POSICAINE N SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ARTICAINE HYDROCHLORIDE; EPINEPHRINE (EPINEPHRINE BITARTRATE)

Available from:

NOVOCOL PHARMACEUTICAL OF CANADA INC

ATC code:

N01BB58

INN (International Name):

ARTICAINE, COMBINATIONS

Dosage:

40MG; 0.005MG

Pharmaceutical form:

SOLUTION

Composition:

ARTICAINE HYDROCHLORIDE 40MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.005MG

Administration route:

BLOCK/INFILTRATION

Units in package:

50X1.7ML

Prescription type:

Ethical

Therapeutic area:

VASOCONSTRICTORS

Product summary:

Active ingredient group (AIG) number: 0226661002; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-03-30

Summary of Product characteristics

Novocol Pharmaceutical of Canada, Inc.
1 of 13
PRODUCT MONOGRAPH
POSICAINE SP
(articaine hydrochloride 4% with 1:100,000 epinephrine (as bitartrate)
INJECTION)
POSICAINE N
(articaine hydrochloride 4% with 1:200,000 epinephrine (as bitartrate)
INJECTION)
Local Anaesthetic for Dental Use
Novocol Pharmaceutical of Canada, Inc.,
Date of Preparation : March 27, 2012
25 Wolseley Court,
Cambridge, Ontario,
Canada
Control No.: 153590
N1R 6X3
Novocol Pharmaceutical of Canada, Inc.
2 of 13
NAME OF DRUG
POSICAINE N
(articaine hydrochloride 4% with 1:200,000 epinephrine (as bitartrate)
INJECTION) POSICAINE SP
(articaine hydrochloride 4% with 1:100,000 epinephrine (as bitartrate)
INJECTION)
THERAPEUTIC CLASSIFACTION
Local Anaesthetic for Dental Use
CLINICAL PHARMACOLOGY
Posicaine is a local anaesthetic that has the reversible effect of
blocking the conduction of
painful sensations. Posicaine decreases nerve conduction by
diminishing the sodium ion
influx during the action potential period. The epinephrine is a
vasoconstrictor added to
Posicaine to slow down the passage into the general circulation and
thus ensure the prolonged
maintenance of an active tissue concentration. The anaesthesia is
obtained rapidly (1 to 3
minutes) and lasts from 45 to 75 minutes per cartridge.
Injected in the mouth by the submucosal route with a solution
containing 1:200,000
epinephrine, articaine reaches the blood concentration peak about 17
minutes after the
injection. The half-life elimination is very short: about 25 minutes.
Articaine is excreted
mainly through the urine with total elimination of 76 % and 89 %
following intramuscular
and intravenous administration, respectively. Two unidentified
metabolites of articaine are
detected in the urine following intramuscular injection accounting for
87 % and 2 % of the
administered dose. No metabolites are detected in the blood following
intravenous
administration.
INDICATIONS AND CLINICAL USE
Posicaine is indicated for infiltration anaesthesia and nerve block
anaesthesia in clinical
dentistry. This