INDICATIONS AND USAGE
Major Depressive DisorderPAXIL CR is indicated for the treatment of major depressive
disorder.
The efficacy of PAXIL CR in the treatment of a major depressive episode was
established in two 12-week controlled trials of outpatients whose diagnoses
corresponded to the DSM-IV category of major depressive disorder (see CLINICAL
PHARMACOLOGYClinical Trials).
A major depressive episode (DSM-IV) implies a prominent and relatively
persistent (nearly every day for at least 2weeks) depressed mood or loss of
interest or pleasure in nearly all activities, representing a change from
previous functioning, and includes the presence of at least 5 of the following 9
symptoms during the same 2-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.
The antidepressant action of paroxetine in hospitalized depressed patients
has not been adequately studied.
PAXIL CR has not been systematically evaluated beyond 12weeks in controlled
clinical trials; however, the effectiveness of immediate-release paroxetine
hydrochloride in maintaining a response in major depressive disorder for up to
1year has been demonstrated in a placebo-controlled trial (see CLINICAL
PHARMACOLOGYClinical Trials). The physician who elects to use PAXIL CR for
extended periods should periodically re-evaluate the long-term usefulness of the
drug for the individual patient.
Panic DisorderPAXIL CR 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 PAXIL CR controlled-release tablets was established in two
10-week trials in panic disorder patients whose diagnoses corresponded to the
DSM-IV category of panic disorder (see CLINICAL PHARMACOLOGYClinical
Trials).
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
10minutes: (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 with the immediate-release formulation of
paroxetine was demonstrated in a 3-month relapse prevention trial. In this
trial, patients with panic disorder assigned to immediate-release paroxetine
demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL
PHARMACOLOGYClinical Trials). Nevertheless, the physician who prescribes PAXIL
CR for extended periods should periodically re-evaluate the long-term usefulness
of the drug for the individual patient.
Social Anxiety DisorderPAXIL CR 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 1 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 PAXIL CR as a treatment for social anxiety disorder has been
established, in part, on the basis of extrapolation from the established
effectiveness of the immediate-release formulation of paroxetine. In addition,
the efficacy of PAXIL CR was established in a 12-week trial, in adult
outpatients with social anxiety disorder (DSM-IV). PAXIL CR has not been studied
in children or adolescents with social phobia (see CLINICAL
PHARMACOLOGYClinical Trials).
The effectiveness of PAXIL CR in long-term treatment of social anxiety
disorder, i.e., for more than 12 weeks, has not been systematically evaluated in
adequate and well-controlled trials. Therefore, the physician who elects to
prescribe PAXIL CR for extended periods should periodically re-evaluate the
long-term usefulness of the drug for the individual patient (see DOSAGE AND
ADMINISTRATION).
Premenstrual Dysphoric DisorderPAXIL CR is indicated for the treatment of PMDD.
The efficacy of PAXIL CR in the treatment of PMDD has been established in 3
placebo-controlled trials (see CLINICAL PHARMACOLOGYClinical Trials).
The essential features of PMDD, according to DSM-IV, include markedly
depressed mood, anxiety or tension, affective lability, and persistent anger or
irritability. Other features include decreased interest in usual activities,
difficulty concentrating, lack of energy, change in appetite or sleep, and
feeling out of control. Physical symptoms associated with PMDD include breast
tenderness, headache, joint and muscle pain, bloating, and weight gain. These
symptoms occur regularly during the luteal phase and remit within a few days
following the onset of menses; the disturbance markedly interferes with work or
school or with usual social activities and relationships with others. In making
the diagnosis, care should be taken to rule out other cyclical mood disorders
that may be exacerbated by treatment with an antidepressant.
The effectiveness of PAXIL CR in long-term use, that is, for more than 3
menstrual cycles, has not been systematically evaluated in controlled trials.
Therefore, the physician who elects to use PAXIL CR for extended periods should
periodically re-evaluate the long-term usefulness of the drug for the individual
patient.