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Comtan

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Comtan

Comtan

PATIENT INFORMATION

Patients should be instructed to take Comtan (entacapone) only as prescribed.

Patients should be informed that hallucinations can occur.

Patients should be advised that they may develop postural (orthostatic) hypotension with or without symptoms such as dizziness, nausea, syncope, and sweating. Hypotension may occur more frequently during initial therapy. Accordingly, patients should be cautioned against rising rapidly after sitting or lying down, especially if they have been doing so for prolonged periods, and especially at the initiation of treatment with Comtan (entacapone) .

Patients should be advised that they should neither drive a car nor operate other complex machinery until they have gained sufficient experience on Comtan (entacapone) to gauge whether or not it affects their mental and/or motor performance adversely. Because of the possible additive sedative effects, caution should be used when patients are taking other CNS depressants in combination with Comtan (entacapone) .

Patients should be informed that nausea may occur, especially at the initiation of treatment with Comtan (entacapone) .

Patients should be informed that diarrhea may occur with Comtan (entacapone) and it may have a delayed onset. Sometimes prolonged diarrhea may be caused by colitis (inflammation of the large intestine). Patients with diarrhea should drink fluids to maintain adequate hydration and monitor for weight loss. If diarrhea associated with Comtan (entacapone) is prolonged, discontinuing the drug is expected to lead to resolution, if diarrhea continues after stopping entacapone, further diagnostic investigations may be needed.

Patients should be advised of the possibility of an increase in dyskinesia.

Patients should be advised that treatment with entacapone may cause a change in the color of their urine (a brownish orange discoloration) that is not clinically relevant. In controlled trials, 10% of patients treated with Comtan (entacapone) reported urine discoloration compared to 0% of placebo patients.

Although Comtan (entacapone) has not been shown to be teratogenic in animals, it is always given in conjunction with levodopa/carbidopa, which is known to cause visceral and skeletal malformations in the rabbit. Accordingly, patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy (see PRECAUTIONS, Pregnancy).

Entacapone is excreted into maternal milk in rats. Because of the possibility that entacapone may be excreted into human maternal milk, patients should be advised to notify their physicians if they intend to breastfeed or are breastfeeding an infant.

There have been reports of patients experiencing intense urges to gamble, increased sexual urges, and other intense urges and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone, that are generally used for the treatment of Parkinson's disease, including Comtan (entacapone) . Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges or other urges while being treated with Comtan (entacapone) . Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges or other intense urges while taking Comtan (entacapone) . Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Comtan (entacapone) .

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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