Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)
Proficient Rx LP
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 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data Epidemiological studies
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”. Bottles of 10 NDC 71205-647-10 Bottles of 20 NDC 71205-647-20 Bottles of 30 NDC 71205-647-30 Bottles of 60 NDC 71205-647-60 Bottles of 90 NDC 71205-647-90 Store at 20o C to 25o C (68o F to 77o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).
New Drug Application Authorized Generic
MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET PROFICIENT RX LP ---------- 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 • • • DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS Meclizine hydrochloride is contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients. (4) WARNINGS AND PRECAUTIONS • • 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 • • SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 3/2022 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage 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). Tablets: 12.5 mg, 25 mg, and 50 mg (3). Chewable Tablets: 25 mg (3). 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). Coadministration of meclizine hydrochloride with other CNS depressants, including alcohol, may result in increased CNS depression (7.1). CYP2D6 inhibitors: As mecliz Przeczytaj cały dokument