Levodopa (Oral)

Levodopa is used by itself or with carbidopa to treat Parkinson's disease, which is also called shaking palsy. Some patients need both medicines, while others do well with just levodopa. This medicine helps improve muscle control, allowing for more normal body movements.

Levodopa by itself or with carbidopa is available only with your doctor's prescription.

Before having any kind of surgery (including dental surgery) or emergency treatment, inform the medical doctor or dentist in charge that you are taking this medicine.

For patients with diabetes:

• This medicine may cause urine sugar or ketone test results to be incorrect. Check with your doctor before relying on home tests using the paper-strip or tablet method.

This medicine may cause some people to feel dizzy, confused, or have blurred or double vision. Make sure you know how you react to this medicine before driving, using machines, or doing anything else that could be dangerous if you are not alert or unable to see well.

Dizziness, lightheadedness, or fainting may happen, especially when you get up from lying or sitting down. Getting up slowly may help. If the problem continues or worsens, consult your doctor.

For patients taking levodopa by itself:

• Pyridoxine (vitamin B 6) has been shown to reduce the effects of levodopa when levodopa is taken alone. This does not occur with the combination of carbidopa and levodopa. If you are taking levodopa by itself, do not take vitamin products that contain vitamin B 6 during treatment, unless prescribed by your doctor.
• Large amounts of pyridoxine are also found in some foods such as bananas, egg yolks, lima beans, meats, peanuts, and whole grain cereals. Check with your doctor about how much of these foods you can include in your diet while taking levodopa. Also, ask your health care professional for guidance when choosing vitamin products.

As your condition improves and your body movements become easier, be cautious not to overexert yourself with physical activities. Injuries from falls may occur. Physical activities should be increased gradually to allow your body to adapt to changes in balance, circulation, and coordination. This is especially important for the elderly.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it will provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have only been conducted in adult patients, and there is no specific information comparing the use of levodopa or carbidopa in children to other age groups.

Geriatric

Older adults may be more sensitive to the effects of levodopa, which could increase the risk of side effects during treatment.

Breast Feeding

Studies indicate that this medication may change milk production or composition. If an alternative to this medication is not prescribed, you should closely monitor the infant for side effects and ensure adequate milk intake.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. It is crucial for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are highlighted based on their potential significance and do not necessarily include all possible interactions.

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.

• 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Amisulpride
• Bupropion
• Haloperidol
• Isoniazid
• Macimorelin
• Metoclopramide
• Olanzapine
• Sapropterin

Using this medicine with any of the following medicines may increase the 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.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are highlighted based on their potential significance and do not necessarily include all possible interactions.

Using this medicine with any of the following may increase the risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may adjust the dose or how often you use this medicine, or provide special instructions regarding food, alcohol, or tobacco.

• High Protein Food

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Diabetes mellitus (sugar diabetes)—The amount of insulin or antidiabetic medicine you need may change.
• Emphysema, asthma, bronchitis, or other chronic lung diseases
• Glaucoma
• Heart or blood vessel disease
• Hormone problems
• Melanoma (a type of skin cancer) or a history of melanoma
• Mental illness—Levodopa may worsen the condition.
• Kidney disease
• Liver disease—Higher blood levels of levodopa may occur, increasing the risk of side effects.
• Seizure disorders, such as epilepsy (history of)—The risk of seizures may increase.
• Stomach ulcer (history of)—The ulcer may recur.

Along with its necessary effects, a medicine can also cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

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

More common

• Abnormal thinking: holding false beliefs that cannot be changed by fact
• agitation
• anxiety
• clenching or grinding of teeth
• clumsiness or unsteadiness
• confusion
• difficulty swallowing
• dizziness
• excessive watering of mouth
• false sense of well being
• feeling faint
• general feeling of discomfort or illness
• hallucinations (seeing, hearing, or feeling things that are not there)
• hand tremor, increased
• nausea or vomiting
• numbness
• unusual and uncontrolled movements of the body, including the face, tongue, arms, hands, head, and upper body
• unusual tiredness or weakness

Less common

• Blurred vision
• difficult urination
• difficulty opening mouth
• dilated (large) pupils
• dizziness or lightheadedness when getting up from a lying or sitting position
• double vision
• fast, irregular, or pounding heartbeat
• hot flashes
• increased blinking or spasm of eyelids
• loss of bladder control
• mental depression
• other mood or mental changes
• skin rash
• unusual weight gain or loss

Rare

• Back or leg pain
• bloody or black tarry stools
• chills
• convulsions (seizures)
• fever
• high blood pressure
• inability to move eyes
• loss of appetite
• pain, tenderness, or swelling of foot or leg
• pale skin
• prolonged, painful, inappropriate penile erection
• sore throat
• stomach pain
• swelling of face
• swelling of feet or lower legs
• vomiting of blood or material that looks like coffee grounds

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also 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:

More common

• Abdominal pain
• dryness of mouth
• loss of appetite
• nightmares
• passing gas

Less common

• Constipation
• diarrhea
• flushing of skin
• headache
• hiccups
• increased sweating
• muscle twitching
• trouble sleeping

This medicine may sometimes cause the urine, saliva, and sweat to be darker in color than usual. The urine may initially be reddish, then turn nearly black after being exposed to air. Some bathroom cleaning products will produce a similar effect when in contact with urine containing this medicine. This is expected during treatment with this medicine. Additionally, this medicine may cause a bitter taste or a burning sensation in the tongue.

Other side effects not listed may also happen 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.

Pharmacologic Class: Dopamine Precursor

Since protein may interfere with the body's response to levodopa, high protein diets should be avoided. Intake of normal amounts of protein should be spaced equally throughout the day, or taken as directed by your doctor.

For patients taking levodopa by itself:

• Pyridoxine (vitamin B 6) has been found to reduce the effects of levodopa when levodopa is taken by itself. This does not happen with the combination of carbidopa and levodopa. If you are taking levodopa by itself, do not take vitamin products containing vitamin B 6 during treatment, unless prescribed by your doctor.
• Large amounts of pyridoxine are also contained in some foods such as bananas, egg yolks, lima beans, meats, peanuts, and whole grain cereals. Check with your doctor about how much of these foods you may have in your diet while you are taking levodopa. Also, ask your health care professional for help when selecting vitamin products.

At first, levodopa may be taken with a meal or a snack, so that any effects like stomach upset will be lessened. Later, as your body becomes accustomed to the medicine, it should be taken on an empty stomach so that it works better. Be sure to talk to your doctor about the best time for you to take this medicine.

Take this medicine only as directed. Do not take more or less of it, and do not take it more often than your doctor ordered.

For patients taking carbidopa and levodopa extended-release tablets:

• Swallow the tablet whole without crushing or chewing, unless your doctor tells you not to. If your doctor tells you to, you may break the tablet in half.

Some people must take this medicine for several weeks or months before full benefit is received. Do not stop taking it even if you do not think it is working. Instead, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For levodopa
• For Parkinson's disease: For oral dosage form (tablets): Adults and teenagers—At first, 250 milligrams (mg) two to four times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 8000 mg (8 grams) a day. Children up to 12 years of age—Use and dose must be determined by your doctor.

• For levodopa and carbidopa combination
• For Parkinson's disease: For oral tablet dosage form: Adults—At first, 1 tablet three or four times a day. Your doctor may need to change your dose, depending on how you respond to this combination medicine. Children and teenagers—Use and dose must be determined by your doctor. For oral extended-release tablet dosage form: Adults—At first, 1 tablet two times a day. However, you may need to take more than this. Your doctor will decide the right dose for you, depending on your condition and the other medicines you may be taking for Parkinson's disease. Children and teenagers—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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