DESLORATADINE tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Sun Pharmaceutical Industries, Inc.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Blue, circular, biconvex, film-coated tablets debossed with “5” on one side and plain on other side; that are packaged in high-density polyethylene plastic bottles: Bottle of 30’s with child Resistant Cap ………………………… NDC 62756-523-83 Bottle of 100’s with child Resistant Cap ……………………….. NDC 62756-523-88 Bottle of 100’s with Non child Resistant Cap……………………NDC 62756-523-08 Bottle of 500’s with Non child Resistant Cap……………………NDC 62756-523-13 Bottle of 1000’s with Non child Resistant Cap ………………… NDC 62756-523-18 Storage:   Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°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.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DESLORATADINE - DESLORATADINE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESLORATADINE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR DESLORATADINE TABLETS.
DESLORATADINE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
DESLORATADINE IS 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
Dosage (by age): (2)
Adults and Adolescents 12 Years of Age and Over: (2)
Desloratadine tablets - one 5 mg tablet once daily
DOSAGE FORMS AND STRENGTHS
Desloratadine tablets - 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 SUN PHARMACEUTICAL
INDUSTRIES, INC. AT 1-800-818-
4555 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: 5/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Seasonal Alle