DESLORATADINE tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr. Reddy's Laboratories Limited

INN (International Name):

Desloratadine

Composition:

Desloratadine 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Desloratadine orally disintegrating tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older. Desloratadine orally disintegrating tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 months of age and older. Desloratadine orally disintegrating 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) ] Risk Summary The limited available data with desloratadine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are no adequate and well-controlled studies in pregnant women. Desloratadine given during organogenesis to pregnant rats was not teratogenic at the summed area under the concentration-time curve (AUC)-based exposures of desloratadine and its metabo

Product summary:

Desloratadine Orally Disintegrating Tablets 2.5 mg: Desloratadine tablets 2.5 mg are light red colored, speckled, round, flat, uncoated, beveled edged debossed with “R” on one side and “551” on the other side and are supplied in carton of 5 packs containing 6 tablets each. Carton of 5 packs (NDC 55111-551-31), each pack containing 6 tablets (55111-551-06) Desloratadine Orally Disintegrating Tablets 5 mg: Desloratadine tablets 5 mg are light red colored, speckled, round, flat, uncoated, beveled edged debossed with “RDY” on one side and “360” on the other side and are supplied in carton of 5 packs containing 6 tablets each. Carton of 5 packs (NDC 55111-360-31), each pack containing 6 tablets (55111-360-06) Storage: Store orally disintegrating tablets at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESLORATADINE- DESLORATADINE TABLET, ORALLY DISINTEGRATING
DR. REDDY'S LABORATORIES LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESLORATADINE ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR DESLORATADINE
ORALLY DISINTEGRATING TABLETS
DESLORATADINE ORALLY DISINTEGRATING TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
DESLORATADINE IS A HISTAMINE-1 (H1) 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)
DOSAGE AND ADMINISTRATION
DOSAGE (BY AGE):
ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OVER:
Desloratadine orally disintegrating tablets - one 5 mg tablet once
daily (2)
CHILDREN 6 TO 11 YEARS OF AGE:
Desloratadine orally disintegrating tablets - one 2.5 mg tablet once
daily (2)
DOSAGE FORMS AND STRENGTHS
Desloratadine orally-disintegrating tablets - 5 mg (3)
Desloratadine orally-disintegrating tablets - 2.5 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 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 DR. REDDY’S
LABORATORIES INC., AT 1-888-375-3784 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-APPRO