CLARINEX-D 12 HOUR Extended Release Tablets (desloratadine/pseudoephedrine sulfate)(十三)
or each of the individual symptoms of nasal stuffiness/congestion and rhinorrhea. Each symptom was scored on a 4-point severity scale (0=none, 1=mild, 2=moderate, 3=severe). † Mean reduction in score averaged over the 2-week treatment period. ‡ The comparison of interest is shown bolded.
Total Symptom Score (Excluding Nasal Congestion)
CLARINEX-D 12 HOUR Extended Release Tablets BID
(199) 14.18
(0.21) -6.54 (-46.0)
(0.30) -
Pseudoephedrine tablet 120 mg BID
(197) 14.06
(0.21) -5.07 (-35.9)
(0.30) P<0.001
CLARINEX® 5 mg Tablets QD
(197) 14.82
(0.21) -5.09 (-33.5)
(0.30) P<0.001
Nasal Stuffiness/Congestion
CLARINEX-D 12 HOUR Extended Release Tablets BID
(199) 2.47
(0.027) -0.93 (-37.4)
(0.046) -
Pseudoephedrine tablet 120 mg BID
(197) 2.46
(0.027) -0.75 (-31.2)
(0.046) P=0.006
CLARINEX® 5 mg Tablets QD
(197) 2.50
(0.027) -0.66 (-26.7)
(0.046) P<0.001
There were no significant differences in the efficacy of CLARINEX-D 12 HOUR Extended Release Tablets across subgroups of subjects defined by gender, age, or race.
16 HOW SUPPLIED/STORAGE AND HANDLING
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
Bottles of 10
NDC 54868-5708-0
Bottles of 30
NDC 54868-5708-1
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.
17 PATIENT COUNSELING INFORMATION
[see FDA APPROVED PATIENT LABELING]
17.1 Cardiovascular and Central Nervous System Effects
Patients should be informed that pseudoephedrine, on of the active ingredients in CLARINEX-D 12 HOUR Extended Release Tablets may cause cardiovascular or central nervous system effects such as insomnia, dizziness, tremor, or arrhythmia.
17.2 Dosing
Patients should be advised not to increase the dose or dosing frequency of CLARINEX-D 12 HOUR Extended Release Tablets.
17.3 Additional Antihistamines and/or Decongestants
Patients should be advised against the concurrent use of CLARINEX-D 12 HOUR Extended Release Tablets with other antihistamines and/or decongestants.
17.4 Monoamine Oxidase (MAO) Inhibitors
Patients should be informed that due to its pseudoephedrine component, they should not use CLARINEX-D 12 HOUR with a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of an MAO inhibitor.
17.5 Coexisting Conditions
Patients with severe hypertension or severe coronary artery disease, narrow-angle glaucoma, or urinary retention should be advised not to use CLARINEX-D 12 HOUR Extended Release Tablets.
17.6 Instructions for Use
Patients should be instructed not to break, crush or chew the tablet; the tablet should be swallowed whole, and can be taken without regard to meals.
SPL UNCLASSIFIED SECTION
Manufactured by Schering Corporation, a subsidiary of Schering-Plough Corporation,
Kenilworth, NJ 07033 USA.
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