DESLORATADINE tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Paddock Laboratories, LLC

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, FILM COATED
PADDOCK LABORATORIES, LLC
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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
INDICATIONS AND USAGE
DESLORATADINE TABLETS ARE INDICATED FOR: (1)
•
•
DOSAGE AND ADMINISTRATION
DOSAGE (BY AGE): (2)
ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OVER: (2)
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PERRIGO AT
1-866-634-9120 OR FDA AT 1-800-FDA-1088
OR www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 1/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 SEASONAL ALLERGIC RHINITIS
1.2 Perennial Allergic Rhinitis
2 DOSAGE AND ADMINISTRATION
2.1 Adults and adolescents 12 years of age and over
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)
DESLORATADINE TABLETS – ONE 5 MG TABLET ONCE DAILY
DESLORATADINE TABLETS – 5 MG (3)
HYPERSENSITIVITY (4, 6.2)
HYPERSENSITIVITY REACTIONS INCLUDING RASH, PRURITUS, URTICARIAL,
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 (2.5, 8.7, 12.3)
2.5 Adults with Hepatic or Renal Impairment
3