Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
PHENELZINE (PHENELZINE SULFATE)
SEARCHLIGHT PHARMA INC
N06AF03
PHENELZINE
15MG
TABLET
PHENELZINE (PHENELZINE SULFATE) 15MG
ORAL
100
Prescription
MONOAMINE OXIDASE INHIBITORS
Active ingredient group (AIG) number: 0106952001; AHFS:
APPROVED
2022-10-04
PRODUCT MONOGRAPH Pr NARDIL * Phenelzine Sulfate Tablets USP 15 mg ANTIDEPRESSANT Searchlight Pharma Inc. 1600 Notre-Dame West, suite 312 Montreal, Quebec H3J 1M1 Submission Control No.: 267161 Date of Preparation: OCT 4, 2022 2 PRODUCT MONOGRAPH NAME OF DRUG Pr NARDIL * Phenelzine Sulfate Tablets USP 15 mg PHARMACOLOGICAL CLASSIFICATION Antidepressant ACTIONS AND CLINICAL PHARMACOLOGY NARDIL (phenelzine sulfate) is a potent monoamine oxidase (MAO) inhibitor. Monoamine oxidase is a complex enzyme system, widely distributed throughout the body. Drugs that inhibit monoamine oxidase in the laboratory are associated with a number of clinical effects. Thus, it is unknown whether MAO inhibition_ _ _per se_, other pharmacologic actions, or an interaction of both is responsible for the clinical effects observed. All the currently employed MAO inhibitors are readily absorbed after oral administration. They are not given parenterally. These drugs produce maximal inhibition of MAO in biopsy samples from man within 5 to 10 days. However, although their biological activity is prolonged due to the characteristics of their interaction with the enzyme, their clinical efficacy appears to be reduced when given less frequently than once daily. In chronically treated phenelzine patients on 60 mg/day, steady-state trough and peak levels are between 1 and 10 ng/mL. INDICATIONS AND CLINICAL USE NARDIL (phenelzine sulfate) is indicated in the treatment of depressed patients clinically characterized as "atypical", "nonendogenous" or "neurotic". These patients often have mixed anxiety and depression and phobic or hypochondriacal features. There is less conclusive evidence of its usefulness for severely depressed patients with endogenous features. NARDIL is indicated for patients who have failed to respond to the drugs more commonly used for these conditions. CONTRAINDICATIONS NARDIL (phenelzine sulfate) is contraindicated in patients with known hypersensitivity to the drug or its ingredients, with pheochromocytoma, congestive heart failur Přečtěte si celý dokument