Levodopa-Carbidopa: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is LEVODOPA-CARBIDOPA used for?

LEVODOPA-CARBIDOPA is used to treat the symptoms of Parkinson’s disease in adults.

How does LEVODOPA-CARBIDOPA work?

LEVODOPA-CARBIDOPA contains two ingredients:

• Levodopa: this acts to replenish dopamine in the brain.
• Carbidopa: ensures that enough levodopa gets to the brain where it is needed.

It is believed that the symptoms of Parkinson’s disease are caused by a lack of dopamine. Dopamine is a naturally occurring chemical produced by certain brain cells. It has the role of relaying messages in certain regions of the brain that control muscle movement. Difficulty in movement results when too little dopamine is produced.

In many patients, LEVODOPA-CARBIDOPA helps to reduce the symptoms of Parkinson’s disease.

What are the ingredients in LEVODOPA-CARBIDOPA?

Medicinal ingredients: Levodopa and Carbidopa

Non-medicinal ingredients: Croscarmellose sodium, magnesium stearate, microcrystalline cellulose and sorbitol.

LEVODOPA-CARBIDOPA 100 mg / 10 mg and 250 mg / 25 mg tablets also contain Brilliant Blue FCF AL Lake 12% and Indigotine AL Lake 12 - 14% (Blue #2).

LEVODOPA-CARBIDOPA 100 mg / 25 mg tablets contain D&C Yellow #10 Lake 14-18%.

LEVODOPA-CARBIDOPA comes in the following dosage forms:

Tablets: 100 mg / 25 mg (yellow), 100 mg / 10 mg and 250 mg / 25 mg (blue).

LEVODOPA-CARBIDOPA tablets are available in a levodopa: carbidopa 4:1 ratio (LEVODOPA-CARBIDOPA 100 mg / 25 mg) and in a 10:1 ratio of levodopa to carbidopa (LEVODOPA-CARBIDOPA 100 mg / 10 mg and 250 mg / 25 mg).

Do not use LEVODOPA-CARBIDOPA if:

• you are allergic to levodopa, carbidopa, or to any other ingredients in LEVODOPA-CARBIDOPA.
• you are taking certain monoamine oxidase inhibitors (MAOIs) (such as those used to treat depression). Most MAOIs should be stopped at least two weeks before starting therapy with LEVODOPA-CARBIDOPA.
• you have an untreated heart, liver, kidney, lung, blood or hormonal disease.
• you have a serious eye condition called narrow-angle glaucoma.

• you have been told that you should not take sympathomimetic medicines such as:

  • isoproterenol (used to treat asthma and certain heart conditions)
  • amphetamines (used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy (uncontrollable urge to sleep))
  • epinephrine (used to treat life-threatening allergic reactions)
• you have any suspicious skin lesions (moles) which have not been examined by your healthcare professional or if you have ever had skin cancer.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LEVODOPA-CARBIDOPA. Talk about any health conditions or problems you may have, including if you:

• are taking or have taken levodopa in the past.
• have a history of heart problems (heart attack or irregular heartbeat). Your healthcare professional should carefully monitor you in an appropriate facility when you first start taking LEVODOPA-CARBIDOPA.
• have or have had ulcers in your gut (called "duodenal" or "peptic” ulcers).
• have a history of convulsions/seizures.
• have dyskinesia, which are severe uncontrolled involuntary movements that can look like fidgeting, writhing or swaying.
• have any unusual conditions related to your eyes or eyesight (glaucoma).
• are going to have an operation that requires general anesthesia.
• suffer from a medical condition called psychosis.
• have or had skin cancer (melanoma).

• are pregnant, think you might be pregnant or become pregnant while taking LEVODOPA-CARBIDOPA. Your healthcare professional will advise whether you should take LEVODOPA-CARBIDOPA while you are pregnant.

• are breastfeeding or wish to breastfeed. Your healthcare professional will decide whether you should take LEVODOPA-CARBIDOPA while breastfeeding.
• have allergies.
• have problems with your lungs, kidneys, or liver.
• have hormonal problems.

Other warnings you should know about:

Laboratory tests and monitoring: When you take LEVODOPA-CARBIDOPA for a prolonged time, your healthcare professional may:

• monitor your liver, kidney and heart function
• do blood tests

Physical activity: As you improve on LEVODOPA-CARBIDOPA you may increase your physical activity slowly depending if you have any other medical conditions.

Uncontrollable movements: LEVODOPA-CARBIDOPA may cause uncontrollable movements and “on and off” episodes. This may happen soon after you take LEVODOPA-CARBIDOPA.

Mental health changes/disturbances: LEVODOPA-CARBIDOPA may cause changes to your mental health.

• Tell your healthcare professional right away if you start to feel depressed or have thoughts of suicide.
• Hallucinations (seeing or hearing things that are not there) can occur when taking LEVODOPA-CARBIDOPA.

Neuroleptic malignant syndrome: This is a disorder that causes you to have a high fever, confusion, altered states or consciousness and stiffness in your muscles. Neuroleptic malignant syndrome may happen if you suddenly:

• Reduce your dose
• Stop taking LEVODOPA-CARBIDOPA
• Switch medicines

Your healthcare professional should monitor you when your dose is reduced or when you stop taking LEVODOPA-CARBIDOPA, especially if you take antipsychotic medicines.

Compulsive behaviours: While taking LEVODOPA-CARBIDOPA, you may have unusual urges and/or behaviours such as excessive:

• gambling
• sexual behaviour
• eating
• spending

You or your caregiver should tell your healthcare professional if either of you notice that you have new or changes to your behaviour.

Skin: People with Parkinson’s disease have a higher risk of developing skin cancer (melanoma). Your healthcare professional should monitor you for skin cancer while you are taking LEVODOPA-CARBIDOPA. Tell your healthcare professional if you have:

• suspicious, undiagnosed changed patches of pigmented skin
• irritated or irregular moles
• moles in which you have noticed changes

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may also interact with LEVODOPA-CARBIDOPA:

• antihypertensive medicines (used to treat high blood pressure)
• some medications used to treat psychiatric conditions or mental depression (including phenothiazines, butyrophenones, risperidone, selegiline, and tricyclic antidepressants)
• phenytoin (used to treat and control seizures)
• papaverine (used to treat intestinal spasms)
• tetrabenazine (used to treat conditions related to involuntary movements such as Huntington’s Disease)
• isoniazid (used to treat tuberculosis)
• anesthetics (medicines used during surgery)
• iron salts (such as multivitamins tablets)
• metoclopramide (used to relieve nausea and vomiting)
• foods that are high in protein. This includes meat, fish, dairy products, seeds and nuts

How to take LEVODOPA-CARBIDOPA:

• Swallow tablets whole with a glass of water. Do not chew, divide or crush tablets. LEVODOPA-CARBIDOPA tablets have a score line on one side. Breaking the tablet in half may not give you half the dose.

DO NOT:

• stop taking LEVODOPA-CARBIDOPA, reduce the amount of LEVODOPA-CARBIDOPA you take or change your dose unless your healthcare professional tells you to. If you suddenly stop or reduce your dose, you may experience the following symptoms: stiff muscles, fever and mental changes.
• take any other medicines used to treat Parkinson’s disease without first consulting your healthcare professional. This includes other medicines containing levodopa and carbidopa.
• give LEVODOPA-CARBIDOPA to other people.
• use LEVODOPA-CARBIDOPA for any other condition.

Usual dose:

• Your healthcare professional will tell you how many tablets of LEVODOPA-CARBIDOPA

  • Take LEVODOPA-CARBIDOPA exactly as your healthcare professional has told you.
• Tell your healthcare professional right away if you notice any changes in your symptoms during your treatment, such as nausea or abnormal movements. Your healthcare professional may need to adjust your dose.

Overdose:

Missed Dose:

If you have missed a dose, take it as soon as you remember. If it is almost time to take your next dose, do not take the dose you have missed, and take your next dose as scheduled.

What are possible side effects from using LEVODOPA-CARBIDOPA?

These are not all the possible side effects you may have when taking LEVODOPA-CARBIDOPA. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Nausea or vomiting
• Slow movements
• Sleepiness, abnormal dreams, difficulty to fall asleep or stay asleep
• Headache
• Dizziness
• Mental changes, confusion, feeling agitated
• Hair loss
• Dark-coloured saliva, urine and sweat
• Chest pain
• Feeling weak and tired
• Changes in blood pressure
• Dry mouth, changes in tastes, drooling, burning sensation of the tongue, grinding or clenching of the teeth
• Diarrhea, constipation, stomach pain, heartburn, gas
• Back, shoulder or leg pain
• Muscle cramps
• Bladder infection
• Hiccups
• Changes in weight, eating disorder (anorexia)
• Blurred or double vision
• Spasms that move the eye(s) into a fixed position (oculogyric crisis)

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store your tablets in a tightly closed container at room temperature (15°C to 30°C). Protect from light and moisture.

Keep out of reach and sight of children.

Do not use outdated medicine.

If you want more information about LEVODOPA-CARBIDOPA:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: MAY 30, 2024