INDICATIONS AND USAGE
Major Depressive Disorder Effexor XR (venlafaxine hydrochloride) extended-release capsules
is indicated for the treatment of major depressive disorder.
The efficacy of Effexor XR in the treatment of major depressive disorder was
established in 8- and 12-week controlled trials of adult outpatients whose
diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major
depressive disorder (see
Clinical Trials
).
A major depressive episode (DSM-IV) implies a prominent and relatively
persistent (nearly every day for at least 2 weeks) depressed mood or the loss of
interest or pleasure in nearly all activities, representing a change from
previous functioning, and 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.
The efficacy of Effexor (immediate release) in the treatment of major
depressive disorder in adult inpatients meeting diagnostic criteria for major
depressive disorder with melancholia was established in a 4-week controlled
trial (see
Clinical
Trials
). The safety and efficacy of Effexor XR in hospitalized
depressed patients have not been adequately studied.
The efficacy of Effexor XR in maintaining a response in major depressive
disorder for up to 26 weeks following 8 weeks of acute treatment was
demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate
release) in maintaining a response in patients with recurrent major depressive
disorder who had responded and continued to be improved during an initial 26
weeks of treatment and were then followed for a period of up to 52 weeks was
demonstrated in a second placebo-controlled trial (see
Clinical Trials
). Nevertheless,
the physician who elects to use Effexor/Effexor XR for extended periods should
periodically re-evaluate the long-term usefulness of the drug for the individual
patient (see
DOSAGE AND
ADMINISTRATION
).
Generalized Anxiety Disorder Effexor XR is indicated for the treatment of Generalized Anxiety
Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the
stress of everyday life usually does not require treatment with an anxiolytic.
The efficacy of Effexor XR in the treatment of GAD was established in 8-week
and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD
according to DSM-IV criteria (see
Clinical Trials
).
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety
and worry (apprehensive expectation) that is persistent for at least 6 months
and which the person finds difficult to control. It must be associated with at
least 3 of the following 6 symptoms: restlessness or feeling keyed up or on
edge, being easily fatigued, difficulty concentrating or mind going blank,
irritability, muscle tension, sleep disturbance.
Although the effectiveness of Effexor XR has been demonstrated in 6-month
clinical trials in patients with GAD, the physician who elects to use Effexor XR
for extended periods should periodically re-evaluate the long-term usefulness of
the drug for the individual patient (see
DOSAGE AND ADMINISTRATION
).
Social Anxiety Disorder Effexor XR is indicated for the treatment of Social Anxiety
Disorder, also known as Social Phobia, as defined in DSM-IV (300.23).
Social Anxiety Disorder (DSM-IV) 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 a marked distress about having the phobias. Lesser
degrees of performance anxiety or shyness generally do not require
psychopharmacological treatment.
The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was
established in four 12-week and one 6-month placebo-controlled trials in adult
outpatients with Social Anxiety Disorder (DSM-IV) (see
Clinical Trials
).
Although the effectiveness of Effexor XR has been demonstrated in a 6-month
clinical trial in patients with Social Anxiety Disorder, the physician who
elects to use Effexor XR for extended periods should periodically re-evaluate
the long-term usefulness of the drug for the individual patient (see
DOSAGE AND
ADMINISTRATION
).
Panic Disorder Effexor XR 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.
Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic
attacks, ie, a discrete period of intense fear or discomfort, in which four (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.
The efficacy of Effexor XR in the treatment of panic disorder was established
in two 12-week placebo-controlled trials in adult outpatients with panic
disorder (DSM-IV). The efficacy of Effexor XR in prolonging time to relapse in
panic disorder among responders following 12 weeks of open-label acute treatment
was demonstrated in a placebo-controlled study (see
CLINICAL PHARMACOLOGY, Clinical
Trials
). Nevertheless, the physician who elects to use Effexor
XR for extended periods should periodically re-evaluate the long-term usefulness
of the drug for the individual patient (see
DOSAGE AND ADMINISTRATION
).