MAJEPTIL TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

THIOPROPERAZINE (THIOPROPERAZINE MESYLATE)

Disponibil de la:

SEARCHLIGHT PHARMA INC

Codul ATC:

N05AB08

INN (nume internaţional):

THIOPROPERAZINE

Dozare:

10MG

Forma farmaceutică:

TABLET

Compoziție:

THIOPROPERAZINE (THIOPROPERAZINE MESYLATE) 10MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PHENOTHIAZINES

Rezumat produs:

Active ingredient group (AIG) number: 0148782001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2000-10-02

Caracteristicilor produsului

PRODUCT MONOGRAPH
Pr
Majeptil *
THIOPROPERAZINE MESYLATE TABLETS
10MG THIOPROPERAZINE (AS THIOPROPERAZINE MESYLATE)
NEUROLEPTIC
Searchlight Pharma Inc.
1600 Notre-Dame West, suite 312
Montreal, Quebec
H3J 1M1
Submission Control No.: 267651
Date of
Preparation:
OCT
25,
2022
2
PR
MAJEPTIL®
Searchlight Pharma Inc.
Thioproperazine Mesylate Tablets
Neuroleptic
ACTION
Thioproperazine is a potent neuroleptic with antipsychotic properties.
Thioproperazine has a marked cataleptic and antiapomorphine activity
associated with relatively
slight sedative, hypothermic and spasmolytic effects. It is virtually
without antiserotonin and
hypotensive action and has no antihistaminic property.
INDICATIONS
All types of acute and chronic schizophrenia, including those which
did not respond to the usual
neuroleptics; manic syndromes.
CONTRAINDICATIONS
Comatose or depressive states including those induced by CNS
depressants; Parkinson's disease;
blood dyscrasias; in patients with spastic diseases and in senile
patients with pre-existing
Parkinson-like symptoms; in children under 3 years of age and in
patients generally sensitive to
phenothiazines.
WARNINGS
Treatment should be discontinued if a severe neurologic syndrome is
observed, especially when
hypertonia is accompanied by dysphagia and/or marked autonomic
disturbances.
Neuroleptic phenothiazines may potentiate QT interval prolongation
which increases the risk of
onset of serious ventricular arrhythmias of the torsade de pointes
type, which is potentially fatal
(sudden death). QT prolongation is exacerbated, in particular, in the
presence of bradycardia,
hypokalemia, and congenital or acquired (i.e. drug induced) QT
prolongation. If the clinical
situation permits, medical and laboratory evaluations should be
performed to rule out possible risk
factors before initiating treatment with a neuroleptic agent and as
deemed necessary during
treatment. (See also ADVERSE REACTIONS).
Tardive Dyskinesia: As with all antipsychotic agents, tardive
dyskinesia may appear in some
patients on long-