Carbidopa; Levodopa Suspension

What is this medication?

CARBIDOPA; LEVODOPA (kar bi DOE pa; lee voe DOE pa) treats the symptoms of Parkinson disease. It works by increasing the amount of dopamine in your brain, a substance which helps manage body movements and coordination. This reduces the symptoms of Parkinson, such as body stiffness and tremors.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Duopa

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Drink alcohol
• Glaucoma
• Heart disease
• High blood pressure
• History of irregular heartbeat
• Kidney disease
• Liver disease
• Low blood pressure
• Lung or breathing disease, like asthma
• Mood or behavior changes
• Narcolepsy
• Sleep apnea
• Stomach or intestine problems
• Suicidal thoughts, plans or attempt; a previous suicide attempt by you or a family member
• An unusual or allergic reaction to levodopa, carbidopa, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Your prescribed dose will be programmed into your pump by your care team. Your care team will show you how to use this medication cassette with the pump before you use it for the first time. See the "Instructions for Use" for complete instructions. Your dose will only be changed by your care team or while you are with your care team. Do not stop using this medication or change your dose without the approval of your care team.

This medication should be used at room temperature. Take one medication cassette out of the refrigerator and out of the carton 20 minutes prior to use. Use the product at room temperature, or you may not get the right dose. The medication is given continuously over 16 hours. A small pump (CADD-Legacy 1400) is used to move the medication from the medication cassette into your PEG-J tube. Each cassette can only be used one time. An opened cassette should not be reused. The cassette should not be used for longer than 16 hours.

Disconnect the pump from your PEG-J tube after the 16 hour dosing time is finished. Use a syringe filled with room temperature water to flush your PEG-J tube. After your daily infusion, you should take your usual nighttime dose of oral carbidopa-levodopa tablets as prescribed. Keep a supply of oral regular-release carbidopa-levodopa tablets with you in case you are unable to receive your infusion.

This medication is not used in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you stop your infusion for more than 2 hours during your 16 hour dosing time for any reason, call your care team and take oral carbidopa-levodopa tablets as prescribed until you are able to restart your infusion. If you stop your infusion for less than 2 hours, you do not need to take the carbidopa-levodopa tablets, but your care team may tell you to take an extra dose of your infusion.

Keep a supply of oral immediate-release carbidopa-levodopa tablets with you in case you are unable to receive your infusion.

What may interact with this medication?

Do not take this medication with any of the following:

• MAOIs like Marplan, Nardil, and Parnate
• Reserpine
• Tetrabenazine

This medication may also interact with the following:

• Alcohol
• Droperidol
• Entacapone
• Iron supplements or multivitamins with iron
• Isoniazid, INH
• Linezolid
• Medications for depression, anxiety, or psychotic disturbances
• Medications for high blood pressure
• Medications for sleep
• Metoclopramide
• Papaverine
• Procarbazine
• Tedizolid
• Rasagiline
• Selegiline
• Tolcapone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. Do not stop taking except on your care team's advice. You may develop a severe reaction. Your care team will tell you how much medication to take.

Talk to your care team about what you need to do to care for your PEG-J tube site. Watch for signs of infection. Complications in the stomach or intestines can occur from the PEG-J tube procedure. Contact your care team immediately if you experience stomach pain, constipation that does not go away, nausea, vomiting, fever, or black stools.

If your PEG-J tube becomes kinked, knotted, or blocked, this may cause your Parkinson's symptoms to worsen or cause recurring movement problems (motor fluctuations). Call your care team if your Parkinson's symptoms get worse or you have slow movement while you are treated with this medication.

Eating high protein foods may affect how this medication works. Tell your care team if you change your diet.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

When taking this medication, you may fall asleep without notice. You may be doing activities like driving a car, talking, or eating. You may not feel drowsy before it happens. Contact your care team right away if this happens to you.

There have been reports of increased sexual urges or other strong urges such as gambling while taking this medication. If you experience any of these while taking this medication, you should report this to your care team as soon as possible.

Patients and their families should watch out for new or worsening depression or thoughts of suicide. Call your care team right away if you feel depressed or have thoughts of suicide.

You may experience a 'wearing off' effect before the time for your next dose of this medication. You may also experience an 'on-off' effect where the medication apparently stops working for any time from a minute to several hours, then suddenly starts working again. Tell your care team if any of these symptoms happen to you. Your dose may need adjustment.

If you have diabetes, you may get a false-positive result for sugar in your urine. Check with your care team.

This medication may discolor the urine or sweat, making it look darker or red in color. This is of no cause for concern. However, this may stain clothing or fabrics.

This medication may cause a decrease in vitamin B6. You should make sure that you get enough vitamin B6 while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bowel blockage—stomach cramping, unable to have a bowel movement or pass gas, loss of appetite, vomiting
• Falling asleep during daily activities
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• New or worsening uncontrolled and repetitive movements of the face, mouth, or upper body
• Pain, tingling, or numbness in the hands or feet
• Site infection—skin redness, swelling, warmth, or pain around tube site
• Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Urges to engage in impulsive behaviors such as gambling, binge eating, sexual activity, or shopping in ways that are unusual for you

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dark red or black saliva, sweat, or urine
• Dizziness
• Drowsiness
• Headache
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store unopened cassettes in the refrigerator between 2 degrees C and 8 degrees C (36 degrees F to 46 degrees F). Do not freeze. Protect the cassette from light and keep it in the carton before using. Use before the expiration date printed on the cassette. Throw away any expired medication.

Once a carton is removed from the refrigerator, opened, or in use, discard after 16 hours, even if it contains medication. Use before the expiration date printed on the cassette.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.