Paxil - Indications & Dosage

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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 . Clinical Trials). Nevertheless, the physician who elects to use PAXIL for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Panic Disorder

PAXIL 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 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 PHARMACOLOGY . Clinical 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 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 . Clinical Trials). Nevertheless, the physician who prescribes PAXIL for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.