APO-ACYCLOVIR OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ACYCLOVIR

Available from:

APOTEX INC

ATC code:

D06BB03

INN (International Name):

ACICLOVIR

Dosage:

5%

Pharmaceutical form:

OINTMENT

Composition:

ACYCLOVIR 5%

Administration route:

TOPICAL

Units in package:

4/5/15/30G

Prescription type:

Prescription

Therapeutic area:

ANTIVIRALS

Product summary:

Active ingredient group (AIG) number: 0115506007; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-06-08

Summary of Product characteristics

_APO-Acyclovir Ointment Product Monograph_
1
PRODUCT MONOGRAPH
PR
APO-ACYCLOVIR OINTMENT
Acyclovir Ointment 5% w/w, USP
ANTIVIRAL AGENT
APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9
Date of Revision:
June 7, 2018
Control Number: 209409
_APO-Acyclovir Ointment Product Monograph_
2
PRODUCT MONOGRAPH
PR
APO-ACYCLOVIR OINTMENT
Acyclovir Ointment 5% w/w, USP
ANTIVIRAL AGENT
ACTIONS AND CLINICAL PHARMACOLOGY
Apo-Acyclovir Ointment (acyclovir ointment), an acyclic nucleoside
analog, is a substrate
specific for herpesvirus-specified thymidine kinase. It inhibits
replication of these viruses.
Normal cellular thymidine kinase does not effectively utilize
acyclovir as a substrate.
Herpesvirus-specified thymidine kinase transforms acyclovir to its
monophosphate which is then
transformed by cellular enzymes to acyclovir diphosphate and acyclovir
triphosphate. Acyclovir
triphosphate is both an inhibitor of, and a substrate for,
herpesvirus-specified DNA polymerase.
Although the cellular α-DNA polymerase in infected cells may also be
inhibited by acyclovir
triphosphate, this occurs only at concentrations of acyclovir
triphosphate which are higher than
those which inhibit the herpesvirus-specified DNA polymerase.
Acyclovir is preferentially taken
up and selectively converted to its active form by
herpesvirus-infected cells. Thus, acyclovir has
a very much lower toxic potential for normal uninfected cells because:
1) less is taken up; 2) less
is converted to the active form; 3) cellular α-DNA polymerase has a
lower affinity for the active
form of the drug.
INDICATIONS AND CLINICAL USE
Apo-Acyclovir Ointment (acyclovir ointment) is indicated for the
management of initial episodes
of genital herpes simplex infections. It is also indicated in the
management of nonlife-threatening
cutaneous herpes simplex virus infections in immunocompromised
patients. The prophylactic
use of this preparation has not been established.
In genital herpes, appropriate examinations should be performed to
rule out other sexually
transmitted disea