Posology : מינונים

3   DOSAGE AND ADMINISTRATION

3.1 Recommended Dosage
XANAX XR Tablets may be administered once daily, preferably in the morning. The tablets should be taken intact; they should not be chewed, crushed, or broken.

Posology of Alprazolam XR Tablets

Indication            Usual Starting Dose           Usual Dose Range or Population         (if side effects occur,
dose should be lowered)

Anxiety               1 mg daily in one or two      0.5 to 4 mg daily, in one or two doses doses

Depression            1 mg daily in one or two      0.5 to 4.5 mg daily, in one or two doses doses

Panic Disorders       0.5 to 1.0 mg given at        Dose should be adjusted to patient response, bedtime or 0.5 mg two times   with increments no greater than 1 mg/day daily                         every 3 to 4 days.

[In clinical trials the mean maintenance dose was between 5 and 6 mg/day, given as a single daily dose or divided into two doses daily,
with occasional patients needing up to 10 mg/day]

Dosage should be individualized for maximum beneficial effect. While the suggested total daily dosages given will meet the needs of most patients, there will be some patients who require doses greater than 6 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.
Dose Titration
Treatment with XANAX XR may be initiated with a dose of 0.5 mg to 1 mg once daily.
Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. Slower titration to the dose levels may be advisable to allow full expression of the pharmacodynamic effect of XANAX XR.

Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.

Dose Maintenance
In controlled trials conducted to establish the efficacy of XANAX XR Tablets in panic disorder, doses in the range of 1 to 10 mg/day were used. Most patients showed efficacy in the dose range of 3 to 6 mg/day. Occasional patients required as much as 10 mg/day to achieve a successful response. The necessary duration of treatment for panic disorder patients responding to XANAX XR is unknown. However, periodic reassessment is advised.
After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.[see DOSAGE AND ADMINISTRATION (3.2)]

3.2   Discontinuation or Dosage Reduction of XANAX XR

Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided [see WARNINGS, PRECAUTIONS (5), DRUG ABUSE AND DEPENDENCE (9)].

In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.

In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every three days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.

3.3 Dosage Recommendations in Geriatric Patients
In elderly patients the usual starting dosage of XANAX XR is 0.5 mg once daily. This may be gradually increased if needed and tolerated (see Dose Titration).The elderly may be especially sensitive to the effects of benzodiazepines [see Use in Specific Populations (8.5), Clinical Pharmacology (12.2)].

3.4     Dosage Recommendations in Patients with Hepatic Impairment
In patients with hepatic impairment or in patients with debilitating disease, the usual starting dosage of XANAX XR is 0.5 mg once daily. This may be gradually increased if needed and tolerated [see Use in Specific Populations (8.6), Clinical Pharmacology (12.2)].