Country: Canada
Language: English
Source: Health Canada
HYDROXYZINE HYDROCHLORIDE
ERFA CANADA 2012 INC
N05BB01
HYDROXYZINE
50MG
SOLUTION
HYDROXYZINE HYDROCHLORIDE 50MG
INTRAMUSCULAR
10ML
Prescription
MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS
Active ingredient group (AIG) number: 0106172004; AHFS:
CANCELLED POST MARKET
2005-08-18
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 Read the complete document