Duopa 4.63 mg-20 mg/mL suspension in j-tube pump

Generic name:
Carbidopa/levodopa suspension - intestinal

Pronunciation
(KAR-bi-DOE-pa/LEE-voe-DOE-pa)

Brand name(s)
Duopa

This medication is used to treat symptoms of Parkinson's disease (such as shakiness, stiffness, difficulty moving).

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. Carbidopa prevents the breakdown of levodopa in the bloodstream so more levodopa can enter the brain. Carbidopa can also reduce some of levodopa's side effects such as nausea and vomiting.

By giving this medication as a continuous infusion, it can help reduce the amount of "off" time (periods of slow movement or stiffness).

Read the Medication Guide and the Instructions for Use provided by your health care professional before you start using this medication and each time you get a refill. If you have any questions, ask your health care professional.

Give this medication as directed as a continuous infusion into the small intestine using an infusion pump. It is usually given over 16 hours a day and stopped at bedtime. At bedtime, take your dose of immediate-release carbidopa/levodopa tablets by mouth as directed.

When you first start using this medication, it is given through a tube through the nose into the small intestine. After a few days, if the doctor decides that this product is right for you, then the medication will be given through a tube through the abdomen into the small intestine. Getting the tube through the abdomen will require surgery.

Follow all instructions from your health care professional about how to properly use this medication and the infusion pump. Take a cassette containing the medication from the refrigerator and leave it at room temperature for 20 minutes before using. Do not use a cassette for longer than 16 hours or re-use it, even if there is medication left in it. Learn how to store and discard medical supplies safely. Also learn how to properly care for the small hole in your abdomen and the skin area around the tube, and how to avoid infection.

The dosage is based on your medical condition and response to treatment. Your daily dose is made up of a morning dose, a continuous dose, and extra doses. An extra dose is a small dose of this medication that can be given as needed during the day to treat sudden "off" symptoms. Extra doses should not be given more often than one every 2 hours to avoid causing or worsening movements you cannot control.

It is best to avoid a high-protein diet (it decreases the amount of levodopa that your body takes in) during treatment, unless directed otherwise by your doctor. Separate your dose of this medication by as many hours as possible from any iron supplements or products containing iron (such as multivitamins with minerals) you may take. Iron can reduce the amount of this medication absorbed by the body. Consult your doctor or pharmacist for more details.

Do not stop using this medication without consulting your doctor. Some conditions may become worse when this medication is suddenly stopped. Also, if you suddenly stop using this medication, you may have withdrawal symptoms (such as anxiety, depression, confusion, fever, muscle stiffness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

If you plan to be disconnected from the pump for a short period of time (less than 2 hours, for example, to shower), ask your doctor ahead of time if you should use an extra dose of this medication before you disconnect. If you plan to be disconnected from the pump for longer than 2 hours, ask your doctor what you should do and discuss how you should take carbidopa/levodopa tablets by mouth during this time.

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

Dizziness, nausea, vomiting, trouble sleeping, and headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

This medication may cause urine, sweat, or saliva to turn red, brown, or black. This effect is harmless, but your clothes may become 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 this medication 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 take part in 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:

• mental/mood changes (such as confusion, agitation, hallucinations)
• unusual strong urges (such as increased gambling, increased sexual urges)
• new/worsening movements you can't control/spasms
• greatly increased eye blinking/twitching
• easy bruising/bleeding
• unusual tiredness
• tingling/numbness/weakness of the hands/feet
• vision changes (such as blurred/double/decreased vision)
• eye pain

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

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

• constipation that doesn't go away
• nausea/vomiting that doesn't stop
• vomit that looks like coffee grounds
• bloody/black/tarry stools
• stomach/abdominal pain
• signs of infection (such as fever, chills)
• redness/swelling/pain/oozing around the tube site
• 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 carbidopa or levodopa; or to foscarbidopa or 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:

• bleeding disorders
• breathing problems (such as asthma, emphysema)
• glaucoma
• heart or blood vessel problems (such as irregular heartbeat, heart attack, angina)
• high blood pressure
• kidney disease
• liver disease
• mental/mood disorders (such as depression, schizophrenia)
• numbness/tingling of the hands/feet
• seizures
• sleep disorder
• stomach/intestinal problems (such as ulcers, past stomach/abdominal surgery)

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).

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

Levodopa passes into breast milk. It is unknown if carbidopa passes into breast milk. Consult your doctor before breastfeeding.

See also How to Use section.

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 taking 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. Consult your doctor for more details.

This drug is to be given continuously as an infusion throughout the day, usually stopping at bedtime. If your infusion is interrupted, contact your doctor or pharmacist right away.

Store the cassettes in the refrigerator. Keep them in the carton to protect them from light until ready to use. Do not freeze. (See also How to Use section.) 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.