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Carbidopa/Levodopa Gel - Intestinal

Pronunciation: KAR-bi-DOE-pa/LEE-voe-DOE-pa

Common Brand Name(s): Duodopa

Important: 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.

Uses

This product is used to treat symptoms of Parkinson's disease (such as shakiness, stiffness, difficulty moving). It is used when the usual medications taken by mouth for Parkinson's disease are not effective. 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.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given as a continuous infusion into the small intestine using an infusion pump. It is given throughout the day, usually stopping at bedtime. At bedtime, take your dose of carbidopa/levodopa tablets by mouth as directed. This medication can only be prescribed by doctors who have completed a special program which explains the risks, benefits, and use of this product. 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. The tube through the abdomen will require surgery.

Follow all instructions from your health care professional about how to properly use and prepare this medication and the infusion pump. The cassettes containing the medication should not be used longer than 16 hours or re-used. Learn how to properly care for the tube insertion site and how to avoid infection. Also learn how to store and discard medical supplies safely. If you have any questions about the use of this medication or the infusion pump, consult your health care professional.

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.

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.

Tell your doctor if your condition does not improve or if it worsens, or if you need more than 5 extra doses of the medication per day.

Side Effects

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

This medication may cause saliva, urine, or sweat 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 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 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
  • fainting
  • vision changes (such as blurred/double/decreased vision)
  • eye pain
  • mental/mood changes (such as confusion, agitation, hallucinations)
  • easy bruising/bleeding
  • unusual tiredness
  • tingling/numbness/weakness of the hands/feet
  • unusual strong urges (such as increased gambling, increased sexual urges)

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:

  • nausea/vomiting/constipation that doesn't go away
  • 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

Abruptly 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
  • rapid breathing

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.

Precautions

Before using this medication, tell your doctor or pharmacist if you are allergic to carbidopa or levodopa; 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)
  • heart disease (such as irregular heartbeat, heart attack)
  • kidney disease
  • stomach/intestinal problems (such as ulcers, past stomach/abdominal surgery, ileus)
  • mental/mood disorders (such as depression, schizophrenia)
  • blood disorders
  • bleeding disorders
  • seizures
  • sleep disorder
  • disease of the pancreas (pancreatitis)
  • high blood pressure
  • numbness/tingling of the hands/feet

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 in small amounts and may affect how much milk you make. It is unknown if carbidopa passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

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.

Some products that may interact with this drug include:

  • antipsychotic drugs (such as chlorpromazine, haloperidol, thioridazine)
  • certain drugs used to treat high blood pressure (such as methyldopa)

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 laboratory tests (including urine catecholamine/glucose/ketone tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

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 their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, irregular heartbeat, mental/mood changes (such as agitation).

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, heart/kidney/liver function, vitamin B6/B12 and folic acid/homocysteine/methylmalonic acid levels, blood pressure) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

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.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store the cassettes in the refrigerator. Keep them in their original carton to protect them from light until ready to use. Do not freeze. The gel in the cassette may become slightly yellow when it is near its expiration date or when it has been used for close to 16 hours. This is normal and will not affect how the drug works. 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.

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