Description
Selegiline is used in combination with levodopa or levodopa and carbidopa combination to treat Parkinson's disease (sometimes called "shaking palsy" or "paralysis agitans"). This medicine works to increase and extend the effects of levodopa, and may help to slow the progress of Parkinson's disease.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Disintegrating
- Capsule
- Tablet
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of selegiline in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of selegiline in the elderly. However, elderly patients are more likely to have unwanted effects (eg, high or low blood pressure, orthostatic hypotension, unusual drowsiness), which may require caution for patients receiving selegiline.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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.
- Amitriptyline
- Amoxapine
- Amphetamine
- Apraclonidine
- Atomoxetine
- Benzphetamine
- Brimonidine
- Bupropion
- Carbamazepine
- Carbinoxamine
- Citalopram
- Clomipramine
- Codeine
- Cyclobenzaprine
- Cyproheptadine
- Desipramine
- Desvenlafaxine
- Deutetrabenazine
- Dexfenfluramine
- Dexmethylphenidate
- Dextroamphetamine
- Dextromethorphan
- Diethylpropion
- Dihydrocodeine
- Doxylamine
- Duloxetine
- Ephedrine
- Escitalopram
- Fenfluramine
- Fluoxetine
- Fluvoxamine
- Furazolidone
- Gepirone
- Guanadrel
- Guanethidine
- Hydroxytryptophan
- Imipramine
- Iproniazid
- Isocarboxazid
- Isometheptene
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.
- Albuterol
- Alfentanil
- Alizapride
- Amineptine
- Amitriptylinoxide
- Atropine
- Benzhydrocodone
- Bromperidol
- Buprenorphine
- Buspirone
- Butalbital
- Butorphanol
- Carbidopa
- Clovoxamine
- Dibenzepin
- Difenoxin
- Diphenoxylate
- Dolasetron
- Domperidone
- Dothiepin
- Doxepin
- Droperidol
- Epinephrine
- Ethchlorvynol
- Femoxetine
- Fentanyl
- Fluspirilene
- Formoterol
- Frovatriptan
- Granisetron
- Guarana
- Haloperidol
- Hydrocodone
- Hydromorphone
- Iobenguane I 123
- Iobenguane I 131
- Kava
- Lasmiditan
- Levodopa
- Levorphanol
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.
- Acarbose
- Chlorpropamide
- Desogestrel
- Dienogest
- Dopamine
- Drospirenone
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Gestodene
- Ginseng
- Glimepiride
- Glipizide
- Glyburide
- Insulin
- Insulin Aspart, Recombinant
- Insulin Bovine
- Insulin Degludec
- Insulin Detemir
- Insulin Glargine, Recombinant
- Insulin Glulisine
- Insulin Lispro, Recombinant
- Levonorgestrel
- Mestranol
- Metformin
- Nateglinide
- Nomegestrol
- Norethindrone
- Norgestimate
- Norgestrel
- Repaglinide
- Tolazamide
- Tolbutamide
Other Interactions
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.
- Avocado
- Bitter Orange
- 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:
- Dyskinesia (abnormal muscle movements) or
- Hypertension (high blood pressure) or
- Hypotension (low blood pressure) or
- Mental illness (eg, psychosis) or
- Postural hypotension (dizziness, lightheadedness, or fainting when getting up from a lying or sitting position)—Use with caution. May make these conditions worse.
- Kidney disease (eg, end-stage kidney disease), severe—Use is not recommended in patients with this condition.
- Liver disease—Use with caution. Higher blood levels of selegiline may result, and cause an increase in side effects.
- Phenylketonuria (PKU)—The disintegrating tablet contains phenylalanine, which can make this condition worse.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
It is best to take the capsules or tablets in the morning during breakfast and lunch. You should not use it with dinner because you may have trouble sleeping.
If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet on the top of your tongue, where it will melt quickly. Do not eat food or drink liquids for 5 minutes before or after taking this medicine. It is best to take this medicine before breakfast.
Dosing
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 Parkinson's disease:
- For oral dosage forms (capsules or tablets):
- Adults—5 milligrams (mg) two times a day, taken at breakfast and lunch. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (oral disintegrating tablets):
- Adults—At first, 1.25 milligrams (mg) once a day before breakfast, for at least 6 weeks. After 6 weeks, your doctor may increase your dose to 2.5 mg once a day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage forms (capsules or tablets):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to allow for changes in your dose. Blood tests may be needed to check for any unwanted effects.
Do not take selegiline if you have used narcotic pain medicines (including meperidine, methadone, tramadol, Demerol®, Dolophine®, Ultram®) or an MAO inhibitor (MAOI) (eg, isocarboxazid, linezolid, phenelzine, tranylcypromine, Marplan®, Nardil®, Parnate®, Zyvox®) within the past 14 days. If you do, you may develop agitation, confusion, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe seizures.
Do not take cyclobenzaprine, dextromethorphan (Robitussin®, Pediacare®), propoxyphene (Darvon®), or St. John's wort while you are using this medicine. Using these medicines together can cause unwanted effects.
Selegiline may cause a condition called serotonin syndrome when used together with certain MAO inhibitors (eg, phenelzine, rasagiline, tranylcypromine) and medicines to treat depression (eg, amitriptyline, doxepin, fluoxetine, fluvoxamine, nortriptyline, paroxetine, sertraline, Elavil®, Luvox®, Pamelor®, Paxil®, Prozac®, or Zoloft®). Check with your doctor right away if you have anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there.
When selegiline is taken at doses of 10 mg or less per day for the treatment of Parkinson's disease, there are no restrictions on food or beverages you eat or drink. However, the chance exists that dangerous reactions, including sudden high blood pressure, may occur if doses higher than those used for Parkinson's disease are taken with certain foods, beverages, or other medicines. These foods, beverages, and medicines include:
- Foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses, fava or broad bean pods, yeast or meat extracts, smoked or pickled meat, poultry, or fish, fermented sausage (bologna, pepperoni, salami, summer sausage) or other fermented meat, sauerkraut, or any overripe fruit. If a list of these foods and beverages is not given to you, ask your doctor to provide one.
- Alcoholic beverages or alcohol-free or reduced-alcohol beer and wine.
- Large amounts of caffeine-containing food or beverages such as coffee, tea, cola, or chocolate.
- Any other medicine unless approved or prescribed by your doctor. This especially includes nonprescription (over-the-counter [OTC]) medicine, such as that for colds (including nose drops or sprays), cough, asthma, hay fever, and appetite control, “keep awake” products, or products that make you sleepy.
Also, for at least 2 weeks after you stop taking this medicine, these foods, beverages, and other medicines may continue to react with selegiline if it was taken in doses higher than those usually used for Parkinson's disease.
Check with your doctor or hospital emergency room immediately if severe headache, stiff neck, chest pains, fast heartbeat, or nausea and vomiting occur while you are taking this medicine. These may be symptoms of a serious side effect that should have a doctor's attention.
This medicine may make you drowsy. It may even cause you to fall asleep without warning while you drive, talk, or eat. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.
Check with your doctor right away if you have pain when swallowing, pain in the mouth, redness, swelling, or sores in your mouth while receiving this medicine.
Selegiline may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having unusual urges, such as gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while using this medicine.
Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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:
More common
- Twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
Less common
- Blurred vision
- bruising
- chest pain or tightness
- decreased urine
- difficult or labored breathing
- difficulty with swallowing
- discouragement
- dizziness
- dry mouth
- feeling sad or empty
- headache
- increased thirst
- irregular heartbeat
- irritability
- large, flat, blue or purplish patches in the skin
- loss of appetite
- loss of interest or pleasure
- mood changes
- muscle pain or cramps
- nausea or vomiting
- nervousness
- numbness or tingling in the hands, feet, or lips
- pounding in the ears
- seeing, hearing, or feeling things that are not there
- seizures
- shakiness and unsteady walk
- shakiness in the legs, arms, hands, or feet
- sleepiness or unusual drowsiness
- slow or fast heartbeat
- swelling or inflammation of the mouth
- tiredness
- trouble concentrating
- trouble sleeping
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual tiredness or weakness
Incidence not known
- Agitation
- diarrhea
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fever
- overactive reflexes
- poor coordination
- restlessness
- shivering
- sweating
- talking or acting with excitement you cannot control
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Agitation
- chest pain
- difficulty opening the mouth or lockjaw
- dizziness (severe) or fainting
- fast or irregular pulse (continuing)
- high fever
- high or low blood pressure
- severe spasm where the head and heels are bent backward and the body arched forward
- trouble breathing
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:
More common
- Dry skin
- hives, itching, or skin rash
- itching, scaling, severe redness, soreness, or swelling of the skin
- runny or stuffy nose
- sneezing
Less common
- Acid or sour stomach
- back pain
- belching
- bloated or full feeling
- body aches or pain
- congestion
- cough
- difficulty having a bowel movement (stool)
- difficulty with moving
- dryness or soreness of the throat
- excess air or gas in the stomach or intestines
- heartburn
- hoarseness
- indigestion
- joint pain
- leg cramps
- muscle aches, cramps, pains, or stiffness
- passing gas
- stomach discomfort, upset, or pain
- swollen joints
- tender, swollen glands in the neck
- tooth problems
- voice changes
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.
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