DESLORATADINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

DESLORATADINE

Composition:

DESLORATADINE 5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESLORATADINE- DESLORATADINE TABLET
SANDOZ 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 USE
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Contraindications (4) 04/2014
INDICATIONS AND USAGE
DESLORATADINE TABLETS IS AN H -RECEPTOR ANTAGONIST INDICATED FOR:
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•
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DOSAGE AND ADMINISTRATION
DOSAGE (BY AGE): (2)
ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OVER: (2)
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ, INC., AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 OR www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Seasonal Allergic Rhinitis
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)
Desloratadine tablets - one 5 mg tablet once daily
Desloratadine Tablets - 5 mg (3)
Hypersensitivity (4, 6.2)
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)
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)
Renal impairment: dosage adjustment is recommended (2.5, 8.6, 12.3)
Hepatic impairment: dosage adjustment is recommended