levodopa 42 mg capsule with inhalation device

Generic name:
Levodopa powder in capsule - oral inhalation

Pronunciation
(LEE-voe-DOE-pa)

Brand name(s)
Inbrija

This medication is used when needed to treat the return of Parkinson's symptoms (known as OFF episodes) in people with Parkinson's disease who are treated with carbidopa/levodopa medicines. Parkinson's disease tends to worsen over time, and you may need extra levodopa from time to time to keep symptoms (such as shakiness, stiffness, difficulty moving) from returning. This medication does not replace your regular carbidopa/levodopa medicine. Keep taking your carbidopa/levodopa medicine regularly as directed by your doctor.

Parkinson's disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain. Levodopa changes into dopamine in the brain, helping to control movement.

Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using levodopa inhalation powder and each time you get a refill. Learn how to use the inhaler properly. If you have any questions, ask your doctor or pharmacist.

Do not swallow the capsules. Use the special inhaler to inhale the powder in the capsules. Inhale this medication by mouth as directed by your doctor, when symptoms of an OFF period start. Each dose is 2 of the 42-milligram capsules. Make sure your hands are clean and dry before preparing your dose. Load one capsule in the inhaler and breathe out completely, holding the inhaler level and away from your mouth. While keeping the inhaler level, close your lips firmly around the mouthpiece and take a deep, comfortable breath. You should hear and feel the capsule "whirl" (spin) as you breathe in. Take the inhaler out of your mouth and hold your breath for 5 seconds, then breathe out. Remove the used capsule from the inhaler. Repeat with a second capsule to finish a full dose. Take used capsules out of the inhaler before storing the inhaler. Do not store unused capsules in the inhaler for a future dose.

The dosage is based on your medical condition and response to treatment. Do not use more than 1 dose per OFF period. Do not use more than 5 doses in one day.

Tell your doctor if your condition does not get better or if it gets worse.

Coughing or a feeling of choking may occur during or after using a dose. Dizziness, lightheadedness, nausea, trouble sleeping, unusual dreams, stuffy/runny nose, sore throat, or fever may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

This medication may cause saliva or nasal discharge to turn a dark color. This effect is harmless, but your clothes may be stained.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people using this medication have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with levodopa even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or do other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.

Tell your doctor right away if you have any serious side effects, including:

• new/worsening movements you can't control/spasms
• greatly increased eye blinking/twitching
• vision changes (such as blurred vision, double vision)
• eye pain
• severe stomach/abdominal pain
• black/tarry stools
• vomit that looks like coffee grounds
• mental/mood changes (such as agitation, hallucinations, depression, thoughts of suicide)
• signs of infection (such as sore throat that doesn't go away)
• easy bleeding/bruising
• unusual tiredness
• tingling of the hands/feet
• unusual strong urges (such as increased gambling, increased sexual urges)

Get medical help right away if you have any very serious side effects, including:

• chest pain
• fainting

Suddenly stopping or reducing the dose of this medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms:

• fever
• unusual muscle stiffness
• severe confusion
• sweating
• fast/irregular heartbeat

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to levodopa; or to foslevodopa; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• glaucoma
• breathing problems (such as asthma, chronic obstructive pulmonary disease-COPD)
• heart disease (such as heart attack, irregular heartbeat)
• kidney disease
• stomach/intestinal ulcer
• mental/mood disorders (such as depression, schizophrenia)
• blood disorders
• seizures
• sleep disorders

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). See also Side Effects section.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially cough, stuffy/runny nose, sore throat, or fever.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Levodopa passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. However, certain MAO inhibitors (rasagiline, safinamide, selegiline) may be used with careful monitoring by your doctor. Ask your doctor when to start or stop using this medication.

This medication may interfere with certain lab tests (such as urine catecholamine/glucose/ketone tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe dizziness, irregular heartbeat, mental/mood changes (such as agitation).

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, heart/kidney/liver function, blood pressure) should be done while you are using this medication. Keep all medical and lab appointments.

Not applicable.

Store at room temperature away from light and moisture. Keep the inhaler and capsules dry. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.