DESLORATADINE tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

DESLORATADINE (UNII: FVF865388R) (DESLORATADINE - UNII:FVF865388R)

제공처:

Bionpharma Inc.

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older. Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older. Desloratadine tablets are indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older. Desloratadine tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [see Warnings and Precautions (5.1) and Adverse Reactions ( 6.2)]. Risk Summary The limited available data with desloratadine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are no adequate and well-controlled studies in pregnant women. Desloratadine given during organogenesis to pregnant rats was

제품 요약:

Desloratadine Tablets, USP: Light blue colored, film coated, circular, biconvex tablets debossed with “D” on one side and plain on the other side are supplied as follows: Bottles of 100 NDC 69452-363-20, with a child-resistant closure. Bottles of 500 NDC 69452-363-30, with a child-resistant closure. Storage: Desloratadine Tablets, USP: Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Heat sensitive. Avoid exposure at or above 30°C (86°F). Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

DESLORATADINE- DESLORATADINE TABLET, FILM COATED
BIONPHARMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESLORATADINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DESLORATADINE
TABLETS.DESLORATADINE TABLETS FOR ORAL USEINITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
DESLORATADINE TABLETS ARE A HISTAMINE-1 (H1) RECEPTOR ANTAGONIST
INDICATED FOR: (1)
SEASONAL ALLERGIC RHINITIS: relief of nasal and non-nasal symptoms in
patients 12 years of age and
older. (1.1)
PERENNIAL ALLERGIC RHINITIS: relief of nasal and non-nasal symptoms in
patients 12 years of age and
older. (1.2)
CHRONIC IDIOPATHIC URTICARIA: symptomatic relief of pruritus,
reduction in the number of hives, and
size of hives in patients 12 years of age and older. (1.3)
DOSAGE AND ADMINISTRATION
ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OVER: (2)
Desloratadine tablets - one 5 mg tablet once daily.
DOSAGE FORMS AND STRENGTHS
Desloratadine tablets, USP - 5 mg (3)
CONTRAINDICATIONS
Hypersensitivity (4, 6.2)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions including rash, pruritus, urticaria, edema,
dyspnea, and anaphylaxis have
been reported. In such cases, stop desloratadine at once and consider
alternative treatments. (5.1)
ADVERSE REACTIONS
The most common adverse reactions (reported in ≥ 2% of adult and
adolescent patients with allergic
rhinitis and greater than placebo) were pharyngitis, dry mouth,
myalgia, fatigue, somnolence,
dysmenorrhea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BIONPHARMA INC. AT
1-888-235-BION OR
1-888-235-2466 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Renal impairment: dosage adjustment is recommended (2.5, 8.6, 12.3)
Hepatic impairment: dosage adjustment is recommended (2.5, 8.7, 12.3)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 11/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 SEASONAL ALLERGIC RHINITIS
1.2 PERE