ERYBID TABLET

Summary of Product characteristics

                                - 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
                                
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