Generic Name and Formulations:
Selegiline HCl 1.25mg; orally-disintegrating tabs; contains phenylalanine.
Valeant Pharmaceuticals, Inc
Indications for ZELAPAR:
Adjunct in Parkinson's disease in patients with deteriorating response to levodopa/carbidopa.
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.
<16yrs: not established.
During or within 2 weeks of meperidine, tramadol, methadone, propoxyphene, MAOIs (eg, other forms of selegiline). Concomitant St. John's wort, cyclobenzaprine, dextromethorphan.
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.
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.
Constipation, skin disorders, vomiting, dizziness, dyskinesia, insomnia, dyspnea, myalgia, rash; orthostatic hypotension (usually transient), hypertension, hallucinations, somnolence, irritation of the buccal mucosa.
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