CLARINEX-D 12 HOUR Extended Release Tablets (desloratadine/pseudoephedrine sulfate)(二)
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Seasonal Allergic Rhinitis
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Cardiovascular and Central Nervous System Effects
17.2 Dosing
17.3 Additional Antihistamines and/or Decongestants
17.4 Monoamine Oxidase (MAO) Inhibitors
17.5 Coexisting Conditions
17.6 Instructions for Use
* Sections or subsections omitted from the full prescribing information are not listed.
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 POST-MARKETING EXPERIENCE (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
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