Zelapar Orally Disintegrating TabletsGeneric Name: Selegiline
Zelapar Orally Disintegrating Tablets are used for:
Treating Parkinson disease. It is used along with carbidopa/levodopa.
Zelapar Orally Disintegrating Tablets are a monoamine oxidase inhibitor (MAOI). It works by helping levodopa to work against Parkinson disease for a longer period of time. This may help to slow the progression of Parkinson disease.
Do NOT use Zelapar Orally Disintegrating Tablets if:
- you are allergic to any ingredient in Zelapar Orally Disintegrating Tablets
- you are taking fluoxetine or have taken it within the past 5 weeks
- you are taking bupropion, buspirone, cyclobenzaprine, dextromethorphan, meperidine, methadone, a norepinephrine reuptake inhibitor (eg, atomoxetine), propoxyphene, a selective serotonin reuptake inhibitor (SSRI) (eg, fluoxetine), a serotonin and norepinephrine reuptake inhibitor (eg, venlafaxine, duloxetine), St. John's wort, a tetracyclic antidepressant (eg, mirtazapine), tramadol, or a tricyclic antidepressant (eg, amitriptyline)
- you are taking other forms of selegiline, another MAOI (eg, phenelzine), or a sympathomimetic, including amphetamines, cold products, or certain diet pills or preparations (eg, pseudoephedrine, phenylephrine, phenylpropanolamine, ephedrine)
- you are taking apraclonidine, methylphenidate, nefazodone, sibutramine, or a 5-HT agonist (eg, sumatriptan)
- you will be undergoing elective surgery with general anesthesia or will be receiving cocaine or local anesthesia containing sympathomimetic vasoconstrictors
- you have schizophrenia
Contact your doctor or health care provider right away if any of these apply to you.
Before using Zelapar Orally Disintegrating Tablets:
Some medical conditions may interact with Zelapar Orally Disintegrating Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of liver or kidney problems, mood or mental problems, uncontrolled muscle movements (eg, twitching of the face and tongue or involuntary movements of the arms and legs), or phenylketonuria
Some MEDICINES MAY INTERACT with Zelapar Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Bupropion, cyclobenzaprine, dextromethorphan, MAOIs (eg, phenelzine), meperidine, methadone, norepinephrine reuptake inhibitors (eg, atomoxetine), other forms of selegiline, propoxyphene, serotonin and norepinephrine reuptake inhibitors (eg, duloxetine,venlafaxine), sibutramine, SSRIs (eg, fluoxetine), St. John's wort, sympathomimetics (eg, amphetamine, ephedrine, phenylephrine, pseudoephedrine), tetracyclic antidepressants (eg, mirtazapine), or tricyclic antidepressants (eg, amitriptyline) because serotonin syndrome (eg, fever, muscle stiffness or rigidity, vital sign changes, mental or mood changes, coma) may occur
- Apraclonidine or buspirone because severe high blood pressure may occur
- Nefazodone, tramadol, or tryptophan because nausea, dizziness, mental or mood changes, seizures, fever, or breathing or heart problems may occur
- Carbamazepine, nafcillin, phenobarbital, phenytoin, and rifampin because they may decrease Zelapar Orally Disintegrating Tablets's effectiveness
- 5-HT agonists (eg, sumatriptan), insulin, meglitinide antidiabetics (eg, nateglinide), methylphenidate, or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Zelapar Orally Disintegrating Tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Zelapar Orally Disintegrating Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Zelapar Orally Disintegrating Tablets:
Use Zelapar Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Keep the medicine blister in the outer pouch until you are ready to take a dose.
- Take Zelapar Orally Disintegrating Tablets in the morning before breakfast. Do not eat or drink within 5 minutes before or after you take it.
- To take Zelapar Orally Disintegrating Tablets, remove a dose from the blister pack. Make sure that your hands are dry before you open the blister. Peel back the foil to expose the tablet. Do not push the tablet through the blister. This could damage the tablet.
- Take your dose immediately after you remove it from the blister pack. Do not store the removed tablet for future use.
- Place the entire tablet on the tongue. It will dissolve quickly. Do not break, crush or chew the tablet. Do not swallow it whole.
- Continue to use Zelapar Orally Disintegrating Tablets even if you feel well. Do not miss any doses.
- If you miss a dose of Zelapar Orally Disintegrating Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.
Important safety information:
- Zelapar Orally Disintegrating Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Zelapar Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are taking Zelapar Orally Disintegrating Tablets.
- Zelapar Orally Disintegrating Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- If you already take carbidopa/levodopa, your doctor may change your dose when you start Zelapar Orally Disintegrating Tablets.
- Do NOT take more than the recommended dose without checking with your doctor. Doing so may increase the risk of side effects.
- Eating foods high in tyramine (eg, aged cheeses, red wines, beer, certain meats and sausages, liver, sour cream, soy sauce, raisins, bananas, avocados) while you use an MAOI may cause severe high blood pressure. Such a reaction is NOT likely to occur with recommended doses of Zelapar Orally Disintegrating Tablets. Most people who use Zelapar Orally Disintegrating Tablets can eat a normal diet. Although it is not likely to occur, seek medical care at once if symptoms of severe high blood pressure occur. These may include severe headache, fast or irregular heartbeat, sore or stiff neck, nausea, vomiting, sweating, enlarged pupils, or sensitivity to light. Check with your health care provider if you have questions about eating foods that contain tyramine while you use Zelapar Orally Disintegrating Tablets.
- Do not take any medicine that has dextromethorphan, pseudoephedrine, or phenylephrine in it while you are using Zelapar Orally Disintegrating Tablets. Before you start any new medicine, check the label to see if it has dextromethorphan, pseudoephedrine, or phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Do not suddenly stop taking Zelapar Orally Disintegrating Tablets. Doing so may cause side effects similar to neuroleptic malignant syndrome (NMS). Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms. Check with your doctor before you change your dose or stop Zelapar Orally Disintegrating Tablets.
- Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while using Zelapar Orally Disintegrating Tablets. Tell your doctor right away if you notice such effects.
- Tell your doctor or dentist that you take Zelapar Orally Disintegrating Tablets before you receive any medical or dental care, emergency care, or surgery.
- You may need to stop Zelapar Orally Disintegrating Tablets before you have certain medical or dental procedures. Check with your doctor before you stop taking Zelapar Orally Disintegrating Tablets.
- If your doctor tells you to stop taking Zelapar Orally Disintegrating Tablets, you will need to wait at least 14 days before you start to take certain other medicines (eg, meperidine, other medicines that contain selegiline, selective serotonin reuptake inhibitors, tricyclic antidepressants). Ask your doctor if you are not sure when you should start to take your new medicines after you have stopped Zelapar Orally Disintegrating Tablets.
- Zelapar Orally Disintegrating Tablets contains phenylalanine. If you must have a diet that is low in phenylalanine, check with your health care provider.
- Lab tests, including skin checks, may be performed while you use Zelapar Orally Disintegrating Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Zelapar Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness and drowsiness.
- Zelapar Orally Disintegrating Tablets should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been determined.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zelapar Orally Disintegrating Tablets while you are pregnant. It is not known if Zelapar Orally Disintegrating Tablets are found in breast milk. Do not breast-feed while taking Zelapar Orally Disintegrating Tablets.
Possible side effects of Zelapar Orally Disintegrating Tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Back pain; constipation; dizziness; drowsiness; dry mouth; headache; mild sores, pain, or irritation in the mouth; nausea; runny or stuffy nose; sore throat; trouble sleeping; upset stomach; vomiting.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavior or mood changes (eg, depression); change in the amount of urine produced; chest pain; confusion; dark growths on the skin; fainting; fast or irregular heartbeat; fever; hallucinations; increased sweating; memory loss; neck or muscle stiffness or soreness; pain when swallowing; severe or persistent dizziness or drowsiness; severe or persistent headache or nausea; swelling of the arms or legs; unusual or intense urges (eg, gambling, sexual urges); unusual muscle movements or loss of muscle control; unusual weakness or fatigue; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include coma; cool, clammy skin; difficulty breathing; excessive sweating; fast or irregular heartbeat; fever; hallucinations; hyperactivity; seizures; severe dizziness, drowsiness, or headache.Proper storage of Zelapar Orally Disintegrating Tablets:
Store Zelapar Orally Disintegrating Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store blister packs in the original pouch. Store away from heat, moisture, and light. Do not store in the bathroom. Throw away any medicine that has not been used within 3 months after you first open the moisture-resistant pouch. Keep Zelapar Orally Disintegrating Tablets out of the reach of children and away from pets.
- If you have any questions about Zelapar Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.
- Zelapar Orally Disintegrating Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Zelapar Orally Disintegrating Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.