Serotonin syndrome and hyperpyrexia have been reported with the combined treatment of an antidepressant (e.g., selective serotonin reuptake inhibitors-SSRIs, serotonin-norepinephrine reuptake inhibitors-SNRIs, tricyclic antidepressants, tetracyclic antidepressants, triazolopyridine antidepressants) and a non-selective MAOI (e.g., phenelzine, tranylcypromine) or selective MAO-B inhibitors, such as selegiline (ELDEPRYL), rasagiline (AZILECT), and olanzapine (Zydis) selegiline (Zelapar). Zelapar contains phenylalanine, a component of aspartame. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Selegiline is also sold under the brand name Eldepryl. Each Zelapar 1.25 mg tablet contains 1.25 mg phenylalanine. Package insert / product label Results of a tyramine challenge study indicate that Zelapar is relatively selective for MAO-B at the recommended dose. This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome. Table 2: Mean Percentage Change from Baseline in Daily "Off" Hours at End of Treatment, (Average of Weeks 10 and 12) for Intent-to-Treat Population. 2021 Bausch Health Companies Inc. or its affiliates Zelapar Orally Disintegrating Tablets contain selegiline hydrochloride, a levorotatory acetylenic derivative of phenethylamine. Selegiline is more rapidly absorbed from the 1.25 or 2.5 mg dose of Zelapar (Tmax range: 10-15 minutes) than from the swallowed 5 mg selegiline tablet (Tmax range: 40-90 minutes). Zelapar may also be used for purposes not listed in this medication guide. Check with your doctor before you change your dose or stop Zelapar. Bridgewater, NJ 08807 USA Do not double the dose to catch up. Dizziness, abdominal pain, dry mouth, nausea, stomach upset, trouble sleeping, and headache may occur. Instruct patients to report, immediately, severe headache or other atypical or unusual symptoms not previously experienced or very high blood pressure. No dose adjustment of Zelapar is required in patients with mild to moderate renal impairment (creatinine clearance [CLcr] 30 to 89 mL/min). Do not use this medicine in larger or smaller amounts or for longer than recommended. Your doctor may need to change your treatment plan if you use any of the following drugs: cough medicine that contains dextromethorphan; meperidine (Demerol) or other narcotic (opioid) pain medicine; an antidepressant - citalopram, desvenlafaxine, duloxetine, escitalopram, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, nefazodone, paroxetine, venlafaxine, vilazodone, vortioxetine, and others; or. Patients should be advised to exercise caution while driving, operating machines, or working at heights during treatment with Zelapar. BLISTER PACKS AND SACHET POUCHES ARE NOT CHILD-RESISTANT. In Canada - Call your doctor for medical advice about side effects. Certain adverse reactions were reported at a higher frequency by patients 65 years of age compared to patients <65 years [see Use in Specific Populations (8.5)]. Zelapar is a prescription-only medication that is given in combination with other medications to treat Parkinson's disease. At that time, the incidence of systolic orthostatic hypotension was about 21% in Zelapar-treated patients and 9% in placebo-treated patients. Before taking Zelapar, tell your doctor: If you are allergic to Zelapar; any part of this medicine; or any other drugs, foods, or substances. Do not share this medication with others. Store blister tablets in sachet pouch at all times. To prevent a very serious high blood pressure reaction, it is very important that you do not increase your dose. Your doctor may adjust your dose if needed. Clinical studies of Zelapar did not allow concomitant use of any selective serotonin re-uptake inhibitor (e.g., fluoxetine-Prozac, fluvoxamine-Luvox, paroxetine-Paxil, sertraline, venlafaxine-Effexor, or nefazodone-Serzone) or any non-selective serotonin reuptake inhibiting antidepressant drug (except when taken at a low dose and only at night for the purpose of effective sleep) with Zelapar. Before having surgery, tell your doctor or dentist you are taking this medication. For this reason, in cases of overdose with selegiline, dietary tyramine restriction should be observed for several weeks to avoid the risk of a hypertensive reaction. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. Adequate studies have not been done investigating the effect of CYP3A4 inducers on selegiline. Reports of hypertensive reactions have occurred in patients who ingested tyramine-containing consumables (i.e., food or drink) while receiving swallowed selegiline at the recommended dose (a dose believed to be relatively selective for MAO-B). Tri-County Packaging is an authorized distributor of some of the largest and best packaging companies in the world, including (but not limited to): Sealed Air, Eastey, Texwrap, and Storopack. Distribution It also may prevent the removal of dopamine between nerve endings and enhance release of dopamine from nerve cells. Otherwise, call a poison control center right away. Skip to main content. Select a condition to view a list of medication options. fresh meat, poultry, or fish (including lunch meat, hot dogs, breakfast sausage, and cooked sliced ham); any vegetables except broad bean pods (fava beans); processed cheese, mozzarella, ricotta, cottage cheese; To take Zelaparorally disintegrating tablets:p>. Therefore, immediate hospitalization, with continuous patient observation and monitoring for a period of at least two days following the ingestion of such drugs in overdose, is strongly recommended. We comply with the HONcode standard for trustworthy health information. Use within 3 months of opening pouch and immediately upon opening individual blister. Drug class: dopaminergic antiparkinsonism agents, 10 TABLET, ORALLY DISINTEGRATING in 1 POUCH. The background risk of major birth defects and miscarriage in the indicated population is unknown. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Support respiration, including management of the airway, use of supplemental oxygen, and mechanical ventilatory assistance, as required. NOTE: The following description of presenting symptoms and clinical course is based upon overdose descriptions of non-selective MAO inhibitors and does not include information from patients who have overdosed on oral selegiline or Zelapar. It works by Consult your doctor before breast-feeding. To help you remember, use it at the same time each day. Methamphetamine and amphetamine metabolite AUC values were not affected by liver dysfunction [see Dosage and Administration (2.2) and Use in Specific Populations (8.6)]. Take Zelapar exactly as it was prescribed for you. Selective MAO-B inhibitors lose their selectivity for MAO-B when taken in doses higher than recommended. Zelapar is indicated as an adjunct in the management of patients with Parkinsons disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. Zelapar is used along with carbidopa and levodopa to treat symptoms of Parkinson's disease. Death has been reported following overdosage. If MAO is inhibited in the gastrointestinal tract and liver, ingestion of exogenous amines contained in some foods such as fermented cheese, herring, or over-the-counter cough/cold medicines may be absorbed systemically causing release of norepinephrine and a rise in systemic blood pressure with the potential for uncontrolled hypertension. Tell patients to report hallucinations or psychotic-like behavior to their healthcare provider promptly should they develop [see Warnings and Precautions (5.6)]. Avoid drinking alcohol while you are taking Zelapar. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. In some cases, sleep occurred without any feelings of drowsiness beforehand. An increase in tyramine sensitivity for blood pressure responses appears to begin at a dose of 5 mg Zelapar daily [see Warnings and Precautions (5.1)]. The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Some medicines can cause unwanted or dangerous effects when used with Zelapar. Store this medicine at room temperature away from moisture and heat. This abnormal thinking and behavior can consist of one or more of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium. You may report side effects to FDA at 1-800-FDA-1088. The AUC and Cmax of selegiline were 1.5-fold higher and the AUC and Cmax of the metabolite desmethylselegiline were 1.4-fold and 1.2-fold higher. Overdose symptoms may include severe headache, hallucinations, vision problems, sweating, cool or clammy skin, fast or uneven heart rate, feeling light-headed, fainting, or seizure (convulsions). Keep all medications away from children and pets. After 6 weeks, the dose may be increased to 2.5 mg given once a day if a desired benefit has not been achieved and the patient is tolerating ZELAPAR. Low levels of this chemical are associated with Parkinson's disease. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. The treatment effect size in males was twice that in females, but, given the size of this single trial, this finding is of doubtful significance. In vitro metabolism studies indicate that CYP2B6 and CYP3A4 are involved in the metabolism of selegiline. an MAO inhibitor - isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others. A pharmacodynamic study investigating daily Zelapar doses of 2.5 mg, 5 mg, and 10 mg for tyramine sensitivity showed that increased tyramine sensitivity resulting in increased blood pressure (because of MAO-A inhibition and decreased selectivity for MAO-B) occurred with dosing above the recommended level (2.5 mg daily). Swallow several times as the tablet dissolves. Withdrawal Emergent Hyperpyrexia and Confusion. Throw away any tablets not used within 3 months after you have opened the pouch containing the blister pack. Does Zelapar interact with other drugs you are taking? Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Zelapar. Zelapar prevents the breakdown of a chemical in your brain called dopamine. Bausch Health US, LLC Instruct patients not to remove the blister from the sachet pouch until just prior to dosing. Small increments in serum BUN and creatinine have been observed in patients who received Zelapar 10 mg daily (4 times the recommended dose). Although adequate studies to investigate the effect of CYP3A4-inducers on selegiline have not been performed, drugs that induce CYP3A4 (e.g., phenytoin, carbamazepine, nafcillin, phenobarbital, and rifampin) should be used with caution. at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Patients treated with Zelapar had a 13% reduction from baseline in daily OFF time, compared with a 5% reduction for patients treated with placebo. This medicine may contain aspartame. Distributed by: Zelapar-treated patients had an average reduction from baseline of OFF time of 2.2 hours per day, compared with a reduction of 0.6 hours in placebo-treated patients. Mean (SD) maximum plasma concentrations of 3.34 (1.68) and 4.47 (2.56) ng/mL are reached after single dose of 1.25 and 2.5 mg Zelapar compared to 1.12 ng/mL (1.48) for the swallowed 5 mg selegiline tablets (given as 5 mg bid). Some people taking selegiline have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Zelapar is contraindicated in patients with: Zelapar should not be used at daily doses exceeding those recommended (2.5 mg/day) because of the risks associated with non-selective inhibition of MAO [see Drug Interactions (7.3) and Clinical Pharmacology (12.2)]. The overall incidence of adverse reactions was increased in geriatric patients (65 years) compared to non-geriatric patients (<65 years). What are the side effects of Zelapar? Keep each Zelapar tablet in the foil blister pack until you are ready to take it. Tell your doctor if you are breast-feeding a baby. The safe use of Zelapar at doses above 2.5 mg daily without dietary tyramine restrictions has not been established. Generic name: selegiline (oral) [se-LE-ji-leen] In rabbits administered selegiline orally (5, 30, and 60 mg/kg/day) throughout the period of organogenesis, embryolethality was observed at the highest dose tested and reduced fetal body weight was observed at the mid and high doses. a light-headed feeling, like you might pass out; confusion, hallucinations, unusual thoughts or behavior; increased tremors or uncontrolled muscle movements; worsening side effects of your other medications; high levels of serotonin in the body (when taken with an antidepressant) - agitation, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; or. The combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior. Medically reviewed by Drugs.com. Zelapar Orally Disintegrating Tablets are available for oral administration (not to be swallowed) in a strength of 1.25 mg. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: aspartame, citric acid, gelatin, glycine, mannitol, opatint yellow, purified water, and grapefruit flavor. Maintenance of fluid and electrolyte balance is essential. 60 Tablets The no-effect doses for reproductive impairment in rats (10 mg/kg/day in males and 5 mg/kg/day in females) are approximately 40 (males) and 20 (females) times the maximum recommended human dose of 2.5 mg/day on a mg/m2 basis. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Zelapar [see Warnings and Precautions (5.7)]. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Blocking MAO-B helps increase dopamine levels, and thus helps improve symptoms of . Postmarketing reports indicate that patients may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior during Zelapar treatment or after starting or increasing the dose of Zelapar. ZELAPAR, a monoamine oxidase type B (MAO-B) inhibitor, is indicated as an adjunct in the management of patients with Parkinson's disease being treated with levodopa/carbidopa who exhibit. Be careful if you drive or do anything that requires you to be alert. Advise patients that they may experience impulse control and/or compulsive behaviors while taking one or more of the medications generally used for the treatment of Parkinsons disease, including Zelapar. Drug Label Information Updated October 26, 2011 If you are a consumer or patient please visit this version. See also Side Effects section. Talk to your doctor if you are using marijuana (cannabis). Do not start, stop, or change the dosage of any medicines without your doctor's approval. Zelapar Office: (847) 821-0032 FAX: (847) 821-0066 www.altpandassociates.com Drug Description Find Lowest Prices on What is Zelapar and how is it used? Tell your doctor or pharmacist if you are using any of these medications before, during, or within 2 weeks after treatment with selegiline. Effect of CYP3A inhibitor itraconazole: Itraconazole (200 mg once daily) did not affect the pharmacokinetics of selegiline (single 10 mg oral, swallowed dose). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Do not swallow the tablet whole. The primary efficacy outcome was the reduction in average percentage daily OFF time during waking hours from baseline to the end of the trial (averaging results at Weeks 10 and 12). Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Consult your doctor for more details. Coordinates: 42.4297, -83.7525. Many drug and food interactions can increase this risk. It is not known whether selegiline passes into breast milk or if it could harm a nursing baby. There is no evidence from controlled studies that Zelapar has any beneficial effect in the absence of concurrent levodopa therapy [see Clinical Studies (14)]. A very serious allergic reaction to this drug is rare. ZELAPAR is not recommended in patients with severe hepatic impairment (Child-Pugh score >9) [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)]. Potency cannot be guaranteed after 3 months of opening the sachet pouch. Advise patients about the potential for sedating effects associated with Zelapar, including somnolence and particularly to the possibility of falling asleep while engaged in activities of daily living. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this drug safely. Zelapar Used for Parkinson's Disease expand_more Customize this coupon to save at your pharmacy Check your prescription Make sure the following details match. Potency cannot be guaranteed after 3 months of opening the sachet pouch. Estimated Retail Price* of Zelapar: 30 tablets: $2,162/month *Source: drugs.com . Examples include street drugs such as MDMA/"ecstasy," St. John's wort, dextromethorphan, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine, TCAs such as amitriptyline/doxepin), certain opioid medications (such as meperidine, methadone, pentazocine, propoxyphene, tramadol, tapentadol), among others. Hypertensive crisis has also been reported with Zelapar use that was not above the recommended dosing. An increase in tyramine sensitivity for blood pressure responses appears to begin at a dose of 5 mg Zelapar daily [see Drug Interactions (7.5)]. Do not stop or change the dose of any of your medications without first talking with your doctor. This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson's disease), possibly causing false test results. Initiate treatment with 1.25 mg given once a day for at least 6 weeks. Get medical help right away if you notice symptoms of very high blood pressure such as unusually fast/slow heartbeat, vomiting, unexplained sweating, headache, chest pain, sudden vision changes, weakness on one side of the body, trouble speaking. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. There was an increased risk for somnolence in geriatric patients (65 years) vs. non-geriatric patients treated with Zelapar. No fertility studies have been conducted with selegiline using the buccal route. CYP2A6 may play a minor role in the metabolism. Get medical help right away if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitching muscle. Signs and symptoms of central nervous system stimulation, including convulsions, should be treated with diazepam, given slowly intravenously. Set Dosage 10 Tablets Disintegrating / 30 Box. The enzyme, monoamine oxidase (MAO) (primarily type A), in the gastrointestinal tract and liver provides protection from ingested amines (e.g., tyramine) that, if absorbed, have the capacity to cause uncontrolled hypertension (tyramine reaction). Patients with Parkinsons disease treated with Zelapar or other drugs increasing dopaminergic tone have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Patients with mild to moderate hepatic impairment (Child-Pugh score 5 to 9) may require a dose reduction of ZELAPAR (from 2.5 to 1.25 mg daily) depending on the clinical response. Tell your doctor or pharmacist if you have taken fluoxetine during at least 5 weeks before starting selegiline. Some people taking this medicine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Patients should not attempt to push Zelapar through the foil backing. Catalent Pharma Solutions Limited Many people using this medication do not have serious side effects. You may fall asleep suddenly, even after feeling alert. Inform patients that Zelapar may cause irritation of the buccal mucosa including swallowing pain, mouth pain, discrete areas of focal reddening, edema, and/or ulceration [see Warnings and Precautions (5.9)]. If patients eat foods very rich in tyramine and do not feel well soon after eating, they should contact their healthcare provider [see Warnings and Precautions (5.1)]. Treatments Parkinson's Disease Zelapar Print Save Zelapar Generic name: selegiline (oral) [ se-LE-ji-leen ] Brand names: Eldepryl, Zelapar Drug classes: Dopaminergic antiparkinsonism agents, Monoamine oxidase inhibitors Medically reviewed by Drugs.com. Characteristically, signs and symptoms of non-selective MAO inhibitor overdose may not appear immediately. Zelapar (selegiline) is a member of the dopaminergic antiparkinsonism agents drug class and is commonly used for Parkinson's Disease. This sleep effect may occur anytime during treatment with selegiline even if you have used this medication for a long time. 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