NOZINAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

METHOTRIMEPRAZINE (METHOTRIMEPRAZINE MALEATE)

Tersedia dari:

SANOFI-AVENTIS CANADA INC

Kode ATC:

N05AA02

INN (Nama Internasional):

LEVOMEPROMAZINE

Dosis:

50MG

Bentuk farmasi:

TABLET

Komposisi:

METHOTRIMEPRAZINE (METHOTRIMEPRAZINE MALEATE) 50MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

PHENOTHIAZINES

Ringkasan produk:

Active ingredient group (AIG) number: 0134080003; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2007-07-18

Karakteristik produk

PRODUCT MONOGRAPH
NOZINAN
®
METHOTRIMEPRAZINE MALEATE TABLETS
5, 25, 50 MG METHOTRIMEPRAZINE AS METHOTRIMEPRAZINE MALEATE
METHOTRIMEPRAZINE HYDROCHLORIDE INJECTION
25 MG/ML METHRORIMEPRAZINE AS METHOTRIMEPRAZINE HYDROCHLORIDE
NEUROLEPTIC
sanofi-aventis Canada Inc.
Date of Revision:
2150 St. Elzear Blvd. West
May 18, 2007
Laval, Quebec H7L 4A8
Submission Control No.: 111761
s-a Version 4.0 dated
Page 2 of 15
P
RODUCT
M
ONOGRAPH
N
AME OF
D
RUG
NOZINAN
®
_ _
Methotrimeprazine Maleate Tablets
Methotrimeprazine Hydrochloride Injection
T
HERAPEUTIC
C
LASSIFICATION
Neuroleptic
A
CTION AND
C
LINICAL
P
HARMACOLOGY
Nozinan possesses antipsychotic, tranquilizing, anxiolytic, sedative
and analgesic properties and
it is also a potent potentiator of anesthetics.
I
NDICATIONS AND
C
LINICAL
U
SE
Psychotic disturbances: acute and chronic schizophrenias, senile
psychoses, manic-depressive
syndromes.
Conditions associated with anxiety and tension: autonomic
disturbances, personality disturbances,
emotional troubles secondary to such physical conditions as resistant
pruritus, etc.
Nozinan is also employed:
-
As an analgesic: In pain due to cancer, zona, trigeminal neuralgia and
neurocostal
neuralgia and in phantom limb pains and muscular discomforts.
-
As a potentiator of anesthetics: In general anesthesia where it can be
used as both a pre-
and post-operative sedative and analgesic.
-
As an antiemetic: For the treatment of nausea and vomiting of central
origin.
-
As a sedative: For the management of insomnia.
C
ONTRAINDICATIONS
In cases of coma or CNS depression due to alcohol, hypnotics,
analgesics or narcotics.
It is also contraindicated in patients with blood dyscrasia, hepatic
troubles or a sensitivity to
phenothiazines.
Page 3 of 15
W
ARNINGS
_Occupational Hazards_
: Nozinan can reduce psychomotor activity especially during the first
few
days of treatment. Patients should therefore be cautioned not to drive
a motor vehicle or to
participate in activities requiring total mental alertness.
As with other neuroleptics, very rare