ODAN-ERYTHROMYCIN OINTMENT

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ERYTHROMYCIN

Disponible desde:

ODAN LABORATORIES LTD

Código ATC:

S01AA17

Designación común internacional (DCI):

ERYTHROMYCIN

Dosis:

5MG

formulario farmacéutico:

OINTMENT

Composición:

ERYTHROMYCIN 5MG

Vía de administración:

OPHTHALMIC

Unidades en paquete:

1G/3.5G

tipo de receta:

Prescription

Área terapéutica:

ANTIBACTERIALS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2015-07-31

Ficha técnica

PRESCRIBING INFORMATION
PR
ODAN-ERYTHROMYCIN
ERYTHROMYCIN OPHTHALMIC OINTMENT, USP
5 MG / G
ANTIBIOTIC
ODAN LABORATORIES LTD.
325 Stillview Ave., Pointe Claire,
Québec H9R 2Y6
Submission Control No: 211571
Date of Revision:
January 5, 2018
www.odanlab.com
1
PRESCRIBING INFORMATION
PR
ODAN-ERYTHROMYCIN
ERYTHROMYCIN O
PHTHALMIC 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 ODAN-
ERYTHROMYCIN and other antibacterial drugs, ODAN-ERYTHROMYCIN should
be used
only
to treat infections that are proven or strongly suspected to be caused
by susceptible
bacteria.
When c