eldepryl prescribing information

A reduction of 10 to 30% was achieved with the typical ELDEPRYL (selegiline hcl) capsules are available containing 5 mg of selegiline hydrochloride. Important information.

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.

The maximum concentrations of amphetamine and methamphetamine, however, are far below those ordinarily expected to produce clinically important effects.Single oral dose studies do not predict multiple dose kinetics, however, at steady state the peak plasma level of selegiline is 4 fold that obtained following a single dose. 2 0 obj This contraindication is often extended to other opioids. to predict the extent of MAO-B inhibition from steady state plasma levels. Serious drug interactions can occur when certain medicines are used together with Eldepryl. Rare cases of hypertensive reactions associated with ingestion of tyramine-containing foods have been reported in patients taking the recommended daily dose of selegiline. These effects may often be mitigated by reducing the dose of levodopa by approximately 10 - 30%. Estimates of systemic clearance of selegiline are not available. Two of its three principal metabolites, amphetamine and methamphetamine, have pharmacological actions of their own; they interfere with neuronal uptake and enhance release of several neurotransmitters (e.g., norepinephrine, dopamine, serotonin). In particular, patients should be urged to report, immediately, any severe headache or other atypical or unusual symptoms not previously experienced.You are encouraged to report negative side effects of prescription drugs to the FDA. In addition, one case of hypertensive crisis has been reported in a patient taking the recommended dose of selegiline and a sympathomimetic medication, ephedrine. Whether or not this mechanism or an alternative one actually accounts for the observed beneficial effects of adjunctive selegiline is unknown.Selegiline's benefit in Parkinson's disease has only been documented as an adjunct to levodopa/carbidopa. One index of relative importance, however, is whether or not a reaction caused treatment discontinuation. 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. 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 ELDEPRYL 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 (PROZAC) and non-selective MAOIs. Mylan manufactures ELDEPRYL®* (selegiline hydrochloride) capsules (Eldepryl) in strengths of 5 mg Whether or not it might be effective as a sole treatment is unknown, but past attempts to treat Parkinson's disease with non-selective MAOI monotherapy are reported to have been unsuccessful. * indicates events reported only at doses greater than 10 mg/day.No specific information is available about clinically significant overdoses with ELDEPRYL. In short, attention to the dose dependent nature of selegiline's selectivity is critical if it is to be used without elaborate restrictions being placed on diet and concomitant drug use although, as noted above, a few cases of hypertensive reactions have been reported at the recommended dose.

Each capsule contains 5 mg selegiline hydrochloride. It combines three medicines into one pill so you don't have to take so many pills daily. they do not provide the kind of information necessary to estimate the incidence of adverse events. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking ELDEPRYL.No specific laboratory tests are deemed essential for the management of patients on ELDEPRYL. Always check with your healthcare provider before taking any medications with Eldepryl (see Eldepryl Drug Interactions for more information… However, experience gained during selegiline's development reveals that some individuals exposed to doses of 600 mg of d,l-selegiline suffered severe hypotension and psychomotor agitation.Since the selective inhibition of MAO-B by selegiline hydrochloride is achieved only at doses in the range recommended for the treatment of Parkinson's disease (e.g., 10 mg/day), overdoses are likely to cause significant inhibition of both MAO-A and MAO-B.