MECLIZINE HYDROCHLORIDE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

REMEDYREPACK INC.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride is 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 2-4% and 15-20%, 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 (25-250 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/m2) 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 and any potential adverse effects on the breastfed infant from meclizine hydrochloride 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 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 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 is administered to patients with CYP2D6 polymorphism, monitor for adverse reactions and clinical effect accordingly.

Tóm tắt sản phẩm:

Tablets Meclizine hydrochloride 12.5 mg tablets are oval shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “34” and one white to off white layer debossed with “L”. NDC: 70518-3768-00 PACKAGING: 30 in 1 BOTTLE PLASTIC Store at 20oC to 25oC (68oF to 77oF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP). Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Tình trạng ủy quyền:

New Drug Application Authorized Generic

Đặc tính sản phẩm

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MECLIZINE
HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR MECLIZINE
HYDROCHLORIDE.
MECLIZINE HYDROCHLORIDE TABLETS, FOR ORAL USE
MECLIZINE HYDROCHLORIDE CHEWABLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1957
INDICATIONS AND USAGE
Meclizine hydrochloride is 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).
Chewable Tablets: Must be chewed or crushed before swallowing; do not
swallow whole ( 2.2).
DOSAGE FORMS AND STRENGTHS
Tablets: 12.5 mg( 3).
CONTRAINDICATIONS
Meclizine hydrochloride is 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, CONTACT RISING PHARMACEUTICALS,
INC. AT 1-866-
562-4597 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Coadministration of meclizine hydrochloride 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 and CYP2D6 inhibitors (
7.2).
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICA