ELDEPRYL (Selegiline)

What is Eldepryl and how is it used?

Eldepryl is a prescription medicine used to treat the symptoms of Parkinson Disease. Eldepryl may be used alone or with other medications.

Eldepryl belongs to a class of drugs called Antiparkinson Agents, MAO Type B Inhibitors.

It is not known if Eldepryl is safe and effective in children.

What are the possible side effects of Eldepryl?

Eldepryl may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• lightheadedness,
• confusion,
• hallucinations,
• unusual thoughts or behavior,
• increased tremors,
• uncontrolled muscle movements,
• worsening side effects of your other medications,
• agitation,
• fever,
• fast heart rate,
• overactive reflexes,
• nausea,
• vomiting,
• diarrhea,
• loss of coordination,
• fainting,
• severe headache,
• blurred vision,
• pounding in your neck or ears,
• anxiety,
• severe chest pain,
• shortness of breath,
• pounding heartbeats,
• seizure,
• increased sexual urges, and
• unusual urges to gamble or other intense urges

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Eldepryl include:

• dizziness,
• nausea,
• stomach pain,
• constipation,
• skin rash or other irritation,
• sleep problems,
• mouth sores or ulcers, and
• pain with swallowing (while using selegiline orally disintegrating tablets),

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Eldepryl. For more information, ask your doctor or pharmacist.

DESCRIPTION

ELDEPRYL (selegiline hydrochloride) is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl.

The chemical name is: (R)-(-)-N,2-dimethyl-N-2-propynylphenethylamine hydrochloride. It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.75. The structural formula is as follows:

Each aqua blue capsule is band imprinted with the Somerset logo on the cap and “Eldepryl (selegiline hcl) 5 mg” on the body. Each capsule contains 5 mg selegiline hydrochloride. Inactive ingredients are citric acid, lactose, magnesium stearate, and microcrystalline cellulose.

DOSAGE AND ADMINISTRATION

ELDEPRYL (selegiline hcl) is intended for administration to Parkinsonian patients receiving levodopa/carbidopa therapy who demonstrate a deteriorating response to this treatment. The recommended regimen for the administration of ELDEPRYL (selegiline hcl) is 10 mg per day administered as divided doses of 5 mg each taken at breakfast and lunch. There is no evidence that additional benefit will be obtained from the administration of higher doses. Moreover, higher doses should ordinarily be avoided because of the increased risk of side effects.

After two to three days of selegiline treatment, an attempt may be made to reduce the dose of levodopa/carbidopa. A reduction of 10 to 30% was achieved with the typical participant in the domestic placebo controlled trials who was assigned to selegiline treatment. Further reductions of levodopa/carbidopa may be possible during continued selegiline therapy.

SIDE EFFECTS

Introduction

The number of patients who received selegiline in prospectively monitored pre-marketing studies is limited. While other sources of information about the use of selegiline are available (e.g., literature reports, foreign post-marketing reports, etc.) they do not provide the kind of information necessary to estimate the incidence of adverse events. Thus, overall incidence figures for adverse reactions associated with the use of selegiline cannot be provided. Many of the adverse reactions seen have also been reported as symptoms of dopamine excess.

Moreover, the importance and severity of various reactions reported often cannot be ascertained. One index of relative importance, however, is whether or not a reaction caused treatment discontinuation. In prospective pre-marketing studies, the following events led, in decreasing order of frequency, to discontinuation of treatment with selegiline: nausea, hallucinations, confusion, depression, loss of balance, insomnia, orthostatic hypotension, increased akinetic involuntary movements, agitation, arrhythmia, bradykinesia, chorea, delusions, hypertension, new or increased angina pectoris, and syncope. Events reported only once as a cause of discontinuation are ankle edema, anxiety, burning lips/mouth, constipation, drowsiness/lethargy, dystonia, excess perspiration, increased freezing, gastrointestinal bleeding, hair loss, increased tremor, nervousness, weakness, and weight loss.

Experience with ELDEPRYL (selegiline hcl) obtained in parallel, placebo controlled, randomized studies provides only a limited basis for estimates of adverse reaction rates. The following reactions that occurred with greater frequency among the 49 patients assigned to selegiline as compared to the 50 patients assigned to placebo in the only parallel, placebo controlled trial performed in patients with Parkinson’s disease are shown in the following Table. None of these adverse reactions led to a discontinuation of treatment.