DESLORATADINE- desloratadine tablet, film coated
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
11-04-2019
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Active ingredient:
DESLORATADINE (UNII: FVF865388R) (DESLORATADINE - UNII:FVF865388R)
Available from:
Mylan Pharmaceuticals Inc.
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)] . 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 teratoge
Product summary:
Desloratadine Tablets, USP are available containing 5 mg of desloratadine, USP. The 5 mg tablets are red, film-coated, round, unscored tablets debossed with M on one side of the tablet and D17 on the other side. They are available as follows: NDC 0378-4017-01 bottles of 100 tablets NDC 0378-4017-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Heat sensitive. Avoid exposure at or above 30ºC (86ºF). Protect from moisture. 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, FILM COATED
MYLAN PHARMACEUTICALS 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
INDICATIONS AND USAGE
DESLORATADINE TABLETS ARE A HISTAMINE-1 (H1) RECEPTOR ANTAGONIST
INDICATED FOR:
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•
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DOSAGE AND ADMINISTRATION
DOSAGE (BY AGE):
ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OVER:
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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
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX), 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: 4/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Seasonal Allergic Rhinitis
1.2 Perennial Allergic Rhinitis
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.
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