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Meclizine Hydrochloride

Pronunciation

Class: Antihistamines
VA Class: CN550
CAS Number: 31884-77-2
Brands: Antivert, Bonine, Dramamine Less Drowsy, Meni-D

Introduction

Antiemetic; piperazine-derivative antihistamine.a b c

Uses for Meclizine Hydrochloride

Motion Sickness

Self-medication for prevention and treatment of nausea, vomiting, and/or dizziness associated with motion sickness.b c e

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Vertigo

Symptomatic management of vertigoe associated with diseases affecting the vestibular system (e.g., labyrinthitis, Ménière’s disease).a b

Other Uses

Use in allergic states not evaluated.a

Meclizine Hydrochloride Dosage and Administration

Administration

Oral Administration

For prevention of motion sickness, administer orally 1 hour before exposure to motion; may repeat every 24 hours for duration of journey.101 102 d

Dosage

Available as meclizine hydrochloride; dosage expressed in terms of meclizine.b c d

Pediatric Patients

Motion Sickness
Oral

For self-medication in children ≥12 years of age, 25–50 mg once daily or as directed by clinician.a b c d e

Adults

Motion Sickness
Oral

For self-medication, 25–50 mg once daily or as directed by clinician.a b c d

Vertigo
Oral

25–100 mg daily, administered in divided doses, depending on clinical response.a b

Cautions for Meclizine Hydrochloride

Contraindications

  • Known hypersensitivity to meclizine.b

Warnings/Precautions

Warnings

CNS Effects

Possible drowsiness.b e

Possible additive CNS depression with other CNS depressants.b e (See Specific Drugs under Interactions.)

Anticholinergic Effects

Due to potential anticholinergic activity, use with caution in patients with breathing problems (e.g., asthma, emphysema, chronic bronchitis), angle-closure glaucoma, or prostatic hypertrophy.b c d e

Sensitivity Reactions

Tartrazine Sensitivity

Some formulations contain tartrazine dye (FD&C; yellow No. 5), which may cause allergic reactions (i.e., bronchial asthma) in susceptible individuals.d Incidence of tartrazine sensitivity is low, but it frequently occurs in patients who have aspirin hypersensitivity.d

Specific Populations

Pregnancy

Category B.b

Lactation

Antihistamines may inhibit lactation and small amounts appear to be distributed into milk.f Due to potential for serious adverse effects (e.g., CNS effects) in nursing infants, discontinue nursing or the drug.f

Pediatric Use

Safety and efficacy not established in children <12 years of age.a b c e

Common Adverse Effects

Drowsiness, fatigue, dry mouth.a b c

Interactions for Meclizine Hydrochloride

Specific Drugs

Drug

Interaction

Comments

CNS depressants (e.g., alcohol, barbiturates, tranquilizers)

Additive CNS depressionb e

Avoid alcoholic beverages;b e use other CNS depressants with cautiona

Meclizine Hydrochloride Pharmacokinetics

Absorption

Onset

About 1 hour.a

Duration

Effects persist for 8–24 hours following a single oral dose.a

Distribution

Extent

Distributed throughout most body tissues; crosses placenta.a

Elimination

Metabolism

Metabolic fate in humans is unknown.a In rats, metabolized (probably in the liver) to norchlorcyclizine.a

Elimination Route

Excreted in feces as unchanged drug and in urine as norchlorcyclizine.a

Half-life

6 hours.a

Stability

Storage

Oral

Capsules and Tablets

Tight, light-resistant container at 15–30°C.a c d

Actions

  • Exhibits CNS depressant, anticholinergic, antiemetic, antispasmodic, and local anesthetic effects in addition to antihistaminic activity.a

  • Depresses labyrinth excitability and conduction in vestibular-cerebellar pathways.a

  • Antiemetic and antimotion-sickness actions result, at least in part, from central anticholinergic and CNS depressant properties.a

Advice to Patients

  • Risk of drowsiness; use caution when driving or operating machinery.b c d

  • Importance of avoiding alcohol during therapy.b c d

  • Importance of patients informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses.b c d

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b c d

  • Importance of informing patients of other important precautionary information.b c d (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Meclizine Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

25 mg

Meni-D

Seatrace

Tablets

12.5 mg*

Antivert

Pfizer

25 mg*

Antivert

Pfizer

Dramamine Less Drowsy

Pfizer

50 mg*

Antivert (scored)

Pfizer

Tablets, chewable

25 mg*

Bonine (scored)

Insight

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Antivert 12.5MG Tablets (PFIZER U.S.): 30/$32.54 or 90/$73.47

Antivert 25MG Tablets (PFIZER U.S.): 30/$49.34 or 90/$118.62

Antivert 50MG Tablets (PFIZER U.S.): 30/$71.39 or 90/$204.73

Meclizine HCl 12.5MG Tablets (PAR): 30/$18.99 or 60/$26.97

Meclizine HCl 25MG Tablets (PAR): 30/$19.99 or 60/$30.97

Travel Sickness 25MG Chewable Tablets (RUGBY): 100/$14.99 or 200/$18.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

100. Food and Drug Administration. Antiemetic drug products for over-the-counter human use; final monograph. Fed Regist. 1987; 52:15886-93.

101. Leeming Division. Bonine (meclizine hydrochloride) chewable tablets prescribing information. In: Huff BB, ed. Physicians’ desk reference for nonprescription drugs. 9th ed. Oradell, NJ: Medical Economics Company Inc; 1988:569.

102. Roerig. Antivert tablets, Antivert25 tablets, Antivert25 chewable tablets, and Antivert50 tablets prescribing information. In: Huff BB, ed. Physicians’ desk reference. 43rd ed. Oradell, NJ: Medical Economics Company Inc; 1989:1774.

103. Food and Drug Administration. Over-the-counter drug products; final monographs for antiemetic, antitussive, bronchodilator, and antihelmintic drug products; updating and technical changes. Fed Regist. 1988; 53:35808-10.

a. AHFS drug information 2004. McEvoy GK, ed. Meclizine hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2787-8.

b. Antivert (meclizine hydrochloride) tablets prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2003. Updated 1996 Jun.

c. Bonine (meclizine hydrochloride) tablets prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2003.

d. Par Pharmaceutical, Inc. Meclizine hydrochloride tablets prescribing information. Spring Valley, NY; 2000 Apr.

e. Department of Health and Human Services, Food and Drug Administration. Antiemetic drug products for over-the-counter human use. (21CFR336). 2001 Apr; 5:231-3.

f. AHFS drug information 2004. McEvoy GK, ed. Antihistamines. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2-9.

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