Carbidopa and levodopa may be used alone or in combination with other medication to treat symptoms of Parkinson’s disease, such as stiffness or tremors in adults.

Carbidopa and levodopa is also used in adults to treat Parkinson’s disease caused by infection, carbon monoxide poisoning or manganese intoxication.

Carbidopa and levodopa may also be used for purposes not listed in this medication guide.

Carbidopa and levodopa side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, aggressive, more active or talkative, or have thoughts about suicide or hurting yourself.

Some people taking carbidopa and levodopa have fallen asleep during normal daytime activities such as working or driving after starting carbidopa and levodopa and up to a year after. Tell your doctor if you have any problems with daytime sleepiness.

Carbidopa and levodopa may cause serious side effects. Call your doctor at once if you have:

• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• uncontrolled muscle movements, blurred vision, eye pain or redness, seeing halos around lights; or
• severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Your dose may be reduced or permanently discontinued if you have certain side effects.

Common side effects of carbidopa and levodopa may include:

• uncontrolled muscle movements;
• dry mouth, anxiety, headache, dizziness;
• drops in blood pressure or feeling light-headed when standing up;
• sleep problems (insomnia), strange dreams, muscle contractions; or
• nausea, vomiting, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Do not use this medicine if you have used a MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

Some people have thoughts about suicide while taking carbidopa and levodopa. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Before taking this medicine

You should not use carbidopa and levodopa if you are allergic to it or any of its ingredients, or if you have narrow-angle glaucoma.

Do not use carbidopa and levodopa if you have used a MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take carbidopa and levodopa.

If you already take levodopa, you must stop taking it at least 12 hours before you start taking carbidopa and levodopa.

Tell your doctor if you have or have ever had:

• an endocrine disease, heart disease, high blood pressure, or heart attack;
• asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;
• skin cancer (melanoma), a stomach or intestinal ulcer;
• glaucoma, depression, mental illness, or psychosis;
• if you received general anesthesia; or
• liver or kidney disease.

The orally disintegrating tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU). Ask your doctor about your risk.

Some people have thoughts about suicide while taking carbidopa and levodopa. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Ask your doctor about skin symptoms to watch for.

It is not known if carbidopa and levodopa will harm an unborn baby. The benefit of this treatment may outweigh any risks to the mother and baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using carbidopa and levodopa.

How should I take carbidopa and levodopa?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Stop taking any other medications that contain carbidopa and levodopa when you start taking the extended-release form.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.

Take this medicine at evenly spaced intervals. Follow your doctor’s instructions about whether to take your medication with food or on an empty stomach.

Swallow the capsule whole and do not crush, chew, break, or open it. The tablet is sometimes broken in half to give the correct dose. Always swallow a whole or half tablet without chewing or crushing.

If you cannot swallow an extended-release capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing.

Remove an orally disintegrating tablet from the package with dry hands only when you are ready to use the medicine. Allow the orally disintegrating tablet to dissolve in your mouth without chewing.

It may take up to several weeks before your symptoms improve. Tell your doctor if your symptoms do not improve or if the effects of this medicine wear off quickly between doses.

Carbidopa and levodopa will most likely darken the color of your saliva, urine, or sweat to an orange or red color. This is a normal effect and is not harmful. This may also cause stains to your underwear that may be permanent.

You may need frequent medical tests and your doctor will need to check your progress on a regular basis.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using carbidopa and levodopa.

Do not stop using carbidopa and levodopa suddenly, or you could have unpleasant withdrawal symptoms (such as agitation, confusion, tingling). Ask your doctor before stopping the medicine.

You may need to follow a special diet. Learn about the foods you should eat or avoid.

Store tightly closed at room temperature, away from moisture, heat, and light.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking carbidopa and levodopa?

Avoid driving or hazardous activity until you know how carbidopa and levodopa will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries. Also avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Drinking alcohol with this medicine can cause side effects.

Avoid taking iron supplements, high-fat, or high-calorie meals before or after taking carbidopa and levodopa. These can make it harder for your body to absorb carbidopa and levodopa.

What other drugs will affect carbidopa and levodopa?

Using carbidopa and levodopa with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

When you start or stop taking carbidopa and levodopa, your doctor may need to adjust the doses of other medicines you use on a regular basis.

Tell your doctor about all your other medicines, especially:

• phenytoin, metoclopramide;
• papaverine, isoniazid, selegiline, reserpine, tetrabenazine;
• vitamin or mineral supplements that contain iron; or
• medicine to treat blood pressure, nausea or vomiting, anxiety, mood disorders, or mental illness such as schizophrenia.

Azilect works by increasing the levels of certain chemicals in the brain.

Azilect is used to treat symptoms of Parkinson’s disease (stiffness, tremors, spasms, poor muscle control).

Azilect is sometimes used with another medicine called levodopa.

Warnings

Do not Azilect if you have used a MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, selegiline, or tranylcypromine.

Tell your doctor about all medicines you have used in the 2-week period before you start taking Azilect. Many drugs can interact with rasagiline, and some drugs should not be used together.

Before you take this medicine, tell your doctor if you have liver disease.

There are many other drugs that can cause serious medical problems if you take them together with Azilect. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

While you are taking this medicine and for 2 weeks after you stop taking it, you may not be able to eat certain types of cheese. Follow your doctor’s instructions. Rasagiline may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Before taking this medicine

You should not take Azilect if you are allergic to rasagiline.

Do not use Azilect if you have used any other MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, selegiline, tranylcypromine, and others.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with Azilect. Your doctor may change your treatment plan if you also use:

• cyclobenzaprine (a muscle relaxer);
• dextromethorphan (contained in many over-the-counter cough medicines);
• meperidine (Demerol);
• methadone;
• St. John’s wort; or
• tramadol (Ultram, Ultracet).

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with rasagiline and cause a serious condition called serotonin syndrome.

To make sure Azilect is safe for you, tell your doctor if you have ever had:

• high or low blood pressure;
• liver or kidney disease; or
• if you take ciprofloxacin (an antibiotic).

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Ask your doctor about skin symptoms to watch for.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

How should I take Azilect?

Take Azilect exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

If you take Azilect alone, your dose may be different than if you take it with other Parkinson’s medications. Follow your doctor’s dosing instructions very carefully.

Azilect may be only part of a complete program of treatment that also includes a special diet. Follow the diet plan created for you by your doctor or nutrition counselor.

Get familiar with the list of foods you should avoid to help prevent certain side effects of rasagiline.

Call your doctor if your Parkinson’s symptoms do not improve, or if they get worse while using Azilect.

Store at room temperature away from moisture and heat.

Do not stop using Azilect suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Dosing information

Usual Adult Dose for Parkinson’s Disease:

Monotherapy:
Recommended dose: 1 mg orally once a day

Adjunct therapy:
Initial dose (in patients on concomitant levodopa): 0.5 mg orally once a day
Initial dose (in patients not on concomitant levodopa): 1 mg orally once a day
Maintenance dose: 0.5 mg to 1 mg orally once a day

Maximum dose: 1 mg orally once a day

Comments: May be used as adjunct therapy in patients on levodopa therapy, with or without other drugs used in the treatment of Parkinson’s disease.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of rasagiline can be fatal.

Overdose symptoms may include drowsiness, dizziness, severe headache, rapid pulse, feeling agitated or irritable, muscle spasms in your neck or jaw, sweating, cold or clammy skin, shallow breathing, fainting, or seizure (convulsions). These symptoms may be delayed for 12 to 24 hours after an overdose.

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid drinking alcohol, especially red wine, vermouth, and tap beers or ale.

Also avoid eating foods that are high in tyramine, such as aged cheeses, fava beans, soy sauce, herring, pickled or processed meats and fish, and meats that are aged, dried, smoked, or fermented. Eating tyramine while you are taking Azilect can raise your blood pressure to dangerous levels which could cause life-threatening side effects.

Azilect side effects

Get emergency medical help if you have signs of an allergic reaction to Azilect: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe headache, blurred vision, pounding in your neck or ears;
• extreme drowsiness or falling asleep suddenly, even after feeling alert;
• unusual changes in mood or behavior;
• hallucinations;
• a light-headed feeling, like you might pass out; or
• worsening symptoms of Parkinson’s disease (especially uncontrolled muscle movements).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Some people taking Azilect with levodopa have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common Azilect side effects may include:

• depressed mood;
• sleep problems (insomnia), strange dreams;
• involuntary muscle movements;
• loss of appetite, weight loss;
• indigestion, stomach pain, nausea, vomiting, constipation;
• joint pain or stiffness;
• rash;
• cough or other flu symptoms;
• dry mouth; or
• swelling in your hands or feet.

What is Gocovri?

Gocovri is a prescription medicine containing amantadine.

Gocovri is used to treat dyskinesia (sudden uncontrolled movements) in people with Parkinson’s disease who are treated with levodopa or levodopa plus other medicines that increase the effects of dopamine in the brain.

Gocovri is also used with the medicines levodopa and carbidopa in people with Parkinson’s disease who are having “off” episodes.

Gocovri may also be used for purposes not listed in this medication guide.

Warnings

You should not use Gocovri if you received a nasal flu vaccine in the past 14 days.

Do not receive a nasal flu vaccine while taking Gocovri, and for at least 48 hours after your last dose.

Before taking this medicine

You should not use Gocovri if you are allergic to amantadine, or if:

• you have severe kidney disease; or
• you have received a “live” nasal flu vaccine (FluMist) within the past 14 days.

Tell your doctor if you have ever had:

• kidney disease;
• daytime drowsiness (caused by a sleep disorder or taking certain medicines);
• congestive heart failure;
• eczema;
• glaucoma;
• liver disease;
• a seizure;
• low blood pressure, fainting spells;
• alcoholism or drug addiction; or
• mental illness, psychosis, or suicidal thoughts or actions.

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether Gocovri will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breast-feed while using Gocovri.

How should I take Gocovri?

Take Gocovri exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take Gocovri with or without food. You may need to take this medicine only at bedtime. Follow your doctor’s instructions.

Swallow the capsule whole and do not crush, chew, or break it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

Call your doctor if your symptoms do not improve, or if you have a fever with a headache, cough, skin rash, or other new symptoms.

If you take Gocovri for Parkinson symptoms: You should not stop using this medicine suddenly or your condition may become worse. Stopping suddenly may also cause unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Gocovri.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Dosing information

Usual Adult Dose for Parkinson’s Disease
Extended-release (ER) capsules:
Initial dose: 137 mg orally once a day for 1 week, then 274 mg orally once a day; doses should be taken at bedtime.
Take orally once a day at bedtime with or without food
-Swallow whole; do not crush, chew, or divide capsules
-If unable to swallow whole, may open the capsule and sprinkle the entire contents on a small amount of soft food and swallow immediately without chewing.
-Concomitant use with alcohol is not recommended as it may result in dose-dumping.

Renal Dose Adjustments:
Extended-release capsules:
-Mild renal impairment (CrCl 60 to 89 mL/min/1.73 m2): No adjustment recommended
-Moderate renal impairment (CrCl 30 to 59 mL/min/1.73 m2): Initial dose: 68.5 mg orally once a day at bedtime; increase after 1 week to 137 mg/day if needed
-Severe renal impairment (CrCl 15 to 29 mL/min/1.73 m2): 68.5 mg orally once a day at bedtime
-ESRD: Contraindicated
Note: extended-release tablets and extended-release capsules have different release profiles; they are not interchangeable.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Call your doctor if you miss several doses in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of Gocovri can be fatal.

Overdose symptoms may include confusion, agitation, behavior changes, hallucinations, severe headache or pounding in your ears, muscle stiffness, problems with balance or walking, trouble breathing, fast heartbeats, or seizure.

What to avoid

Do not drink alcohol. Dangerous side effects could occur.

Avoid driving or operating machinery until you know how Gocovri will affect you. Amantadine may impair your thinking or reactions. Some people taking Gocovri have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with amantadine can increase your risk of unpleasant side effects.

Gocovri side effects

Get emergency medical help if you have signs of an allergic reaction to Gocovri: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• extreme drowsiness, falling asleep suddenly even after feeling alert;
• a light-headed feeling, like you might pass out;
• shortness of breath (even with mild exertion), swelling in your hands or feet;
• painful or difficult urination;
• depression, agitation, aggression, behavior changes, hallucinations, thoughts of hurting yourself;
• a seizure; or
• severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking Gocovri. Talk with your doctor if this occurs.

Side effects may be more likely in older adults.

Common Gocovri side effects may include:

• dizziness, falls;
• dry mouth;
• swelling in your legs or feet;
• nausea, constipation; or
• sleep problems (insomnia).

What is Inbrija?

Inbrija is an inhaled prescription medicine used to treat symptoms of Parkinson’s disease that come back (OFF episodes) while you are taking another medicine called carbidopa and levodopa.

Inbrija is not to be used in place of any medicine you take daily for Parkinson’s disease.

It is not known if Inbrija is safe or effective in children.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Do not use Inbrija if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

To make sure Inbrija is safe for you, tell your doctor if you have:

• asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;
• glaucoma;
• involuntary muscle movements;
• a sleep disorder that causes daytime sleepiness;
• dizziness, nausea, or fainting spells when standing from a sitting or lying position;
• mental illness or psychosis; or
• an intense urge or compulsive behavior (such as sexual urges, binge eating, gambling, or spending money).

It is not known whether Inbrija inhalation will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I use Inbrija?

Use Inbrija exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Inbrija is for use only in people who are currently taking carbidopa and levodopa. Do not stop taking your daily Parkinson’s medications or change your dosing schedule without your doctor’s advice.

For best results, use Inbrija when an “off episode” begins (when your Parkinson’s symptoms start to return). Do not use Inbrija more than 5 times per day.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Inbrija is a powder that comes with a special inhaler device and blister packs containing capsules of the medicine. You will load 2 capsules (one at a time) into the inhaler device each time you use the medicine. Pushing the handle of the device onto the mouthpiece will pierce the capsule and release the medicine into the inhaler.

Do not swallow a Inbrija capsule. It is for use only in the Inbrija inhaler device.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Inbrija.

Do not stop using Inbrija suddenly after long-term regular use, or you could have unpleasant withdrawal symptoms (fever, confusion, muscle stiffness, changes in breathing and heart rate). Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep each capsule in the blister pack until you ready to load the inhaler device. Do not store capsules inside the device.

Throw away the device when your capsules run out. Always use the inhaler device that comes with each new prescription.

Dosing information

Usual Adult Dose for Parkinson’s Disease:

84 mg via oral inhalation as needed when OFF period starts to return; may dose up to 5 times a day
Maximum dose per OFF period: 84 mg
Maximum daily dose: 420 mg

Comments:
-Therapy should be taken when symptoms of an OFF period start to return.
-This drug has shown efficacy only in combination with levodopa/carbidopa therapy.
-Oral inhalation capsules should only be used with the Inbrija(R) inhaler; capsules should not be swallowed whole as the intended effect will not be obtained.

Use: For the intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with carbidopa/levodopa.

What happens if I miss a dose?

Since Inbrija is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include muscle pain or weakness, fever, dark colored urine, little or no urination, fast heartbeats, or fainting.

What should I avoid while using Inbrija?

Avoid driving or hazardous activity until you know how Inbrija will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Inbrija side effects

Get emergency medical help if you have signs of an allergic reaction to Inbrija: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Inbrija and call your doctor or seek emergency medical attention if you have a wheezing, chest tightness, or trouble breathing after inhaling this medicine.

Call your doctor at once if you have:

• extreme drowsiness, falling asleep suddenly (even after feeling alert);
• nausea, sweating, and a light-headed feeling (like you might pass out);
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• confusion, paranoia, hallucinations (seeing or hearing things that are not real);
• unusual thoughts or behavior;
• trouble sleeping, or increased dreaming;
• agitation, aggression; or
• increased sexual urges, unusual urges to gamble, or other intense urges.

Some people using this medicine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. This side effect has occurred up to 1 year after the start of treatment with Inbrija. Tell your doctor if you have any problems with daytime drowsiness.

Common Inbrija side effects may include:

• cough;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• nausea; or
• sweat, urine, or saliva that appears dark in color.

What is Kynmobi?

Kynmobi is a prescription medicine used to treat short-term (acute), intermittent “off” episodes in people with Parkinson’s disease (PD).

It is not known if this medicine is safe and effective in children.

Who should not take Kynmobi?

Do not take Kynmobi if you are:

• taking certain medicines to treat nausea called 5HT3 antagonists including ondansetron, granisetron, dolasetron, palonosetron, and alosetron.
• People taking ondansetron together with apomorphine, the active ingredient in Kynmobi, have had very low blood pressure and lost consciousness or “blacked out.”
• allergic to apomorphine hydrochloride or to any of the other ingredients. See the end of the page for a complete list of ingredients.
• Kynmobi also contains a sulfite called sodium metabisulfite. Sulfites can cause severe, life-threatening allergic reactions in some people. An allergy to sulfites is not the same as an allergy to sulfa. People with asthma are more likely to be allergic to sulfites.
  Call your healthcare provider or get emergency help right away if you get any of the following symptoms of a severe life-threatening allergic reaction:
  • hives
  • itching
  • rash
  • swelling of the lips, tongue, and mouth
  • redness of your face (flushing)
  • throat tightness
  • trouble breathing or swallowing

Before taking Kynmobi

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have difficulty staying awake during the daytime.
• have dizziness.
• have fainting spells.
• have low blood pressure.
• have asthma.
• are allergic to any medicines containing sulfites
• have liver problems.
• have kidney problems.
• have heart problems.
• have had a stroke or other brain problems.
• have a mental problem called a major psychotic disorder.
• drink alcohol.
• are pregnant or plan to become pregnant. It is not known if Kynmobi will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Kynmobi passes into your breast milk. You and your healthcare provider should decide if you will take Kynmobi or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription medicines and, over-the-counter medicines, vitamins, and herbal supplements.

Kynmobi may affect the way other medicines work, and other medicines can affect how Kynmobi works.

Taking Kynmobi with other medicines may cause serious side effects.

• If you take nitroglycerin under your tongue (sublingual) while using Kynmobi, your blood pressure may decrease and cause dizziness. You should lie down before and after taking sublingual nitroglycerin.

Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take Kynmobi?

• Read the step-by-step Instructions for Use that comes with your prescription.
• Take Kynmobi exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much to take and teach you the right way to take it.
• Your healthcare provider may change your dose if needed.
• Do not change your dose or take it more often than prescribed unless your healthcare provider has told you to.
• Do not take more than 1 dose of Kynmobi to treat a “OFF” episode.
• Do not take another dose of Kynmobi sooner than 2 hours after the last dose.
• Do not take Kynmobi more than 5 times a day.
• Do not cut, chew or swallow the sublingual film.

Your healthcare provider may prescribe another medicine for nausea called an antiemetic to take while you are taking Kynmobi. Antiemetic medicines help to decrease the symptoms of nausea and vomiting that can happen during treatment.

What should I avoid while taking Kynmobi?

• Do not drink alcohol while you are taking Kynmobi. It can increase your chance of developing serious side effects.
• Do not take medicines that make you sleepy while you are using Kynmobi.
• Do not drive, operate machinery, or do other dangerous activities until you know how Kynmobi affects you.
• Do not change your body position too fast. Get up slowly from sitting or lying. Kynmobi can lower your blood pressure and cause dizziness or fainting.

What are the possible side effects of Kynmobi?

Kynmobi can cause serious side effects, including:

• nausea and vomiting. Nausea is a common side effect. Nausea and vomiting can happen with Kynmobi. Your healthcare provider may prescribe a medicine called an antiemetic, such as trimethobenzamide, to help prevent nausea and vomiting. Some patients can stop taking trimethobenzamide after using Kynmobi, when advised by your healthcare provider. Some patients may need to keep taking trimethobenzamide to help treat nausea and vomiting. Talk to your healthcare provider before you stop taking trimethobenzamide.
• sleepiness or falling asleep during the day. Sleepiness is a serious and common side effect. Some people treated with Kynmobi may get sleepy during the day or fall asleep without warning while doing everyday activities such as talking, eating, or driving a car. allergic reactions.
• dizziness. Dizziness is a serious, and common side effect. Kynmobi may lower your blood pressure and cause dizziness. Dizziness can happen when treatment is started or when the dose is increased. Do not get up too fast from sitting or after lying down, especially if you have been sitting or lying down for a long period of time.
• mouth (oral) irritation. Mouth (oral) irritation is a common side effect. You should call your healthcare provider if you develop any of these signs or symptoms:
  • redness
  • swelling
  • mouth sores (ulceration)
  • pain
  • dryness of the mouth, lips or tongue pain with swallowing
    These signs and symptoms may go away if treatment is stopped.
• falls. The changes that can happen with PD, and the effects of some PD medicines, can increase the risk of falling. Kynmobi may also increase your risk of falling.
• hallucinations or psychotic-like behavior. Kynmobi may cause or make psychotic-like behavior worse including hallucinations (seeing or hearing things that are not real), confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs (believing things that are not real), and disorganized thinking.
  strong (intense) urges. Some people with PD have reported new or strong uncontrollable urges to gamble, increased sexual urges, increased urges to spend money (compulsive shopping), and other intense urges, while taking PD medicines, including Kynmobi. If you or your family members notice that you have strong urges, talk to your healthcare provider. The strong urges may go away if your Kynmobi dose is lowered or stopped.
• high fever and confusion. Kynmobi may cause a problem that can happen in people who suddenly lower their dose, stop using, or change their dose. Symptoms include:
  • very high fever
  • stiff muscles
  • confusion
  • changes in breathing and heartbeat
    Do not stop taking Kynmobi or change your dose unless you are told to do so by your healthcare provider.
• heart problems. If you have shortness of breath, fast heartbeat, chest pain, or feel like you are going to pass out (faint) while taking Kynmobi, call your healthcare provider or get emergency help right away.
• tissue changes (fibrotic complications). Some people have had changes in the tissues of their pelvis, lungs, and heart valves when taking medicines called nonergot derived dopamine agonists like Kynmobi.
• prolonged painful erections (priapism). Kynmobi may cause prolonged, painful erections in some people. If you have a prolonged and painful erection you should call your healthcare provider or go to the nearest hospital emergency room right away.

If you have any of these symptoms, stop treatment and call your healthcare provider right away before taking another dose.

The most common side effects include:

• nausea
• sleepiness
• dizziness
• mouth swelling, pain, or sores

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA .

How should I store Kynmobi?

• Store at room temperature between 68°F to 77°F (20°C to 25°C).
• Store film in the foil pouch until you are ready to take it.

Keep medicines out of the reach of children and pets.

General information about the safe and effective use of Kynmobi.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information that is written for health professionals.

What are the ingredients in Kynmobi?

Active ingredient: apomorphine hydrochloride
Inactive ingredients: disodium EDTA, dihydrate, FD& C Blue #1, glycerol, glyceryl monostearate, hydroxyethyl cellulose, hypromellose, maltodextrin, (-) menthol, pyridoxine hydrochloride, sodium hydroxide, sodium metabisulfite, sucralose, and white ink.

INSTRUCTIONS FOR USE

1. Open Carton Open carton from the end with the arrow. Push in both tabs to unlock. Hold tabs in. Lift up tray handle. Pull out tray.
2. Remove Pouch Push finger up through the hole in the bottom of tray. Firmly pull one pouch from the tray.
3. Close Carton To close, slide tray in until it clicks. This ensures the carton remains child resistant.
4. Your healthcare provider has told you to take Kynmobi film 10 mg, 15 mg, 20 mg, 25 mg, or 30 mg.
5. Drink water. Before taking each film, drink water to moisten your mouth. This helps the film dissolve more easily
6. Open the foil pouch. Hold the wing tabs on the pouch between your thumb and pointer finger of each hand. Make sure to place your fingers directly on the raised dots on each wing tab. Gently pull the wing tabs apart to open the pouch.
7. Take film out of the pouch. Hold film between your fingers by the outside edges and remove the entire film from the pouch. Kynmobi must be taken whole. Throw away film if it is broken or missing pieces. Use a new film for your dose.
8. Place entire film under your tongue. Place Kynmobi as far back under your tongue as you can. Close your mouth.
9. Keep Kynmobi in place until it has completely dissolved. Do not chew or swallow. Do not swallow your saliva or talk while film is dissolving because this can affect how well the medicine is absorbed.
10. Open your mouth to check if film has completely dissolved. It can take about 3 minutes for film to dissolve. After the film completely dissolves, you may swallow.

What is levodopa inhalation?

Levodopa inhalation is used to treat symptoms of Parkinson’s disease that come back (OFF episodes) while you are taking another medicine called carbidopa and levodopa.

Levodopa inhalation is not to be used in place of any medicine you take daily for Parkinson’s disease.

Levodopa inhalation may also be used for purposes not listed in this medication guide.

Levodopa inhalation side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using levodopa inhalation and call your doctor or seek emergency medical attention if you have a wheezing, chest tightness, or trouble breathing after inhaling levodopa inhalation.

Levodopa inhalation may cause serious side effects. Call your doctor at once if you have:

• extreme drowsiness, falling asleep suddenly (even after feeling alert);
• nausea, sweating, and a light-headed feeling (like you might pass out);
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• confusion, paranoia, hallucinations (seeing or hearing things that are not real);
• unusual thoughts or behavior;
• trouble sleeping, or increased dreaming;
• agitation, aggression; or
• increased sexual urges, unusual urges to gamble, or other intense urges.

Some people using this medicine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. This side effect has occurred up to 1 year after the start of treatment with levodopa inhalation. Tell your doctor if you have any problems with daytime drowsiness.

Common side effects of levodopa inhalation may include:

• cough;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• nausea; or
• sweat, urine, or saliva that appears dark in color.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Do not use levodopa inhalation if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you have ever had:

• asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;
• glaucoma;
• involuntary muscle movements;
• a sleep disorder that causes daytime sleepiness;
• dizziness, nausea, or fainting spells when standing from a sitting or lying position;
• mental illness or psychosis; or
• an intense urge or compulsive behavior (such as sexual urges, binge eating, gambling, or spending money).

It is not known whether levodopa inhalation will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I use levodopa inhalation?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Levodopa inhalation is for use only in people who are currently taking carbidopa and levodopa. Do not stop taking your daily Parkinson’s medications or change your dosing schedule without your doctor’s advice.

For best results, use levodopa inhalation when an “off episode” begins (when your Parkinson’s symptoms start to return). Do not use levodopa inhalation more than 5 times per day.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Levodopa inhalation (Inbrija) is a powder that comes with a special inhaler device and blister packs containing capsules of the medicine. You will load 2 capsules (one at a time) into the inhaler device each time you use the medicine. Pushing the handle of the device onto the mouthpiece will pierce the capsule and release the medicine into the inhaler.

Do not swallow a levodopa inhalation capsule. It is for use only in the Inbrija inhaler device.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using levodopa inhalation.

Do not stop using levodopa inhalation suddenly after long-term regular use, or you could have unpleasant withdrawal symptoms (fever, confusion, muscle stiffness, changes in breathing and heart rate). Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep each capsule in the blister pack until you ready to load the inhaler device. Do not store capsules inside the device.

Throw away the device when your capsules run out. Always use the inhaler device that comes with each new prescription.

Levodopa inhalation dosing information

Usual Adult Dose for Parkinson’s Disease:

84 mg via oral inhalation as needed when OFF period starts to return; may dose up to 5 times a day
Maximum dose per OFF period: 84 mg
Maximum daily dose: 420 mg

Comments:
-Therapy should be taken when symptoms of an OFF period start to return.
-This drug has shown efficacy only in combination with levodopa/carbidopa therapy.
-Oral inhalation capsules should only be used with the Inbrija(R) inhaler; capsules should not be swallowed whole as the intended effect will not be obtained.

Use: For the intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with carbidopa/levodopa.

What happens if I miss a dose?

Since levodopa inhalation is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include muscle pain or weakness, fever, dark colored urine, little or no urination, fast heartbeats, or fainting.

What should I avoid while using levodopa inhalation?

Avoid driving or hazardous activity until you know how levodopa inhalation will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

What other drugs will affect levodopa inhalation?

Using levodopa inhalation with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• isoniazid;
• metoclopramide;
• risperidone or other antipsychotic medication;
• iron medication, such as ferrous fumarate, ferrous gluconate, or ferrous sulfate;
• a multivitamin or mineral supplement that contains iron; or
• other medicines to treat Parkinson’s disease.

What is Neupro?

Neupro has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson’s disease.

Neupro skin patches are used to treat symptoms of Parkinson’s disease, such as stiffness, tremors, muscle spasms, and poor muscle control.

Neupro is also used to treat restless legs syndrome (RLS).

Warnings

Some people using Neupro have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how rotigotine will affect you, be careful if you drive or do anything that requires you to be awake and alert.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while using Neupro.

Do not stop using Neupro suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using Neupro. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by rotigotine. Tell your doctor if you regularly use any of these other medicines. Drinking alcohol can increase certain side effects of rotigotine. The Neupro patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test. Neupro may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you have hallucinations.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Neupro if you are allergic to rotigotine.

To make sure Neupro is safe for you, tell your doctor if you have:

• asthma or a sulfite allergy;
• high or low blood pressure;
• heart problems;
• kidney disease;
• schizophrenia, bipolar disorder, or psychosis;
• narcolepsy or other sleep disorder; or
• if you feel light-headed or nauseated when you stand up.

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breast-feed while using rotigotine.

How should I use Neupro?

Use Neupro skin patches exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Apply the patch to clean, dry, and hairless skin. Avoid placing the patch where it will be rubbed by a waistband or tight clothing. Press the patch firmly into place for about 30 seconds. You may leave the patch on while bathing, showering, or swimming.

Remove the skin patch after 24 hours and replace it with a new one. Choose a different place on your body to wear the patch each time you put on a new one. Do not use the same skin area twice within 14 days.

If a patch falls off, put a new patch on a different place on your body and wear it the rest of the day. Then replace the patch the next day at your regular time.

Wash your hands with soap and water after applying or removing the patch.

Keep used and unused Neupro skin patches out of the reach of children or pets.

If you are using Neupro for RLS, call your doctor if your symptoms get worse, or if they start earlier in the day than usual.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Neupro.

The Neupro patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

Do not stop using Neupro suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Keep the skin patch in its sealed pouch until you are ready to use it. Store the pouches at room temperature away from heat and moisture.

After removing a patch, fold it in half so it sticks together and throw it away in a place where children or pets cannot get to it.

Dosing information

Usual Adult Dose for Parkinson’s Disease:

Initial doses:
Early-stage Parkinson’s disease: Apply 2 mg topically once a day
Advanced-stage Parkinson’s disease: Apply 4 mg topically once a day

Maintenance dose: Increase weekly in 2 mg/24 hours increments if additional therapeutic effect is needed
Lowest effective dose: 4 mg/24 hours
Maximum dose for Early-stage Parkinson’s disease: 6 mg/24 hours
Maximum dose for Advanced-stage Parkinson’s disease: 8 mg/24 hours

Comments:
-Upon discontinuation, reduce the daily dose by a maximum of 2 mg every 24 hours, if possible; reduce the dose every other day until withdrawal is complete.

Use: Treatment of Parkinson’s disease

Usual Adult Dose for Restless Legs Syndrome:

Initial dose: Apply 1 mg topically once a day
Maintenance dose: Increase weekly in 1 mg/24 hours increments if additional therapeutic effect is needed
Lowest effective dose: 1 mg/24 hours
Maximum dose: 3 mg/24 hours

Comments:
-Upon discontinuation, reduce the daily dose by a maximum of 1 mg every 24 hours, if possible; reduce the dose every other day until withdrawal is complete

Use: Treatment of moderate-to-severe primary Restless Legs Syndrome

What happens if I miss a dose?

If you forget to change a patch on your scheduled day, remove and replace the patch as soon as you remember. Wear the new patch until your next regular patch-changing time. Do not change your schedule, even if you wear the new patch for less than 24 hours.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Neupro?

Drinking alcohol with this medicine can increase side effects.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid applying a patch to skin that is irritated, or to skin where you have applied lotion, oil, cream, ointment, or powder.

Do not expose the skin patch to heat while you are wearing it. This includes a hot tub, heating pad, sauna, or heated water bed. Heat can increase the amount of drug absorbed through your skin and may cause harmful effects.

Neupro side effects

Get emergency medical help if you have signs of an allergic reaction to Neupro: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe skin irritation that does not clear up within several hours after removing a skin patch;
• extreme drowsiness, falling asleep suddenly, even after feeling alert;
• a light-headed feeling, like you might pass out;
• agitation, confusion, hallucinations, paranoia (most commonly in elderly people);
• fast heart rate;
• increased sexual urges, unusual urges to gamble, or other intense urges;
• unusual thoughts or behavior; or
• uncontrolled muscle movements.

Some people using Neupro have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

Common Neupro side effects may include:

• nausea, vomiting, loss of appetite;
• headache, dizziness, drowsiness;
• vision problems;
• swelling in your hands or feet, rapid weight gain;
• increased sweating;
• sleep problems (insomnia); or
• redness, itching, or swelling where a patch was worn.

What is pramipexole?

Pramipexole has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson’s disease.

Pramipexole is used to treat symptoms of Parkinson’s disease (stiffness, tremors, muscle spasms, and poor muscle control). Pramipexole is also used to treat restless legs syndrome (RLS).

Only immediate-release pramipexole (Mirapex) is approved to treat either Parkinson symptoms or RLS. Extended-release pramipexole (Mirapex ER) is approved only to treat Parkinson symptoms.

Parkinson’s and RLS are two separate disorders. Having one of these conditions will not cause you to have the other condition.

Pramipexole may also be used for purposes not listed in this medication guide.

Pramipexole side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking pramipexole have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

Pramipexole may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• hallucinations (seeing or hearing things that are not real);
• extreme drowsiness, falling asleep suddenly, even after feeling alert;
• tremors, twitching or uncontrollable muscle movements;
• unexplained muscle pain, tenderness, or weakness;
• vision problems; or
• posture changes you cannot control, such as involuntary bending forward of your neck, bending forward at the waist, or tilting sideways when you sit, stand, or walk.

Side effects such as confusion or hallucinations may be more likely in older adults.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking pramipexole. Talk with your doctor if this occurs.

Common side effects of pramipexole may include:

• muscle spasm or muscle weakness;
• drowsiness, dizziness, weakness;
• confusion, memory problems;
• dry mouth;
• nausea, constipation;
• increased urination; or
• sleep problems (insomnia), unusual dreams.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use pramipexole if you are allergic to it.

Tell your doctor if you have ever had:

• low blood pressure;
• dizziness after getting up too fast;
• daytime drowsiness;
• kidney disease; or
• problems controlling your muscle movements.

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether pramipexole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using pramipexole.

It is not known whether pramipexole passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take pramipexole?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

If you are taking immediate-release pramipexole (Mirapex) you should not take extended-release pramipexole (Mirapex ER) at the same time.

The dose and timing of pramipexole in treating Parkinson’s disease is different from the dose and timing in treating RLS. Follow the directions on your prescription label. Ask your pharmacist if you have any questions about the kind of pramipexole you receive at the pharmacy.

Pramipexole can be taken with or without food. Take the medication with food if it upsets your stomach.

Do not crush, chew, or break an extended-release tablet (Mirapex ER). Swallow it whole.

If you are taking this medication for RLS, tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

Do not stop using pramipexole suddenly, or you could have unpleasant withdrawal symptoms. Follow your doctor’s instructions about tapering your dose.

Store at room temperature away from moisture, heat, and light.

Pramipexole dosing information

Usual Adult Dose for Parkinson’s Disease:

Immediate-release:
Initial dose: 0.125 mg orally three times a day
Titration: Increase gradually in small dose increments no more frequently than ever 5 to 7 days
Maintenance dose: 1.5 to 4.5 mg per day based on efficacy and tolerability
Maximum dose: 4.5 mg per day

Comment: The following dose titration was used in clinical trials:
Week 2, 0.25 mg 3 times a day
Week 3, 0.5 mg 3 times a day
Week 4, 0.75 mg 3 times a day
Week 5, 1 mg 3 times a day
Week 6, 1.25 mg 3 times a day
Week 7, 1.5 mg 3 times a day.
-When used in combination with levodopa, the levodopa dose was reduced by an average of 27% from baseline providing a concomitant dose of approximately 800 mg per day.

Extended-release:
Initial dose: 0.375 mg orally once a day
Titration: Increase gradually no more frequently than every 5 to 7 days, first dose increase should be to 0.75 mg once a day followed by incremental increases of 0.75 mg; assess therapeutic response and tolerability at a minimum of 5 days after each dose increase.
Maximum dose: 4.5 mg per day

SWITCHING FROM IMMEDIATE-RELEASE TO EXTENDED-RELEASE:
-Patients may be switched overnight from immediate-release tablets to extended-release tablets at the same daily dose; monitor closely to determine if dose adjustments may be necessary.

Comments:
-If a significant interruption in therapy occurs, re-titration may be necessary; upon discontinuation, doses should be tapered.

Use: Treatment of Parkinson’s disease

Usual Adult Dose for Restless Legs Syndrome:

Immediate-release:
Initial dose: 0.125 mg orally once a day 2 to 3 hours before bedtime
Titration: If needed, dose may be titrated upwards by increments of 0.125 mg every 4 to 7 days.
Maximum dose: 0.5 mg orally once a day

Comments:
-Extended-release tablets are not indicated for Restless Legs Syndrome.
-Doses of 0.75 mg once a day were used in clinical trials, but were not found to provide additional benefit as compared to the 0.5 mg dose.

Use: For the treatment of moderate to severe primary Restless Legs Syndrome.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking pramipexole?

Do not drink alcohol. Dangerous side effects can occur when alcohol is combined with pramipexole.

Avoid driving or hazardous activity until you know how pramipexole will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

What is Requip?

Requip is a dopaminergic agent and it has some of the same effects as dopamine, a naturally occuring chemical found in your body. Low levels of dopamine in the brain are associated with Parkinson’s disease.

Requip is used to treat symptoms of Parkinson’s disease (stiffness, tremors, muscle spasms, and poor muscle control). Ropinirole is also used to treat restless legs syndrome (RLS).

Only immediate-release Requip is approved to treat either Parkinson symptoms or RLS. Extended-release Requip XL is approved only to treat Parkinson symptoms.

Parkinson’s and RLS are two separate disorders. Having one of these conditions will not cause you to have the other condition.

Warnings

Requip may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking Requip.

Do not share this medication with another person, even if they have the same symptoms you do. Avoid drinking alcohol, which can increase some of the side effects of Requip. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by ropinirole. Tell your doctor if you regularly use any of these other medicines.

Requip may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you experience hallucinations.

Do not stop using Requip or change your dose without first talking to your doctor. You may have side effects such as fever, muscle stiffness, and confusion if you stop the medication suddenly or if you change doses.

Some people taking medicines for Parkinson’s disease have developed skin cancer (melanoma). However, people with Parkinson’s disease may have a higher risk than most people for developing melanoma. Talk to your doctor about your specific risk and what skin symptoms to watch for. You may need to have regular skin examinations.

Before taking this medicine

You should not use Requip if you are allergic to ropinirole.

To make sure Requip is safe for you, tell your doctor if you have:

• high or low blood pressure;
• kidney disease (or if you are on dialysis);
• heart disease, heart rhythm problems;
• a sleep disorder such as narcolepsy, or other conditions that may cause daytime sleepiness; or
• if you smoke.

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether Requip will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ropinirole passes into breast milk or if it could affect the nursing baby. Ropinirole may slow breast milk production. Tell your doctor if you are breast-feeding.

Requip is not approved for use by anyone younger than 18 years old.

How should I take Requip?

Take Requip exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

If you are taking immediate-release Requip tablets you should not take the extended-release tablets at the same time.

The dose and timing of Requip in treating Parkinson’s disease is different from the dose and timing in treating RLS. Follow the directions on your prescription label. Ask your pharmacist if you have any questions about the kind of ropinirole you receive at the pharmacy.

Requip can be taken with or without food. Take the medicine at the same time each day.

Do not crush, chew, or break an extended-release Requip XL tablet. Swallow the tablet whole.

Call your doctor if you see part of the tablet in your stool. This is a sign that your body may not have absorbed all of the medicine.

If you are taking this medicine for RLS, tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Do not stop using Requip suddenly, or you could have unpleasant withdrawal symptoms. Follow your doctor’s instructions about tapering your dose.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Dosing information

Usual Adult Dose of Requip for Parkinson’s Disease:

Immediate-release tablets:
Initial: 0.25 mg orally three times daily

After 1 week, the dose may be titrated up in weekly increments based on individual efficacy and tolerability:
Week 2: give 0.5 mg orally 3 times daily
Week 3: give 0.75 mg orally 3 times daily
Week 4: give 1 mg orally 3 times daily
After week 4, increase by 1.5 mg/day on a weekly basis up to a dose of 9 mg/day, then increase by 3 mg/day on a weekly basis up to a maximum daily dose of 24 mg
Maximum Dose: 8 mg orally three times a day

Extended-release tablets:
Initial: 2 mg orally once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals, depending on therapeutic response and tolerability
Maximum dose: 24 mg orally once a day

Patients may switch from immediate-release to extended-release: The initial dose of extended-release tablet should most closely match the total daily dose of immediate-release formulation. Following conversion, adjust dose depending on response and tolerability.

Comments:
-If significant interruption in therapy occurs, retitration may be necessary; upon discontinuation, this drug should be gradually tapered over a 7-day period.
-The extended-release tablet is designed to release medication over a 24-hour period, if rapid gastrointestinal transit occurs, and tablet residue is observed in the stool, there is a risk of incomplete release of medication,

Use: For the treatment of Parkinson’s disease.

Usual Adult Dose for Restless Legs Syndrome:

Immediate-release tablets:
Initial: 0.25 mg orally once a day on Day 1 and Day 2
Dose titration: May titrate as follows based on individual efficacy and tolerability:
Days 3 to 7: give 0.5 mg orally once a day
-Week 2: give 1 mg orally once a day
-Week 3: give 1.5 mg orally once a day
-Week 4: give 2 mg orally once a day
-Week 5: give 2.5 mg orally once a day
-Week 6: give 3 mg orally once a day
-Week 7: give 4 mg orally once a day
Maximum Dose: 4 mg orally once a day

Comments:
-Take 1 to 3 hours before bedtime.
-In clinical trials, this drug was not tapered prior to discontinuation.

Use: For the treatment of moderate to severe Restless Legs Syndrome.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Dizziness may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Drinking alcohol can increase certain side effects of Requip.

Requip side effects

Get emergency medical help if you have signs of an allergic reaction to Requip: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking Requip have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Call your doctor at once if you have:

• extreme drowsiness, falling asleep suddenly (even after feeling alert);
• worsening or no improvement in your symptoms;
• a light-headed feeling, like you might pass out;
• unusual changes in mood or behavior;
• tremors, twitching uncontrollable muscle movements; or
• hallucinations (seeing or hearing things that are not real).

Side effects such as confusion or hallucinations may be more likely in older adults.

Common Requip side effects may include:

• drowsiness, dizziness, weakness;
• headache, confusion, hallucinations;
• increased blood pressure (severe headache, pounding in your neck or ears, nosebleed, irregular heartbeats);
• nausea, vomiting, upset stomach, constipation;
• flu symptoms (fever, chills, body aches);
• sudden muscle movements;
• increased sweating; or
• swelling in your legs or feet.

What is ropinirole?

Ropinirole has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson’s disease.

Ropinirole is used to treat symptoms of Parkinson’s disease (stiffness, tremors, muscle spasms, and poor muscle control). Ropinirole is also used to treat restless legs syndrome (RLS).

Only immediate-release ropinirole (Requip) is approved to treat either Parkinson symptoms or RLS. Extended-release ropinirole (Requip XL) is approved only to treat Parkinson symptoms.

Parkinson’s and RLS are two separate disorders. Having one of these conditions will not cause you to have the other condition.

Ropinirole may also be used for purposes not listed in this medication guide.

Ropinirole side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking ropinirole have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking ropinirole. Talk with your doctor if this occurs.

Ropinirole may cause serious side effects. Call your doctor at once if you have:

• extreme drowsiness, falling asleep suddenly (even after feeling alert);
• worsening or no improvement in your symptoms;
• a light-headed feeling, like you might pass out;
• unusual changes in mood or behavior;
• tremors, twitching uncontrollable muscle movements; or
• hallucinations (seeing or hearing things that are not real).

Side effects such as confusion or hallucinations may be more likely in older adults.

Common side effects of ropinirole may include:

• drowsiness, dizziness, weakness;
• headache, confusion, hallucinations;
• increased blood pressure (severe headache, pounding in your neck or ears, nosebleed, irregular heartbeats);
• nausea, vomiting, upset stomach, constipation;
• flu symptoms (fever, chills, body aches);
• sudden muscle movements;
• increased sweating; or
• swelling in your legs or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use ropinirole if you are allergic to it.

To make sure ropinirole is safe for you, tell your doctor if you have:

• high or low blood pressure;
• kidney disease (or if you are on dialysis);
• heart disease, heart rhythm problems;
• a sleep disorder such as narcolepsy, or other conditions that may cause daytime sleepiness; or
• if you smoke.

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether ropinirole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ropinirole passes into breast milk or if it could affect the nursing baby. Ropinirole may slow breast milk production. Tell your doctor if you are breast-feeding.

Ropinirole is not approved for use by anyone younger than 18 years old.

How should I take ropinirole?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

If you are taking immediate-release ropinirole (Requip) you should not take extended-release ropinirole (Requip XL) at the same time.

The dose and timing of ropinirole in treating Parkinson’s disease is different from the dose and timing in treating RLS. Follow the directions on your prescription label. Ask your pharmacist if you have any questions about the kind of ropinirole you receive at the pharmacy.

Ropinirole can be taken with or without food. Take the medicine at the same time each day.

Do not crush, chew, or break an extended-release tablet (Requip XL). Swallow it whole.

Call your doctor if you see part of the ropinirole tablet in your stool. This is a sign that your body may not have absorbed all of the medicine.

If you are taking this medicine for RLS, tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Do not stop using ropinirole suddenly, or you could have unpleasant withdrawal symptoms. Follow your doctor’s instructions about tapering your dose.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking ropinirole?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Dizziness may impair your thinking or reactions. Avoid driving or operating machinery until you know how ropinirole will affect you.

What is Rytary?

Rytary contains a combination of carbidopa and levodopa.

Rytary extended release capsules are used to treat symptoms of Parkinson’s disease, such as muscle stiffness, tremors, spasms, and poor muscle control. Parkinson’s disease may be caused by low levels of a chemical called dopamine (DOE pa meen) in the brain.

Rytary is also used to treat Parkinson symptoms caused by carbon monoxide carbon monoxide poisoning or manganese intoxication.

Warnings

You should not use Rytary if you have narrow-angle glaucoma.

Do not use Rytary if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

Before taking this medicine

You should not use Rytary if you are allergic to carbidopa or levodopa, or if you have:

• narrow-angle glaucoma.

Do not use Rytary if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

To make sure Rytary is safe for you, tell your doctor if you have:

• heart disease, high blood pressure, or heart attack;
• liver or kidney disease;
• an endocrine (hormonal) disorder;
• asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;
• a stomach or intestinal ulcer;
• open-angle glaucoma; or
• depression, mental illness, or psychosis.

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

Tell your doctor if you are pregnant or breastfeeding.

How should I take Rytary?

Take Rytary exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

If you already take levodopa, you must stop taking it at least 12 hours before you start taking Rytary.

Rytary can be taken with or without food. Take your doses at regular intervals to keep a steady amount of the drug in your body at all times.

Swallow the capsule whole and do not crush, chew, break, or open it.

It may take up to several weeks of using Rytary before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment. Also tell your doctor if the effects of this medication seem to wear off quickly in between doses.

If you use Rytary long-term, you may need frequent medical tests.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Rytary.

Do not stop using Rytary suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light.

Dosing information

Usual Adult Dose for Parkinson’s Disease:

Optimum dosage is determined by careful individual titration: All doses expressed as CARBIDOPA-LEVODOPA

Rytary extended-release capsules:
-Initial dose (levodopa-naive): 23.75 mg-95 mg orally 3 times a day for 3 days; on the fourth day, may increase to 36.25 mg-145 mg 3 times a day
-Dosing interval may be increased up to a maximum of 5 times a day, if tolerated
-Maximum daily dose: 612.5 mg-2450 mg
Conversion from IMMEDIATE-RELEASE carbidopa-levodopa to Rytary: These recommended starting doses should be divided and given three times a day:
-For patients receiving levodopa 400 to 549 mg/day: total daily dose of levodopa in Rytary – 855 mg/day
-For patients receiving levodopa 550 to 749 mg/day: total daily dose of levodopa in Rytary – 1140 mg/day
-For patients receiving levodopa 750 to 949 mg/day: total daily dose of levodopa in Rytary – 1305 mg/day
-For patients receiving levodopa 950 to 1249 mg/day: total daily dose of levodopa in Rytary – 1755 mg/day
-For patients receiving levodopa equal or greater than 1250 mg/day: Rytary levodopa dose should be 2205 or 2340 mg/day

Comments:
-Peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 to 100 mg/day; patient’s receiving less than this amount of carbidopa are more likely to experience nausea and vomiting; experience with carbidopa doses greater than 200 mg/day is limited.
-Rytary products are not interchangeable with other carbidopa-levodopa products; for patients receiving carbidopa-levodopa plus catechol-O-methyl transferase (COMT) inhibitors, the initial recommended total daily dose of levodopa may need to be increased.

Use: For the treatment of the symptoms of idiopathic Parkinson’s disease, postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Rytary?

Avoid driving or hazardous activity until you know how Rytary will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid taking iron supplements or eating a diet that is high in protein (protein sources include meat, eggs, and cheese). These things can make it harder for your body to digest and absorb carbidopa and levodopa. Talk with your doctor or dietitian about the best foods to eat while you are taking this medicine.

Rytary side effects

Get emergency medical help if you have signs of an allergic reaction to Rytary: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• worsening of tremors (uncontrolled shaking);
• severe or ongoing vomiting or diarrhea;
• confusion, hallucinations, unusual changes in mood or behavior;
• depression or suicidal thoughts; or
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Some people taking Rytary have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.

What is amantadine?

Amantadine is an antiviral medicine that blocks the actions of viruses in your body.

Amantadine is used to treat Parkinson’s disease and “Parkinson-like” symptoms such as stiffness or tremors, shaking, and repetitive uncontrolled muscle movements that may be caused by the use of certain drugs.

Amantadine is also used to treat or prevent influenza A in adults and children. It may not be effective during every flu season because certain strains of the virus may be resistant to amantadine. This medicine should not be used in place of getting a yearly flu shot. The Centers for Disease Control recommends an annual flu shot to help protect you each year from new strains of influenza virus.

Amantadine is available as tablets, capsules, and oral solution.

Warnings

You should not use amantadine if you received a nasal flu vaccine in the past 14 days.

Do not receive a nasal flu vaccine while taking amantadine, and for at least 48 hours after your last dose. You may receive a flu shot (injection) while taking amantadine.

Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this amantadine affects you.

To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.

Heat stroke has happened in people taking amantadine. Be careful in hot weather and during physical activity.

If you have kidney problems, talk with your doctor. Your dose may need to be changed based on how well your kidneys work. Deaths have happened in people with kidney problems whose dose was too high for their kidney function.

Do not stop taking amantadine all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop amantadine, you will want to slowly stop it as ordered by your doctor.

Before taking this medicine

You should not use amantadine if you are allergic to it, or if:

• you have severe kidney disease; or
• you received a “live” nasal flu vaccine (FluMist) within the past 14 days.

To make sure amantadine is safe for you, tell your doctor if you have ever had:

• kidney disease;
• daytime drowsiness (caused by a sleep disorder or taking certain medicines);
• congestive heart failure;
• eczema;
• glaucoma;
• liver disease;
• a seizure;
• low blood pressure, fainting spells;
• alcoholism or drug addiction; or
• mental illness, psychosis, or suicidal thoughts or actions.

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether amantadine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breast-feed while using this medicine.

Amantadine is not approved for influenza in a child younger than 1 year old. Gocovri is not approved for use by anyone younger than 18 years old.

How should I take amantadine?

Take amantadine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

If you take amantadine to treat influenza A, start taking the medicine within 24 to 48 hours after flu symptoms begin. Keep taking this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

You may take amantadine with or without food. You may need to take this medicine only at bedtime. Follow your doctor’s instructions.

Measure liquid oral solution carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Swallow the capsule or tablet whole and do not crush, chew, or break it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

Call your doctor if your symptoms do not improve, or if you have a fever with a headache, cough, skin rash, or other new symptoms.

If you take amantadine for Parkinson symptoms: You should not stop using amantadine suddenly or your condition may become worse. Stopping suddenly may also cause unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Call your doctor if you miss several doses in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of amantadine can be fatal.

Overdose symptoms may include confusion, agitation, behavior changes, hallucinations, severe headache or pounding in your ears, muscle stiffness, problems with balance or walking, trouble breathing, fast heartbeats, or seizure.

What to avoid

Do not receive a nasal flu vaccine while using amantadine, and for at least 48 hours after your last dose. The vaccine may not work as well during this time, and may not protect you from influenza. You may receive a flu shot (injection) while taking amantadine.

Do not drink alcohol. Dangerous side effects could occur.

Avoid driving or operating machinery until you know how amantadine will affect you. Amantadine may impair your thinking or reactions. Some people taking this medicine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with amantadine can increase your risk of unpleasant side effects.

Amantadine side effects

Get emergency medical help if you have signs of an allergic reaction to amantadine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• extreme drowsiness, falling asleep suddenly even after feeling alert;
• a light-headed feeling, like you might pass out;
• shortness of breath (even with mild exertion), swelling in your hands or feet;
• painful or difficult urination;
• depression, agitation, aggression, behavior changes, hallucinations, thoughts of hurting yourself;
• a seizure; or
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Side effects may be more likely in older adults.

Common amantadine side effects may include:

• dizziness, falls;
• dry mouth;
• swelling in your legs or feet;
• nausea, constipation; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect amantadine?

Using amantadine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• glaucoma medication; or
• medicine that contains sodium bicarbonate (such as Alka-Seltzer).

This list is not complete. Other drugs may interact with amantadine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is Xadago?

Xadago is monoamine oxidase inhibitor type B (MAO-B). This medicine works by allowing a chemical called dopamine (DOE pa meen) to work for longer periods of time in the brain. Low levels of dopamine in the brain are associated with Parkinson’s disease.

Xadago is given with levodopa and carbidopa to treat “wearing-off” episodes (muscle stiffness, loss of muscle control) in people with Parkinson’s disease.

Warnings

You should not use Xadago if you have severe liver disease.

TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE. Some medicines can cause unwanted or dangerous effects (including death) when used within 14 days of when you take Xadago.

Before taking this medicine

You should not use Xadago if you are allergic to safinamide, or if you have:

• severe liver disease.

Some medicines can cause unwanted or dangerous effects (including death) when used with Xadago. You should not use any of the following medicines within 14 days before or 14 days after you take Xadago:

• amphetamines (Adderall, Dexedrine, and others);
• cough medicine that contains dextromethorphan;
• cyclobenzaprine;
• methylphenidate (Concerta, Ritalin, Daytrana, and others);
• St. John’s wort;
• another MAO inhibitor – isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others;
• certain antidepressants such as amitriptyline (Elavil), desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), maprotiline (Ludiomil) , milnacipran (Savella), trimipramine (Surmontil), venlafaxine (Effexor), vilazodone (Viibryd), and many others; or
• opioid (narcotic) medicine such as meperidine (Demerol), methadone, propoxyphene (Darvon), tramadol (Ultram, Ultracet), and others.

To make sure Xadago is safe for you, tell your doctor if you have ever had:

• liver disease;
• high or low blood pressure;
• bipolar disorder, schizophrenia, or psychosis;
• unusual urges or impulses;
• abnormal muscle movements;
• problems with retina of your eye; or
• narcolepsy or other sleep disorder (or if you take medicine to help you sleep).

It is not known whether Xadago will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether safinamide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Xadago pregnancy and breastfeeding warnings 

How should I take Xadago?

Take Xadago exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Safinamide must be given in combination with levodopa and carbidopa and it should not be used alone.

Xadago is usually taken once per day at the same time each day.

You may take this medicine with or without food.

Your blood pressure will need to be checked often.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Parkinson’s Disease:

Initial dose: 50 mg orally once a day
Maintenance dose: After 2 weeks, may increase dose to 100 mg orally once a day based on individual need and tolerability
Maximum dose: 100 mg per day

Comment:
-Higher doses have not been shown to provide additional benefit while they do increase the risk for adverse reactions.
-This drug has only been shown effective in combination with levodopa/carbidopa.

Use: As adjunctive treatment to levodopa/carbidopa in patients with PD experiencing “off” episodes.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

While taking Xadago and for 14 days after you stop, avoid eating foods that are high in tyramine, including: pickled food (such as eggs or herring), and meats that are aged, cured, smoked, or fermented.

Eating tyramine while you are taking safinamide can raise your blood pressure to dangerous levels which could cause life-threatening side effects. You should become very familiar with the list of foods to avoid while you are taking Xadago.

Some people taking this medicine have fallen asleep during normal daytime activities such as working, driving, or other physical activity. Avoid driving or operating machinery until you know how this medicine will affect you.

Xadago side effects

Get emergency medical help if you have signs of an allergic reaction to Xadago: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• vision changes;
• twitching or uncontrolled muscle movements;
• confusion, agitation, unusual thoughts or behavior;
• hallucinations (seeing or hearing things that are not real);
• a seizure;
• fever, sweating, fast heart rate, overactive reflexes;
• nausea, vomiting, diarrhea; or
• increased blood pressure – severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common Xadago side effects may include:

• involuntary muscle movements;
• falls;
• nausea; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Xadago?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• imatinib;
• irinotecan;
• lapatinib;
• methotrexate
• metoclopramide;
• mitoxantrone;
• rosuvastatin;
• sulfasalazine; or
• topotecan.

This list is not complete. Other drugs may interact with safinamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.