CLARINEX-D 12 HOUR Extended Release Tablets (desloratadine/pseudoephedrine sulfate)(一)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CLARINEX-D ® 12 HOUR Extended Release Tablets safely and effectively. See full prescribing information for CLARINEX-D 12 HOUR Extended Release Tablets.
CLARINEX-D 12 HOUR Extended Release Tablets (desloratadine/pseudoephedrine sulfate) for oral use.
Initial U.S. Approval: 2005
INDICATIONS AND USAGE
CLARINEX-D 12 HOUR is a combination product containing an H1-receptor antagonist and a sympathomimetic amine 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)
DOSAGE AND ADMINISTRATION
For oral use only
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)
DOSAGE FORMS AND STRENGTHS
Desloratadine 2.5 mg/Pseudoephedrine sulfate 120 mg tablets. (3)
CONTRAINDICATIONS
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)
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).
ADVERSE REACTIONS
The most common adverse reactions (reported in ≥2% of patients) were insomnia, headache, mouth dry, fatigue, somnolence, pharyngitis, dizziness, nausea, insomnia and anorexia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Schering Corporation at 800-526-4099 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Monoamine Oxidase (MAO) Inhibitors: Do not use. May potentiate the effect of pseudoephedrine on vascular system. (7.1)
USE IN SPECIFIC POPULATIONS
Renal impairment: Avoid in patients with renal impairment (8.6)
Hepatic impairment: Avoid in patients with hepatic impairment (8.7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2010
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Seasonal Allergic Rhinitis
2 DOSAGE AND ADMINISTRATION
2.1 Adults and Adolescents 12 years of Age and Over
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Cardiovascular and Central Nervous System Effects
5.2 Coexisting Conditions
5.3 Co-Administration with Monoamine Oxidase (MAO) Inhibitors
5.4 Hypersensitivity Reactions
5.5 Renal Impairment
5.6 Hepatic Impairment
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
7.1 Monoamine Oxidase Inhibitors
7.2 Beta-adrenergic blocking agents
7.3 Digitalis
7.4 Inhibitors of cytochrome P450 3A4
7.5 Fluoxetine
7.6 Cimetidine
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
8.8 Gender
8.9 Race
9 DRUG ABUSE AND DEPENDENCE
10 OVERDOSAGE
10.1 Desloratadine
10.2 Sympathomimetics
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
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