Land: Kanada
Sprache: Englisch
Quelle: Health Canada
CLOXACILLIN SODIUM
APOTEX INC
J01CF02
CLOXACILLIN
125MG
POWDER FOR SOLUTION
CLOXACILLIN SODIUM 125MG
ORAL
60/100/200ML
Prescription
PENICILLINASE-RESISTANT PENICILLINS
Active ingredient group (AIG) number: 0105904003; AHFS:
CANCELLED POST MARKET
2019-12-03
PRESCRIBING INFORMATION PR APO-CLOXI (Cloxacillin Sodium) 250 AND 500 MG CAPSULES 125 MG/5 ML POWDER FOR ORAL SOLUTION USP ANTIBIOTIC APOTEX INC. DATE OF PREPARATION: 150 SIGNET DRIVE July 26, 2000 WESTON, ONTARIO DATE OF REVISION: M9L 1T9 May 16, 2019 Control No.: 221440 1 PHARMACEUTICAL INFORMATION Drug Substance Proper/Common Name: Cloxacillin Sodium Chemical Names: 1) 4-Thia-1-azabicyclol[3.2.0]heptane-2-carboxylic acid, 6-[[[3- (2- chlorophenyl)-5-methyl-4-isoxazolyl]carbonyl]amino]-3,3- dimethyl-7- oxo-, monosodium salt, monohydrate, [2_S_- (2 ,5 ,6 )]- 2) Monosodium (2_S, _5_R, _6_R_)-6-[3-(_o_-chlorophenyl)-5- methyl-4- isoxazolecarboxamido]-3,3-dimethyl-7-oxo-4-thia- 1-azabicyclo [3.2.0]heptane-2-carboxylate monohydrate Structural Formula: Molecular Formula: C 19 H 17 ClN 3 NaO 5 S H 2 O Molecular Weight: 475.88 g/mol Description: Cloxacillin sodium is a white, odorless, crystalline powder. It is freely soluble in water, soluble in alcohol and slightly soluble in chloroform. Composition In addition to cloxacillin sodium, APO-CLOXI capsules also contain the non-medicinal ingredients colloidal silicon dioxide, stearic acid, and talc (as an antistatic agent). The capsule shells, imprinted with edible white ink, contain the non-medicinal ingredients D&C yellow #10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide. In addition to cloxacillin sodium, APO-CLOXI powder for oral solution also contains the non- medicinal ingredients FD&C red #40, sodium benzoate, sodium citrate (anhydrous), sodium cyclamate, sucrose, and artificial cherry flavour. 2 PRESCRIBING INFORMATION PR APO-CLOXI (Cloxacillin Sodium) 250 mg and 500 mg Capsules 125 mg/5 mL Powder for Oral Solution USP THERAPEUTIC CLASSIFICATION Cloxacillin sodium is an antibiotic belonging to the semi-synthetic penicillin family. ACTION APO-CLOXI exhibits a bacterial action against sensitive organisms during the active multiplication stage. It acts through the inhibition of biosyn Lesen Sie das vollständige Dokument