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ZELAPAR
Parkinsonism
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Drug Name:

ZELAPAR Rx

Generic Name and Formulations:
Selegiline HCl 1.25mg; orally-disintegrating tabs; contains phenylalanine.

Company:
Valeant Pharmaceuticals, Inc

Therapeutic Use:

Indications for ZELAPAR:

Adjunct in Parkinson's disease in patients with deteriorating response to levodopa/carbidopa.

Adult:

Take (without liquids) in the AM before breakfast; do not eat/drink within 5 minutes (before or after). Place tablet on tongue, do not swallow. ≥16yrs: 1.25mg once daily for at least 6 weeks; if needed, may increase to max 2.5mg once daily if tolerated. Mild-to-moderate hepatic disease: reduce to 1.25mg once daily. Do not exceed max dose. Not bioequivalent to other forms of selegiline.

Children:

<16yrs: not established.

Contraindications:

During or within 2 weeks of meperidine, tramadol, methadone, propoxyphene, MAOIs (eg, other forms of selegiline). Concomitant St. John's wort, cyclobenzaprine, dextromethorphan.

Warnings/Precautions:

Severe hepatic (Child-Pugh score >9) or renal (CrCl<30mL/min) impairment, ESRD: not recommended. Monitor for new onset or exacerbation of hypertension. Monitor for somnolence; discontinue if daytime sleepiness or episodes of falling asleep develops. Psychosis. Impulse control/compulsive behaviors; consider dose reduction or discontinue if intense urges develop. Monitor for melanoma; perform periodic skin exams. Avoid abrupt cessation. Elderly (higher risk of orthostatic hypotension). Pregnancy (Cat.C). Nursing mothers.

Interactions:

See Contraindications. Avoid sympathomimetics. Risk of serotonin syndrome with concomitant antidepressants, SSRIs, SNRIs, MAOIs; allow at least 14 days after discontinuing selegiline before starting an SSRI (eg, fluoxetine), SNRI, tricyclic, tetracyclic, or triazolopyridine antidepressant; allow 5 weeks after discontinuing fluoxetine before starting selegiline. Caution with CYP3A4 inducers (eg, phenobarbital, phenytoin, carbamazepine, nafcillin, rifampin). May be antagonized by dopamine antagonists (eg, antipsychotics, metoclopramide). Consider reducing concomitant levodopa/carbidopa dose if dyskinesia occurs. Caution with tyramine-containing food or drink.

Pharmacological Class:

MAO-B inhibitor.

Adverse Reactions:

Constipation, skin disorders, vomiting, dizziness, dyskinesia, insomnia, dyspnea, myalgia, rash; orthostatic hypotension (usually transient), hypertension, hallucinations, somnolence, irritation of the buccal mucosa.

How Supplied:

Tabs—60

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