ARTG Entry
ALPRAX
ARTG entry for ALPRAX (alprazolam 2 mg), ARTG 82644 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Aspen Pharmacare
- Active ingredient: alprazolam 2 mg
- Therapeutic area: Psychiatry
What it is
ALPRAX is an anti-anxiety, benzodiazepine derivative chemically and pharmacologically related to other drugs of this class. ALPRAX is available in tablet strengths of 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam.
Approved indications
— Short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression. — Treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks.
Dosing overview
The optimum dosage of ALPRAX should be individualised, based upon the severity of the symptoms and individual patient response, with the daily dosage meeting the needs of most patients. Patients who have not previously received psychotropic medication will require lower doses than those previously treated with minor tranquillizers, antidepressants, or hypnotics or those with a history of chronic alcoholism. It is recommended that the general principle of using the lowest effective dosage be followed to preclude the development of oversedation or ataxia.
Key safety warnings
Although current evidence supports the long-term clinical effectiveness of alprazolam in panic disorder, the continuing use of ALPRAX needs to be weighed against the difficulties that can occur with dependence and discontinuation.
PBS listing
ALPRAX 0.5 mg tablet and 1 mg tablet are each listed on the PBS with authority required restriction, at ex-manufacturer prices of A$2.96 and A$3.50 respectively.
Regulatory history
ALPRAX was first listed on the ARTG on 30 July 2002, with seven registered variants across 0.25 mg, 0.5 mg, 1 mg, and 2 mg tablet strengths in both bottle and blister pack formats. In November 2015, the PBAC expressed intention to remove the 2 mg strength from the PBS and reduce pack size for other strengths to 10 tablets with nil repeats.