CLARINEX-D 12 HOUR Extended Release Tablets (desloratadine/pseudoephedrine sulfate)(三)
-D 12 HOUR Extended Release Tablets contain pseudoephedrine sulfate a sympathomimetic amine and therefore should be used with caution in patients with diabetes and hyperthyroidism. Also use with caution in patients with prostatic hypertrophy or increased intraocular pressure, as urinary retention and narrow angle glaucoma may occur [see CONTRAINDICATIONS (4)].
5.3 Co-Administration with Monoamine Oxidase (MAO) Inhibitors
CLARINEX-D 12 HOUR Extended Release Tablets should not be used in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment as an increase in blood pressure or hypertensive crisis, may occur [see CONTRAINDICATIONS (4) and DRUG INTERACTIONS (7.1)].
5.4 Hypersensitivity Reactions
Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of desloratadine a component of CLARINEX-D 12 HOUR Extended Release Tablets. If such a reaction occurs, therapy with CLARINEX-D 12 HOUR Extended Release Tablets should be stopped and alternative treatment should be considered [see POST-MARKETING (6.2)].
5.5 Renal Impairment
CLARINEX-D 12 HOUR Extended Release Tablets should generally be avoided in patients with renal impairment [see CLINICAL PHARMACOLOGY (12)].
5.6 Hepatic Impairment
CLARINEX-D 12 HOUR Extended Release Tablets should generally be avoided in patients with hepatic impairment [see CLINICAL PHARMACOLOGY (12)].
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:
Cardiovascular and Central Nervous System effects [see WARNINGS AND PRECAUTIONS (5.1)]
Increased Intraocular pressure [see WARNINGS AND PRECAUTIONS (5.2)]
Urinary retention in patients with prostatic hypertrophy [see WARNINGS AND PRECAUTIONS (5.2)]
Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS (5.4)].
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety data described below are from 2 clinical trials with CLARINEX-D 12 HOUR Extended Release Tablets that included 1248 patients with seasonal allergic rhinitis, of which 414 patients received CLARINEX-D 12 HOUR Extended Release Tablets twice daily for up to 2 weeks. The majority of patients were between 18 and <65 years of age with a mean age of 35.8 years and were predominantly women (64%). Patient ethnicity was 82 % Caucasian, 9% Black, 6 % Hispanic and 3% Asian/other ethnicity. The percentage of subjects receiving CLARINEX-D 12 HOUR Extended Release Tablets and who discontinued from the clinical trials because of an adverse event was 3.6%. Adverse reactions that were reported by ≥2% of subjects receiving CLARINEX-D 12 HOUR Extended Release Tablets are shown in Table 1.
TABLE 1: Incidence of Adverse Reactions Reported by ≥2% of Subjects Receiving CLARINEX-D 12 HOUR Extended Release Tablets
Adverse Reaction CLARINEX-D®
12 HOUR BID
(N = 414) Desloratadine
5 mg QD
(N = 412) Pseudoephedrine
120 mg BID
(N = 422)
Gastrointestinal Disorders
Mouth Dry 8% 2% 8%
Nausea 2% 1% 3%
General Disorders and A |
