ERYTHROMYCIN OPHTHALMIC OINTMENT USP

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ERYTHROMYCIN

Disponibil de la:

STERI-MED PHARMA INC.

Codul ATC:

S01AA17

INN (nume internaţional):

ERYTHROMYCIN

Dozare:

5MG

Forma farmaceutică:

OINTMENT

Compoziție:

ERYTHROMYCIN 5MG

Calea de administrare:

OPHTHALMIC

Unități în pachet:

3.5/1.0G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTIBACTERIALS

Rezumat produs:

Active ingredient group (AIG) number: 0105708019; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2021-06-03

Caracteristicilor produsului

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_ERYTHROMYCIN ophthalmic ointment USP _
_Prescribing Information _
_Page 1 of 6_
PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ERYTHROMYCIN OPHTHALMIC OINTMENT USP
Erythromycin ophthalmic ointment USP
5mg / g
ANTIBIOTIC
Steri-Med Pharma Inc.
242 St-Cyrille Ouest
Upton, Quebec, Canada
J0H 2E0
Date of Revision:
May 3, 2021
Submission Control No: 251871
_ _
_ERYTHROMYCIN ophthalmic ointment USP _
_Prescribing Information _
_Page 2 of 6_
PRESCRIBING INFORMATION
Pr
ERYTHROMYCIN OPHTHALMIC OINTMENT USP
Erythromycin ophthalmic ointment USP 5mg / 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 bact