DESLORATADINE

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

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 desloratadine 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. The frequency of reasonably related undesirable effects is presented as the excess incidence in 1866 patients who received desloratadine 5 mg tablets compared to that seen in 1857 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 desloratadine 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 desloratadine 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 desloratadine. 6% of patients in excess of those treated with placebo. The incidence of treatment- related adverse events reported by  1% of subjects treated with Desloratadine 5 mg in multiple-dose clinical trials is presented in Table 2.

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 (Desloratadine Tablets) Page 6 of 33 Desloratadine 5 mg 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, Desloratadine 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 desloratadine during pregnancy has not been established. The use of Desloratadine 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 Desloratadine. 3 Pediatrics <12 years of age: The efficacy and safety of Desloratadine Tablets in children under 12 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.