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Parkinson's Disease HOL-emblem1-web.GIF (3556 bytes)

Tolcapone

BRAND: Tasmar

Tolcapone (Tasmar) is a potent, reversible COMT inhibitor. Animal studies have demonstrated that Tolcapone exerts central as well as peripheral COMT inhibition. It is rapidly absorbed. Side effects are mostly those relating to increased dopaminergic stimulation. Patients with levodopa-induced dyskinesia often have an initial rapid increase in dyskinesia necessitating a 25-50% reduction in levodopa dose.

Alternatively, the levodopa dose can be reduced by 25-50% at the time Tolcapone is initiated and then titrated further as appropriate. Additional dopaminergic side effects include nausea, hallucinations, and hypotension. These side effects can usually be reduced or eliminated by decreasing the levodopa dose. Approximately 10% of patients experience diarrhea and 3% discontinue tolcapone because of this side effect. Onset of diarrhea is usually delayed for four to twelve weeks after initiation of therapy but uncommon after six months. The mechanism of this side effect is unknown.

Tolcapone has been demonstrated in prospective, double-blind studies to improve motor function and allow levodopa dose reductions in patients on levodopa therapy with either a stable response or with motor fluctuations. in a three month study comparing tolcapone (200 mg nD) with placebo in patients with motor fluctuations on levodopa, Tolcapone permitted a 24% reduction in levodopa dose compared with a 1.6% increase in placebo- treated patients. Mean reduction in 'off' time was 18.8% in the Tolcapone group compared with 7.8% in the placebo group.

In a six month study evaluating tolcapone in patients on levodopa without motor fluctuations, motor function improved 12% in tolcapone-treated patients compared with 1. 5% in placebo-treated patients. Over the six months, placebo patients had a mean increase in levodopa dose of 13% while the Tolcapone groups had decreases of 6 and 9%.

In rare cases, tolcapone has caused severe liver damage resulting in death. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, dark urine, or clay-colored stools. These symptoms may be early signs of liver damage. Your doctor will want to monitor your liver function with blood tests during treatment with tolcapone.

Important Information About Tolcapone

Caution:

Several cases of fatal hepatitis appeared soon after the introduction of Tolcapone. This prompted the US-FDA to place severe restrictions on its use by mandating frequent blood testing of liver function. Entacapone may be a safer drug to use.

In rare cases, tolcapone has caused severe liver damage resulting in death. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, dark urine, or clay colored stools. These symptoms may be early signs of liver damage. Your doctor will want to monitor your liver function with blood tests during treatment with tolcapone.

Due to the risk of serious liver damage, tolcapone is only to be used in combination with carbidopa and levodopa by patients who are not responding adequately to carbidopa and levodopa and who cannot take other medicines to treat their condition.

Use caution when driving, operating machinery, or performing other hazardous activities. tolcapone may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Dizziness may be more likely to occur when rising from a sitting or lying position. To avoid falls, rise slowly from a sitting or lying position.

Do Not Take Tolcapone

Do not take tolcapone without first talking to your doctor if you
bulletHave liver disease;
bulletAre taking a monoamine oxidase inhibitor (maoi) such as isocarboxazid (marplan), phenelzine (nardil), or tranylcypromine (parnate); or
bulletHave ever experienced muscle damage or elevated body temperature and confusion because of a medication.

You may not be able to take tolcapone if you have any of the conditions listed above.

Before taking tolcapone, tell your doctor if you
bulletHave kidney disease, or
bulletHave low blood pressure.

You may not be able to take tolcapone, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Tolcapone is in the FDA pregnancy category C. This means that it is not known whether tolcapone will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant.

It is not known whether tolcapone passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

If you are over 75 years of age, you may be more likely to experience hallucinations while taking tolcapone. You may need a dose adjustment or special monitoring during treatment.

Drug Overdose

Seek emergency medical attention if had a drug overdose.

Symptoms of a tolcapone overdose include nausea, vomiting, and dizziness.

Avoid While Taking Tolcapone
bulletUse caution when driving, operating machinery, or performing other hazardous activities. tolcapone may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
bulletDizziness may be more likely to occur when you rise from a sitting or lying position. To avoid falls, rise slowly.
bulletAvoid alcohol or use it cautiously while taking tolcapone. Alcohol may increase drowsiness and dizziness when taken with tolcapone.

Side Effects of Tolcapone

 If you experience any of the following serious side effects, stop taking tolcapone and seek emergency medical attention or notify your doctor immediately:
bulletAn allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives)
bulletLiver damage (nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, dark urine, or clay-colored stools)
bulletA fever and confusion
bulletBlood in your urine

Other, less serious side effects may be more likely to occur. Notify your doctor if you experience:
bulletDiarrhea
bulletHallucinations or confusion
bulletAbnormal movements of the muscles
bulletMuscle pain or cramps
bulletDizziness or fainting
bulletNausea or vomiting
bulletLoss of appetite
bulletDry mouth
bulletInsomnia or excessive dreaming
bulletDrowsiness
bulletIncreased sweating
bulletDiscolored urine

Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Drug Interaction

Do not take tolcapone without first talking to your doctor if you are taking a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate).

These medicines should not be taken with tolcapone.

Before taking tolcapone, tell your doctor if you are taking
bulletAn oral anticoagulant such as warfarin (Coumadin); or
bulletMethyldopa (Aldoclor, Aldomet, Aldoril).

You may require a dosage adjustment or special monitoring during treatment with tolcapone.

Tolcapone may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines or herbs.

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