MECLIZINE HYDROCHLORIDE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)

Tilgængelig fra:

Golden State Medical Supply, Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see Adverse Reactions ( 6) and Description ( 11)] . Risk Summary 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, at doses similar to those used clinically. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data Epidemiological studies reporting on pregnancies exposed to meclizine have not identified an association between the use of meclizine during pregnancy and an increased risk of major birth defects. Animal Data In a published study, oral administration of meclizine (25 to 250 mg/kg) to pregnant rats during the period of organogenesis resulted in a high incidence of fetal malformations. These effects occurred at doses as low as 25 mg/kg, which is approximately 2 times the maximum recommended human dose (100 mg) on a body surface area (mg/m 2 ) basis. Risk Summary There are no data on the presence of meclizine in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for meclizine hydrochloride tablets and any potential adverse effects on the breastfed infant from meclizine hydrochloride tablets or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established. 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. The effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated. As meclizine hydrochloride undergoes metabolism, hepatic impairment may result in increased systemic exposure of meclizine. Treatment with meclizine hydrochloride tablets should be administered with caution in patients with hepatic impairment. The effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated. Because of a potential for drug/metabolite accumulation, meclizine hydrochloride tablets should be administered with caution in patients with renal impairment and in the elderly, as renal function generally declines with age. The genetic polymorphism of CYP2D6 that results in poor-, intermediate-, extensive-, and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure. Therefore, when meclizine hydrochloride tablets are administered to patients with CYP2D6 polymorphism, monitor for adverse reactions and clinical effect accordingly.

Produkt oversigt:

Meclizine Hydrochloride Tablets USP 25 mg are yellow and light yellow double layered, oval tablets, debossed “ANI” on the yellow side and “842” on the light yellow side. Bottles of 1000 NDC 51407-629-10 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
MECLIZINE HYDROCHLORIDE TABLETS. THESE HIGHLIGHTS DO NOT INCLUDE ALL
THE INFORMATION
NEEDED TO USE MECLIZINE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR MECLIZINE HYDROCHLORIDE TABLETS.
MECLIZINE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1957
INDICATIONS AND USAGE
Meclizine hydrochloride tablets are indicated for the treatment of
vertigo associated with diseases
affecting the vestibular system in adults ( 1).
DOSAGE AND ADMINISTRATION
Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1).
Tablets: Swallow whole ( 2.2).
DOSAGE FORMS AND STRENGTHS
Tablets: 12.5 mg and 25 mg ( 3).
CONTRAINDICATIONS
Meclizine hydrochloride tablets are contraindicated in patients with
hypersensitivity to meclizine or any of
the inactive ingredients ( 4).
WARNINGS AND PRECAUTIONS
May cause drowsiness: Use caution when driving a car or operating
dangerous machinery ( 5.1).
Potential anticholinergic action: this drug should be prescribed with
care to patients with a history of
asthma, glaucoma, or enlargement of the prostate gland ( 5.2).
ADVERSE REACTIONS
Common adverse reactions are anaphylactic reaction, drowsiness, dry
mouth, headache, fatigue, and
vomiting. On rare occasions blurred vision has been reported ( 6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACTANI PHARMACEUTICALS,
INC. AT 1-800-308-
6755OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Coadministration of meclizine hydrochloride tablets with other CNS
depressants, including alcohol, may
result in increased CNS depression ( 7.1).
CYP2D6 inhibitors: As meclizine is metabolized by CYP2D6, there is a
potential for drug-drug
interactions between meclizine hydrochloride tablets and CYP2D6
inhibitors ( 7.2).
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRAT