XANAX TABLET 0.25 mg

TABLET, FILM COATED

**4.2 Posology and method of administration** The optimum dosage of XANAX™ (alprazolam) should be individualized based upon the severity of the symptoms and individual patient response. In patients who require higher doses, dosage should be increased cautiously to avoid adverse effects. In general, patients who have not previously received psychotropic medications will require somewhat lower doses than those previously treated with minor tranquilizers, antidepressants, or hypnotics. It is recommended that the general principle of using the lowest effective dose be followed, especially in elderly or debilitated patients to preclude the development of oversedation or ataxia. If XANAX™ XR is to be given once daily, it is preferable to administer the dose in the morning. The tablets should be taken intact; they should not be chewed, crushed, or broken. Dosage recommendations for XANAX™ XR Tablets for use in panic disorders are based on short term clinical trials in patients with panic disorders and a comparable pharmacokinetic profile in normal subjects, between XANAX™ Tablets given three or four times daily and XANAX™ XR Tablets given twice daily. Dosing recommendations for XANAX™ XR Tablets for use in anxiety, depression, mixed anxiety-depression and in geriatric patients are based on a comparable pharmacokinetic profile in normal subjects between XANAX™ Tablets given three or four times daily and XANAX™ XR Tablets given twice daily. When equal daily doses of XANAX™ Tablets, dosed three or four times daily, and XANAX™ XR Tablets, dosed twice daily, were given, the steady-state serum concentration levels of alprazolam achieved with XANAX™ XR fell between the steady-state peak and trough serum concentration levels obtained with XANAX™ Tablets. The total amount of alprazolam absorbed is equivalent for XANAX™ Tablets and XANAX™ XR Tablets.   The safety and efficacy of XANAX™ in children less than 18 years of age has not been established. **Duration of Treatment** The risk of dependence may increase with dose and duration of treatment, therefore, the lowest possible effective dose and duration should be used and the need for continued treatment reassessed frequently (see section **4.4 Special warnings and precautions for use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Discontinuation therapy** To discontinue alprazolam treatment, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of XANAX™ be decreased by not more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction (see section **4.4 Special warnings and precautions for use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).