Pronunciation:

lee-voe-DOE-pa

Brand Names:

• Inbrija

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Antiparkinsonian

Pharmacologic—

Dopamine Precursor

Uses of This Medicine:

Levodopa inhalation is used together with carbidopa and levodopa combination to treat the return of Parkinson’s symptoms (known as OFF episodes) in people with Parkinson’s disease.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of levodopa in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levodopa in the elderly.

Breast-feeding—

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bromopride
• Clorgyline
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Sulpiride
• Toloxatone
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amisulpride
• Bupropion
• Haloperidol
• Isoniazid
• Macimorelin
• Metoclopramide
• Olanzapine
• Sapropterin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fosphenytoin
• Indinavir
• Kava
• Phenylalanine
• Phenytoin
• Spiramycin
• Tyrosine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• High Protein Food

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dyskinesia (abnormal muscle movements) or
• Glaucoma—Use with caution. May make these conditions worse.

• Lung disease (eg, asthma, COPD) or
• Mental illness—Use is not recommended in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly as directed and when symptoms of an OFF period start to return. It is important that you do not stop using your medicine unless ordered by your doctor. It is also important not to start using other medicines for your Parkinson's disease without first talking with your doctor.

This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

The capsules are for inhalation only and should be used with the inhaler. Do not swallow or open the capsule.

Do not use any capsule that looks crushed, damaged, or wet.

To use the inhaler:

• Your hands should be clean and dry when using the inhaler and capsules.
• Remove the blue cap of the inhaler. Twist off the white mouthpiece. Load 1 capsule into the capsule chamber of the inhaler. Do not load 2 capsules at the same time. Attach the mouthpiece until you hear a click.
• Breathe out fully and try to get as much air out of your lungs as possible. Put the mouthpiece just in front of your mouth and breathe in (inhale) deeply. If you did not hear or feel the capsule “whirl” (spin) while inhaling, you may need to take a deeper, longer breath. If you cough or stop your dose, repeat the step using the same capsule.
• Hold your breath for about 5 to 10 seconds, then breathe out slowly.
• Twist and pull off the mouthpiece. Remove the used capsule, then load a second capsule into the inhaler. Repeat the same steps.
• Remove the used capsule, then load a second capsule into the inhaler and breathe in. Do not load 2 capsules at the same time.
• You may use a dry cotton swab or tissue to clean the mouthpiece.

If you are taking multivitamin tablets or plan to start taking them, discuss this first with your doctor. Iron salts (in vitamins) may keep this medicine from working properly.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (powder):
  • For OFF episodes in patients with Parkinson’s disease:
    • Adults—Two 42-milligram (mg) capsules (84 mg) taken as needed, for up to 5 times a day. Your doctor may adjust your dose as needed. However the dose is usually not more than 84 mg per OFF episode (not more than 1 dose or 2 capsules per OFF episode) or 420 mg per day (not more than 5 doses per day).
    • Children—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

This medicine is used when symptoms of an OFF period start to return.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not store the capsules inside the inhaler.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not take this medicine if you are using or have used a monoamine oxidase (MAO) inhibitor (eg, phenelzine, tranylcypromine, Nardil®, Parnate®) within the past 2 weeks.

Do not stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely.

This medicine may cause dizziness, drowsiness, trouble in controlling movements, or even cause you to fall asleep without warning. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded or dizzy.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you are using this medicine.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having unusual urges, such as gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while using this medicine.

This medicine may increase your risk for breathing problems (eg, bronchospasm), especially if you have a lung disease (eg, asthma, COPD). Check with your doctor right away if you have a cough, difficulty or noisy breathing, or tightness in the chest.

This medicine might cause your saliva, sweat, or urine to become dark in color. This is nothing to worry about, but it could stain your clothes.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

chills

cough

difficulty in breathing

ear congestion

fever

headache

loss of voice

sneezing

sore throat

stuffy or runny nose

unusual tiredness or weakness

Less common

Blurred vision

chest pain or discomfort

confusion

cough producing mucus

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

muscle aches

sneezing

sweating

tightness in the chest

twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Discolored sputum or nasal discharge

falls

mouth or throat pain

nausea

pain in the arms or legs

skin scraping or tearing

trouble sleeping

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.