MECLIZINE HYDROCHLORIDE

MECLIZINE HYDROCLORIDE

Manufacturer: Denton Pharma, Inc. dba Northwind Pharmaceuticals

Score: 141.0

Quick Summary

Meclizine hydrochloride is a histamine (H1) receptor antagonist used for the treatment of vertigo associated with diseases affecting the vestibular system in adults. The recommended dosage is 25 mg to 100 mg daily, administered orally in divided doses. Meclizine is contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients. The drug may cause adverse reactions such as anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. Special population considerations include cautious dose selection for elderly patients, and the drug's safety and effectiveness in pediatric patients have not been established.

Key Clinical Findings and Indications

Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.
The precise mechanism by which meclizine exerts its therapeutic effect is unknown but is presumed to involve antagonism of the histamine H1 receptor.

Important Safety Information

Warning

Coadministration of Meclizine hydrochloride with other CNS depressants, including alcohol, may result in increased CNS depression.

Contraindications

Hypersensitivity to meclizine or any of the inactive ingredients.

Adverse Reactions

Anaphylactic reaction
Drowsiness
Dry mouth
Headache
Fatigue
Vomiting
Blurred vision (rare)

Dosing Recommendations

General Guidance

Cautious dose selection for elderly patients, usually starting at the low end of the dosing range.

Vertigo associated with diseases affecting the vestibular system

Adult Dose

25 mg to 100 mg daily, administered orally in divided doses

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy.
However, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis.

Nursing Mothers

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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