Bula do remedy Comtan

the package insert of the medicine Comtan.

what For?

an Adjuvant in the preparation of standard dosing of levodopa/benserazide or levodopa/carbidopa in patients with Parkinson’s disease and motor fluctuations-end of dose that cannot be stabilized by these associations.

Contraindications

When should I not use?

known Hypersensitivity to entacapone or any other components of the formulation. Pregnancy and breast-feeding. Dysfunction of the liver. The entacapone is contraindicated to patients with pheochromocytoma because of the increased risk of hypertensive crisis. The concomitant use of entacapone with inhibitors not selective oxidase (MAO-A and MAO-B), (p. ex.: phenelzine, tranylcypromine) is contraindicated. In the same way the concomitant use of entacapone with the selective inhibitor of MAO-a selective inhibitor of MAO-B is contraindicated. The entacapone can be used with selegiline (a selective inhibitor of MAO-B), but the daily dose of selegiline should not exceed 10 mg (see Drug interactions and other forms of interactions). Previous history of the syndrome neuroléptica malignant (non-MFIS), and/or rhabdomyolysis non-traumatic.

Dosage

How to use?

Entacapone is administered orally and in combination with doses of levodopa/carbidopa or levodopa/benserazida. The prescription for these preparations of levodopa is applicable to the concurrent use of same with entacapone. Entacapone can be administered with or without food. Administered a 200 mg tablet with each dose of levodopa/inhibitor of dopa decarboxylase. The maximum recommended dose is 200 mg ten times a day, that is, 2 g of entacapone. The entacapone enhances the effects of levodopa. Thus, to reduce the adverse effects dopamine related with levodopa, p. ex., dyskinesias, nausea, vomiting and hallucinations, is often necessary to adjust the dose of levodopa during the first days or first weeks after the start of treatment with entacapone. The daily dose of levodopa should be reduced by about 10% to 30% by the increase of the intervals between the administrations and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient. If the treatment with entacapone is stopped, it is necessary to adjust the dose of the other treatments antiparkinsonianos, especially levodopa, to achieve a level of sufficient control of symptoms. The entacapone increases the bioavailability of levodopa in the preparations patterns of dosing of levodopa/benserazide in a little more (5-10%) in formulations of levodopa/carbidopa. Therefore, patients who receive preparations of conventional dosing of levodopa/benserazide should have a reduction of levodopa dose when the treatment with entacapone is started. The renal failure does not affect the pharmacokinetics of entacapone, and there is in this case the need for dose adjustment. However, for dialysis patients, a longer interval between doses should be considered.
Use in elderly: it is not necessary to adjust doses in elderly patients.
Use in children: how the entacapone has not been studied in patients under the age of 18 years, not recommended for use of the medicine in these patients. – Overdose: there is no reported cases of an overdose with entacapone. The treatment of overdosage acute is symptomatic.

Side Effects

What are the evils that can cause me?

In studies carried out in the phase III double-blind, placebo-control adverse reactions very common found were: dyskinesia, nausea and the urine abnormal. Adverse reactions common found in studies in the phase III double-blind, placebo-controlled are: diarrhea, worsening of parkinsonism, dizziness, abdominal pain, insomnia, dry mouth, fatigue, hallucinations, constipation, dystonia, increased sweating, hyperkinesia, headache, cramps in the legs, confusion, paroníria, fall, postural hypotension, vertigo and tremor. Many of the adverse effects caused by entacapone relate to the activity of dopaminergic increased and they occur more frequently at the beginning of the treatment. The reduction of the dose of levodopa decreases the frequency and severity of these effects. The other major class of adverse events are gastrointestinal symptoms, including nausea, vomiting, abdominal pain, constipation and diarrhea. The color of urine may change to reddish-brown by entacapone, but this phenomenon is harmless. Usually the adverse effects caused by entacapone are mild to moderate. The most common adverse events leading to discontinuation of treatment with entacapone are gastrointestinal symptoms (p. ex., diarrhea) and symptoms dopamine (p. ex., dyskinesias). Have been reported after the administration of entacapone with frequency greater than the placebo, dyskinesias, nausea, diarrhea, abdominal pain, and dry mouth. Some of the adverse events, such as dyskinesia, nausea and abdominal pain, may be more common with higher doses (1.4 to 2.0 g per day) than with lower doses of entacapone. A slight decrease of hemoglobin, counting of eritrócito and hematocrit have been reported during treatment with entacapone. The basic mechanism involves a decrease in the absorption of iron in the gastrointestinal tract. It was observed during a prolonged period of treatment (6 months) with entacapone, a decrease in significant clinical haemoglobin in some patients. Have been reported increases in clinical significant liver enzymes in rare cases.