NARDIL TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

PHENELZINE (PHENELZINE SULFATE)

Mevcut itibaren:

SEARCHLIGHT PHARMA INC

ATC kodu:

N06AF03

INN (International Adı):

PHENELZINE

Doz:

15MG

Farmasötik formu:

TABLET

Kompozisyon:

PHENELZINE (PHENELZINE SULFATE) 15MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

MONOAMINE OXIDASE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0106952001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2022-10-04

Ürün özellikleri

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