Product Dossier
KALMA
Product Dossier for KALMA (alprazolam, Alphapharm). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Alphapharm
- Active ingredient: alprazolam
- Therapeutic area: Psychiatry
- Related brand: ALPRAX
- Same area: REXULTI
- Same area: NICORETTE
What it is
KALMA is an anti-anxiety benzodiazepine derivative containing alprazolam. KALMA is available in four tablet strengths: 0.25 mg, 0.5 mg, 1 mg, and 2 mg.
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 KALMA should be individualised, based upon the severity of the symptoms and individual patient response. Patients who have not previously received psychotropic medication will require lower doses than those previously treated with minor tranquillisers, 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. Patients should be periodically reassessed and dosage adjustments made, as appropriate.
Key safety warnings
Although current evidence supports the long-term clinical effectiveness of alprazolam in panic disorder, the continuing use of alprazolam needs to be weighed against the difficulties that can occur with dependence and discontinuation.
PBS listing
KALMA 250 microgram tablet is listed on the PBS with authority required restriction at an ex-manufacturer price of A$2.50.
Regulatory history
KALMA 0.25 mg, 0.5 mg, and 1 mg tablets were first listed on the ARTG on 22 October 1993. KALMA 2 mg tablet in bottle form was first listed on the ARTG on 18 May 1998. Blister pack formulations of all four strengths were registered on the ARTG on 31 August 2022.