Important Prescribing Information

Dear Doctor:

Schering announces the introduction of new oval-shaped CLARITIN-D 24 HOUR (10 mg loratadine/240 mg pseudoephedrine sulfate, USP) Extended Release Tablets to replace the existing round-shaped CLARITIN-D 24 HOUR Extended Release Tablets. This conversion will occur immediately and will coincide with the discontinuation of the current tablet.

Associated with the current round CLARITIN-D 24 HOUR, there have been postmarketing reports of mechanical upper gastrointestinal tract and esophageal/pharyngeal obstruction. In many of these cases, patients have required endoscopy to remove the tablet, and two of these patients have experienced esophageal perforation. Although some of these patients have had prior swallowing difficulties, most events have occurred in patients with no prior history. Therefore, swallowing difficulties cannot always be predicted.

As a result, a new oval-shaped CLARITIN-D 24 HOUR tablet will be made available immediately to replace this round-shaped tablet. The new oval-shaped tablet is similar to that of a variety of other medications which have been safely marketed worldwide.

The new product will include the following labeling:

PRECAUTIONS: General: Because there have been reports of esophageal obstruction and perforation in patients who have taken a previously marketed formulation of CLARITIN-D 24 HOUR Extended Release Tablets, it is recommended that patients who have a history of difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal esophageal peristalsis not use this product. Furthermore, since it is not known whether this formulation of CLARITIN-D 24 HOUR Extended Release Tablets has the potential for this adverse event, it is reasonable to recommend that all patients take this product with a full glass of water.

ADVERSE REACTIONS: There have been postmarketing reports of mechanical upper gastrointestinal tract obstruction and esophageal perforation in patients taking a previously marketed formulation of CLARITIN-D 24 HOUR Extended Release Tablets. In some, but not all, of these cases, patients have had known upper gastrointestinal narrowing or abnormal esophageal peristalsis. It is not known whether this reformulation of CLARITIN-D 24 HOUR Extended Release Tablets has the potential for this adverse event.

DOSAGE AND ADMINISTRATION: Adults and children 12 years of age and over: one tablet daily taken with a full glass of water.

Your Schering sales representative will make available to you sample packages of the new oval-shaped CLARITIN-D 24 HOUR (10 mg loratidine/240 mg pseudoephedrine sulfate, USP) Extended Release Tablets that you can provide to patients that you believe should not continue to use their current supply of the round-shaped CLARITIN-D 24 HOUR tablet.

You can further our understanding of adverse events by reporting all cases to Schering at 1-800-526-4099 or to the FDA MedWatch program by phone 1-800-FDA-1088, by FAX at 1-800-FDA-0178, or by mail:

Additional questions concerning either the new or current CLARITIN-D 24 HOUR tablets should be directed to Schering's Drug Information Services at 1-800-526-4099.

Please see enclosed full Prescribing Information.

Sincerely,

Richard Lorber, MD
Senior Director, Clinical Research, Allergy

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