Carbidopa; Levodopa enteral suspension

What is this medicine?

CARBIDOPA;LEVODOPA (kar bi DOE pa; lee voe DOE pa) enteral suspension is used to treat certain symptoms of advanced Parkinson's disease.

How should I use this medicine?

Your prescribed dose will be programmed into your pump by a healthcare provider. Your healthcare provider 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 healthcare provider or while you are with your healthcare provider. Do not stop using this medicine or change your dose without the approval of your healthcare provider.

This medicine 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 medicine is given continuously over 16 hours. A small pump (CADD-Legacy 1400) is used to move the medicine 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 night time 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.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• blood in your stool or a dark tarry stool

• changes in emotions or moods

• chest pain

• constipation that does not go away

• falling asleep during normal activities like driving

• fast, irregular heartbeat

• hallucinations

• new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges

• severe nausea and vomiting

• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• stomach pain

• suicidal thoughts

• uncontrollable movements of the arms, face, head, mouth, neck, or upper body

• weakness or numbness or loss of sensation in the fingers or feet

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

• headache

• loss of appetite

• nausea

• swelling of legs and feet

• trouble sleeping

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• MAOIs like Marplan, Nardil, and Parnate

• reserpine

• tetrabenazine

This medicine may also interact with the following medications:

• alcohol

• droperidol

• entacapone

• iron supplements or multivitamins with iron

• isoniazid, INH

• linezolid

• medicines for depression, anxiety, or psychotic disturbances

• medicines for high blood pressure

• medicines for sleep

• metoclopramide

• papaverine

• procarbazine

• tedizolid

• rasagiline

• selegiline

• tolcapone

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 healthcare provider 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 healthcare provider 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.

Where should I keep my medicine?

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 medicine.

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.

What should I tell my health care provider before I take this medicine?

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 medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

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

Talk to your healthcare provider 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 healthcare provider 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 healthcare provider if your Parkinson's symptoms get worse or you have slow movement while you are treated with this medicine.

Eating high protein foods may affect how this medicine works. Tell your healthcare provider 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 medicine 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 medicine. Avoid alcoholic drinks.

When taking this medicine, 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 health care provider 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 medicine. If you experience any of these while taking this medicine, you should report this to your health care provider as soon as possible.

Patients and their families should watch out for new or worsening depression or thoughts of suicide. Call your healthcare provider 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 medicine. You may also experience an 'on-off' effect where the medicine apparently stops working for any time from a minute to several hours, then suddenly starts working again. Tell your doctor or health care professional 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 doctor or health care professional.

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