ODAN PROCTOMYXIN HC OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HYDROCORTISONE; DIBUCAINE HYDROCHLORIDE; FRAMYCETIN SULFATE; ESCULIN

Available from:

ODAN LABORATORIES LTD

ATC code:

C05AA01

INN (International Name):

HYDROCORTISONE

Dosage:

0.5%; 0.5%; 1%; 1%

Pharmaceutical form:

OINTMENT

Composition:

HYDROCORTISONE 0.5%; DIBUCAINE HYDROCHLORIDE 0.5%; FRAMYCETIN SULFATE 1%; ESCULIN 1%

Administration route:

RECTAL

Units in package:

15/30G

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0404592001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-08-11

Summary of Product characteristics

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
PR
ODAN PROCTOMYXIN HC
Hydrocortisone, Framycetin Sulfate, Cinchocaine Hydrochloride and
Esculin Ointment
5 mg, 10 mg, 5 mg and 10 mg
PR
ODAN PROCTOMYXIN HC SUPPOSITORIES
Hydrocortisone, Framycetin Sulfate, Cinchocaine Hydrochloride and
Esculin Suppositories
5 mg, 10 mg, 5 mg and 10 mg
Antibacterial – Corticosteroid – Anorectal Therapy
Odan Laboratories Ltd.
325 Stillview ave.
Pointe Claire, QC
H9R 2Y6
Date of Revision
June 17, 2021
www.odanlab.com
Submission Control Number: 251272
_Odan Proctomyxin HC and Odan Proctomyxin HC Suppositories _
_Page 2 of 11 _
PRESCRIBING INFORMATION
PR
ODAN PROCTOMYXIN HC
PR
ODAN PROCTOMYXIN HC SUPPOSITORIES
Hydrocortisone, Framycetin Sulfate, Cinchocaine Hydrochloride and
Esculin Ointment
and
Hydrocortisone, Framycetin Sulfate, Cinchocaine Hydrochloride and
Esculin Suppositories
THERAPEUTIC CLASSIFICATION
Antibacterial – Corticosteroid – Anorectal Therapy
ACTIONS AND CLINICAL PHARMACOLOGY
Framycetin sulfate, also known as neomycin B, is an aminoglycoside
antibiotic which forms the
major component of neomycin sulfate and has similar actions and uses.
Aminoglycosides are taken up into sensitive bacterial cells by an
active transport process which
is inhibited in anærobic, acidic, or hyperosmolar environments.
Within the cell, they bind to the
30S and to some extent to the 50S subunits of the bacterial ribosome,
inhibiting protein synthesis
and generating errors in the transcription of the genetic code. The
manner in which cell death is
brought about is imperfectly understood, and other mechanisms may
contribute, including effects
on membrane permeability.
In general, neomycin is active against many ærobic gram-negative
bacteria and some aerobic
gram-positive bacteria. Bacterial strains susceptible to neomycin
include: _Escherichia coli_,
_Hæmophilus influenzæ,_ _Moraxella lacunata_, indole-positive and
indole-negative _Proteus_,
_Staphylococcus aureus_,_ S. epidermidis_ and _Serratia_. Neomycin is
only mini