Land: Kanada
Språk: engelska
Källa: Health Canada
ERYTHROMYCIN
AMDIPHARM LIMITED
J01FA01
ERYTHROMYCIN
500MG
TABLET
ERYTHROMYCIN 500MG
ORAL
100
Prescription
ERYTHROMYCINS
Active ingredient group (AIG) number: 0105708004; AHFS:
CANCELLED POST MARKET
2017-06-22
- 1 - PRESCRIBING INFORMATION PR ERYBID ® (erythromycin tablets) 500 mg Dispertab ® tablets PR EES ® -200/400 (erythromycin ethylsuccinate oral suspension USP) 200 or 400 mg erythromycin activity/5 mL PR PCE ® (erythromycin tablets) 333 mg Dispertab ® tablets Therapeutic Classification Antibiotic Amdipharm Limited, DATE OF PREPARATION: Temple Chamber, 3 Burlington Road, July 14, 2009 Dublin, Dublin 4, Ireland Distributed by: Methapharm Inc. DATE OF REVISION: Brantford, Ontario, N3S 7X6 Submission Control Number: 130061, 130055, 130053 - 2 - PRESCRIBING INFORMATION NAME OF DRUG ERYBID ® (erythromycin tablets) 500 mg Dispertab ® tablets EES ® -200/400 (erythromycin ethylsuccinate oral suspension USP) 200 or 400 mg erythromycin activity/5 mL PCE ® (erythromycin tablets) 333 mg Dispertab ® tablets THERAPEUTIC CLASSIFICATION Antibiotic ACTION AND CLINICAL PHARMACOLOGY Erythromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible bacteria and suppressing protein synthesis. Erythromycin is usually bacteriostatic but may be bactericidal in high concentrations or against highly susceptible organisms. Orally administered erythromycin base and its salts are absorbed in the microbiologically active form. Significant inter- individual variations in the absorption of erythromycin were observed and some patients do not achieve maximal serum levels. Erythromycin is largely bound to plasma proteins (over 70%). In the presence of normal hepatic function, erythromycin is concentrated in the liver and is excreted in the bile; the effect of hepatic dysfunction on biliary excretion of erythromycin is not known. Erythromycin diffuses readily into most body fluids. Only low concentrations are normally achieved in the spinal fluid, but passage of the drug across the blood-brain barrier increases in meningitis. From 12 to 15 percent of intravenously administered erythromycin is excreted in active form in the urine. After oral administration, less than 5% of the administered dose can be recov Läs hela dokumentet