ANTIVERT
-
meclizine hydrochloride tablet
Roerig
----------
ANTIVERT®Tablets/12.5 mg meclizine HCl
ANTIVERT®/25
Tablets/25 mg meclizine HCl
ANTIVERT®/50
Tablets/50 mg meclizine HCl
DESCRIPTION
Chemically, Antivert® (meclizine HCl) is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.
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.
ACTIONS
Antivert is an antihistamine which shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.
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.
CONTRAINDICATIONS
Meclizine HCl is contraindicated in individuals who have shown a previous hypersensitivity to it.
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.
ADVERSE REACTIONS
Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.
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.
Motion Sickness
The initial dose of 25 to 50 mg of Antivert should be taken one hour prior to embarkation for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.
HOW SUPPLIED
Antivert®—12.5 mg tablets:
Bottles of 100
(NDC 0662-2100-66),
(NDC 0049-2100-66)
Bottles of 1000
(NDC 0662-2100-82),
(NDC 0049-2100-82)
Antivert®/25—25 mg tablets:
Bottles of 100
(NDC 0662-2110-66),
(NDC 0049-2110-66)
Bottles of 1000
(NDC 0662-2110-82),
(NDC 0049-2110-82)
Antivert®/50—50 mg tablets:
Bottles of 100
(NDC 0662-2140-66),
(NDC 0049-2140-66)
LAB-0142-2.0
October 2006
PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label
NDC 0049-2100-66
100 Tablets
Antivert®
(meclizine HCl)
12.5 mg
Pfizer
Distributed by
Roerig
Division of Pfizer Inc, NY, NY 10017
PRINCIPAL DISPLAY PANEL - 25 mg Tablet Label
NDC 0049-2110-66
100 Tablets
Antivert®
(meclizine HCl)
25 mg
Pfizer
Distributed by
Roerig
Division of Pfizer Inc, NY, NY 10017
PRINCIPAL DISPLAY PANEL - 50 mg Tablet Label
NDC 0049-2140-66
100 Tablets
Antivert®
(meclizine HCl)
50 mg
Pfizer
Distributed by
Roerig
Division of Pfizer Inc, NY, NY 10017
| ANTIVERT
meclizine hydrochloride tablet |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA010721 | 04/11/1997 | |
| ANTIVERT
meclizine hydrochloride tablet |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA010721 | 04/11/1997 | |
| ANTIVERT
meclizine hydrochloride tablet |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA010721 | 04/11/1997 | |
| Labeler - Roerig (829076996) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Pfizer Pharmaceuticals LLC | 829084545 | API MANUFACTURE, MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| DR. REDDY'S LABORATORIES LIMITED (Mexico site) | 812915445 | API MANUFACTURE | |