Monograph: |
Buclizine Hydrochloride
Indications: Motion sickness; Nausea, secondary to motion sickness
DESCRIPTION:
Each Tablet Contains:
Buclizine hydrochloride is 1-(p-tert-Butylbenzyl)-4-(p-chloro-alpha-phenylbenzyl) piperazine dihydrochloride.
CLINICAL PHARMACOLOGY:
Bucladin-S acts centrally to suppress nausea and vomiting.
INDICATIONS AND USAGE:
It is effective in the management of nausea, vomiting and dizziness associated with motion sickness.
CONTRAINDICATIONS:
Buclizine hydrochloride, when administered to the pregnant rat, induced fetal abnormalities at doses above the human therapeutic range. Clinical data are not adequate to establish nonteratogenicity in early pregnancy. Until such data are available, buclizine hydrochloride is contraindicated for use in early pregnancy.
Buclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.
WARNINGS:
Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against engaging in activities requiring mental alertness, such as driving a car, or operating heavy machinery or appliances. Safe and effective dosage in children has not been established.
PRECAUTIONS:
This product contains yellow 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of yellow 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
ADVERSE REACTIONS:
Occasionally drowsiness, dryness of mouth, headache and jitteriness are encountered.
DOSAGE AND ADMINISTRATION:
Bucladin-S Softab tablets can be taken without swallowing water. Place the Softab tablet in the mouth and allow it to dissolve, or the tablet may be chewed.
Adults: One tablet usually serves to alleviate nausea. In severe cases, three tablets a day may be taken. The usual maintenance dosage is one tablet twice daily.
In the prevention of motion sickness, one tablet taken at least 1/2 hour before beginning travel usually suffices. For extended travel, a second tablet may be taken after 4 to 6 hours.
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