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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

desloratadine (UNII: FVF865388R) (desloratadine - UNII:FVF865388R), pseudoephedrine sulfate (UNII: Y9DL7QPE6B) (pseudoephedrine - UNII:7CUC9DDI9F)

Available from:

Organon LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 Risk Summary The limited available data with CLARINEX-D 12 HOUR in pregnant wom

Product summary:

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 high-density polyethylene bottles of 100 (NDC 78206-120-01). 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.

Authorization status:

New Drug Application

Summary of Product characteristics

CLARINEX-D 12 HOUR- DESLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET,
EXTENDED RELEASE
ORGANON LLC
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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 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)
DOSAGE AND ADMINISTRATION
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)
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, 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.
DRUG INTERACTIONS
MONOAMINE OXIDASE (MAO) INHIBITORS: Do not use. May