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Basic Drug Info
Drug Name:Selegiline Hydrochloride
Manufacturer:ALPHAPHARM PTY LTD.
Other Info:

NOTE: Because there is no recorded experience with selegiline overdose, the following suggestions are offered based upon the assumption that selegiline overdose may be modeled by non-selective MAOI poisoning.

In any case, up-to-date information about the treatment of overdose can often be obtained from a certified Regional Poison Control Center.

Telephone numbers of certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR).Treatment of overdose with non-selective MAOIs is symptomatic and supportive.

Induction of emesis or gastric lavage with instillation of charcoal slurry may be helpful in early poisoning, provided the airway has been protected against aspiration.

Signs and symptoms of central nervous system stimulation, including convulsions, should be treated with diazepam, given slowly intravenously.

Phenothiazine derivatives and central nervous system stimulants should be avoided.

Hypotension and vascular collapse should be treated with intravenous fluids and, if necessary, blood pressure titration with an intravenous infusion of a dilute pressor agent.

It should be noted that adrenergic agents may produce a markedly increased pressor response.

Respiration should be supported by appropriate measures, including management of the airyway, use of supplemental oxygen, and mechanical ventilatory assistance, as required.

Body temperature should be monitored closely.

Intensive management of hyperpyrexia may be required.

Maintenance of fluid and electrolyte balance is essential.



Clinical Trials:


Indications and Usage

Selegiline hydrochloride is indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy.

There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy.

Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa.

Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of ‘off’ time, and patient self-rating of treatment success.

Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).
AKINESIA --

Tremor -- Cyclical movement of a body part that can represent either a physiologic process or a manifestation of disease. Intention or action tremor, a common manifestation of CEREBELLAR DISEASES, is aggravated by movement. In contrast, resting tremor is maximal when there is no attempt at voluntary movement, and occurs as a relatively frequent manifestation of PARKINSON DISEASE.

Contraindications

Selegiline hydrochloride is contraindicated in patients with a known hypersensitivity to this drug.

Selegiline hydrochloride is contraindicated for use with meperidine.

This contraindication is often extended to other opioids.

(see PRECAUTIONS, Drug Interactions.)
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Selegiline should not be used at daily doses exceeding those recommended (10 mg/day) because of the risks associated with non-selective inhibition of MAO.

(see CLINICAL PHARMACOLOGY.)The selectivity of selegiline for MAO B may not be absolute even at the recommended daily dose of 10 mg a day.

Rare cases of hypertensive reactions associated with ingestion of tyramine-containing foods have been reported in patients taking the recommended daily dose of selegiline.

The selectivity is further diminished with increasing daily doses.

The precise dose at which selegiline becomes a non-selective inhibitor of all MAO is unknown, but may be in the range of 30 to 40 mg a day.

Severe CNS toxicity associated with hyperpyrexia and death have been reported with the combination of tricyclic antidepressants and non-selective MAOIs (Phenelzine, Tranylcypromine).

A similar reaction has been reported for a patient on amitriptyline and selegiline.

Another patient receiving protriptyline and selegiline developed tremors, agitation and restlessness followed by unresponsiveness and death two weeks after selegiline was added.

Related adverse events including hypertension, syncope, asystole, diaphoresis, seizures, changes in behavioral and mental status, and muscular rigidity have also been reported in some patients receiving selegiline and various tricyclic antidepressants.

Serious, sometimes fatal, reactions with signs and symptoms that may include hyperthermia, rigidity, myoclonus, autonomic instability with rapid fluctuations of the vital signs, and mental status changes that include extreme agitation progressing to delirium and coma have been reported with patients receiving a combination of fluoxetine hydrochloride and non-selective MAOIs.

Similar signs have been reported in some patients on the combination of selegiline (10 mg a day) and selective serotonin reuptake inhibitors including fluoxetine, sertraline and paroxetine.

Since the mechanisms of these reactions are not fully understood, it seems prudent, in general, to avoid this combination of selegiline and tricyclic antidepressants as well as selegiline and selective serotonin reuptake inhibitors.

At least 14 days should elapse between discontinuation of selegiline and initiation of treatment with a tricyclic antidepressant or selective serotonin reuptake inhibitors.

Because of the long half lives of fluoxetine and its active metabolite, at least five weeks (perhaps longer, especially if fluoxetine has been prescribed chronically and/or at higher doses) should elapse between discontinuation of fluoxetine and initiation of treatment with selegiline.
Branded Drugs
The following US Branded drugs contain Selegiline Hydrochloride


ELDEPRYL -- SOMERSET PHARMACEUTICALS INC

ZELAPAR -- VALEANT PHARMACEUTICALS INTERNATIONAL


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