DESLORATADINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE

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)]. 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

Product summary:

Desloratadine Tablets: Debossed “5”, light blue, round tablets  Bottles of 90 (NDC 42291-240-90). Storage: Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESLORATADINE- DESLORATADINE TABLET
AVKARE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
DESLORATADINE TABLETS
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESLORATADINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DESLORATADINE.
DESLORATADINE (DESLORATADINE) TABLET 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 AVKARE, INC. AT
1-855-361-3993 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.
REVISED: 7/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 SEASONAL ALLERGIC RHINITIS
1.2 PERENNIAL ALLERGIC RHINITIS
1.3 CHRONIC IDIOPATHIC URTICARIA
2