June, 1998

IMPORTANT ALERT REGARDING PRESCRIPTION DISPENSING ERRORS

Glaxo Wellcome Inc. has received reports of prescription dispensing errors involving LAMICTAL (lamotrigine)Tablets and LAMISIL (terbinafine hydrochloride) Tablets. Lamictal, which is distributed by Glaxo Wellcome, has been marketed since 1995. Lamisil Tablets were introduced into the market in 1996 by Novartis Pharmaceuticals Corp., although Lamisil Cream has been commercially available for years. These reports involve dispensing Lamictal when Lamisil was prescribed and the reverse scenario.

Lamictal is an antiepileptic drug marketed as 25-, 100-, 150-, and 200-mg six-sided, shield-shaped tablets bearing "Lamictal" and the numeric representation of the strength (e.g., "Lamictal 150"). To initiate therapy with Lamictal, the dose is titrated over a period of several weeks. The usual adult maintenance dosage is 100 to 150 mg per day in two divided doses or 300 to 500 mg per day in two divided doses, depending on other concomitant antiepileptic drugs. Patients with epilepsy who do not receive Lamictal due to a dispensing error would be inadequately treated and could experience serious consequences. Conversely, patients erroneously receiving Lamictal would be unnecessarily subjected to a risk of potential side effects (including serious rash). This is especially true if patients received an initial high dose of Lamictal (see Prescribing Information for Lamictal, DOSAGE AND ADMINISTRATION section).

Lamisil is an antifungal drug marketed as 250-mg circular, biconvex, bevelled tablets bearing "Lamisil" on one side and "250" on the other side. The recommended dosage for Lamisil is one 250-mg tablet daily.

Please be alert for both written and oral prescriptions for Lamictal and Lamisil. If you become aware of a prescription dispensing error involving these products, please contact the appropriate manufacturer (Glaxo Wellcome Inc.: 1-800-334-4155; Novartis Pharmaceuticals Corp.: 1-888-669-6682) or the USP Medication Errors Reporting Program (1-800-233-7767). Thank you.

Sincerely,

R. Scott Sykes, MD
Vice President
North American Product Surveillance

PLEASE CONSULT COMPLETE PRESCRIBING INFORMATION FOR LAMICTAL ENCLOSED.

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