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warnings and cautions
5 WARNINGS 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 24 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 24 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 24 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 or narrow-angle glaucoma may occur [see Contraindications (4) ]. 5.3 Co-Administration with Monoamine Oxidase (MAO) Inhibitors CLARINEX-D 24 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 24 HOUR Extended Release Tablets. If such a reaction occurs, therapy with CLARINEX-D 24 HOUR Extended Release Tablets should be stopped and alternative treatment should be considered [see Adverse Reactions (6.2) ]. 5.5 Renal Impairment CLARINEX-D 24 HOUR Extended Release Tablets should generally be avoided in patients with renal impairment [see Clinical Pharmacology (12.3) ]. 5.6 Hepatic Impairment CLARINEX-D 24 HOUR Extended Release Tablets should generally be avoided in patients with hepatic impairment [ see Clinical Pharmacology (12.3) ].
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) ]. Severe Skin Reactions The most common adverse reactions (reported in ≥2% of patients) were mouth dry, headache, insomnia, fatigue, pharyngitis, somnolence, nausea, dizziness, nervousness, psychomotor hyperactivity and anorexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 24 HOUR Extended Release Tablets that included 2852 patients, of which 708 patients received CLARINEX-D 24 HOUR Extended Release Tablets daily for up to 15 days. The majority of patients were between 18 and <65 years of age with a mean age of 34.3 years and were predominantly women (63%). Patient ethnicity was 79 % Caucasian, 10% Black, 8 % Hispanic and 3% Asian/other ethnicity. The percentage of subjects receiving CLARINEX-D 24 HOUR Extended Release Tablets, and who discontinued from the clinical trials because of an adverse event was 3.4%. Adverse reactions that were reported by ≥ 2% of subjects receiving CLARINEX-D 24 HOUR Extended Release Tablets are shown in Table 1 . Table 1: Incidence of Adverse Reactions Reported by ≥2% of Subjects Receiving CLARINEX-D 24 HOUR Extended Release Tablets Adverse Reaction CLARINEX-D 24 HOUR (N=708) Desloratadine 5 mg (N=712) Pseudoephedrine 240 mg (N=719) Gastrointestinal Disorders Mouth Dry 8% 2% 11% Nausea 2% 1% 3% Anorexia 2% 0% 2% General Disorders and Administration Site Conditions Fatigue 3% 3% 2% Nervous System Disorders Headache 6% 5% 7% Somnolence 3% 2% 3% Dizziness 2% 1% 2% Psychomotor hyperactivity 2% 0% 2% Psychiatric Disorders Insomnia 5% 1% 8% Nervousness 2% 1% 1% Respiratory, Thoracic and Mediastinal Disorders Pharyngitis 3% 2% 3% There were no relevant differences in adverse reactions for subgroups of patients as defined by gender, age, or race. 6.2 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 24 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 24 HOUR Extended Release Tablets include: Cardiac disorders: palpitations Immune system disorders: urticaria Skin and subcutaneous tissue disorders: pruritus In addition to these events, the following spontaneous adverse events have been reported during the marketing of desloratadine as a single ingredient product: Cardiac disorders: tachycardia Nervous system disorders: headache, somnolence, dizziness, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures (reported in patients with and without a known seizure disorder) Immune system disorders: hypersensitivity reactions (such as rash, edema, dyspnea, and anaphylaxis) Investigations: elevated liver enzymes including bilirubin Hepatobiliary disorders: hepatitis Metabolism and nutrition disorders: increased appetite Cases of severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing products.