The Following Letter was Disseminated in December, 1996 to Health Care Professionals and Announces Amplified Labeling for Eldepryl® Capsules.
Somerset Pharmaceuticals, Inc. ("Somerset") manufactures and markets Eldepryl® Capsules, 5mg (selegiline hydrochloride) for use as adjunctive therapy in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy.
Somerset calls to your attention new safety information that has recently been included in the Clinical Pharmacology, Warnings, Information for Patients and Precautions sections of the Eldepryl® product labeling. The revised labeling notes that, although rare, a few reports of hypertensive reactions have occurred in patients receiving Eldepryl® at the recommended dose (5mg bid) associated with ingestion of tyramine containing foods. To date, two reports have been received. One additional case of a hypertensive reaction has been reported in a patient on the recommended dose selegiline treated with levodopa plus carbidopa, lisuride, maprotiline, theophylline and a concomitant sympathomimetic medication, ephedrine. A more detailed description of this event can be found in Clinical Endocrinology, "Pseudo-phaeochromocytoma after multiple drug interactions involving the selective monoamine inhibitor selegiline," (1995) 42, 95-99. Although these reports are incomplete and do not constitute conclusive proof that the observed hypertension resulted from Eldepryl®, it is prudent to include this information with our labeling.
While hypertensive events are rarely encountered when the labeled Eldepryl® dose regimen is employed, these risks significantly increase when patients are exposed to higher doses. Accordingly, careful monitoring is required for patients who are prescribed Eldepryl® in doses exceeding 10 mg per day and for those patients who are transferred from one selegiline preparation to another.
For your convenience, Somerset has enclosed the revised labeling for Eldepryl® Capsules.
Sincerely,
Cheryl D. Blume, Ph.D.
Executive Vice President
and Chief Operations Officer
The Following Letter was Disseminated in May, 1996 to Health Care Professionals and Announced the Introduction and Launch of New Eldepryl® Capsules
Somerset Pharmaceuticals, Inc. is pleased to announce that Eldepryl® (selegiline hydrochloride) is now available in easy-to-identify capsules, which will replace the tablet form. The new aquamarine capsules are imprinted with "Somerset", "Eldepryl®," and "5mg" to help ensure that patients are receiving their proper anti-Parkinson's medication.
Because Eldepryl Capsules contain the same trusted formulation, in the same dosage strength, no dosage adjustment is needed. The recommended dosage and instructions for use remain the same: 10mg per day, in two doses of 5mg each, taken at breakfast and lunch. Please alert your Parkinson's disease patients that Eldepryl will look different in capsule form but contains the same trusted medication.
For further information about Eldepryl® (selegiline hydrochloride) or the many educational services that Somerset Pharmaceuticals, Inc. provides, please call Somerset Professional Services at 1-800-892-8889.
Sincerely yours,
Cheryl Blume, Ph.D.
Executive Vice President