Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)
Denton Pharma, Inc. dba Northwind Pharmaceuticals
ORAL
PRESCRIPTION DRUG
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 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data H
Meclizine hydrochloride tablets, USP are available in the following strengths and package sizes: 12.5 mg (Blue, oval shaped tablets, debossed with “TL 122” with score on one side and plain on the other side.) Bottles of 30 NDC 70934-695-30 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] . Dispense in a tight, light-resistant container (USP).
Abbreviated New Drug Application
MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 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 RX ONLY 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). DOSAGE FORMS AND STRENGTHS Tablets: 12.5 mg, and 25 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 JUBILANT CADISTA PHARMACEUTICALS INC. AT 1-800313-4623 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: 7/2019 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage 2.2 Прочетете целия документ