PAXIL CR

INDICATIONS AND USAGE

Major Depressive Disorder: PAXIL 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.

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, 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 12 weeks in controlled clinical trials; however, the effectiveness of immediate-release paroxetine hydrochloride in maintaining a response in major depressive disorder for up to 1 year has been demonstrated in a placebo-controlled trial. 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 Disorder: PAXIL 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.

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 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. 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 Disorder: PAXIL 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 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 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.

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. Premenstrual Dysphoric Disorder: PAXIL CR is indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD).

The efficacy of PAXIL CR in the treatment of PMDD was established in 2 placebo-controlled 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 reevaluate the long-term usefulness of the drug for the individual patient.

There have been several studies looking at the effects of Paxil CR for a variety of conditions.

Depression
Studies have shown Paxil CR to be effective for depression treatment in adults. In these studies, people taking it had more improvement in their depression symptoms than people who were not taking the medication. Also, long-term studies have shown that Paxil CR can help prevent relapse (or a return of depression symptoms).

Panic Disorder
Several studies have looked at using Paxil CR to treat adults with panic disorder. In these studies, people taking it had fewer panic attacks and less severe panic attacks when compared to people not taking the medicine. Also, in long-term studies, Paxil CR helped to prevent panic attacks from coming back.

Social Anxiety Disorder
Short-term studies have shown that Paxil CR is effective at treating social anxiety disorder in adults. In these studies, up to 64 percent of people taking Paxil CR felt that their social anxiety symptoms were "very much improved" or "much improved," compared to only 34.7 percent of those not taking the drug.

Premenstrual Dysphoric Disorder (PMDD)
Paxil CR was studied in three clinical trials for PMDD. Two studies looked at using it every day for PMDD treatment. These two studies did not include women who were on oral contraceptives (birth control pills). The third study looked at using Paxil CR only for the last two weeks of the menstrual cycle. All three studies showed Paxil CR to be effective for treating PMDD.

As with any medicine, there are possible side effects with Paxil CR. However, not everyone who takes the medication will experience side effects. In fact, most people tolerate the drug well. When side effects do occur, in most cases they are minor and either require no treatment or can easily be treated by you or your healthcare provider. Serious side effects are less common.

Some of the most common side effects of Paxil CR include:

• Headaches -- in up to 27 percent of people
• Ejaculation problems -- up to 27 percent
• Nausea -- up to 23 percent
• Drowsiness -- up to 22 percent
• Insomnia -- up to 20 percent
• Weakness -- up to 18 percent
• Diarrhea -- up to 18 percent
• Dry mouth -- up to 18 percent
• Dizziness -- up to 14 percent
• Increased sweating -- up to 14 percent
• Constipation -- up to 13 percent
• Indigestion -- up to 13 percent
• A decreased sex drive (libido) -- up to 13 percent
• A loss of appetite -- up to 12 percent
• Female orgasm problems -- up to 10 percent
• Impotence (erectile dysfunction or ED) -- up to 10 percent.

Other common side effects (occurring in 5 to 9 percent of people) included:

• Infections
• Injuries (trauma)
• Gas
• Shakiness (tremors)
• Nervousness
• Abdominal pain (stomach pain)
• Back pain
• Muscle pain
• Anxiety
• Yawning
• Vision changes.