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Comtan

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Comtan

Comtan

INDICATIONS

Comtan (entacapone) is indicated as an adjunct to levodopa/carbidopa to treat patients with idiopathic Parkinson's Disease who experience the signs and symptoms of end-of-dose “wearing-off” (see CLINICAL PHARMACOLOGY, Clinical Studies).

Comtan (entacapone) 's effectiveness has not been systematically evaluated in patients with idiopathic Parkinson's Disease who do not experience end-of-dose “wearing-off”.

DOSAGE AND ADMINISTRATION

The recommended dose of Comtan (entacapone) is one 200 mg tablet administered concomitantly with each levodopa/carbidopa dose to a maximum of 8 times daily (200 mg x 8 = 1600 mg per day). Clinical experience with daily doses above 1600 mg is limited.

Comtan (entacapone) should always be administered in association with levodopa/carbidopa. Entacapone has no antiparkinsonian effect of its own.

In clinical trials, the majority of patients required a decrease in daily levodopa dose if their daily dose of levodopa had been ≥ 800 mg or if patients had moderate or severe dyskinesias before beginning treatment.

To optimize an individual patient's response, reductions in daily levodopa dose or extending the interval between doses may be necessary. In clinical trials, the average reduction in daily levodopa dose was about 25% in those patients requiring a levodopa dose reduction. (More than 58% of patients with levodopa doses above 800 mg daily required such a reduction.)

Comtan (entacapone) can be combined with both the immediate and sustained-release formulations of levodopa/carbidopa.

Comtan (entacapone) may be taken with or without food (see CLINICAL PHARMACOLOGY).

Patients With Impaired Hepatic Function

Patients with hepatic impairment should be treated with caution. The AUC and Cmax of entacapone approximately doubled in patients with documented liver disease, compared to controls. However, these studies were conducted with single-dose entacapone without levodopa/dopa decarboxylase inhibitor coadministration, and therefore the effects of liver disease on the kinetics of chronically administered entacapone have not been evaluated (see CLINICAL PHARMACOLOGY, Pharmacokinetics of Entacapone).

Withdrawing Patients from Comtan (entacapone)

Rapid withdrawal or abrupt reduction in the Comtan (entacapone) dose could lead to emergence of signs and symptoms of Parkinson's Disease (see CLINICAL PHARMACOLOGY, Clinical Studies), and may lead to Hyperpyrexia and Confusion, a symptom complex resembling the neuroleptic malignant syndrome (see PRECAUTIONS, Other Events Reported With Dopaminergic Therapy). This syndrome should be considered in the differential diagnosis for any patient who develops a high fever or severe rigidity. If a decision is made to discontinue treatment with Comtan (entacapone) , patients should be monitored closely and other dopaminergic treatments should be adjusted as needed. Although tapering Comtan (entacapone) has not been systematically evaluated, it seems prudent to withdraw patients slowly if the decision to discontinue treatment is made.

HOW SUPPLIED

Comtan (entacapone) is supplied as 200-mg film-coated tablets for oral administration. The oval-shaped tablets are brownish-orange, unscored, and embossed “COMTAN (entacapone) ” on one side. Tablets are provided in HDPE containers as follows:

Bottles of 100...NDC 0078-0327-05

Store at 25°C (77°F) excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]

Comtan (entacapone) tablets are manufactured by Orion Corporation, Orion Pharma (Espoo, Finland) and marketed by Novartis Pharmaceuticals Corporation (East Hanover, N.J. 07936, U.S.A.). Rev: September 2010.

Last reviewed on RxList: 11/4/2010
This monograph has been modified to include the generic and brand name in many instances.

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Comtan - User Reviews

Comtan User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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