Duopa

Some people using carbidopa and levodopa have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Avoid driving or operating machinery until you know how Duopa will affect you. Dizziness or severe drowsiness can cause falls or other accidents. Also avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol with this medicine can cause side effects.

Avoid taking iron supplements or eating a diet that is high in protein (protein sources include meat, eggs, and cheese). These things can make it harder for your body to digest and absorb carbidopa and levodopa. Talk with your doctor or nutrition counselor about the best foods to eat while you are using Duopa.

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Duopa with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• isoniazid;
• metoclopramide;
• blood pressure medication;
• medicines, vitamins, or mineral supplements that contain iron; or
• medicine to treat a psychiatric disorder (such as Abilify, Geodon, Risperdal, Seroquel, Symbyax, or Zyprexa).

This list is not complete. Other drugs may interact with carbidopa and levodopa, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Duopa, there are no specific foods that you must exclude from your diet when receiving this medication.

However, tell your doctor if you plan on changing your diet to include foods that are high in protein, such as meat, poultry, and dairy products, since these foods can affect the way your body uses the mediction.

Take Duopa exactly as prescribed.

This combination medication is available as an enteral suspension to be given through a tube placed in the stomach or intestines. It is administered continuously over 16 hours once a day.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Duopa at the same time.

Do not use carbidopa and levodopa if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of levodopa and carbidopa combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Duopa® in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution in patients receiving this medicine.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amisulpride
• Bromopride
• Clorgyline
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Sulpiride
• Toloxatone
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Isoniazid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Droxidopa
• Fosphenytoin
• Indinavir
• Iron
• Kava
• Metoclopramide
• Phenylalanine
• Phenytoin
• Spiramycin
• Tyrosine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• High Protein Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Arrhythmia (heart rhythm problem) or
• Depression, history of or
• Dyskinesia (abnormal muscle movements) or
• Glaucoma or
• Heart attack, history of or
• Heart disease or
• Hypertension (high blood pressure) or
• Neuropathy (nerve problems) or
• Psychosis (mental disorder), or history of or
• Sleep disorders or
• Stomach or bowel problems (eg, bezoar, ileus, bowel blockage, perforation, post operative wound infection, ulcers)—Use with caution. May make these conditions worse.

• Melanoma (skin cancer), suspicious or a history of or
• Skin lesions, undiagnosed (rashes that involve changes in color or texture of the skin)—Should not be used in patients with these conditions.

It is very important that your doctor check your progress at regular visits to allow changes in your dose and to check for any unwanted effects.

Do not take this medicine if you have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine, tranylcypromine, Nardil®, Parnate®) in the past 2 weeks.

Using this medicine may cause stomach or bowel problems. Call your doctor right away if you have abdominal or stomach pain, constipation that does not go away, nausea, vomiting, fever, or dark, tarry stools.

This medicine may cause dizziness, drowsy, faint, lightheaded, trouble in controlling movements, or trouble in concentrating or seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having problems with gambling or an increased interest in sex while using this medicine.

If you develop any unusual or strange thoughts and behavior while receiving this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness.

Check with your doctor right away if you have burning, numbness, tingling, or painful sensations, weakness in the arms, hands, legs, or feet, or unsteadiness or awkwardness while you are using this medicine. These may be symptoms of peripheral neuropathy.

Check with your doctor right away if you have chest pain or discomfort, irregular heartbeat, nausea or vomiting, pain in the shoulders, arms, jaw, or neck, or sweating after receiving this medicine.

It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blurred vision
• chills
• cold sweats
• confusion
• discouragement
• dizziness
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position
• feeling sad or empty
• full feeling
• headache
• irritability
• lack of appetite
• loss of interest or pleasure
• nervousness
• pounding in the ears
• pressure in the stomach
• rapid weight gain
• slow or fast heartbeat
• swelling of the abdominal or stomach area
• tingling of the hands or feet
• tiredness
• trouble concentrating
• trouble sleeping
• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• unusual weight gain or loss

• Burning, numbness, tingling, or painful sensations
• confusion about identity, place, and time
• dry mouth
• false beliefs that cannot be changed by facts
• feeling that others are watching you or controlling your behavior
• holding false beliefs that cannot be changed by fact
• hyperventilation
• irregular heartbeats
• restlessness
• seeing, hearing, or feeling things that are not there
• severe constipation
• severe mood or mental changes
• severe vomiting
• shaking
• shortness of breath
• trouble sleeping
• unsteadiness or awkwardness
• unusual behavior
• unusual excitement, nervousness, or restlessness
• weakness in the arms, hands, legs, or feet

• Change in size, shape, or color of existing mole
• mole that leaks fluid or bleeds
• new mole

• Blindness
• chest pain or discomfort
• constipation that does not go away
• convulsions
• dark, tarry stools
• decreased vision
• difficulty with breathing
• eye pain
• high fever
• increased sweating
• loss of bladder control
• nausea or vomiting
• pain in the shoulders, arms, jaw, or neck
• severe muscle stiffness
• tearing
• unusually pale skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• cough
• difficulty with swallowing
• ear congestion
• excess air or gas in the stomach or intestines
• heartburn
• loss of voice
• nasal congestion
• passing gas
• redness at the incision site
• runny nose
• sneezing
• sore throat

• Acid or sour stomach
• belching
• diarrhea
• heartburn
• indigestion
• rash
• stomach discomfort or upset

• Sleepiness
• unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat Parkinson's disease.
• It is used to treat signs like Parkinson's disease caused by other health problems.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to levodopa, carbidopa, or any other part of Duopa (carbidopa and levodopa enteral suspension).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Glaucoma, a skin lump or growth, or a history of skin cancer.
• If you are taking any of these drugs: Reserpine or tetrabenazine.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking another drug that has the same drug in it.

This is not a list of all drugs or health problems that interact with Duopa.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion through a tube connected to your bowels.
• Your doctor will teach you how to take Duopa.
• Follow how to use as you have been told by the doctor or read the package insert.
• Take the oral form of this medicine as you have been told by your doctor.
• This medicine needs to be at room temperature before use. Take a cassette out of the carton and out of the refrigerator 20 minutes before using.
• Do not reuse casettes. Do not use a cassette for longer than 16 hours, even if some drug is left.
• If you need to disconnect the pump for a short time (less than 2 hours), follow what your doctor has told to do or read the package insert. If you need to disconnect the pump for longer than 2 hours, call your doctor to find out what to do.
• If you take an iron product or a multivitamin that has iron, ask your doctor or pharmacist how to take it with Duopa. Iron may lower how well your body is able to absorb this medicine.
• Diets high in protein, fat, or calories may lower how well your body absorbs Duopa; tell your doctor if you have a diet like this or if you will be changing your diet. Talk with your doctor.
• Do not stop taking this medicine all of a sudden or lower your dose without calling your doctor. Side effects may happen. Talk with your doctor.
• Take even during sign-free periods.
• Keep a diary of your signs.
• Keep taking Duopa as you have been told by your doctor or other health care provider, even if you feel well.
• Take this medicine at the same time of day.
• To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Bad dreams.
• Hard stools (constipation).
• Dizziness.
• Feeling sleepy.
• Dry mouth.
• Headache.
• Not able to sleep.
• Throat pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.