Country: United States
Language: English
Source: NLM (National Library of Medicine)
DESLORATADINE (UNII: FVF865388R) (DESLORATADINE - UNII:FVF865388R), PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)
Physicians Total Care, Inc.
DESLORATADINE
DESLORATADINE 2.5 mg
ORAL
PRESCRIPTION DRUG
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)] . 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 Pregnancy Category C: There are no adequate and well-controlled stu
CLARINEX-D 12 HOUR Extended Release Tablets are oval-shaped, blue and white bilayer tablets with "D12" embossed in the blue layer, containing 2.5 mg desloratadine in the blue immediate-release layer and 120 mg of pseudoephedrine sulfate USP in the white extended-release layer. CLARINEX-D 12 HOUR Extended Release Tablets are supplied in Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Avoid exposure at or above 30°C (86°F). Protect from excessive moisture. Protect from light.
New Drug Application
CLARINEX-D 12 HOUR - DESLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, EXTENDED RELEASE PHYSICIANS TOTAL CARE, INC. ---------- 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 T ABLE TS. 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 ef Read the complete document