PMS-LOXAPINE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

LOXAPINE (LOXAPINE SUCCINATE)

제공처:

PHARMASCIENCE INC

ATC 코드:

N05AH01

INN (국제 이름):

LOXAPINE

복용량:

10MG

약제 형태:

TABLET

구성:

LOXAPINE (LOXAPINE SUCCINATE) 10MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

MISCELLANEOUS ANTIPSYCHOTICS

제품 요약:

Active ingredient group (AIG) number: 0111557004; AHFS:

승인 상태:

APPROVED

승인 날짜:

2021-04-15

제품 특성 요약

_ _
_pms-LOXAPINE (loxapine) _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-LOXAPINE
Loxapine Succinate Tablets
Tablets 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg
USP
Antipsychotic
Pharmascience Inc.
6111 Royalmount Avenue, Suite 100
Montréal, QC, Canada
H4P 2T4
Date of Initial Authorization:
April 13, 2021
Submission Control Number: 249106
_ _
_ _
_pms-LOXAPINE (loxapine) _
_Page 2 of 36_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
..........................................................................................................
6
4.5
Missed Dose
..............................................................................................................
6
5
OVERDOSAGE
.............................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
........