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Dr. Bob is Robert Hsiung, MD,
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Posted by Jaynee on February 27, 2003, at 17:49:47
Food and Drug Administration Approvals, February 2003
from Medscape PharmacistsCentral Nervous System Agents
Xanax XR (alprazolam) Extended-release Tablets
Manufacturer: Pharmacia & UpjohnDrug Approval Classification: Original NDA (approval date: 1/17/03)
Indication:Xanax XR, a new extended-release form of Xanax (alprazolam), was approved. Xanax XR is indicated for the treatment of panic disorder, with or without agoraphobia.
Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, 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:
palpitations, pounding heart, or accelerated heart rate;
sweating;
trembling or shaking;
sensations of shortness of breath or smothering;
feeling of choking;
chest pain or discomfort;
nausea or abdominal distress;
feeling dizzy, unsteady, lightheaded, or faint;
derealization (feelings of unreality) or depersonalization (being detached from oneself);
fear of losing control;
fear of dying;
paresthesias (numbness or tingling sensations);
chills or hot flushes.
The longer-term efficacy of Xanax XR 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.Dosing: The recommended dose of Xanax XR is 1 tablet daily. Tablets should be taken intact; they should not be chewed, crushed, or broken.
The suggested total daily dose ranges from 3 to 6 mg/day. Dosage should be individualized for maximum beneficial effect.
Xanax XR is available in 0.5-mg, 1-mg, 2-mg, and 3-mg extended-release tablets.
Dose titration is recommended at intervals of 3 to 4 days in increments of no more than 1 mg/day. Dose reductions should be in increments of 0.5 mg every 3 days.
Patients who are currently being treated with divided doses of Xanax (immediate-release) tablets may be switched to Xanax XR tablets at the same total daily dose taken once daily.
Clinical Summary: Patients with panic disorder were enrolled in two 6-week, placebo-controlled studies. Efficacy was based on the change in multiple measures of panic attack frequency. The mean dose was 4.2 mg/day and 4.6 mg/day, respectively, in each study. Efficacy beyond 6 weeks has not been established.
Adverse Effects: Most frequent adverse events were similar to those seen with immediate-release alprazolam; they include sedation, somnolence, and memory impairment.
Pharmacokinetics:Xanax XR maintains a constant concentration for 5 to 11 hours after dosing. A high-fat meal given up to 2 hours before dosing with Xanax XR tablets increased the mean Cmax by about 25%. The effect of this meal on Tmax depended on the timing of the meal, with a reduction in Tmax by about one third for subjects eating immediately before dosing and an increase in Tmax by about one third for subjects eating 1 hour or more after dosing.
Reference
Xanax XR (alprazolam) Extended-release Tablets LabelingMedscape DrugInfo
Xanax XR (alprazolam) Extended-release Tablets--------------------------------------------------------------------------------
Section 8 of 11
Medscape Pharmacists 4(1), 2003. (c) 2003 Medscape
Posted by Ame Sans Vie on February 27, 2003, at 18:57:25
In reply to extended release xanax approved, posted by Jaynee on February 27, 2003, at 17:49:47
This is the end of the thread.
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