Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
Metronidazole benzoate
Sanofi-Aventis Australia Pty Ltd
Medicine Registered
Flagyl S PI CCDSv8 PIv8 10 Sep 13 Page 1 PRODUCT INFORMATION FLAGYL S SUSPENSION ® NAME OF THE MEDICINE Flagyl S Suspension NON-PROPRIETARY NAME Metronidazole benzoate CHEMICAL STRUCTURE CAS NUMBER Chemical abstracts No: [13182-89-3] DESCRIPTION Metronidazole benzoate is 1-(2-benzoyloxyethyl)-2-methyl-5-nitroimidazole. Slightly yellow crystalline powder with a melting point of 99 to 102°C. Solubility at 25°C (g/100 mL solvent): 12.2 x 10-3 in water, 2 in ethanol, 5 in methanol and 25.6 in acetone. The pH of metronidazole benzoate suspensions in water is 5 to 6.5. PHARMACOLOGY Metronidazole benzoate itself is not systemically available following oral administration. It is hydrolysed before or during absorption through the gut wall so that only metronidazole can be detected in the circulation. PHARMACOKINETICS Maximum mean plasma metronidazole concentration are 16.6 micrograms/mL at 5.1 hours after administration of a single oral dose of metronidazole benzoate, equivalent to 2 g metronidazole and 4.6 micrograms/mL at 3.2 hours after administration of a single oral dose of metronidazole benzoate, equivalent to 400 mg metronidazole. An oral dose of two 200 mg tablets of metronidazole in the same trial gave mean peak serum levels of 8.5 microgram/mL at 0.8 hours after administration. Total absorption from metronidazole benzoate suspension was somewhat lower than from the tablets. In children the time to reach peak serum level is quite variable (3.6 to 5.1 hours). Mean elimination half-lives are 9.7 hours following metronidazole benzoate suspension (2 g metronida Lue koko asiakirja