Страна: Канада
Язык: английский
Источник: Health Canada
CLOXACILLIN (CLOXACILLIN SODIUM)
TEVA CANADA LIMITED
J01CF02
CLOXACILLIN
500MG
CAPSULE
CLOXACILLIN (CLOXACILLIN SODIUM) 500MG
ORAL
100/500/1000
Prescription
PENICILLINASE-RESISTANT PENICILLINS
Active ingredient group (AIG) number: 0131306001; AHFS:
APPROVED
2014-04-24
____________________________________________________________________________________ _TEVA-CLOXACILLIN 1 of 14_ PRODUCT MONOGRAPH PR TEVA-CLOXACILLIN (cloxacillin sodium) 250 and 500 mg Capsules 125 mg/5 mL Granules for Oral Solution USP Antibiotic Teva Canada Limited Date of Revision: 30 Novopharm Court March 17, 2020 Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Control: 235602 ____________________________________________________________________________________ _TEVA-CLOXACILLIN 2 of 14_ STRUCTURAL FORMULA AND CHEMISTRY Cloxacillin Sodium Molecular Formula: C 19 H 17 ClN 3 NaO 5 S●H 2 O Molecular Weight: 475.88 g/mol Chemical Name: Monosodium 6-[3-(o-chlorophenyl)-5-methyl-4- isoxazolecarboxamido]- 3,3-dimethyl-7-oxo-4- thia-l-azabicyclo[3.2.0]heptane-2-carboxy- late monohydrate. Description: Cloxacillin sodium is a white, odorless, crystalline powder, with an intensely bitter taste. Each g represents 2.1 mEq of sodium. One part is soluble in 2.5 parts of water, and a 10% aqueous solution has a pH of 5 to 7. ____________________________________________________________________________________ _TEVA-CLOXACILLIN 3 of 14_ NAME OF DRUG PR TEVA-CLOXACILLIN (cloxacillin sodium) 250 and 500 mg Capsules 125 mg/5_ _mL Granules for Oral Solution THERAPEUTIC CLASSIFICATION Cloxacillin sodium is an antibiotic belonging to the semi-synthetic penicillin family. ACTION TEVA-CLOXACILLIN exhibits a bacterial action against sensitive organisms during the active multiplication stage. It acts through the inhibition of biosynthesis of cell wall mucopeptides. INDICATIONS AND CLINICAL USE TEVA-CLOXACILLIN (cloxacillin sodium) finds use in the treatment of infections caused by streptococci when associated with sensitive penicillinase-producing staphylococci; also in the treatment of all staphylococcal infections, whether penicillin G-sensitive or resistant. In infections suspected of being caused by penicillinase-producing staphylococci, cloxacillin may be used for initial treatment after appropriate specimens have been taken fo Прочитать полный документ