Levodopa inhalation

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

Levodopa inhalation is not to be used instead of any medicine you take every day for Parkinson's disease.

Levodopa inhalation may also be used for reasons not mentioned in this medication guide.

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

Levodopa inhalation is only for 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 are 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.

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

Do not use levodopa inhalation if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could happen. 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 issues;
• glaucoma;
• involuntary muscle movements;
• a sleep disorder that causes daytime sleepiness;
• dizziness, nausea, or fainting spells when standing up from sitting or lying down;
• 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 if 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 risks.

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 wheezing, chest tightness, or trouble breathing after inhaling levodopa inhalation.

Levodopa inhalation may cause serious side effects. Call your doctor right away if you have:

• extreme drowsiness, falling asleep suddenly (even after feeling alert);
• nausea, sweating, and feeling light-headed (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 starting 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 at 1-800-FDA-1088.

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 dayMaximum dose per OFF period: 84 mgMaximum daily dose: 420 mgComments:-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.

Since levodopa inhalation is used as needed, you might not have a regular dosing schedule. If you miss a dose and it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

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

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

Avoid driving or engaging in hazardous activities until you know how levodopa inhalation will affect you. Dizziness or drowsiness can lead to falls, accidents, or serious injuries.

Using levodopa inhalation with other medications that cause drowsiness can make you feel even more tired. Talk to your doctor before using opioid painkillers, sleeping pills, muscle relaxers, or medicines for anxiety or seizures.

Inform your doctor about all the other medicines you are taking, especially:

• isoniazid;
• metoclopramide;
• risperidone or other antipsychotic medication;
• iron medications, like ferrous fumarate, ferrous gluconate, or ferrous sulfate;
• a multivitamin or mineral supplement that contains iron; or
• other medicines for Parkinson's disease.

This list is not complete. Other drugs may affect levodopa inhalation, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are included here.