PMS-LOXAPINE TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

LOXAPINE (LOXAPINE SUCCINATE)

Inapatikana kutoka:

PHARMASCIENCE INC

ATC kanuni:

N05AH01

INN (Jina la Kimataifa):

LOXAPINE

Kipimo:

5MG

Dawa fomu:

TABLET

Tungo:

LOXAPINE (LOXAPINE SUCCINATE) 5MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Eneo la matibabu:

MISCELLANEOUS ANTIPSYCHOTICS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0111557002; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2021-04-15

Tabia za bidhaa

_ _
_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
........