Country: Kanada
Tungumál: enska
Heimild: Health Canada
LINCOMYCIN (LINCOMYCIN HYDROCHLORIDE)
PFIZER CANADA ULC
J01FF02
LINCOMYCIN
500MG
CAPSULE
LINCOMYCIN (LINCOMYCIN HYDROCHLORIDE) 500MG
ORAL
100
Prescription
LINCOMYCINS
Active ingredient group (AIG) number: 0105826001; AHFS:
CANCELLED POST MARKET
2006-08-02
PRODUCT MONOGRAPH LINCOCIN * LINCOMYCIN INJECTION USP 300 MG/ML STERILE SOLUTION LINCOMYCIN HYDROCHLORIDE CAPSULES USP 500 MG CAPSULES ANTIBIOTIC Pfizer Canada Inc 17,300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Date of revision: April 8, 2008 CONTROL NUMBER: 119402 * TM Pharmacia & Upjohn Company LLC Pfizer Canada Inc, Licensee © Pfizer Canada Inc 2008 2 LINCOCIN * LINCOMYCIN INJECTION USP 300 MG/ML STERILE SOLUTION LINCOMYCIN HYDROCHLORIDE CAPSULES USP 500 MG CAPSULES THERAPEUTIC CLASSIFICATION ANTIBIOTIC ACTION, CLINICAL PHARMACOLOGY The mode of action of lincomycin hydrochloride is the inhibition of protein synthesis by the inhibition of the binding of aminoacyl sRNA to the messenger ribosome complex at the 50S ribosomal unit. INDICATIONS AND CLINICAL USES LINCOCIN (lincomycin hydrochloride) is indicated in the treatment of serious infections due to sensitive gram positive organisms (staphylococci, including penicillinase-producing staphylococci, streptococci and pneumococci) when the patient is intolerant of, or the organism resistant to other appropriate antibiotics. LINCOCIN is indicated in the treatment of osteomyelitis, when the causative organism has been found to be sensitive to this antibiotic. CONTRAINDICATIONS As with all drugs, the use of LINCOCIN (lincomycin hydrochloride) is contraindicated in patients previously found to be hypersensitive to the drug or patients who have previously been found hypersensitive to clindamycin (Dalacin C) or to any other component of the product. 3 LINCOCIN should not be given to persons with known pre-existing monilial infections. Until further clinical experience is obtained, LINCOCIN is not indicated in the newborn. WARNINGS _Clostridium difficile_ -associated disease (CDAD) has been reported with use of many antibacterial agents, including LINCOCIN ( lincomycin hydrochloride). CDAD may range in severity from mild diarrhoea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhoea, or symptoms of colitis, pseudomembr Lestu allt skjalið