ATARAX CAP 10MG CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HYDROXYZINE HYDROCHLORIDE

Available from:

ERFA CANADA 2012 INC

ATC code:

N05BB01

INN (International Name):

HYDROXYZINE

Dosage:

10MG

Pharmaceutical form:

CAPSULE

Composition:

HYDROXYZINE HYDROCHLORIDE 10MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Product summary:

Active ingredient group (AIG) number: 0106172003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2005-09-15

Summary of Product characteristics

PRESCRIBING INFORMATION
PRODUCT MONOGRAPH
ATARAX SYRUP, 2MG/ML
Hydroxyzine Hydrochloride Syrup USP 10 mg/5 mL
ATARAX IM SOL 50MG/ML
Hydroxyzine Hydrochloride Injection USP 50 mg/mL
For Intramuscular Use Only
ATARAX CAPSULES 10 MG, 25 MG, 50 MG
Hydroxyzine Hydrochloride Capsules 10 mg, 25 mg, 50 mg
Anxiolytic - Antihistamine Agent
Date of Preparation:
September 6, 2005
Control No. 100902
PRODUCT INFORMATION
ATARAX*
Hydroxyzine Hydrochloride Syrup USP 10 mg/5 mL
ATARAX*
Hydroxyzine Hydrochloride Injection USP 50 mg/mL
For Intramuscular Use Only
ATARAX*
Hydroxyzine Hydrochloride Capsules 10 mg, 25 mg, 50 mg
Anxiolytic - Antihistamine Agent
INDICATIONS
ORAL
ATARAX (hydroxyzine hydrochloride) is indicated in the management of
anxiety and tension as
in the preparation for dental procedures and in acute emotional
problems. Also used in the
management of anxiety associated with organic disturbances and as
adjunctive therapy in
alcoholism and allergic conditions with strong emotional overlay, such
as in asthma.
ATARAX (hydroxyzine hydrochloride) is useful in the management of
pruritus due to allergic
conditions such as chronic urticaria and atopic and contact
dermatoses.
3
ATARAX (hydroxyzine hydrochloride) is also useful in the control of
nausea and vomiting,
excluding nausea and vomiting of pregnancy (see CONTRAINDICATIONS
section).
INTRAMUSCULAR
ATARAX (hydroxyzine hydrochloride) Injection I.M. is indicated in the
treatment of the
following types of patients when this route of administration is
desirable:
1.
The acute disturbed or hysterical patient.
2.
The acute or chronic alcoholic with anxiety, withdrawal symptoms or
delirium tremens.
3.
As pre- and post-operative, and pre- and post-partum adjunctive
medication to allay
anxiety, and to permit substantial reduction in narcotic dosage and to
control emesis,
excluding nausea and vomiting of pregnancy (see CONTRAINDICATIONS
section).
Patients may be started on parenteral therapy when indicated by the
clinical situation. They
should be maintained on oral therapy whenever