DESLORATADINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

DESLORATADINE

Composition:

DESLORATADINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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) ]. Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, desloratadine should be used during pregnancy only if clearly needed. Desloratadine was not teratogenic in rats or rabbits at a

Product summary:

Desloratadine Tablets: Debossed "5", light blue, round tablets that are packaged in high-density polyethylene plastic bottles of 30 (NDC 76439-107-30), 100 (NDC 76439-0107-10) and 500 (NDC 76439-107-50). Storage:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESLORATADINE- DESLORATADINE TABLET
BRYANT RANCH PREPACK
----------
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 USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Desloratadine Tablets are indicated for:
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 Tablets 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 VIRTUS PHARMACEUTICALS
AT 813-283-1344 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: 6/2012
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Seasonal Allergic Rhinitis
1.2 Perennial Allergic Rhinitis
1.3 Chronic Idiop