CLARINEX-D 12 HOUR

CLARINEX-D 12 HOUR- desloratadine and pseudoephedrine sulfate tablet, extended release
Organon LLC

1 INDICATIONS AND USAGE

1.1 Seasonal Allergic Rhinitis

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)].

2 DOSAGE AND ADMINISTRATION

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.

2.1 Adults and Adolescents 12 years of Age and Over

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)].

3 DOSAGE FORMS AND STRENGTHS

CLARINEX-D 12 HOUR Extended Release Tablets are oval shaped, blue and white bilayer tablets with “D12” embossed in the blue layer. Each tablet contains 2.5 mg desloratadine in the blue immediate-release layer and 120 mg of pseudoephedrine sulfate USP in the white extended-release layer.

4 CONTRAINDICATIONS

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

5 WARNINGS AND PRECAUTIONS

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 [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 Adverse Reactions (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 (12.3)].

5.6 Hepatic Impairment

CLARINEX-D 12 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

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 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.