HYDROXYZINE CAPSULE

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

HYDROXYZINE HYDROCHLORIDE

Disponibbli minn:

AA PHARMA INC

Kodiċi ATC:

N05BB01

INN (Isem Internazzjonali):

HYDROXYZINE

Dożaġġ:

50MG

Għamla farmaċewtika:

CAPSULE

Kompożizzjoni:

HYDROXYZINE HYDROCHLORIDE 50MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100/500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0106172004; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2018-07-09

Karatteristiċi tal-prodott

_HYDROXYZINE (hydroxyzine hydrochloride capsules) _
_Page 1 of 22_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
HYDROXYZINE
Hydroxyzine Hydrochloride Capsules
Capsules, 10 mg, 25 mg, 50 mg, Oral
Anxiolytic – Antihistamine agent
AA Pharma Inc.
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
www.aapharma.ca
Date of Initial Authorization:
August 29, 1985
Date of Revision:
October 12, 2023
Submission Control Number: 275592
_HYDROXYZINE (hydroxyzine hydrochloride capsules) _
_Page 2 of 22_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
10/2022
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.5
Missed dose
........................................................................................................5
5
OVERDOSAGE
...............................................................................................................6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
.......