Desloratadine

Desloratadine Tablets are a histamine-1 (H1) receptor antagonist indicated for: • 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 ) 1.1 Seasonal Allergic Rhinitis 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 may be taken without regard to meals
• Dosage (by age): Adults and Adolescents 12 Years of Age and Over: • Desloratadine Tablets - one 5 mg tablet once daily
• Adults and Adolescents 12 Years of Age and Over The recommended dose of Desloratadine Tablets is one 5-mg tablet once daily
• Adults with Hepatic or Renal Impairment In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data
• Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [ see Clinical Pharmacology ]

Desloratadine Tablets are light blue round tablets debossed with "5" containing 5 mg desloratadine. • Desloratadine Tablets - 5 mg ( 3 )

• The recommended dose of Desloratadine Oral Solution in the pediatric population is based on cross-study comparison of the plasma concentration of Desloratadine
• In adults and pediatric subjects
• The safety of Desloratadine Oral Solution has been established in 246 pediatric subjects aged 6 months to 11 years in three placebo-controlled clinical studies. …

Clinical studies of desloratadine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences between the elderly and younger patients. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Information for Patients • Patients should be instructed to use Desloratadine Tablets as directed. • As there are no food effects on bioavailability, patients can be instructed that Desloratadine Tablets may be taken without regard to meals. • Patients should be advised not to increase the dose or dosing frequency as studies have not demonstrated increased effectiveness at higher doses and somnolence may occur

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) ]. • Hypersensitivity ( 4 , 6.2 )

7.1 Inhibitors of Cytochrome P450 3A4 In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [ See Clinical Pharmacology (12.3) .] 7.2 Fluoxetine In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. …

• 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 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of desloratadine. If such a reaction occurs, therapy with Desloratadine Tablets should be stopped and alternative treatment should be considered. [ See Adverse Reactions (6.2) .]

The following adverse reactions are discussed in greater detail in other sections of the label: • Hypersensitivity reactions. [ See Warnings and Precautions (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 ) To report SUSPECTED ADVERSE REACTIONS, contact Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy 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. …

In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis. Information regarding acute overdosage is limited to experience from post-marketing adverse event reports and from clinical trials conducted during the development of the Desloratadine product. In a dose-ranging trial, at doses of 10 mg and 20 mg/day somnolence was reported. …

There is no information to indicate that abuse or dependency occurs with Desloratadine Tablets.

Storage • Desloratadine Tablets: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Heat sensitive. Avoid exposure at or above 30°C (86°F). …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.