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Zelapar Generic Name & Formulations
Legal Class
Rx
General Description
Selegiline HCl 1.25mg; orally-disintegrating tabs; contains phenylalanine.
Pharmacological Class
MAO-B inhibitor.
How Supplied
Tabs—60
Manufacturer
Zelapar Indications
Indications
Adjunct in Parkinson's disease in patients with deteriorating response to levodopa/carbidopa.
Zelapar Dosage and Administration
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.
Zelapar Contraindications
Contraindications
During or within 2 weeks of opioids (eg, meperidine, tramadol, methadone), MAOIs (including linezolid). Concomitant St. John's wort, cyclobenzaprine, dextromethorphan.
Zelapar Boxed Warnings
Not Applicable
Zelapar Warnings/Precautions
Warnings/Precautions
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. Avoid abrupt cessation. Phenylketonuria. Severe hepatic (Child-Pugh score >9) or renal (CrCl<30mL/min) impairment, ESRD: not recommended. Elderly (higher risk of orthostatic hypotension). Pregnancy. Nursing mothers: not recommended (during and for 7 days after the last dose).
Zelapar Pharmacokinetics
See Literature
Zelapar Interactions
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.
Zelapar Adverse Reactions
Adverse Reactions
Constipation, skin disorders, vomiting, dizziness, dyskinesia, insomnia, dyspnea, myalgia, rash; orthostatic hypotension (usually transient), hypertension, hallucinations, somnolence, irritation of the buccal mucosa.
Zelapar Clinical Trials
See Literature
Zelapar Note
Not Applicable
Zelapar Patient Counseling
See Literature
