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Tolcapone Oral tablet

It is used in combination with levodopa-carbidopa therapy to treat Parkinson's disease.

Generic Name: tolcapone  |  Brand Name: Tasmar

Brand Names: Tasmar

There is an FDA Alert for this drug. Click here to view it.

  • Tolcapone should not be initiated until the clinician has fully explained the risks and the patient (or representative) has provided written informed consent.
  • Use with caution in patients with severe dystonia or dyskinesia. (See Rhabdomyolysis under Cautions.)

  • Risk of potentially fatal, acute fulminant hepatic failure. Incidence may be 10- to 100-fold higher than the background incidence in the general population.
  • Generally reserve tolcapone therapy for patients with parkinsonian syndrome receiving levodopa/carbidopa who are experiencing symptom fluctuations and are not responding adequately to or are not candidates for other adjunctive therapies (e.g., ergot- and nonergot-derivative dopamine receptor agonists, selegiline).
  • Do not initiate tolcapone in patients with clinical evidence of active liver disease, ALT or AST concentrations exceeding the ULN, or any other evidence of hepatocellular dysfunction.
  • Discontinue tolcapone if the patient does not experience symptomatic improvement within 3 weeks of initiating therapy.
  • Discontinue tolcapone if aminotransferase concentrations exceed the ULN or if clinical manifestations suggest the onset of hepatic failure (e.g., persistent nausea, fatigue, lethargy, anorexia, jaundice, dark urine, pruritus, upper right quadrant tenderness).
  • Advise patients of the need for self-monitoring for signs or symptoms of liver disease.
  • Patients who develop evidence of hepatocellular injury while receiving tolcapone and in whom such therapy is discontinued for any reason may be at increased risk for hepatic injury if tolcapone is reintroduced. Retreatment with tolcapone ordinarily should not be considered in such patients.
  • Perform appropriate tests to exclude hepatic disease prior to initiation of therapy and monitor patients receiving tolcapone for evidence of emergent liver injury.
  • Evaluate serum AST and ALT at baseline, every 2 weeks during the first year of therapy, every 4 weeks during the next 6 months of therapy, and every 8 weeks thereafter. If dosage is increased to 200 mg 3 times daily, determine serum AST and ALT prior to increasing the dosage and then at the same frequency as that recommended when therapy is initiated.
  • Not known whether baseline and periodic monitoring of liver enzymes will prevent the occurrence of fulminant tolcapone-induced hepatic failure; however, frequent laboratory monitoring for evidence of hepatocellular injury is considered essential. Early detection of drug-induced hepatic injury along with immediate discontinuance of the suspect drug is believed to enhance the likelihood for recovery. Baseline monitoring is recommended, since patients with preexisting liver disease may be more vulnerable to hepatotoxins.

What is this medicine?

TOLCAPONE (TOLE ka pone) is used in combination with levodopa-carbidopa therapy to treat Parkinson's disease.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • kidney disease
  • liver disease
  • severe movement disorder
  • an unusual or allergic reaction to tolcapone, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • isoniazid
  • medicines called MAO Inhibitors like Nardil, Parnate, Marplan, Eldepryl
  • procarbazine

This medicine may also interact with the following medications:

  • apomorphine
  • dobutamine
  • isoproterenol
  • methyldopa
  • phenelzine
  • warfarin

What should I watch for while using this medicine?

Visit your doctor for regular check ups. You will need to have important blood work done while you are taking this medicine. Tell your doctor if your symptoms do not get better or if they get worse.

You may get dizzy or have difficulty controlling your movements. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can increase possible dizziness. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

There have been reports of increased sexual urges or other strong urges such as gambling while taking some medicines for Parkinson's disease. If you experience any of these urges while taking this medicine, you should report it to your health care provider as soon as possible.

You should check your skin often for changes to moles and new growths while taking this medicine. Call your doctor if you notice any of these changes.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • confusion
  • dark urine
  • feeling faint or lightheaded
  • fever
  • general ill feeling or flu-like symptoms
  • hallucinations
  • involuntary muscle movements
  • light-colored stools
  • loss of appetite, nausea
  • right upper belly pain
  • severe diarrhea
  • unusually weak or tired
  • yellowing of eyes, skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation
  • headache
  • increased sweating
  • muscle cramping
  • stomach upset
  • trouble sleeping

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Last Updated: September 03, 2009
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