Antivert

Generic Name: meclizine hydrochloride

Dosage Form: tablet
Antivert®

Tablets/12.5 mg meclizine HCl

 

Antivert®/25

Tablets/25 mg meclizine HCl

 

Antivert®/50

Tablets/50 mg meclizine HCl

Antivert 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 that 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.

Precautions

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when meclizine is administered to a nursing woman.

Adverse Reactions

Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.

Antivert 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 is Antivert Supplied

Antivert: 12.5 mg tablets:

  Bottles of 100

    (NDC 0049-2100-66)

Antivert/25: 25 mg tablets:

  Bottles of 100

    (NDC 0049-2110-66)

Antivert/50: 50 mg tablets:

  Bottles of 100

    (NDC 0049-2140-66)

Rx only

LAB-0142-3.0

May 2010

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

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-2100 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength meclizine hydrochloride (meclizine) meclizine hydrochloride 12.5 mg

Inactive Ingredients Ingredient Name Strength anhydrous dibasic calcium phosphate   magnesium stearate   polyethylene glycols   sucrose   FD&C Blue No. 1

Product Characteristics Color BLUE, WHITE Score no score Shape OVAL Size 10mm Flavor Imprint Code Antivert;210 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0049-2100-66 100 TABLET In 1 BOTTLE None 2 0049-2100-82 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA010721	04/11/1997

Antivert  meclizine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-2110 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength meclizine hydrochloride (meclizine) meclizine hydrochloride 25 mg

Inactive Ingredients Ingredient Name Strength anhydrous dibasic calcium phosphate   magnesium stearate   polyethylene glycols   sucrose   FD&C Yellow No. 6   D&C Yellow No. 10   Aluminum Oxide

Product Characteristics Color YELLOW, WHITE Score no score Shape OVAL Size 13mm Flavor Imprint Code Antivert;211 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0049-2110-66 100 TABLET In 1 BOTTLE None 2 0049-2110-82 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA010721	04/11/1997

Antivert  meclizine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-2140 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength meclizine hydrochloride (meclizine) meclizine hydrochloride 50 mg

Inactive Ingredients Ingredient Name Strength anhydrous dibasic calcium phosphate   magnesium stearate   polyethylene glycols   sucrose   FD&C Blue No. 1   D&C Yellow No. 10   Aluminum Oxide

Product Characteristics Color YELLOW, BLUE Score 2 pieces Shape OVAL Size 16mm Flavor Imprint Code Antivert;214 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0049-2140-66 100 TABLET In 1 BOTTLE None

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
UCB Pharma S.A.		372274485	MANUFACTURE

Revised: 07/2011Roerig

More Antivert resources

• Antivert Side Effects (in more detail)
• Antivert Dosage
• Antivert Use in Pregnancy & Breastfeeding
• Drug Images
• Antivert Drug Interactions
• Antivert Support Group
• 4 Reviews for Antivert - Add your own review/rating

• Antivert Consumer Overview


• Antivert MedFacts Consumer Leaflet (Wolters Kluwer)


• Meclizine Professional Patient Advice (Wolters Kluwer)


• Meclizine Hydrochloride Monograph (AHFS DI)

Compare Antivert with other medications

• Motion Sickness
• Nausea/Vomiting
• Vertigo