PROCTOL SUPPOSITORIES SUPPOSITORY

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:

5MG; 5MG; 10MG; 10MG

Pharmaceutical form:

SUPPOSITORY

Composition:

HYDROCORTISONE 5MG; DIBUCAINE HYDROCHLORIDE 5MG; FRAMYCETIN SULFATE 10MG; ESCULIN 10MG

Administration route:

RECTAL

Units in package:

12/24

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0404592002; AHFS:

Authorization status:

MARKETED

Authorization date:

2004-03-15

Summary of Product characteristics

PRESCRIBING INFORMATION
Including Patient Medication Information
PR
PROCTOL
® OINTMENT
and
PR
PROCTOL
® SUPPOSITORIES
(Cinchocaine Hydrochloride, Esculin, Framycetin Sulfate,
Hydrocortisone)
Anorectal Therapy
ODAN LABORATORIES LTD.
325 Stillview Ave.,
Pointe Claire, (QC) H9R 2Y6
Submission Control No: 220680
Date of Revision:
January 31, 2019
www.odanlab.com
2
PRESCRIBING INFORMATION
PROCTOL OINTMENT AND PROCTOL SUPPOSITORIES
(Cinchocaine
Hydrochloride, Esculin, Framycetin Sulfate, Hydrocortisone)
ANORECTAL THERAPY
INDICATIONS:
The
reduction
of
swelling,
pain
and
inflammation
of hemorrhoids and other rectal
lesions.
The
management
of
acute
and
chronic
nonspecific
proctitis,
acute
internal
hemorrhoids, cryptitis, fissures and incomplete fistulas, internal and
external pruritus
ani. May be used in pre-and postoperative hemorrhoidectomy and repair
of fissures.
PROCTOL
OINTMENT
and
PROCTOL
SUPPOSITORIES
contain
an
antibacterial
ingredient,
framycetin.
To
reduce
the
development
of
drug-resistant
bacteria
and
maintain
the
effectiveness
of
framycetin,
PROCTOL
OINTMENT
and
PROCTOL
SUPPOSITORIES should only be used for the authorized indication and
clinical use.
CONTRAINDICATIONS:
Hydrocortisone
must not
be
used
in the presence
of tuberculosis, fungal
and viral
infections. Sensitivity to any of the components.
PRECAUTIONS:
Discontinue use if sensitization occurs. Hydrocortisone should not be
used until an
adequate proctologic examination
is completed and a diagnosis made.
Other specific measures against infections, allergy, and other causal
factors must not
be
neglected.
The possibility,
however rare, that prolonged use of this preparation
might
produce
systemic
corticosteroid
effects,
should
be
borne
in
mind.
Patients
should
be
advised
to
inform
subsequent
physicians
of
the
previous
use
of
hydrocortisone.
The
safe
use
of
topical
corticosteroids
during
pregnancy
has
not
been
fully
established .
Therefore, during pregnancy, they should not be used unnecessarily on
extended areas, in large amounts or for prolonged periods