Pays: Canada
Langue: anglais
Source: Health Canada
CLOXACILLIN (CLOXACILLIN SODIUM)
JAMP PHARMA CORPORATION
J01CF02
CLOXACILLIN
250MG
CAPSULE
CLOXACILLIN (CLOXACILLIN SODIUM) 250MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0131306002; AHFS:
APPROVED
2021-01-06
_JAMP CLOXACILLIN_ _1 of 14_ PRODUCT MONOGRAPH PR JAMP CLOXACILLIN Cloxacillin Sodium Capsules 250 and 500 mg cloxacillin USP Antibiotic JAMP Pharma Corporation Date of Preparation: 1310, rue Nobel January 6, 2021 Boucherville, Québec Canada , J4B 5H3 Control: 239413 _JAMP CLOXACILLIN_ _2 of 14_ STRUCTURAL FORMULA AND CHEMISTRY Proper Name: 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 (2S, 5R, 6R)-6-[3-(o-chlorophenyl)-5-methyl-4- isoxazolecarboxamido]-3,3-dimethyl-7-oxo-4-thia-l- azabicyclo[3.2.0]heptane-2-carboxylate 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. Composition: In addition to cloxacillin sodium, JAMP Cloxacillin capsules also contain the non-medicinal ingredients Magnesium stearate and talc. Capsule shell contains Gelatin, Titanium Dioxide, SLS, Brilliant Blue, Sunset Yellow, Ponceau 4R, Erythrosine and Quinoline Yellow. White printing ink contains Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Strong Ammonia Solution, Potassium Hydroxide and Titanium Dioxide. _JAMP CLOXACILLIN_ _3 of 14_ NAME OF DRUG PR JAMP CLOXACILLIN Cloxacillin Sodium Capsules 250 and 500 mg cloxacillin THERAPEUTIC CLASSIFICATION Cloxacillin sodium is an antibiotic belonging to the semi-synthetic penicillin family. ACTION JAMP 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 JAMP 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 infection Lire le document complet