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.

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.

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.

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.

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.

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.

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

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.

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.

Using Inbrija 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.

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