Nazione: Canada
Lingua: inglese
Fonte: Health Canada
THIOPROPERAZINE (THIOPROPERAZINE MESYLATE)
SEARCHLIGHT PHARMA INC
N05AB08
THIOPROPERAZINE
10MG
TABLET
THIOPROPERAZINE (THIOPROPERAZINE MESYLATE) 10MG
ORAL
100
Prescription
PHENOTHIAZINES
Active ingredient group (AIG) number: 0148782001; AHFS:
APPROVED
2000-10-02
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- Leggi il documento completo