ODAN-ERYTHROMYCIN OINTMENT

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ERYTHROMYCIN

제공처:

ODAN LABORATORIES LTD

ATC 코드:

S01AA17

INN (International Name):

ERYTHROMYCIN

복용량:

5MG

약제 형태:

OINTMENT

구성:

ERYTHROMYCIN 5MG

관리 경로:

OPHTHALMIC

패키지 단위:

1G/3.5G

처방전 유형:

Prescription

치료 영역:

ANTIBACTERIALS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2015-07-31

제품 특성 요약

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