Country: Canada
Language: English
Source: Health Canada
ETHOPROPAZINE (ETHOPROPAZINE HYDROCHLORIDE)
SEARCHLIGHT PHARMA INC
N04AA05
PROFENAMINE
50MG
TABLET
ETHOPROPAZINE (ETHOPROPAZINE HYDROCHLORIDE) 50MG
ORAL
100
Prescription
ANTIPARKINSONIAN AGENTS
Active ingredient group (AIG) number: 0106207001; AHFS:
APPROVED
2000-11-09
PRODUCT MONOGRAPH Pr PARSITAN 50 Ethopropazine Hydrochloride Tablets Tablet, 50 mg ethopropazine (as ethopropazine hydrochloride), Oral Manufacturer’s Standard Antiparkinsonian Agent Searchlight Pharma Inc. 1600 Notre-Dame West, Suite 312 Montreal, Quebec H3J 1M1 Date of Preparation: OCT 06, 2022 Submission Control No: 267409 STRUCTURAL FORMULA AND CHEMISTRY Parsitan 50 is 10-2(2-diethylaminopropyl)phenothiazine. Its structural formula may be represented as follows: Molecular formula: C 19 H 24 N 2 S HCl Molecular weight: 348.92 Melting point: 233 - 225°C It is a fine, white, odorless and non-hygroscopic crystalline powder. It is soluble in absolute alcohol and chloroform, slightly soluble in water at 20°C, very slightly soluble in acetone and insoluble in ether and benzene. ACTION Parsitan 50 is an antiparkinsonian agent with potent anticholinergic, para-sympatholytic and antispasmodic activities but with weak adrenolytic and antihistaminic effects. It exerts a strong antagonist action against nicotine-induced convulsions. INDICATIONS In the symptomatic treatment of drug-induced extrapyramidal reactions and of the manifestations (rigidity, akinesia, sialorrhea, oculogyric crisis, tremor, etc.) of Parkinson's disease of encephalitic, arteriosclerotic or idiopathic origin. CONTRAINDICATIONS Glaucoma and hypersensitivity to phenothiazine drugs are the usual contraindications to the use of Parsitan 50. WARNING Because of its anticholinergic effects, administer Parsitan 50 with great caution in patients with prostatic hypertrophy, pyloric stenosis of cardiovascular diseases. PRECAUTIONS Parsitan 50 treatment should be instituted in low doses which should be increased progressively until a satisfactory maintenance dosage is obtained. When substituting Parsitan 50 for another antiparkinsonian reduce the dosage of the former drug slowly, while progressively increasing the Parsitan 50 dosage: its dosage should be reduced gradually. Phenothiazines may in rare instances cause blood dyscrasias. Even if no such case has Read the complete document