CLARINEX-D 12 HOUR is a combination product containing a histamine-1 (H1) receptor antagonist and an alpha adrenergic agonist indicated for:

• Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. (1.1)

CLARINEX-D^® 12 HOUR Extended Release Tablets is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. CLARINEX-D 12 HOUR Extended Release Tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant properties of pseudoephedrine are desired [see Clinical Pharmacology (12)].

Administer CLARINEX-D 12 HOUR Extended Release Tablet by the oral route only. Do not break, chew, or crush the tablet. Swallow the tablet whole.

For oral use only (2)

Adults and adolescents 12 years of age and over: The recommended dose of CLARINEX-D 12 HOUR Extended Release Tablets is one tablet twice a day. (2.1)

The recommended dose of CLARINEX-D 12 HOUR Extended Release Tablets is 1 tablet twice a day, administered approximately 12 hours apart and with or without a meal. Higher doses or increased dosing frequency of CLARINEX-D 12 HOUR Extended Release Tablets have not demonstrated increased effectiveness. Do not exceed the recommended dose as desloratadine and pseudoephedrine, the active components of CLARINEX-D 12 HOUR Extended Release Tablets have been associated with adverse effects at higher doses [see Overdosage (10.1) and (10.2)].

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)

• 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)

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.

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 [see Contraindications (4)].

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)].

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 Adverse Reactions (6.2)].

CLARINEX-D 12 HOUR Extended Release Tablets should generally be avoided in patients with renal impairment [see Clinical Pharmacology (12.3)].

CLARINEX-D 12 HOUR Extended Release Tablets should generally be avoided in patients with hepatic impairment [see Clinical Pharmacology (12.3)].

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 insomnia, headache, mouth dry, fatigue, somnolence, pharyngitis, dizziness, nausea, and anorexia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

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

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:
Cardiac disorders: tachycardia, palpitations
Respiratory, thoracic and mediastinal disorders: dyspnea
Skin and subcutaneous tissue disorders: rash, pruritus

In addition to these events, the following spontaneous adverse events have been reported during the marketing of desloratadine as a single ingredient product:
Nervous system disorders: headache, somnolence, dizziness, psychomotor hyperactivity, 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 urticaria, edema 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.