"The US Food and Drug Administration (FDA) has approved an extended-release capsule formulation of carbidopa-levodopa (Rytary, IPX066, Impax Pharmaceuticals) for the treatment of Parkinson's disease (PD), postencephalitic parkinsonism, an"...
Instruct patients to take Comtan only as prescribed.
Inform patients that hallucinations and/or other psychotic-like behavior can occur.
Advise patients 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.
Advise patients that they should neither drive a car nor operate other complex machinery until they have gained sufficient experience on Comtan to gauge whether or not it affects their mental and/or motor performance adversely. Warn patients about the possibility of sudden onset of sleep during daily activities, in some cases without awareness or warning signs, when they are taking dopaminergic agents, including Comtan. Because of the possible additive sedative effects, caution should be used when patients are taking other CNS depressants in combination with Comtan.
Inform patients that nausea may occur, especially at the initiation of treatment with Comtan.
Inform patients that diarrhea may occur with Comtan 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 is prolonged, discontinuing the drug is expected to lead to resolution, if diarrhea continues after stopping entacapone, further diagnostic investigations may be needed.
Advise patients about the possibility of an increase in dyskinesia.
Tell patients 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 studies, 10% of patients treated with Comtan reported urine discoloration compared to 0% of placebo patients.
Although Comtan has not been shown to be teratogenic in animals, it is always given in conjunction with levodopa and carbidopa, which is known to cause visceral and skeletal malformations in rabbits. 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, advise patients to notify their physicians if they intend to breastfeed or are breastfeeding an infant.
Tell patients and family members to notify their healthcare practitioner if they notice that the patient develops unusual urges or behaviors.
Last reviewed on RxList: 1/29/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Comtan Information
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