AKAMON Tablet Ref.[28111] Active ingredients: Bromazepam

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Anxiolytics – Benzodiazepine derivatives
ATC code: N05BA08

Bromazepam is a psychotropic substance of the pyridylbenzodiazepine class and has anxiolytic properties. It binds to specific receptors in the central nervous system and particular peripheral organs. The central nervous system benzodiazepine receptors have a close functional connection with the receptors of the GABA-ergic transmitter system. Following binding to the benzodiazepine receptor the inhibitory effect of the GABA0ergic transmission is augmented by bromazepam.

5.2. Pharmacokinetic properties

Absorbtion

Bromazepam is rapidly absorbed from the gastro-intestinal tract. Peak plasma concentration are usually reached within two hours of oral administration of bromazepam. The absolute (versus iv solution) and relative (versus oral solution) bioavailability of the tablet is 60% and 100% respectively.

Distribution

On average 70% of bromazepam is bound to plasma proteins. The volume of distribution is 50 lts. Steady state plasma concentrations are reached in around five to nine days.

Biotransformation

Bromazepam is metabolized in the liver. Quantitatively two metabolites predominate: 3 hydroxy-bromazepam and 2-(2-amino-5-bromo-3-hydroxybenzoyl) pyridine. Metabolites of bromazepam do not contribute significantly to the effects of the drug.

Elimination

Bromazepam has an elimination half life of about 20 hours (between approximately 16 and 30 hours). The clearance is 40 ml/min.

Pharmacokinetics is special populations

The elimination half-life may be prolonged in elderly patients.

5.3. Preclinical safety data

No further information of relevance to the prescriber.

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