ERYTHROMYCIN OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ERYTHROMYCIN

Available from:

PHARMA STULLN INC.

ATC code:

S01AA17

INN (International Name):

ERYTHROMYCIN

Dosage:

5MG

Pharmaceutical form:

OINTMENT

Composition:

ERYTHROMYCIN 5MG

Administration route:

OPHTHALMIC

Units in package:

3.5G

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2017-05-03

Summary of Product characteristics

1
PRESCRIBING
INFORMATION
INCLUDING PATIENT MEDICATION
INFORMATION
PR
ERYTHROMYCIN
ERYTHROMYCIN OPHTHALMIC OINTMENT USP
5 MG/G
ANTIBIOTIC
PHARMA STULLN INC.
6500 TransCanada Highway, Suite 400
Pointe-Claire, Québec
H9R 0A5
DATE OF PREPARATION
:
November 11,2019
REVISION DATE: July 21, 2020
2
PRESCRIBING INFORMATION
PR
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
ERYTHROMYCIN and other antibacterial drugs, ERYTHROMYCIN should be
used only to treat
infections that are proven or strongly suspected to be caused by
susceptible b