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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.

Company: Schering-Plough
Approval Status: Approved August 1996
Treatment Area: nasal congestion

General Information

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 daily dose.

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.

Clinical Results

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

Side Effects

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.

Additional Information

It is estimated that 16 million of the 42 million Americans who suffer from seasonal allergic rhinitis also experience nasal congestion.