PDP-ERYTHROMYCIN OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ERYTHROMYCIN

Available from:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATC code:

S01AA17

INN (International Name):

ERYTHROMYCIN

Dosage:

5MG

Pharmaceutical form:

OINTMENT

Composition:

ERYTHROMYCIN 5MG

Administration route:

OPHTHALMIC

Units in package:

1G/3.5G

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

Active ingredient group (AIG) number: 0105708001; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-07-11

Summary of Product characteristics

_pdp-ERYTHROMYCIN Prescribing Information_
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PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
PR
PDP-ERYTHROMYCIN
ERYTHROMYCIN OPHTHALMIC OINTMENT USP
5 MG/G
ANTIBIOTIC
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount Ave., Suite #100
Montréal, Québec
H4P 2T4
Submission Control No: 200704
DATE OF REVISION: JANUARY 16, 2017
_pdp-ERYTHROMYCIN Prescribing Information_
_ _
2
PRESCRIBING INFORMATION
PR
PDP-ERYTHROMYCIN
ERYTHROMYCIN
OPHTHALMIC OINTMENT USP 5 MG/G
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Erythromycin inhibits protein synthesis by binding to the 50S
ribosomal subunit within the
microorganism. It is usually bacteriostatic but may be bactericidal
depending on the sensitivity
and number of organisms and the concentrations of the drug. Its
spectrum of activity is similar to
that of penicillin G. Resistance to erythromycin of some strains of H.
influenza and
Staphylococci has been demonstrated.
INDICATIONS
For the treatment of superficial ocular infections involving the
conjunctiva and/or cornea caused
by organisms susceptible to erythromycin.
For prophylaxis of ophthalmic neonatorum due to N. gonorrhoeae or C.
trachomatis. The
Canadian Pediatric Society, the Centers for Diseases Control and the
Committee on Drugs (US),
the Committee of Fetus and Newborn and the Committee on Infectious
Diseases of the American
Academy of Pediatrics recommend 1% silver nitrate solution in single
dose ampoules or single
use tubes of an ophthalmic ointment containing 0.5% erythromycin or 1%
tetracycline as
effective and acceptable regimens for prophylaxis of gonococcal
ophthalmia neonatorum.
Erythromycin ophthalmic ointment has also been effective for
prevention of neonatal
conjunctivitis due to C. trachomatis, a condition that may develop one
to several weeks after
delivery in infants of mothers whose birth canal harbor the organism.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of pdp-
ERYTHROMYCIN and other antibacterial drugs,