Paxil CR (paroxetine hydrochloride)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Depression, panic disorder
General Information
Paxil CR, a controlled-release tablet, is approved for the
treatment of panic disorder. Paxil CR was previously approved in
March 1999 as a treatment for major depressive disorder.
Depression affects close to 20 million Americans and is the most
common serious brain disease in the United States. A major
depressive episode is defined as experiencing five of the following
depressive symptoms within a two week period: persistent sad mood,
diminished interest in previously enjoyable activities, changes in
weight or appetite, difficulty sleeping, agitation, fatigue,
feelings of worthlessness or guilt, impaired concentration and
suicidal thoughts.
In a given year, panic disorder affects approximately 2.5
million Americans between the ages of 18 and 54. Half of those
inflicted develop the condition prior to age 24 and women are twice
as likely as men to be diagnosed. Panic disorder is characterized
by unexpected and repeated attacks of intense fear in combination
with four of the following symptoms: chest pain, heart
palpitations, sweating, trembling, shortness of breath, a choking
sensation, nausea, dizziness, distortions of reality, fear of
losing control, fear of dying, numbness and chills or hot
flashes.
Clinical Results
Approval of Paxil CR is supported by results from two
placebo-controlled studies with subjects diagnosed with major
depressive disorder and three flexible-dose studies with subjects
with panic disorder. Paxil CR was shown to be significantly more
effective than placebo in all studies except the third study for
treatment of panic disorder.
Side Effects
Adverse events associated with the use of Paxil CR may include
(but are not limited to) the following:
- Abnormal ejaculation
- Abnormal vision
- Constipation
- Somnolence
- Decreased libido
- Sweating
- Female genital disorders
Mechanism of Action
Paxil CR (paroexetine hydrochloride) is a selective serotonin
reuptake inhibitor with a chemical structure unrelated to that of
other such drugs. The effectiveness of Paxil CR in the treatment of
depression and panic disorder seems to be linked to potentiation of
serotonergic activity in the central nervous system resulting from
the inhibition of neuronal uptake of serotonin.
Additional Information
