elderly or Debilitated, and Patients with
Severe Renal or Hepatic Impairment: The recommended initial
dose is 10 mg/day (immediate-release tablets and oral
suspension) and 12.5 mg/day (controlled-release tablets)
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
(immediate-release tablets and oral suspension) and 50
mg/day (controlled-release tablets).
Switching Patients to or From a Monoamine Oxidase Inhibitor:
At least 14 days should elapse between discontinuation
of a MAOI and initiation of paroxetine HCl therapy. Similarly,
at least 14 days should be allowed after stopping paroxetine
HCl before starting an MAOI.
HOW SUPPLIED
Paxil Immediate-Release Tablets
Film-coated, modified-oval as follows:
10 mg Tablets: Yellow tablets
engraved on the front with PAXIL and on the back with
10.
20 mg Tablets: Pink, scored
tablets engraved on the front with PAXIL and on the back
with 20.
30 mg Tablets: Blue tablets engraved
on the front with PAXIL and on the back with 30.
40 mg Tablets: Green tablets
engraved on the front with PAXIL and on the back with
40.
Storage: Store tablets 15-30°C (59-86°F).
Paxil Oral Suspension
Orange-colored, orange-flavored, 10 mg/5ml.
Storage: Store suspension at or below
25°C (77°F).
NOTE: SHAKE SUSPENSION WELL BEFORE USING.
Paxil CR (Controlled-Release Tablets)
Paxil CR is supplied as an enteric film-coated, controlled-release,
bilayer round tablet.
12.5 mg Tablets: Pale yellow
and white tablets, printed with Paxil CR and 12.5.
25 mg Tablets: Pink and white
tablets, printed with Paxil CR and 25.
Storage: Store at controlled room temperature
between 20-25°C (68-77°F).
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