Posicaine 200 (Articaine Hydrochloride 4% with EpinephrineAdrenaline 1:200000 Injection)

Country: Մալայզիա

language: անգլերեն

source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

active_ingredient:

ADRENALINE ACID TARTRATE; ARTICAINE HYDROCHLORIDE

MAH:

Galla Dental Corporation Sdn Bhd

INN:

ADRENALINE ACID TARTRATE; ARTICAINE HYDROCHLORIDE

units_in_package:

1.8ml mL

manufactured_by:

Novocol Pharmaceutical of Canada, Inc.

SPC

POSICAINE® 200
(articaine hydrochloride 4% with epinephrine/adrenaline 1:200,000
Injection)
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 conduc-
tion 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 for 45 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 elimina-
tion 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 during minor procedures in dentistry.
CONTRAINDICATIONS
POSICAINE is contraindicated in patients with known allergies to
dental anaesthetics. POSICAINE is also contraindicated in patients
with sepsis near
the proposed injection site, severe shock, paroxysmal tachycardia,
frequent arrhythmia, neurological disease, severe hypertension or in
patients with
asthma who may have bronchospastic allergic reactions induced by
sulphites. Since POSICAINE contains epinephrine the caution required
of any vaso-
constrictor drug is in order.
WARNINGS
POSICAINE, along with other local anaesthetics, is capable of
producing methaemoglobinaemia. The clinical sign