CHLORAMPHENICOL OINTMENT

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CHLORAMPHENICOL

Dostopno od:

PHARMA STULLN INC.

Koda artikla:

S01AA01

INN (mednarodno ime):

CHLORAMPHENICOL

Odmerek:

1%

Farmacevtska oblika:

OINTMENT

Sestava:

CHLORAMPHENICOL 1%

Pot uporabe:

OPHTHALMIC

Enote v paketu:

3.5G

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTIBACTERIALS

Povzetek izdelek:

Active ingredient group (AIG) number: 0151341005; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2019-11-23

Lastnosti izdelka

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
CHLORAMPHENICOL
CHLORAMPHENICOL OPHTHALMIC OINTMENT, USP 1.0%
ANTIBIOTIC
Eberth Pharmaceuticals Inc,
56 Eastview Ave.,
Pointe-Claire, Québec H9R 5N6
Control No # 216575
Date of Revision:
May 22, 2019
2
PRESCRIBING INFORMATION
CHLORAMPHENICOL
CHLORAMPHENICOL OPHTHALMIC OINTMENT, USP 1.0%
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Chloramphenicol is a broad-spectrum antibiotic originally isolated
from _Streptomyces venezuelae_. It
is primarily bacteriostatic and acts by blocking protein synthesis via
inhibition of peptidyl transferase
within the 50S ribosomal subunit. This inhibition blocks peptide bond
formation, thereby preventing
the transfer of amino acids to the growing polypeptide chains.
Development of resistance to chloramphenicol can be regarded as
minimal for staphylococci and
many other species of bacteria.
INDICATIONS
This product is indicated for the treatment
of
superficial ocular infections involving
the conjunctiva
and/ or cornea caused by chloramphenicol-susceptible organisms.
Bacteriological studies should be
performed to determine the causative organisms and their sensitivity
to chloramphenicol.
_TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF _
_CHLORAMPHENICOL AND OTHER ANTIBACTERIAL DRUGS, CHLORAMPHENICOL SHOULD
BE USED _
_ONLY TO TREAT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE
CAUSED BY BACTERIA._
CONTRAINDICATIONS
This product is contraindicated in those
persons who have shown hypersensitivity
to any of its
components.
3
WARNINGS
Prolonged or frequent intermittent use of topical chloramphenicol
should be avoided because of possibility
of hypersensitivity reactions, including bone-marrow hypoplasia which
may lead to aplastic anemia.
Overuse of this product may produce increased redness of the eye.
PRECAUTIONS
_SUSCEPTIBILITY/RESISTANCE _
_DEVELOPMENT OF DRUG RESISTANT BACTERIA _
_PRESCRIBING CHLORAMPHENICOL IN THE ABSENCE OF A PROVEN OR STRONGLY
SUSPECTED BACTERIAL _
_INFECTI