Riik: Kanada
keel: inglise
Allikas: Health Canada
MECLIZINE HYDROCHLORIDE
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
R06AE05
MECLOZINE
25MG
TABLET (IMMEDIATE RELEASE)
MECLIZINE HYDROCHLORIDE 25MG
ORAL
100
OTC
ANTIHISTAMINES
Active ingredient group (AIG) number: 0107502001; AHFS:
CANCELLED PRE MARKET
2019-07-31
PRODUCT MONOGRAPH BONAMINE ® MECLIZINE HYDROCHLORIDE TABLETS 25 MG, USP ANTIEMETIC AGENT McNeil Consumer Healthcare, division of Johnson & Johnson Inc. Date of Revision: June 8, 2011 88 McNabb Street Markham, Ontario L3R 5L2 Control No. 142964 © 2011 McNeil Consumer Healthcare, division of Johnson & Johnson Inc. NAME OF DRUG _ _ _BONAMINE_ _®_ _ TABLETS _ _ _ _2 _ BONAMINE ® MECLIZINE HYDROCHLORIDE TABLETS 25 MG, USP THERAPEUTIC CLASSIFICATION Antiemetic Agent ACTION AND CLINICAL PHARMACOLOGY Meclizine hydrochloride has antihistaminic and anticholinergic properties. The site and mechanism of its action in controlling vertigo arising from various conditions have not been clearly defined. Pharmacological studies conducted with other antihistamines show that the peripheral labyrinthine structures may be the site of action. The efficacy of meclizine hydrochloride in controlling the symptoms of motion sickness has been demonstrated in several fields studies, specifically in cases of airsickness and seasickness. Generally, it has been shown to be effective in over 80% of such cases, a single dose providing protection for approximately 24 hours with minimal side effects. INDICATIONS BONAMINE ® (meclizine hydrochloride) is indicated for the prevention and relief of nausea, dizziness and vomiting associated with motion sickness. It is also indicated for the symptomatic management of radiation sickness, Meniere’s syndrome, labyrinthitis and other vestibular disturbances. _ _ _BONAMINE_ _®_ _ TABLETS _ _ _ _3 _ CONTRAINDICATIONS BONAMINE ® (meclizine hydrochloride) is contraindicated in persons with known hypersensitivity to meclizine hydrochloride. WARNINGS Patients should be warned that BONAMINE ® (meclizine hydrochloride) may occasionally cause drowsiness and that they should take the necessary precautions against driving or operating dangerous machinery when taking it. Patients suffering from glaucoma or prostatic enlargement should take BONAMINE ® (meclizine hydrochloride) only under the direction of a physi Lugege kogu dokumenti