Description and Brand Names of Azilect – Rasagiline (Oral Route)
US Brand Name
Rasagiline is used alone or with levodopa for the treatment of Parkinson’s disease. Parkinson’s disease is a condition of the brain that becomes worse over time and may cause movement problems, rigidity, tremors, and slowed physical movement .
This medicine is only available with your doctor’s prescription.
Importance of Diet
If you take this medicine and consume tyramine-rich foods, beverages, or dietary supplements or amines (from over-the-counter medicines), you could experience a hypertensive crisis or “cheese reaction”. A hypertensive crisis (increase in blood pressure) is very serious and requires immediate medical attention. It is very important that you restrict dietary tyramine by avoiding the following tyramine-rich foods and beverages:
- Aged cheese
- Air dried, aged and fermented meats, sausages and salamis (e.g., cacciatore, hard salami and mortadella)
- Animal livers that are spoiled or improperly stored
- Beers and tap beers, all varieties that have not been pasteurized so as to allow for ongoing fermentation
- Broad bean pods (e.g., fava bean pods)
- Meat, poultry, or fish that is spoiled or stored improperly (i.e., foods with changes in coloration, odor, or mold)
- OTC supplements containing tyramine
- Pickled herring
- Red wine
- Soybean products including soy sauce and tofu
- Yeast extract, concentrated (e.g., Marmite)
This product is available in the following dosage forms:
Before Using Azilect – Rasagiline (Oral Route)
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of rasagiline in the pediatric population. Safety and efficacy have not been established .
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of rasagiline in the elderly .
Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- St John’s Wort
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Bitter Orange
- Iobenguane I 123
- Ma Huang
- Morphine Sulfate Liposome
- St John’s Wort
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Tyramine Containing Food
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Mild liver problems – May cause an increased amount of rasagiline in your blood. Your doctor may lower your dose
- Moderate or severe liver problems – This medicine SHOULD NOT be used because it may cause an increased amount of rasagiline in your blood
- Pheochromocytoma (tumor on the adrenal gland) – This medicine SHOULD NOT be used.
Proper Use of Azilect – Rasagiline (Oral Route)
The absorption of rasagiline is not affected by food, so this drug can be taken with or without food .
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For treatment of Parkinson’s disease:
For oral dosage form (tablets):
For rasagiline alone:
- Adults – 1 milligram (mg) once a day
- Children – Use and dose must be determined by your doctor
For rasagiline with levodopa:
- Adults – At first, 0.5 mg once a day. Your doctor may increase your rasagiline dose to 1 mg once a day .
- Children – Use and dose must be determined by your doctor .
- For oral dosage form (tablets):
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
If you experience signs and symptoms of high blood pressure, you should seek immediate medical attention. Signs and symptoms include severe headache, blurred vision or visual disturbances, difficulty thinking, stupor or coma, seizures, chest pain, unexplained nausea or vomiting, or signs and symptoms of a stroke .
You should not use any of the following medicines while you are taking rasagiline, or for 2 weeks after stopping rasagiline:
- Analgesic agents (methadone [e.g., Methadose] propoxyphene [e.g., Darvon], tramadol [e.g., Ultram]) or
- Cold products containing ephedrine, phenylephrine, phenylpropanolamine, or pseudoephedrine or
- Cyclobenzaprine (e.g., Flexeril) or
- MAO inhibitors or
- Meperidine (e.g., Demerol) or
- Mirtazapine (e.g., Remeron)
You should tell your doctor before having any surgery that requires general anesthesia. Rasagiline should be discontinued at least 14 days before surgery .
Some studies have shown that patients with Parkinson’s disease may have a higher risk of developing skin cancer. Therefore, it is very important that a dermatologist check you at regular visits for melanomas. You or your caregiver should also monitor for melanomas frequently and on a regular basis .
If you are taking this medicine with levodopa, you may experience increased dyskinesia (e.g., twitching, twisting, uncontrolled repetitive movements of tongue, lips, face, arms, or legs) and postural low blood pressure (e.g., chills, cold sweats, confusion, dizziness, faintness, or light-headedness when getting up from lying or sitting position).
Side Effects of Azilect – Rasagiline (Oral Route)
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
- Abdominal or stomach pain
- arm, back, or jaw pain
- black, tarry stools
- chest pain or discomfort
- chest tightness or heaviness
- cloudy urine
- difficulty swallowing
- fast or irregular heartbeat
- loss of appetite
- painful or difficult urination
- persistent, non-healing sore
- pink growth on skin
- puffiness or swelling of the eyelids or around the eyes
- reddish patch or irritated area
- redness, blistering, peeling, or loosening of the skin
- seeing, hearing, or feeling things that are not there
- shiny bump
- shortness of breath
- skin rash
- sore throat
- sores, ulcers, or white spots on lips or in mouth
- swollen glands
- tests that show problems with the liver
- tightness in chest
- unusual bleeding or bruising
- unusual tiredness or weakness
- white, yellow or waxy scar-like area
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Acid or sour stomach
- difficulty in moving
- muscle pain or stiffness
- pain in joints
- stomach discomfort or upset
- burning, crawling, itching, numbness, prickling, “pins and needles” or tingling feelings
- burning, dry, or itching eyes
- decreased interest in sexual intercourse
- difficulty breathing
- difficulty in moving
- excessive tearing
- eye discharge
- feeling of constant movement of self or surroundings
- feeling sad or empty
- general feeling of discomfort or illness
- hair loss
- inability to have or keep an erection
- joint pain
- lack of appetite
- large, flat, blue or purplish patches in the skin
- loss in sexual ability, desire, drive, or performance
- loss of interest or pleasure
- muscle aches
- neck pain
- noisy breathing
- redness, pain, swelling of eye, eyelid, or inner lining of eyelid
- runny nose
- sensation of spinning
- stuffy nose
- swelling or redness in joints
- thinning of hair
- trouble concentrating
- trouble sleeping
- weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.