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USP DI Vol. II - LEVODOPA (Systemic)

LEVODOPA (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Atamet 1
  • Larodopa 2
  • Sinemet 1
  • Sinemet CR 1

In Canada?

  • Apo-Levocarb 1
  • Nu-Levocarb 1
  • Sinemet 1
  • Sinemet CR 1

Note:

For quick reference, the following medicines are numbered to matchthe corresponding brand names.

This information applies to the following medicines:
1.Carbidopa and Levodopa (kar-bi-DOE-pa and lee-voe-DOE-pa)??
2.Levodopa (LEE-voe-doe-pa)
? Generic name product may be available in the U.S.
? Generic name product may be available in Canada

Category

  • Antidyskinetic

Description

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

Levodopa alone or in combination is available only with your doctor's prescription.It is available in the following dosage forms:

    Oral
  • Carbidopa and Levodopa
    • Tablets (U.S. and Canada)
    • Extended-release tablets (U.S. and Canada)
  • Levodopa
    • Tablets (U.S.)


Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to levodopa alone or in combination with carbidopa. Alsotell your health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Studies have not been done in pregnantwomen. However, studies in animals have shown that levodopa affects the baby'sgrowth both before and after birth if given during pregnancy in doses manytimes the human dose.

Breast-feeding?Levodopa, alone and in carbidopa and levodopa combination,passes into breast milk and may cause unwanted side effects in the nursingbaby. Also, levodopa may reduce the flow of breast milk.

Children?Studies on this medicine have been done only in adultpatients, and there is no specific information comparing use of levodopa orcarbidopa in children with use in other age groups.

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

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takinglevodopa or carbidopa and levodopa combination, it is especially importantthat your health care professional know if you are taking any of the following:

  • Cocaine?Cocaine use by individuals taking levodopa, alone orin combination with carbidopa, may cause an irregular heartbeat
  • Haloperidol (e.g., Haldol) or
  • Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g.,Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil],perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine[e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril],trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine[e.g., Temaril]) or
  • Thioxanthenes (chlorprothixene [e.g., Taractan], thiothixene [e.g.,Navane])?Taking these medicines with levodopa may lessen the effectsof levodopa
  • Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g.,Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline[e.g., Eldepryl], tranylcypromine [e.g., Parnate])?Taking levodopa whileyou are taking or within 2 weeks of taking monoamine oxidase (MAO) inhibitorsmay cause sudden extremely high blood pressure; at least 14 days should beallowed between stopping treatment with one medicine and starting treatmentwith the other medicine
  • Pyridoxine (vitamin B 6 [e.g., Hexa-Betalin]),present in some foods and vitamin formulas (for levodopa used alone)?Pyridoxinereverses the effects of levodopa
  • Selegiline?Dosage of levodopa or carbidopa and levodopa combinationmay need to be decreased

Other medical problems?The presence of other medicalproblems may affect the use of levodopa. Make sure you tell your doctor ifyou have any other medical problems, especially:

  • Diabetes mellitus (sugar diabetes)?The amount of insulin orantidiabetic 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, increasingthe chance of side effects
  • Seizure disorders, such as epilepsy (history of)?The risk ofseizures may be increased
  • Stomach ulcer (history of)?The ulcer may occur again

Proper Use of This Medicine

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

For patients taking levodopa by itself:

  • Pyridoxine (vitamin B 6) has been foundto reduce the effects of levodopa when levodopa is taken by itself. This doesnot happen with the combination of carbidopa and levodopa. If you are taking levodopa by itself, do not take vitamin products containingvitamin B 6 during treatment, unless prescribedby your doctor.
  • Large amounts of pyridoxine are also contained in some foods suchas 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 yourdiet while you are taking levodopa. Also, ask your health care professionalfor help when selecting vitamin products.

At first, levodopa may be taken with a meal or a snack, so that any effectslike stomach upset will be lessened. Later, as your body becomes accustomedto 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 nottake more or less of it, and do not take it more often than your doctor ordered.

For patients taking carbidopa and levodopa extended-releasetablets:

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

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

Dosing?The dose of levodopa or carbidopa and levodopacombination will be different for different patients. Follow your doctor's orders or the directions on the label. The followinginformation includes only the average doses of levodopa or carbidopa and levodopacombination. If your dose is different, do not changeit unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.Also, the number of doses you take each day, the timeallowed between doses, and the length of time you take the medicine dependon your special needs.

    For levodopa
  • For Parkinson's disease:
    • For oral dosage form (tablets):
      • Adults and teenagers?At first, 250 milligrams (mg) two to fourtimes a day. Your doctor may increase your dose if needed. However, the doseis usually not more than 8000 mg (8 grams) a day.
      • Children up to 12 years of age?Use and dose must be determinedby 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 doctormay need to change your dose, depending on how you respond to this combinationmedicine.
      • Children and teenagers?Use and dose must be determined by yourdoctor.
    • For oral extended-release tablet dosageform:
      • Adults?At first, 1 tablet two times a day. However, you mayneed 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 forParkinson's disease.
      • Children and teenagers?Use and dose must be determined by yourdoctor.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if your next scheduled dose is within 2 hours,skip the missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Beforehaving 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 tobe wrong. Check with your doctor before depending on home tests using thepaper-strip or tablet method.

This medicine may cause some people to become dizzy, confused, or haveblurred or double vision. Make sure you know how youreact to this medicine before you drive, use machines, or do anything elsethat 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. Gettingup slowly may help. If the problem continues or gets worse, check with yourdoctor.

For patients taking levodopa by itself:

  • Pyridoxine (vitamin B 6) has been foundto reduce the effects of levodopa when levodopa is taken by itself. This doesnot happen with the combination of carbidopa and levodopa. If you are taking levodopa by itself, do not take vitamin products containingvitamin B 6 during treatment, unless prescribedby your doctor.
  • Large amounts of pyridoxine are also contained in some foods suchas 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 yourdiet while you are taking levodopa. Also, ask your health care professionalfor help when selecting vitamin products.

As your condition improves and your body movements become easier, be careful not to overdo physical activities. Injuries resultingfrom falls may occur. Physical activities must be increased graduallyto 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 sideeffects may occur, if they do occur they may need medical attention.

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

    More common

      Abnormal thinking: holding false beliefs that cannot be changedby fact; agitation; anxiety; clenching or grinding of teeth; clumsiness or unsteadiness; confusion; difficulty swallowing; dizziness; excessive watering of mouth; false senseof 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 movementsof 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 lightheadednesswhen getting up from a lying or sitting position; double vision; fast, irregular, or pounding heartbeat; hot flashes; increasedblinking or spasm of eyelids; loss of bladder control; mental depression; othermood or mental changes; skin rash; unusual weight gain or loss

    Rare

      Back or leg pain; bloody or black tarrystools; chills; convulsions(seizures); fever; highblood 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 orlower legs; vomiting of blood or material that lookslike coffee grounds

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:

    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 firstbe reddish, then turn to nearly black after being exposed to air. Some bathroomcleaning products will produce a similar effect when in contact with urinecontaining this medicine. This is to be expected during treatment with thismedicine. Also, this medicine may cause a bitter taste, or a burning sensationof the tongue.

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.


Revised: 06/15/1999