AZILECT Oral Warnings
AZILECT Oral Uses
This medication is used alone or with other medications (e.g., levodopa, carbidopa) to treat movement disorders caused by Parkinson's disease. It does not cure Parkinson's disease, but it may improve shakiness (tremor), muscle stiffness, and sudden switching between normal movement and stiffness ("on-off" problems). It may improve your range of motion and ability to walk, dress, and exercise.
Rasagiline is an enzyme blocker (MAO inhibitor) that works by slowing the breakdown of certain natural substances in the brain (neurotransmitters such as dopamine, norepinephrine, and serotonin).
How to use AZILECT OralTake this medication by mouth, usually once daily with or without food or as directed by your doctor. Dosage is based on your medical condition and response to therapy. Do not increase your dose or take it more often than directed.
It may take a few weeks for the full benefits of the drug to be noticed. Do not stop taking this drug without first consulting your doctor. Talk with your doctor if the medication stops working well or if your condition worsens.
AZILECT Oral Side Effects
Dizziness, joint pain, heartburn, nausea, fever, muscle pain, dry mouth, and stomach/abdominal pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
If you are also taking levodopa, you may experience more side effects from the levodopa when taking rasagiline. Tell your doctor immediately if any of these side effects occur: nausea, shakiness, muscle stiffness, mental/mood changes such as hallucinations/abnormal dreams. Your doctor may need to change your medication or dose. Do not stop or change the dose of your levodopa without talking with your doctor first.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, loss of balance, mental/mood changes (e.g., agitation, confusion, depression, hallucinations), worsening muscle stiffness/twitching, changes in sexual ability/interest, increased shaking (tremor), swollen ankles/legs, change in amount of urine, unusual weight gain/loss.
Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds.
This drug may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Many drug and food interactions can increase this risk. (See also Drug Interactions section.) Seek immediate medical attention if any of these serious side effects occur: frequent/severe headache, fast/slow/irregular/pounding heartbeat, chest pain, neck stiffness/soreness, severe nausea/vomiting, sweating/clammy skin (sometimes with fever), widened pupils, vision changes (e.g., double/blurred vision), sudden sensitivity to light (photophobia).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
AZILECT Oral Precautions
Before taking rasagiline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), high blood pressure, history of severe/frequent headaches, moderate to severe liver disease, sore in the stomach/intestine/esophagus (peptic ulcer).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, diabetes, personal/family history of mental/mood disorders (e.g., schizophrenia, bipolar disorder), family history of high blood pressure, heart disease (e.g., coronary artery disease, history of chest pain), mild to moderate liver disease, history of sores in the stomach/intestine/esophagus (peptic ulcer), overactive thyroid (hyperthyroidism).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
To minimize dizziness and the risk of fainting, get up slowly when rising from a sitting or lying position. This is especially important if you are also taking levodopa and when you first start taking rasagiline.
Before having surgery, tell your doctor or dentist you are taking this medication. You may need to stop taking this drug beforehand. Follow your doctor's instructions carefully.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.
AZILECT Oral Interactions
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious (possibly fatal) interactions may occur: antidepressants (e.g., TCAs such as amitriptyline/protriptyline, mirtazapine, nefazodone, SSRIs such as fluoxetine/paroxetine/sertraline, venlafaxine), other MAO inhibitors (furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine), appetite suppressants (e.g., diethylpropion, sibutramine), drugs for attention deficit disorder (e.g., atomoxetine, methylphenidate), certain antihistamines (azatadine, carbetapentane, chlorpheniramine), bronchodilators (e.g., albuterol, salmeterol), bupropion, buspirone, cyclobenzaprine, dextromethorphan, certain drugs for glaucoma (e.g., apraclonidine, brimonidine), certain herbal products (e.g., ephedra/ma huang, St. John's wort), certain drugs for high blood pressure (e.g., guanethidine, methyldopa), nasal decongestants (e.g., phenylephrine, pseudoephedrine), certain narcotic medications (e.g., meperidine, methadone, propoxyphene), street drugs (e.g., MDMA/"ecstasy", LSD, mescaline), stimulants (e.g., amphetamines, ephedrine, epinephrine, phenylalanine), tetrabenazine, "triptan" migraine drugs (e.g., sumatriptan, rizatriptan), tramadol.
If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting rasagiline. Do not take these medications within 2 weeks before, during, or after treatment with rasagiline. If you have been taking fluoxetine, wait at least 5 weeks before starting rasagiline. Discuss with your doctor how much time to wait between starting or stopping any of these drugs and taking rasagiline.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs for anxiety (benzodiazepines such as diazepam), drugs for diabetes (e.g., glyburide, insulin), entacapone, tolcapone, drugs for high blood pressure (e.g., beta blockers such as atenolol, clonidine, rauwolfia alkaloids such as reserpine, "water pills"/diuretics such as hydrochlorothiazide), herbal products (e.g., ginseng), levodopa, certain narcotic medications (e.g., codeine, fentanyl, morphine), tryptophan, drugs affecting liver enzymes that remove rasagiline from your body (e.g., quinolone antibiotics such as ciprofloxacin; certain anticonvulsants such as phenobarbital/phenytoin; rifampin).
Check the labels on all your medicines (e.g., allergy, cough-and-cold products, diet pills) because they may contain dextromethorphan, decongestants, or stimulants. Ask your pharmacist about the safe use of those products.
To prevent a very serious high blood pressure reaction, it is very important that you follow a special diet recommended by your doctor or dietician in order to limit your intake of tyramine while you are taking this medicine and for 2 weeks after you stop taking rasagiline. Avoid foods and beverages that are high in tyramine, including: aged cheeses (e.g., bleu, cheddar, parmesan), dried/aged/fermented meats and sausages (e.g., salami, liverwurst), preserved fish (e.g., pickled herring), products containing large amounts of yeast (e.g., concentrated yeast extract, bouillon cubes, powdered soup/gravy, homemade or sourdough bread), fermented foods (e.g., sauerkraut, kim chee), most soybean products (e.g., soy sauce, tofu), broad/fava beans, red wine, sherry, tap beers, vermouth. Limit or avoid foods that are moderate in tyramine, including: avocados, bananas, eggplant, green beans, raisins, raspberries, red plums, spinach, tomatoes, chocolate, cultured dairy products (e.g., buttermilk, yogurt, sour cream), fish eggs, pate, peanuts, coffee, cola, alcohol-free beer, bottled beer, distilled spirits, port, white wine. Consult your doctor or dietician for more details and a complete list of other tyramine-containing foods you should limit or avoid. Seek immediate medical attention 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, difficulty thinking, slurred speech.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
AZILECT Oral Overdose
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may not appear for up to 12 hours and may include: excitement, irritability, restlessness, dizziness, weakness, drowsiness, flushing, sweating, fast heartbeat, headache, confusion, seizures.
NOTES:Do not share this medication with others.
People with Parkinson's disease may have an increased risk for developing skin cancer (melanoma). Tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams.
MISSED DOSE:If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE:Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).
Information last revised August 2009 Copyright(c) 2009 First DataBank, Inc.












