Pronunciation:

lee-voe-DOE-pa

Classifications:

Pharmacologic—

Dopamine Precursor

Uses of This Medicine:

Levodopa is used alone or in combination with carbidopa to treat Parkinson's disease, sometimes referred to as shaking palsy. Some patients require the combination of medicine, while others benefit from levodopa alone. By improving muscle control, this medicine allows more normal movements of the body.

Levodopa alone or in combination is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

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

Older adults—

Elderly people are especially sensitive to the effects of levodopa. This may increase the chance of side effects during treatment.

Breast-feeding—

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

Other 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 taking 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.

• 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.

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

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.

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

Other interactions—

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:

• Diabetes mellitus (sugar diabetes)—The amount of insulin or antidiabetic medicine that you need to take may change

• Emphysema, asthma, bronchitis, or other chronic lung disease or
• Glaucoma or
• Heart or blood vessel disease or
• Hormone problems or
• Melanoma (a type of skin cancer) (or history of) or
• Mental illness—Levodopa may make the condition worse

• Kidney disease or
• Liver disease—Higher blood levels of levodopa may occur, increasing the chance of side effects

• Seizure disorders, such as epilepsy (history of)—The risk of seizures may be increased

• Stomach ulcer (history of)—The ulcer may occur again

Proper Use of This Medicine:

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 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 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.

Precautions While Using This Medicine:

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

For patients with diabetes:

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

This medicine may cause some people to become dizzy, confused, or have blurred or double vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or not able to see well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with 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.

As your condition improves and your body movements become easier, be careful not to overdo physical activities. Injuries resulting from falls may occur. Physical activities must be increased gradually to allow your body to adjust to changing balance, circulation, and coordination. This is especially important in the elderly.

Side Effects of This Medicine:

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 as soon as possible if any of the following side effects occur:

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 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:

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 in sleeping

This medicine may sometimes cause the urine, saliva, and sweat to be darker in color than usual. The urine may at first be reddish, then turn to 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 to be expected during treatment with this medicine. Also, this medicine may cause a bitter taste, or a burning sensation of the tongue.

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.