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For oral use.

Treatment should be as short as possible. It is recommended that the patient be reassessed at the end of no longer than 4 weeks of treatment and the need for continued treatment established, especially in case the patient is symptom free. The overall duration of treatment should not be more than 8-12 weeks, including a tapering off process.

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ksalol, Tablets are indicated for the treatment of panic disorder, with or without agoraphobia.

This claim is supported on the basis of two positive studies with ksalol conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder  (see Clinical Efficacy Trails).

Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e. 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) paresthesia’s (numbness or tingling sensations);

(13) chills or hot flushes.

The longer-term efficacy of ksalol xanax has not been systematically evaluated. Thus, the physician who elects to use this drug for periods longer than 8 weeks should periodically reassess the usefulness of the drug for the individual patient.

Ksalol is indicated for the short-term treatment of moderate or severe anxiety states and anxiety associated with depression. It is only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.

Ksalol should not be used to treat short-term mild anxiety, such as anxiety or tension associated with the stress of everyday life. As the efficacy of Ksalol in depression and in phobic or obsessional states has yet to be established, specific treatment may have to be considered.

Generalized Anxiety Disorder

Ksalol is indicated for the treatment of generalized anxiety disorder. the efficacy of alprazolam in the treatment of generalized anxiety disorder was demonstrated in 5 short-term, placebo-controlled trials..

Panic Disorder

Ksalol is also indicated for the treatment of panic disorder, with or without agoraphobia, the efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials..

Demonstrations of the effectiveness of ksalol by systematic clinical study are limited to 4 months in duration for generalized anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.


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