Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Pulmonary/Respiratory Diseases
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Claritin-D 24 Hour Extended Release Tablets (10 mg loratadine, 240 mg pseudoephedrine sulfate)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved August 1996
Treatment Area: nasal congestion
Claritin-D 24 Hour Extended Release Tablets (10 mg loratadine,
240 mg pseudoephedrine sulfate), a new once-daily formulation of
the widely prescribed nonsedating antihistamine/decongestant
combination Claritin-D (5 mg loratadine, 120 mg pseudoephedrine
sulfate), has been approved for marketing.
Available by prescription, Claritin-D 24 Hour provides relief of
nasal symptoms and congestion for a full 24-hour period with one
Claritin-D 24 Hour is indicated for the relief of seasonal
allergic rhinitis (hay fever) wit nasal congestion, a common
symptom among many allergy sufferers.
Claritin-D 24 Hour, which will be available nationwide by
prescription in early September, can be administered to adults and
children 12 years of age and older. The recommended dose is one
tablet, once daily.
In clinical trials, improvement in nasal and non-nasal symptoms
of seasonal allergic rhinitis including nasal congestion in
subjects receiving Claritin-D 24 Hour tablets was significantly
greater than in placebo recipients, and was generally greater than
with loratadine or pseudoephedrine sulfate alone
Insomnia is a common side effect of many drugs containing
pseudoephedrine. However, Claritin-D 24 Hour has a low incidence of
insomnia, occurring in only 5% of subjects. Other commonly reported
side effects using the recommended dose of Claritin-D 24 Hour
occurred as a rate similar to placebo and included sedation (6%)
and nervousness (3%). Dry mouth occurred in 8% of subjects.
It is estimated that 16 million of the 42 million Americans who
suffer from seasonal allergic rhinitis also experience nasal