AERIUS

1 Dosing Considerations • In the case of severe hepatic or renal insufficiency, AERIUS should be used with caution. 2 Recommended Dose and Dosage Adjustment • Aerius® (desloratadine USP 5 mg) Adults and children (12 years of age and older): One AERIUS (desloratadine) 5 mg tablet daily regardless of mealtime.

5 mg) AERIUS KIDS syrup once a day, regardless of mealtime. 25 mg) AERIUS KIDS syrup once a day, regardless of mealtime. Do not administer AERIUS KIDS to children between 2 to 12 years of age for longer than 14 days unless recommended by a physician.

2 Recommended Dose and Dosage Adjustment. 4 Missed Dose If you miss taking your dose on time, do not worry; take your dose when you remember. Do not exceed more than one dose in 24 hours.

1 Adverse Reaction Overview No clinically relevant drug-related adverse effects including cardiovascular effects were observed with AERIUS in clinical trials. Very rare cases of hypersensitivity reactions including anaphylaxis and rash have been reported during the marketing of desloratadine.

In addition, cases of tachycardia, palpitations, psychomotor hyperactivity, seizures, elevations of liver enzymes, hepatitis, increased bilirubin, and increased appetite have been reported very rarely. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 5 mg/mL Page 8 of 40 patients who received placebo in multiple-dose clinical trials evaluating the treatment of seasonal and allergic rhinitis and chronic idiopathic urticaria.

The type and frequency of undesirable effects reported throughout the AERIUS allergic rhinitis and chronic idiopathic urticaria (CIU) clinical trials were comparable to those reported with placebo. At the recommended dose of 5 mg daily, undesirable effects with AERIUS were reported in only 3% of patients in excess of those treated with placebo.

No excess incidence of somnolence was reported in patients treated with AERIUS. 6% of patients in excess of those treated with placebo. The incidence of treatment-related adverse events reported by  1% of subjects treated with AERIUS 5 mg in multiple-dose clinical trials is presented in Table 2.

0 mg n = 1866 (%) Placebo n = 1857 (%) No. 9) a: Number of subjects reporting related adverse events at least once during the study. Some subjects may have reported more than one adverse event. b: Considered by the investigator to be possibly or probably related to treatment.

Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. 4 times higher than healthy subjects (n=8); however, these findings are not considered to be clinically relevant. Desloratadine 5mg was administered for 10 days to subjects with normal hepatic function (n=9) or moderate dysfunction (n=11).

Subjects with hepatic dysfunction could experience a 3-fold increase in exposure (AUC) to desloratadine, but these findings are not considered to be clinically relevant. 3 Pharmacokinetics / Hepatic Dysfunction). Neurologic Desloratadine should be administered with caution in patients with a medical or family history of seizures.

In particular, young children may be more susceptible to developing new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment. 5 fold increases in desloratadine mean AUC with minimal change in 3-hydroxy desloratadine concentrations.

3 Pharmacokinetics / Renal Dysfunction). In the case of severe renal insufficiency, AERIUS should be used with caution. 2 Study Results / Efficacy in Seasonal Allergic Rhinitis: Patients with SAR and Concomitant Mild to Moderate Asthma).

2 Pharmacodynamics / Asthmatics). 1 Pregnant Women Since no clinical data on exposed pregnancies are available with desloratadine, the safe use of AERIUS during pregnancy has not been established. The use of AERIUS during pregnancy is therefore not recommended.

No overall effect on rat fertility was observed with desloratadine at an exposure that was 34 times higher than the exposure in humans at the recommended clinical dose. No teratogenic or mutagenic effects were observed in animal trials with desloratadine (see 16 NON-CLINICAL TOXICOLOGY).

2 Breast-feeding Desloratadine passes into breast milk; therefore, breast-feeding is not recommended in lactating women taking AERIUS. 3 Pediatrics (Tablets <12 years of age) and (Syrup < 2 years): The efficacy and safety of AERIUS Tablets in children under 12 years of age and of AERIUS Syrup in children under 2 years of age have not been established.

• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.