Eldepryl

What Is Eldepryl?

Eldepryl (selegiline hydrochloride) is a monoamine oxidase type B (MAO-B) inhibitor prescribed for the management of the symptoms of Parkinson's disease in patients already taking levodopa-carbidopa (also a drug prescribed for the treatment of Parkinson's disease).

What Are Side Effects of Eldepryl?

Side effects of Eldepryl include:

• fainting,
• dry mouth,
• nausea,
• vomiting,
• heartburn,
• diarrhea,
• gas,
• constipation,
• dizziness,
• weakness,
• sleep problems (insomnia),
• runny or stuffy nose,
• back pain,
• mouth sores or ulcers, or
• pain with swallowing (while using Zelapar)

Dosage for Eldepryl

Eldepryl is available in 5mg capsules. The recommended regimen for the administration Eldepryl is 10 mg per day administered as divided doses of 5 mg each taken at breakfast and lunch.

What Drugs, Substances, or Supplements Interact with Eldepryl?

Eldepryl may interact with carbamazepine, diet pills or cold medicines that contain ephedrine, pseudoephedrine, or phenylephrine, nafcillin, phenobarbital, rifampin, or antidepressants. Tell your doctor all medications and supplements you use.

Eldepryl During Pregnancy or Breastfeeding

There are no adequate and well-controlled studies of Eldepryl in pregnant women or in the pediatric population. Selegiline should be used during pregnancy only is the potential benefit justifies the potential risk to the fetus. It is not known selegiline hydrochloride is excreted in human milk.

Additional Information

Our Eldepryl (selegiline hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Eldepryl Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• trouble breathing;
• confusion, hallucinations, unusual thoughts or behavior;
• increased tremors or uncontrolled muscle movements;
• worsening side effects of your other medications;
• high levels of serotonin in the body (when taken with an antidepressant)--agitation, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; or
• dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nausea, vomiting, severe chest pain, shortness of breath, pounding heartbeats, or seizure (convulsions).

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common side effects may include:

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Eldepryl (Selegiline Hcl)

 

Eldepryl Professional Information

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.

INCIDENCE OF TREATMENT-EMERGENT ADVERSE EXPERIENCES IN THE PLACEBO-CONTROLLED CLINICAL TRIAL

Adverse Event	Number of Patients Reporting Events
	selegiline hydrochloride N=49	placebo N=50
Nausea	10	3
Dizziness/Lightheaded/Fainting	7	1
Abdominal Pain	4	2
Confusion	3	0
Hallucinations	3	1
Dry mouth	3	1
Vivid Dreams	2	0
Dyskinesias	2	5
Headache	2	1
The following events were reported once in either or both groups
Ache, generalized	1	0
Anxiety/Tension	1	1
Anemia	0	1
Diarrhea	1	0
Hair Loss	0	1
Insomnia	1	1
Lethargy	1	0
Leg pain	1	0
Low back pain	1	0
Malaise	0	1
Palpitations	1	0
Urinary Retention	1	0
Weight Loss	1	0

In all prospectively monitored clinical investigations, enrolling approximately 920 patients, the following adverse events, classified by body system, were reported.

Central Nervous System

Motor/Coordination/Extrapyramidal

increased tremor, chorea, loss of balance, restlessness, blepharospasm, increased bradykinesia, facial grimace, falling down, heavy leg, muscle twitch*, myoclonic jerks*, stiff neck, tardive dyskinesia, dystonic symptoms, dyskinesia, involuntary movements, freezing, festination, increased apraxia, muscle cramps.

Mental Status/Behavioral/Psychiatric

hallucinations, dizziness, confusion, anxiety, depression, drowsiness, behavior/mood change, dreams/nightmares, tiredness, delusions, disorientation, lightheadedness, impaired memory*, increased energy*, transient high*, hollow feeling, lethargy/malaise, apathy, overstimulation, vertigo, personality change, sleep disturbance, restlessness, weakness, transient irritability.

Pain/Altered Sensation

headache, back pain, leg pain, tinnitus, migraine, supraorbital pain, throat burning, generalized ache, chills, numbness of toes/fingers, taste disturbance.

Autonomic Nervous System

dry mouth, blurred vision, sexual dysfunction.

Cardiovascular

orthostatic hypotension, hypertension, arrhythmia, palpitations, new or increased angina pectoris, hypotension, tachycardia, peripheral edema, sinus bradycardia, syncope.

Gastrointestinal

nausea/vomiting, constipation, weight loss, anorexia, poor appetite, dysphagia, diarrhea, heartburn, rectal bleeding, bruxism*, gastrointestinal bleeding (exacerbation of preexisting ulcer disease).

Genitourinary/Gynecologic/Endocrine

slow urination, transient anorgasmia*, nocturia, prostatic hypertrophy, urinary hesitancy, urinary retention, decreased penile sensation*, urinary frequency.

Skin and Appendages

increased sweating, diaphoresis, facial hair, hair loss, hematoma, rash, photosensitivity.

Miscellaneous

asthma, diplopia, shortness of breath, speech affected.

Postmarketing Reports

The following experiences were described in spontaneous post-marketing reports. These reports do not provide sufficient information to establish a clear causal relationship with the use of ELDEPRYL (selegiline hcl) .

CNS

Seizure in dialyzed chronic renal failure patient on concomitant medications.

* indicates events reported only at doses greater than 10 mg/day.

Read the entire FDA prescribing information for Eldepryl (Selegiline Hcl)