Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ALPRAZOLAM
Abio Marketing Sdn Bhd
ALPRAZOLAM
100tablet Tablets
CHINA CHEMICAL & PHARMACEUTICAL CO., LTD.
COMPOSITION: Each tablet contains 0.5 mg Alprazolam PRODUCT DESCRIPTION: ZOVEX 0.5mg tablet is a pink oval shaped tablet, with a score on one side and "CCP C60" on the other side PHARMACOLOGICAL PROPERTIES: PHARMACODYNAMIc PROPERTIES Alprazolam, like other benzodiazepines, has a high affinity for the benzodiazepine binding site in the brain. It facilitates the inhibitory neurotransmitter action of gamma-aminobutyric acid which mediates both pre- and post-synaptic inhibition in the central nervous system (CNS). PHARMACOKINETIC PROPERTIES Following oral administration, peak plasma concentrations are reached in about 1.7 hours. After a single oral dose of 500 micrograms, the average maximal concentration was 7.1 nanograms/ml. There is a linear relationship between the dose and plasma concentration. At least 80% of the oral dose is absorbed. About 70% of the absorbed dose is bound to plasma proteins. Alprazolam is extensively metabolised in the liver, primarily to hydroxylated metabolites, but about 20% of the dose is excreted as unchanged alprazolam. Elimination occurs mostly via the kidneys; 80% of the dose is excreted into the urine and only 7% into the faeces. The mean elimination half-life is 10-12 hours. INDICATIONS: Zovex Tablets (alprazolam) are indicated for the treatment of: ANXIETY STATES (ANXIETY NEUROSES) Symptoms which occur in such patients include anxiety, tension, agitation, insomnia, apprehension, irritability and/or autonomic hyperactivity resulting in a variety of somatic complaints. MIXED ANXIETY-DEPRESSION Symptoms of both anxiety and depression occur simultaneously in such patients. NEUROTIC OR REACTIVE DEPRESSION Such patients primarily exhibit a depressed mood or a pervasive loss of interest or pleasure. Symptoms of anxiety, psychomotor agitation and insomnia are usually present. Other characteristics include appetite disturbances, changes in weight, somatic complaints, cognitive disturbances, decreased energy, feeling of worthlessness or guilt, or thoughts of death or suicide. ANXIETY STATES Baca dokumen lengkap