How does this medication work? What will it do for me?

This is a combination product containing two medications in the form of a gel: levodopa and carbidopa. It is used to treat Parkinson's disease in people who are responsive to levodopa treatment, have tried other types of Parkinson's disease medication combinations but continue to have symptoms. Levodopa - carbidopa intestinal gel is given using a small portable pump and tube that connects directly into the gut. The medication is given throughout the day, which allows a constant amount of medication to be in the blood and decrease the Parkinson's symptoms.

Levodopa helps to control the symptoms of Parkinson's disease by correcting the chemical imbalance in the brain that produces symptoms. The addition of carbidopa lowers the amount of levodopa that is required and may reduce some of the side effects of levodopa, such as nausea and vomiting.

Although levodopa helps relieve symptoms of Parkinson's disease, it does not slow down the progression of the disease.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each yellow, oval, biconvex tablet, with one side scored and engraved "100 25", contains levodopa 100 mg and anhydrous carbidopa 25 mg. Nonmedicinal ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sorbitol, and D&C Yellow No. 10 Aluminum Lake.

How should I use this medication?

Treatment with levodopa - carbidopa should be started slowly and increased gradually to reduce the risk of side effects while gaining maximum benefit from the medication.

The recommended starting dose for people not already taking levodopa is 1 tablet, containing levodopa 100 mg and carbidopa 25 mg, 3 times a day. Your doctor will usually increase the dosage by 1 tablet daily every 3 days until the best results occur with the least amount of side effects. When the daily dose rises above 3 tablets daily, the dose should be divided into 4 to 6 daily doses. The maximum daily dose of levodopa is 1500 mg.

If you have already been taking levodopa and are starting levodopa - carbidopa, the dose will be much lower than the dose of levodopa taken as a single medction.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

The controlled release (CR tablets) form of this medication should be swallowed whole with fluids. Do not crush or chew the medication as this will destroy the time-release property of the medication.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue on with your regular schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice. If you miss more than one dose, check with your doctor.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use levodopa - carbidopa intestinal gel if you:

  • are allergic to levodopa, carbidopa, or any ingredients of the medication
  • cannot take sympathomimetic amines (e.g., epinephrine, norepinephrine)
  • have a history of stomach or pancreas problems such as swelling or obstruction that prevents placement of a PEG tube (a type of tube that connects to the gut in order to use this medication)
  • have an active infection of the abdominal space
  • have active uncontrolled or severe heart disease, blood-related diseases, endocrine disease, liver disease, lung disease, or kidney disease
  • have narrow-angle glaucoma
  • have suspicious undiagnosed skin lesions or a history of melanoma
  • have or have had a stroke in the last 6 months
  • have used an MAO inhibitor (e.g., phenelzine, tranylcypromine) within the past 2 weeks (as an exception, selegiline can be used safely at the recommended dose with levodopa - carbidopa intestinal gel)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

As this medication is delivered using a pump-tube delivery system, complications can occur from the surgical procedure required to create the small opening in the stomach wall for the intestinal tube and with long-term use of the intestinal tube. This risk should be discussed with your doctor to determine if this medication is a good choice for your treatment.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • diarrhea
  • dizziness
  • increased sweating
  • loss of appetite
  • upset stomach
  • vomiting
  • weight loss

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abnormal thinking – developing urges to gamble, increased sexual urges, excessive eating or spending, and/or other intense urges that could harm yourself or others
  • anxiety
  • cold, burning, tingling, prickling sensations in the hands, feet, arms, or legs
  • falling asleep without warning
  • falls
  • feeling lightheaded or faint after standing
  • hallucinations
  • involuntary movements, muscle cramps
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of skin cancer, irregular or new skin lesions
  • a sudden return of your Parkinson's disease symptoms
  • surgical-procedure-related problems (e.g., abdominal pain, redness or swelling around the surgical wound, infection around the tube, air or gas in the abdomen etc.)
  • symptoms of irregular heart beat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)

The following side effects may be caused from the tubing as you should check you with your doctor as soon as possible if any occurs:

  • tube blockages
  • dislocation of the tube
  • inflammation or infection around the tube leading to swelling or leakage
  • stomach pain, nausea, vomiting
  • worsening movement (or slow movement)

Seek immediate medical attention if any of the following occur:

  • severe abdominal pain which may be associated with fever, vomiting, abdominal tenderness, or swelling of the abdomen
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, redness, itching, or swelling of the skin, face and throat)
  • vomiting of blood or noticing blood in your stools
  • with reduced dosing or stopping the medication resulting in a high fever, muscle rigidity, involuntary movements, altered consciousness, mental status changes such as more frequent breathing, sweating or dizziness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Activities requiring alertness: There have been reports of sudden onset of sleep by individuals taking levodopa and carbidopa combination. The doctor should be informed immediately if any episodes of suddenly falling asleep occur.

Behavioural and mood changes: This medication has been known to cause mood swings, changes in behavior, and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You may notice compulsive behaviour, such as gambling, increased sexual activity, or inappropriate spending. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, or decreased interest in activities, contact your doctor as soon as possible. If you notice compulsive behaviour or signs of depression in a family member, ensure that they see their doctor.

Blood pressure and heart: This medication can cause blood pressure changes, making symptoms of heart conditions worse. If you have an existing heart condition, you should discuss with your doctor about how your condition may affect your medication dosage, or how your dosage may affect your medical condition.

Device-related complications: A sudden decrease in treatment response with increased symptoms of Parkinson's disease may be due to problems with the tubing or pump device, including tube blockages or dislocations. The doctor should be informed immediately if this occurs.

Diet: Protein-rich diets such as diets that contain a lot of meat, poultry, or fish may reduce the beneficial effects of levodopa. Discuss appropriate diet options with your doctor.

Glaucoma: This medication may make symptoms of glaucoma worse by increasing the pressure in the eye. If you have chronic wide-angle glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Medical conditions: People with epilepsy, peptic ulcer or previous surgery in the upper part of the abdomen, heart disease, lung disease (e.g. asthma), liver disease, kidney disease, or hormonal disturbances, should be frequently monitored by their doctor while taking this medication.

Neuroleptic malignant syndrome (NMS): Very rarely, levodopa - carbidopa can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.

Seizures: If you have seizures or a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Skin cancer: People with Parkinson's have been shown to have 2 to 6 times the risk of developing skin cancer compared to the general population. It is unknown if this is caused by the medication or the Parkinson's disease. You should discuss with your doctor regarding regular monitoring of your skin.

Sudden onset of sleep: There are reports of people who use levodopa - carbidopa falling asleep with no warning or drowsiness. If you have a sleep disorder, discuss this with your doctor. If you experience drowsiness while taking this medication, avoid driving or using machinery.

Surgeries: Except in emergencies, levodopa - carbidopa intestinal gel should be stopped 2 to 3 hours before any surgeries that require general anesthesia. Use of anesthesia and this medication together may cause changes in blood pressure or abnormal heart rhythms. Levodopa - carbidopa intestinal gel can be restarted after surgery as soon as the doctor allows you to drink fluids normally.

Pregnancy: The safety and effectiveness of using this medication have not been established for pregnant women. Levodopa - carbidopa intestinal gel should not be used during pregnancy unless the benefits outweigh the risks.

Breast-feeding: It is not known if levodopa - carbidopa passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of levodopa-carbidopa intestinal gel have not been established for use by people less than 18 years of age.

What other drugs could interact with this medication?

There may be an interaction between levodopa - carbidopa intestinal gel and any of the following:

  • alfuzosin
  • alpha agonists (e.g., clonidine, methyldopa)
  • angiotensin-converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzepine, quetiapine, risperidone)
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • brimonidine
  • bupropion
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • conivaptan
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • duloxetine
  • glycopyrrolate
  • iron supplements (e.g., ferrous gluconate, ferrous sulfate)
  • isoniazid
  • kava kava
  • medications for irregular heartbeat such as amiodarone, disopyramide, dofetilide, procainamide, quinidine, or sotalol
  • methylphenidate
  • metoclopramide
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • multivitamins
  • obinutuzumab
  • pentoxifylline
  • phenytoin
  • phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • prochlorperazine
  • pyridoxine (vitamin B6)
  • sapropterin
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2018. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Pro-Levocarb-10025