Description
Diazepam Powder Oral Solution Concentrate Description
Diazepam Powder Oral Solution contains polyethylene glycol. propylene glycol noncrystallizing sorbitol solution sodium citrate anhydrous bitterness modifier flavor. anhydrous citric acid peppermint flavor mint flavor FD&C Red No. 40 aluminum lake D&C Yellow No. 10 aluminum lake and purified water.
Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a white to practically white powder, insoluble in water and has a molecular weight of 284.75. Its structural formula is as follows:Diazepam Oral Solution Concentrate – Clinical Pharmacology
Diazepam is a benzodiazepine that exerts anxiolytic sedativ muscle .relaxant anticonvulsant and amnestic effects. Most of these effects are though to result from a facilitation of the action of gamma aminobutyric acid (GABA). an inhibitory neurotransmitter in the central nervous system.
Pharmacokinetics
Absorption:
After oral administration of diazepam, > 90% of diazepam is absorbe and the average time to achieve peak plasma concentration is 1 to 1.5 hour with a range of 0.25 to 2.5 hours. Absorption is delay and decrease when administere with a moderate fat meal. In the presence of food, mean lag times are approximately 45 minutes as compared with 15 minutes when fasting. There is also an increase in the average time to achieve peak concentrations to about 2.5 hours in the presence of food as compared with 1.25 hours when fasting. This results in an average decrease in Cmax of 20% in addition to a 27% decrease in AUC (range 15% to 50%) when administered with food.
Distribution:
Diazepam and it metabolite are high boun to plasma protein (diazepam 98%).
Diazepam and metabolite cross the blood-brain and placenta barrier .The are also foun in breast milk in concentration .
approximatel one ten of in maternal plasma (days 3 to 9 post-partum).
In young healthy male, the volume of distribution at steady-state is 0.8 to 1.0 L/kg. The decline in the plasma concentration-time profile after oral administration is biphasic. The initial distribution phase has a half-life of approximately 1 hour, although it may range up to > 3 hours
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