DESLORATADINE- desloratadine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Desloratadine (UNII: FVF865388R) (Desloratadine - UNII:FVF865388R)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Desloratadine

Composition:

Desloratadine 0.5 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Desloratadine oral solution is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older. Desloratadine oral solution is indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 months of age and older. Desloratadine oral solution is indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 6 months of age and older. Desloratadine oral solution is 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

Product summary:

Desloratadine oral solution is a clear, pink to light pink colored solution with characteristic bubble gum odor containing 0.5 mg/mL desloratadine and is available in the following sizes: 4 fl oz (118 mL) NDC 51672-4159-8, 6 fl oz (177 mL) NDC 51672-4159-5, 8 fl oz (237 mL) NDC 51672-4159-1. Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESLORATADINE- DESLORATADINE SOLUTION
TARO PHARMACEUTICALS U.S.A., 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.
DESLORATADINE ORAL SOLUTION, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Dosage and Administration (2)
04/2014
Contraindications (4)
04/2014
INDICATIONS AND USAGE
DESLORATADINE ORAL SOLUTION IS AN H -RECEPTOR ANTAGONIST INDICATED
FOR:
SEASONAL ALLERGIC RHINITIS: relief of nasal and non-nasal symptoms in
patients 2 years of age and older. (1.1)
PERENNIAL ALLERGIC RHINITIS: relief of nasal and non-nasal symptoms in
patients 6 months 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 6 months of age and older. (1.3)
DOSAGE AND ADMINISTRATION
DOSAGE (BY AGE):
ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OVER:
2 teaspoonfuls (5 mg in 10 mL) once daily (2)
CHILDREN 6 TO 11 YEARS OF AGE:
1 teaspoonful (2.5 mg in 5 mL) once daily
CHILDREN 12 MONTHS TO 5 YEARS OF AGE:
½ teaspoonful (1.25 mg in 2.5 mL) once daily (2)
CHILDREN 6 TO 11 MONTHS OF AGE:
2 mL (1 mg) once daily (2)
DOSAGE FORMS AND STRENGTHS
Desloratadine Oral Solution - 0.5 mg/mL (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)
This product contains sodium metabisulfite, a sulfite that may cause
allergic-type reactions including anaphylactic
symptoms and life-threatening or less severe asthmatic episodes in
certain susceptible people. (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, dysmen