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SELEGILINE HYDROCHLORIDE
Overview
What is ZELAPAR?
ZELAPAR Orally Disintegrating Tablets contain selegiline hydrochloride, a levorotatory acetylenic derivative of phenethylamine. Selegiline hydrochloride is described chemically as: (-)-(R)-N, α-dimethyl-N-2-propynylphenethylamine hydrochloride and its structural formula is:
Its empirical formula is CHNHCl, representing a molecular weight of 223.75. Selegiline hydrochloride is a white to almost white crystalline powder that is freely soluble in water, chloroform, and methanol.
ZELAPAR Orally Disintegrating Tablets are available for oral administration ( to be swallowed) in a strength of 1.25 mg. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, citric acid, yellow iron oxide, and grapefruit flavor.
What does ZELAPAR look like?
What are the available doses of ZELAPAR?
Orally Disintegrating Tablets: 1.25 mg ()
What should I talk to my health care provider before I take ZELAPAR?
How should I use ZELAPAR?
ZELAPAR is indicated as an adjunct in the management of patients with Parkinson’s disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that ZELAPAR has any beneficial effect in the absence of concurrent levodopa therapy [see ].
Initiate treatment with 1.25 mg given once a day for at least 6 weeks. 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. There is no evidence that doses greater than 2.5 mg a day provide additional benefit, and they should ordinarily be avoided because of the potential increased risk of adverse events.
Take ZELAPAR in the morning before breakfast and without liquid. Patients should avoid ingesting food or liquids for 5 minutes before and after taking ZELAPAR.
Patients should not attempt to push ZELAPAR through the foil backing. Patients should PEEL BACK the backing of one or two blisters (as prescribed) with dry hands, and GENTLY remove the tablet(s). Patients should IMMEDIATELY place the ZELAPAR tablet(s) on top of the tongue where it will disintegrate in seconds.
What interacts with ZELAPAR?
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What are the warnings of ZELAPAR?
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What are the precautions of ZELAPAR?
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What are the side effects of ZELAPAR?
Sorry No records found
What should I look out for while using ZELAPAR?
ZELAPAR is contraindicated in patients using meperidine, tramadol, methadone, or propoxyphene. Serotonin syndrome, a potentially serious condition, which can result in death, has been reported with concomitant use of meperidine (e.g., Demerol and other trade names). At least 14 days should elapse between discontinuation of ZELAPAR and initiation of treatment with these medications [see].
ZELAPAR is contraindicated in patients on any other MAO inhibitor (selective or non-selective), because of an increased risk for hypertensive crisis. At least 14 days should elapse between discontinuation of ZELAPAR and initiation of treatment with any MAO inhibitor.
ZELAPAR is contraindicated in patients using St. John’s wort, or cyclobenzaprine (a tricyclic muscle relaxant).
ZELAPAR is contraindicated in patients using dextromethorphan, because of reported episodes of psychosis or bizarre behavior.
What might happen if I take too much ZELAPAR?
How should I store and handle ZELAPAR?
Store NARCAN Nasal Spray in the blister and cartons provided.Store at controlled room temperature 59°F to 77°F (15°C to 25°C). Excursions permitted up to 40°C (104°F). Do not freeze. Protect from light.Store NARCAN Nasal Spray in the blister and cartons provided.Store at controlled room temperature 59°F to 77°F (15°C to 25°C). Excursions permitted up to 40°C (104°F). Do not freeze. Protect from light.ZELAPAR Orally Disintegrating Tablets are available containing 1.25 mg selegiline hydrochloride in a Zydis formulation. Each pale yellow tablet is imprinted with a stylized “V”. Ten tablets are contained in a moisture-resistant pouch and packaged in a carton. Neither the blister card nor the pouch is child-resistant.ZELAPAR (selegiline hydrochloride) is available as: NDC 0187-0453-02, carton of 6 pouches (60 tablets).Store at controlled room temperature, 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Use within 3 months of opening pouch and immediately upon opening individual blister. Store blister tablets in pouch. Potency cannot be guaranteed after 3 months of opening the pouch.ZELAPAR Orally Disintegrating Tablets are available containing 1.25 mg selegiline hydrochloride in a Zydis formulation. Each pale yellow tablet is imprinted with a stylized “V”. Ten tablets are contained in a moisture-resistant pouch and packaged in a carton. Neither the blister card nor the pouch is child-resistant.ZELAPAR (selegiline hydrochloride) is available as: NDC 0187-0453-02, carton of 6 pouches (60 tablets).Store at controlled room temperature, 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Use within 3 months of opening pouch and immediately upon opening individual blister. Store blister tablets in pouch. Potency cannot be guaranteed after 3 months of opening the pouch.ZELAPAR Orally Disintegrating Tablets are available containing 1.25 mg selegiline hydrochloride in a Zydis formulation. Each pale yellow tablet is imprinted with a stylized “V”. Ten tablets are contained in a moisture-resistant pouch and packaged in a carton. Neither the blister card nor the pouch is child-resistant.ZELAPAR (selegiline hydrochloride) is available as: NDC 0187-0453-02, carton of 6 pouches (60 tablets).Store at controlled room temperature, 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Use within 3 months of opening pouch and immediately upon opening individual blister. Store blister tablets in pouch. Potency cannot be guaranteed after 3 months of opening the pouch.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
ZELAPAR is contraindicated in patients using meperidine, tramadol, methadone, or propoxyphene. Serotonin syndrome, a potentially serious condition, which can result in death, has been reported with concomitant use of meperidine (e.g., Demerol and other trade names). At least 14 days should elapse between discontinuation of ZELAPAR and initiation of treatment with these medications [see].ZELAPAR is contraindicated in patients on any other MAO inhibitor (selective or non-selective), because of an increased risk for hypertensive crisis. At least 14 days should elapse between discontinuation of ZELAPAR and initiation of treatment with any MAO inhibitor.
ZELAPAR is contraindicated in patients using St. John’s wort, or cyclobenzaprine (a tricyclic muscle relaxant).
ZELAPAR is contraindicated in patients using dextromethorphan, because of reported episodes of psychosis or bizarre behavior.
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 and ].
The selectivity of ZELAPAR for MAO-B may not be absolute even at the recommended daily dose of 2.5 mg a day. The selectivity of MAO-B inhibitors, typically decreases and it is ultimately lost as the dose is increased beyond recommended doses. Hypertensive reactions associated with ingestion of tyramine containing foods have been reported even in patients taking the recommended daily dose of swallowed selegiline, a dose which is generally believed to be selective for MAO-B. Selectivity for MAO-B inhibition is gradually lost with increasing daily doses. An increase in tyramine sensitivity for blood pressure responses appears to begin at a dose of 5 mg ZELAPAR daily [see ]. However, the precise dose at which ZELAPAR becomes a non-selective inhibitor of all MAO enzymes in individual patients is unknown.
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).
The safe use of ZELAPAR at doses above 2.5 mg daily without dietary tyramine restrictions has not been established.
A pharmacodynamic study showed increased tyramine sensitivity for increasing blood pressure and decreased selectivity for MAO-B with dosing above the recommended level (2.5 mg daily) [see].
Uncontrolled hypertension has been reported when taking the recommended dose of swallowed selegiline and a sympathomimetic medication (ephedrine).
After starting ZELAPAR, monitor patients for new onset hypertension or exacerbation of hypertension that is not adequately controlled.
The following adverse reactions are discussed in more detail in the Warnings and Precautions section of labeling.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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