Product Description.:
EN1 200
tablet , film-coated , brown , oval oblong
embossed
(entacapone) Tablets
DRUG DESCRIPTION
Comtan? (entacapone) is available as tablets containing 200-mg entacapone.
Entacapone is an inhibitor of catechol-O-methyltransferase (COMT), used in the treatment of Parkinson's Disease as an adjunct to levodopa/carbidopa therapy.
The inactive ingredients of the Comtan tablet are microcrystalline cellulose, mannitol, croscarmellose sodium, hydrogenated vegetable oil, hydroxypropyl methylcellulose, polysorbate 80, glycerol 85%, sucrose, magnesium stearate, yellow iron oxide, red oxide, and titanium dioxide.
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's effectiveness has not been systematically evaluated in patients with idiopathic Parkinson's
Disease who do not experience end-of-dose ?wearing-off?.
SIDE EFFECTS
During the pre-marketing development of entacapone, 1450 patients with Parkinson's Disease were treated with entacapone. Included were patients with fluctuating symptoms, as well as those with stable responses to levodopa therapy. All patients received concomitant treatment with levodopa preparations, however, and were similar in other clinical aspects.
The most commonly observed adverse events ( > 5%) in the double-blind, placebo-controlled trials (N=1003) associated with the use of Comtan (entacapone) and not seen at an equivalent frequency among the placebo-treated patients were: dyskinesia/hyperkinesia, nausea, urine discoloration, diarrhea, and abdominal pain.
Approximately 14% of the 603 patients given entacapone in the double-blind, placebo-controlled trials discontinued treatment due to adverse events compared to 9% of the 400 patients who received placebo. The most frequent causes of discontinuation in decreasing order are: psychiatric reasons (2% vs. 1%), diarrhea (2% vs. 0%), dyskinesia/hyperkinesia (2% vs. 1%), nausea (2% vs. 1%), abdominal pain (1% vs. 0%), and aggravation of Parkinson's Disease symptoms (1% vs. 1%).
