ZELAPAR ODT

ZELAPAR ODT is the brand name for selegiline hydrochloride and is available as an orally disintegrating tablet.

ZELAPAR ODT is available as a 1.25 mg orally disintegrating tablet.

ZELAPAR ODT is a MAO-B inhibitor and is used to relieve “wearing-off” symptoms in people with Parkinson’s disease who are taking combination medications containing carbidopa and levodopa (e.g., Sinemet (carbidopa / levodopa), Rytary (carbidopa / levodopa)).

ZELAPAR ODT is a monoamine oxidase type B (MAO-B) inhibitor. MAO-B is a protein in your brain that breaks down dopamine. Low levels of dopamine in your brain cause symptoms of Parkinson’s disease (PD). It’s not fully understood how selegiline works to relieve your PD symptoms. It’s thought that the medication blocks MAO-B to prevent dopamine from being broken down so that dopamine can stay in your brain longer. This helps control your PD symptoms.

ZELAPAR ODT is dosed as follows:

• Regular tablets and capsules: The typical dose is 5 mg by mouth at breakfast and 5 mg at lunch. Don’t take more than 10 mg of selegiline per day. After 2 to 3 days of taking the medication, your provider might prescribe a lower dose of carbidopa/levodopa, depending on how you respond to selegiline
• Quick-dissolving tablets, also known as orally disintegrating tablets (ODTs): ZELAPAR is the brand name for the ODT form of selegiline. The typical starting dose is 1.25 mg by mouth before breakfast every day for at least 6 weeks. If needed, the dose can be raised to 2.5 mg before breakfast after 6 weeks of taking the starting dose. Don’t take more than 2.5 mg of ZELAPAR per day. Your dose may differ if you have liver problems

ZELAPAR ODT is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if you are using the following drugs: opioid drugs (e.g., meperidine, tramadol, methadone), MAO inhibitors including selective MAO-B inhibitors, dextromethorphan, St. John’s wort, and cyclobenzaprine.

Common side effects of ZELAPAR ODT:

• Nausea
• Dizziness
• General body pain
• Headache
• Trouble sleeping
• Runny nose
• Involuntary movements
• Skin irritation
• Back pain
• Heartburn
• Inflamed or sore mouth

Serious side effects are rare with ZELAPAR ODT. Contact your healthcare provider immediately if you experience any of the following.

• Serotonin syndrome: Hallucinations, coma, seizures, confusion, restlessness, fainting, shivering, sweating, high fevers, headache, racing heart, high blood pressure, diarrhea, muscle stiffness or twitching, tremor
• Neuroleptic malignant syndrome (NMS): Very high fevers, irregular pulse, sweating, muscle stiffness, confusion, changes in blood pressure
• Extremely high blood pressure: Seizures, severe chest pain, severe headache, confusion, blurred vision, anxiety

The following medications may interact with ZELAPAR ODT:

• Opioid Drugs: Because serious, sometimes fatal reactions have been precipitated with concomitant use of opioid drugs (e.g., meperidine and its derivatives, methadone, or tramadol) and MAOIs, including selective MAO-B inhibitors, concomitant use of these drugs with ZELAPAR is contraindicated. At least 14 days should elapse between discontinuation of ZELAPAR and initiation of treatment with these drugs
• Dextromethorphan: The combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior. Therefore, in view of ZELAPAR’s MAO inhibitory activity, dextromethorphan should not be used concomitantly with ZELAPAR.
• MAO Inhibitors: ZELAPAR is contraindicated for concomitant use with other drugs in the MAOI class or
• other drugs that are potent inhibitors of monoamine oxidase (including linezolid, an oxazolidinone antibacterial, which also has reversible nonselective MAO inhibition activity) because of the increased risk for hypertensive crisis. At least 14 days should elapse between discontinuation of ZELAPAR and initiation of treatment with other MAOIs.
• Sympathomimetic Medications: Uncontrolled hypertension, including hypertensive crisis, has been reported when taking the recommended dose of swallowed selegiline and a sympathomimetic medication
• Tricyclic Antidepressants and Selective Serotonin Reuptake Inhibitors
• Severe toxicity has also been reported in patients receiving the combination of tricyclic antidepressants and swallowed selegiline, or selective serotonin reuptake inhibitors and swallowed selegiline

Bausch Health

ZELAPAR ODT may harm your unborn baby, based on animal data. Tell your healthcare provider if you are pregnant or think you are pregnant.

• selegiline hydrochloride