Levodopa Oral Inhalation

Levodopa inhalation is used along with the combination of levodopa and carbidopa (Duopa, Rytary, Sinemet) to treat ''off'' episodes (times of difficulty moving, walking, and speaking that may happen when other medication(s) wear off) in people with Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Levodopa inhalation will not work to prevent ''off'' episodes but will help to control symptoms when an ''off'' episode has already begun. Levodopa is in a class of medications called dopamine agonists. Levodopa works by mimicking the action of dopamine, a natural substance in the brain that is lacking in patients with PD.

Levodopa inhalation comes as a capsule to use with a specially designed oral inhaler. You will use the inhaler to breathe in the dry powder contained in the capsules. It is usually inhaled when needed. You will need to orally inhale the contents of two capsules for a full dose. Do not inhale more than one dose (2 capsules) per "off" period. Do not inhale more than 5 doses in one day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use levodopa inhalation exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not swallow levodopa capsules for inhalation.

Do not open the blister package surrounding a capsule or remove the capsule until just before you are ready to use it. If you accidentally open the package of a capsule that you cannot use immediately, discard that capsule. Do not store the capsules inside the inhaler. Dispose of the inhaler when all of the capsules in the carton have been used. Use the new inhaler that comes with your prescription refill each time.

Only use the inhaler it comes with to inhale the powder in the capsules. Never try to inhale them using any other inhaler. Never use your levodopa inhaler to inhale any other medication.

Before you use levodopa inhalation for the first time, read the written instructions that come with the inhaler. Look at the diagrams carefully and be sure that you recognize all the parts of the inhaler. Ask your doctor, pharmacist, or other healthcare professionals to show you how to use it. Practice using the inhaler while they watch you.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using levodopa inhalation,

• tell your doctor and pharmacist if you are allergic to levodopa, any other medications, or any of the ingredients in levodopa inhalation. Ask your pharmacist for a list of the ingredients.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), and tranylcypromine (Parnate)
• some medications should not be taken with levodopa inhalation. Other medications may cause dosing changes or extra monitoring when taken with levodopa inhalation. Make sure you have discussed any medications you are currently taking or plan to take before using levodopa inhalation with your doctor and pharmacist. Before starting, stopping, or changing any medications while using levodopa inhalation, please get the advice of your doctor or pharmacist.
• the following nonprescription products may interact with levodopa inhalation: iron salts or multivitamins containing iron salts. Be sure to let your doctor and pharmacist know that you are taking these medications before you start using levodopa inhalation. Do not start any of these medications while using levodopa inhalation without discussing with your healthcare provider.
• tell your doctor if you have or have ever had any disease that affects your breathing such as asthma or chronic obstructive pulmonary disease (COPD); glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision); a sleep disorder; or a mental health problem.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using levodopa inhalation, call your doctor.
• you should know that levodopa inhalation may make you drowsy or may cause you to suddenly fall asleep during your regular daily activities while you are using levodopa inhalation and for up to 1 year after treatment. You might not feel drowsy or have any other warning signs before you suddenly fall asleep. Do not drive a car or operate machinery, work at heights, or participate in potentially dangerous activities until you know how this medication affects you. If you suddenly fall asleep while you are doing something such as eating, talking, or watching television, or riding in a car, or if you become very drowsy, especially during the daytime, call your doctor.
• you should know that some people who used medications such as levodopa inhalation developed gambling problems or other intense urges or behaviors that were compulsive or unusual for them, such as increased sexual urges or behaviors. There is not enough information to tell whether the people developed these problems because they took the medication or for other reasons. Call your doctor if you have an urge to gamble that is difficult to control, you have intense urges, or you are unable to control your behavior. Tell your family members about this risk so that they can call the doctor even if you do not realize that your gambling or any other intense urges or unusual behaviors have become a problem.
• you should know that levodopa inhalation may cause dizziness, lightheadedness, nausea, sweating, and fainting when you get up too quickly from a lying or sitting position. To avoid this problem, get out of bed or get up from a seated position slowly, resting your feet on the floor for a few minutes before standing up.

Unless your doctor tells you otherwise, continue your normal diet.

This medication is usually used as needed.

Levodopa inhalation may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• cough
• runny nose
• nausea
• vomiting
• mouth pain
• headache
• dizziness
• change in color of urine, sweat, sputum, and tears

Some side effects can be serious. If you experience any of these symptoms or those in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• fever, sweating, stiff muscles, and loss of consciousness
• chest pain or discomfort
• difficulty breathing
• new or worsening sudden uncontrollable movements
• hallucinations (seeing things or hearing voices that do not exist)
• feeling that others want to harm you
• difficulty falling asleep or staying asleep
• aggressive behavior
• dreaming more than usual
• confusion
• abnormal behavior
• agitation

Levodopa inhalation may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor. Your doctor will order certain lab tests to check your body's response to levodopa inhalation.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using levodopa inhalation.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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