Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ASPEN MIRTAZAPINE 15 mg (Film-coated tablet) ASPEN MIRTAZAPINE 30 mg (Film-coated tablet) ASPEN MIRTAZAPINE 45 mg (Film-coated tablet) SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): ASPEN MIRTAZAPINE 15 mg (Film-coated tablet) ASPEN MIRTAZAPINE 30 mg (Film-coated tablet) ASPEN MIRTAZAPINE 45 mg (Film-coated tablet) COMPOSITION: Each ASPEN MIRTAZAPINE 15 mg film-coated tablet contains 15 mg Mirtazapine . Each ASPEN MIRTAZAPINE 30 mg film-coated tablet contains 30 mg Mirtazapine. Each ASPEN MIRTAZAPINE 45 mg film-coated tablet contains 45 mg Mirtazapine. PHARMACOLOGICAL CLASSIFICATION: A.1.2. Pyschoanaleptics (antidepressants) PHARMACOLOGICAL ACTION: Mirtazapine is a tetracyclic antidepressant, belonging to the piperazino-azapine group of compounds. Mirtazapine is centrally acting as a pre-synaptic alpha 2 -antagonist, which increases the central noradrenergic and serotonergic neurotransmission. It limits the effectiveness of inhibitory alpha 2 -adrenergic heteroreceptors on serotonergic neurons as well as inhibitory alpha 2 -autoreceptors and 5-HT 2A heteroreceptors on noradrenergic neurons, which enhances the release of both amines. It has antagonistic effects at several post synaptic serotonin receptor types (including 5-HT 2A , 5-HT 2C , and 5-HT 3 receptors) and can produce gradual down regulation of 5-HT 2A receptors. These several actions probably contribute to the antidepressant effect. Mirtazapine is also a histamine H l -receptor antagonist, and correspondingly, relatively sedating. Pharmacokinetics Mirtazapine is well absorbed (bioavailability = 50%) from the gastrointestinal tract with peak plasma levels occurring after about two hours. Plasma protein binding is about 85%. Mirtazapine is extensively metabolised in the liver and the major bio-transformation pathways are demethylation and oxid Read the complete document