Country: Canada
Language: English
Source: Health Canada
CHLORAMPHENICOL
SANDOZ CANADA INCORPORATED
S01AA01
CHLORAMPHENICOL
10MG
OINTMENT
CHLORAMPHENICOL 10MG
OPHTHALMIC
3.5G
Prescription
ANTIBACTERIALS
Active ingredient group (AIG) number: 0151341005; AHFS:
CANCELLED POST MARKET
2019-08-01
PRESCRIBING INFORMATION PR PENTAMYCETIN ® Chloramphenicol Ophthalmic Solution USP 0.25%, 0.5% Chloramphenicol Ophthalmic Ointment USP 1% Antibiotic PR PENTAMYCETIN/HC ® Chloramphenicol and Hydrocortisone Eye and Ear Suspension (chloramphenicol 0.2% and hydrocortisone acetate 1%) Chloramphenicol and Hydrocortisone Eye and Ear Ointment (chloramphenicol 1% and hydrocortisone acetate 1%) Antibiotic/Corticosteroid Sandoz Canada Inc. 145 Jules-Léger Date of Revision: June 14, 2018 Boucherville, QC, Canada J4B 7K8 Submission control number: 214703 _ _ _Pentamycetin and Pentamycetin/HC_ _Page 2 of 13 _ PR PENTAMYCETIN ® Chloramphenicol Ophthalmic Solution USP 0.25%, 0.5% Chloramphenicol Ophthalmic Ointment USP 1% Antibiotic PR PENTAMYCETIN/HC ® Chloramphenicol and Hydrocortisone Eye and Ear Suspension (chloramphenicol 0.2% and hydrocortisone acetate 1%) Chloramphenicol and Hydrocortisone Eye and Ear Ointment (chloramphenicol 1% and hydrocortisone acetate 1%) Antibiotic/Corticosteroid INDICATIONS AND CLINICAL USE PENTAMYCETIN, OPHTHALMIC SOLUTION AND OINTMENT Treatment of superficial ocular infections involving the conjunctiva and/or the cornea, caused by microorganisms shown by bacteriological studies to be susceptible to chloramphenicol. PENTAMYCETIN/HC, EYE AND EAR SUSPENSION AND OINTMENT For topical use in superficial ocular and auditory infections, such as non-purulent conjunctivitis and otitis externa, caused by microorganisms shown by bacteriological studies to be susceptible to chloramphenicol. Hydrocortisone acetate has anti-inflammatory effects. TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF PENTAMYCETIN & PENTAMYCETIN/HC AND OTHER ANTIBACTERIAL DRUGS, PENTAMYCETIN & PENTAMYCETIN/HC SHOULD BE USED ONLY TO TREAT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA. WARNINGS Bone marrow hypoplasia, including aplastic anemia and death, has been reported following local application of chloramphenicol. Chloramphenicol should not be used when less poten Read the complete document