Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
ALPRAZOLAM
Orion Corporation
ALPRAZOLAM
0.5 Milligram
Tablets
Withdrawn
2009-06-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alprox 0.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5 mg of Alprazolam. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White or almost white, flat, round scored tablets with a diameter of 7 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the short-term management of anxiety states. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration only. Anxiety The duration of treatment should be as short as possible but not longer than 8-12 weeks, including tapering off process. It is usual to commence with a dose of 500 micrograms (0.5 mg) to 1 mg daily in divided doses, with increments (of no greater than 1 mg every 3-4 days) to the level of optimal control, usually 3 to 4 mg daily. In the elderly or debilitated patient a regimen of 250 micrograms (0.25 mg) twice daily should be used initially with gradual increments if required and tolerance is assured. Initial doses may be given at bedtime to minimise daytime lethargy. If side-effects occur with the starting dose, the dose should be lowered. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient’s status. Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded. 4.3 CONTRAINDICATIONS Myasthenia gravis. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/09/2006_ _CRN 2028462_ _page number: 1_ Hypersensitivity to benzodiazepines or to any Soma hati kamili