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Clarinex-D 12hr

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Clarinex-D 12hr

Side Effects
Interactions

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label:

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 Administration Site Conditions
Fatigue 4% 2% 2%
Metabolism and Nutrition Disorders
Anorexia 2% 0% 2%
Nervous System Disorders
Headache 8% 8% 9%
Somnolence 3% 4% 2%
Dizziness 3% 2% 2%
Psychiatric Disorders
Insomnia 10% 3% 13%
Respiratory, Thoracic, and Mediastinal Disorders
Pharyngitis 3% 3% 3%

There were no relevant differences in adverse reactions for subgroups of patients as defined by gender, age, or race.

Post-Marketing Experience

In addition to the adverse reactions reported during clinical trials and listed above, adverse events have been identified during post approval use of CLARINEX-D 12 HOUR Extended Release Tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse events identified from post-marketing surveillance on the use of CLARINEX-D 12 HOUR Extended Release Tablets include tachycardia, palpitations, dyspnea, rash and pruritus.

In addition to these events, the following spontaneous adverse events have been reported during the marketing of desloratadine as a single ingredient product: headache, somnolence, dizziness and rarely hypersensitivity reactions (such as urticaria, edema and anaphylaxis), psychomotor

hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures, and elevated liver enzymes including bilirubin and, very rarely, hepatitis.

Read the Clarinex-D 12hr (desloratadine and pseudoephedrine sulfate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

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

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 [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

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.

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.

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].

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 [see CLINICAL PHARMACOLOGY].

Cimetidine

In controlled clinical studies co-administration of desloratadine with cimetidine a histamine H2-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 [see CLINICAL PHARMACOLOGY].

Drug Abuse And Dependence

There is no information to indicate that abuse or dependency occurs with CLARINEX or CLARINEX-D 12 HOUR Extended Release Tablets.

Read the Clarinex-D 12hr Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 5/5/2014
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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