DESLORATADINE Drug Interactions: What You Need to Know

INTERACTIONS No specific interaction studies have been conducted with CLARINEX-D 12 HOUR Extended Release Tablets.

Monoamine

Oxidase (MAO) Inhibitors: Do not use. May potentiate the effect of pseudoephedrine on vascular system. ( 7.1 )

7.1 Monoamine Oxidase 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 because the action of pseudoephedrine a component of CLARINEX-D 12 HOUR Extended Release tablets on the vascular system may be potentiated by these agents <span class="opacity-50 text-xs">[see Contraindications (4) and Warnings and Precautions (5.3) ]</span>.

7.2 Beta-Adrenergic Blocking Agents The antihypertensive effects of beta-adrenergic blocking agents, methyldopa, and reserpine, may be reduced by sympathomimetics such as pseudoephedrine. Exercise caution when using CLARINEX-D 12 HOUR Extended Release Tablets with these agents.

7.3 Digitalis Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis. Exercise caution when using CLARINEX-D 12 HOUR Extended Release Tablets with these agents.

7.4 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 <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span>.

7.5 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 <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span>.

7.6 Cimetidine In controlled clinical studies co-administration of desloratadine with cimetidine a histamine H 2 -receptor antagonist resulted in increased plasma concentrations of desloratadine and 3-hydroxydesloratadine but there were no clinically relevant changes in the safety profile of desloratadine <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span>.

CLARINEX-D 12 HOUR Extended Release Tablets are contraindicated in: Patients with hypersensitivity to any of its ingredients, or to loratadine [see Warnings and Precautions (5.4) and Adverse Reactions (6.2) ] Patients with narrow-angle glaucoma Patients with urinary retention Patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment [see Drug Interactions (7.1) ] Patients with severe hypertension or severe coronary artery disease Hypersensitivity ( 4 ) Narrow-Angle Glaucoma ( 4 )

Urinary

Retention ( 4 )

Patients

Receiving MAO Inhibitors or within 14 days of stopping such treatment ( 4 ) Severe hypertension or severe coronary artery disease. ( 4 )

AND PRECAUTIONS Cardiovascular and central nervous system effects: Use with caution in patients with cardiovascular disorders. ( 5.1 ) Coexisting conditions: Use with caution in patients with increased intraocular pressure, prostatic hypertrophy, diabetes mellitus, or hyperthyroidism. ( 5.2 )

5.1 Cardiovascular and Central Nervous System Effects The pseudoephedrine sulfate contained in CLARINEX-D 12 HOUR Extended Release Tablets, like other sympathomimetic amines, can produce cardiovascular and central nervous system (CNS) effects in some patients such as insomnia, dizziness, weakness, tremor, or arrhythmias. In addition, central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension has been reported. Therefore, CLARINEX-D 12 HOUR Extended Release Tablets should be used with caution in patients with cardiovascular disorders, and should not be used in patients with severe hypertension or severe coronary artery disease.

5.2 Coexisting Conditions CLARINEX-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 <span class="opacity-50 text-xs">[see Contraindications (4) ]</span>.

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 <span class="opacity-50 text-xs">[see Contraindications (4) and Drug Interactions (7.1) ]</span>.

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 <span class="opacity-50 text-xs">[see Adverse Reactions (6.2) ]</span>.

5.5 Renal Impairment CLARINEX-D 12 HOUR Extended Release Tablets should generally be avoided in patients with renal impairment <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span>.

5.6 Hepatic Impairment CLARINEX-D 12 HOUR Extended Release Tablets should generally be avoided in patients with hepatic impairment <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span>.