Product Description.:
AN 441
tablet , blue , oval oblong
Debossed
ANTIVERT?/25
(meclizine HCl) Tablets/25 mg
ANTIVERT?/50
(meclizine HCl) Tablets/50 mg
DRUG DESCRIPTION
Inert ingredients for the tablets are: dibasic calcium phosphate magnesium stearate polyethylene glycol starch sucrose. The 12.5 mg tablets also contain: Blue 1. The 25 mg tablets also contain: Yellow 6 Lake Yellow 10 Lake. The 50 mg tablets also contain: Blue 1 Lake Yellow 10 Lake.
INDICATIONS
Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the indications as follows:
Effective: Management of nausea and vomiting, and dizziness associated with motion sickness.
Possibly Effective: Management of vertigo associated with diseases affecting the vestibular system.
Final classification of the less than effective indications requires further investigation.
DOSAGE AND ADMINISTRATION
Vertigo
For the control of vertigo associated with diseases affecting the vestibular system, the recommended dose is 25 to 100 mg daily, in divided dosage, depending upon clinical response.
SIDE EFFECTS
Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.
WARNINGS
Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery.
Patients should avoid alcoholic beverages while taking this drug.
Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.
Usage in Children
Clinical studies establishing safety and effectiveness in children have not been done therefore, usage is not recommended in children under 12 years of age.
Usage in Pregnancy
Pregnancy Category B.Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary.
