Medicinal Products

ENTACAPONE MYLAN 200 mg

Generic drug of Comtan
Therapeutic Class: Neurology-Psychiatry
active ingredients: Entacapone
laboratory: Mylan

Coated tablet
Box of 1 bottle of 100
All forms

Indication

Entacapone is indicated as an adjunct to standard levodopa / benserazide or levodopa / carbidopa therapy in adult patients with Parkinson's disease and motor end-dose fluctuations that can not be stabilized with these combinations.

Dosage ENTACAPONE MYLAN 200 mg Film-coated tablet Box of 1 bottle of 100

Entacapone should be used only in combination with levodopa / benserazide or levodopa / carbidopa. Information regarding the prescription of levodopa medicines is applicable to their use with entacapone.

Dosage

Take one 200 mg tablet with each dose of levodopa / dopa decarboxylase inhibitor.

The maximum recommended dose is 200 mg ten times a day, or 2000 mg of entacapone.

Entacapone increases the effects of levodopa. Therefore, to reduce the adverse dopaminergic reactions of levodopa, such as dyskinesia, nausea, vomiting and hallucinations, it is often necessary to adjust the dosage of levodopa during the first days or weeks of treatment with the drug. entacapone. Depending on the clinical condition of the patient, the daily dose of levodopa may be reduced by approximately 10 to 30% by increasing the interval between doses and / or by reducing the amount of levodopa per dose.

If treatment with entacapone is discontinued, it is necessary to adjust the dosage of other antiparkinsonian treatments, particularly levodopa, to achieve sufficient control of Parkinsonian symptoms.

Entacapone increases the bioavailability of levodopa slightly more (5 to 10%) from standard levodopa / benserazide preparations than with standard levodopa / carbidopa preparations. Therefore, for patients treated with standard levodopa / benserazide preparations, a greater reduction in levodopa dose may be required when initiating treatment with entacapone.

Renal impairment: Renal impairment does not influence the pharmacokinetics of entacapone and therefore no dosage adjustment is required. However, an increase in the interval between doses may be considered in dialysis patients (see section Pharmacokinetic properties ).

Hepatic insufficiency (see section 4.3 ).

Elderly: No adjustment of the dosage of entacapone is required in elderly patients.

Pediatric population

ENTACAPONE MYLAN should not be used in children below the age of 18 due to the lack of data on safety and efficacy.

Administration mode

Entacapone is administered orally simultaneously with each dose of levodopa / carbidopa or levodopa / benserazide.

Entacapone can be taken with or without food (see section Pharmacokinetic properties ).

Against indications

· Hypersensitivity to the active substance or to any of the excipients.

· Hepatic insufficiency.

· Pheochromocytoma.

· The concomitant use of entacapone and non-selective monoamine oxidase inhibitors (MAOI-A and MAO-B) such as phenelzine and tranylcypromine is contraindicated.

· The concomitant use of entacapone and a combination of MAOI-A selective and MAO-B selective is contraindicated (see section Interactions with other medicinal products and other forms of interaction ).

· History of neuroleptic malignant syndrome (NMS) and / or non-traumatic rhabdomyolysis.

Entacapone Mylan side effects

The most common side effects reported with entacapone are related to increased dopaminergic activity and occur most often at the start of treatment. Reducing the dosage of levodopa reduces the severity and frequency of these effects. The other most common side effects are gastrointestinal symptoms including nausea, vomiting, abdominal pain, constipation and diarrhea. The urine may turn red-brown in color with entacapone, but it is a benign phenomenon.

Usually, the adverse effects associated with entacapone are mild to moderate. In clinical studies, the most common adverse events that required cessation of treatment with entacapone were gastrointestinal symptoms (eg, 2.5% diarrhea) and adverse events related to increased blood flow. dopaminergic activity of levodopa (dyskinesia 1.7% for example).

According to data collected from clinical studies involving 406 patients treated with the drug and 296 patients treated with placebo, dyskinesias (27%), nausea (11%), diarrhea (8%), abdominal pain (7%), %) and dry mouth (4.2%) were reported significantly more frequently with entacapone than with placebo.

Some side effects such as dyskinesia, nausea, and abdominal pain may be more common with high doses of entacapone (1400-2000 mg daily) than with lower doses.

The adverse effects listed in Table 1 below are those obtained in clinical studies with entacapone and since its release.

Table 1 Undesirable effects

Adverse effects are ranked in order of decreasing frequency according to the following convention: Very common (≥ 1/10); frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1 / 10, 000), not known (can not be estimated based on available data since no valid estimate can be made based on clinical or epidemiological studies).

Psychiatric disorders

· Frequent:

insomnia, hallucinations, confusion, abnormal dreams.

· Very rare :

agitation.

Nervous system disorders

· Very common :

dyskinesias.

· Frequent:

aggravation of parkinsonian syndrome, vertigo, dystonia, hyperkinesia.

Heart conditions *

· Frequent:

manifestations of ischemic heart disease other than myocardial infarction (eg angina).

· Rare :

myocardial infarction.

Gastrointestinal disorders

· Very common :

nausea.

· Frequent:

diarrhea, abdominal pain, dry mouth, constipation, vomiting.

· Very rare :

anorexia.

· Not known:

colitis.

Hepatobiliary disorders

· Rare:

abnormalities of liver function tests.

· Not known:

cholestatic type hepatitis (see Warnings and Precautions section ).

Skin and subcutaneous tissue disorders

· Rare:

erythematous or maculopapular rash.

· Very rare :

urticaria.

· Not known:

abnormal coloring of the skin, hair, beard and nails.

Renal and urinary disorders

· Very common :

staining of urine.

General disorders and administration site conditions

· Frequent:

Fatigue, hypersudation, fall.

· Very rare :

Weightloss.

* The incidence of myocardial infarction and other manifestations of ischemic heart disease (0.43% and 1.54%, respectively) was derived from an analysis of 13 double-blind studies involving 2082 patients with end-of-dose motor fluctuations. and receiving entacapone.

Isolated cases of excessive daytime sleepiness and sudden onset of sleep apnea have been reported with entacapone in combination with levodopa.

Patients with Parkinson's disease treated with dopamine agonists and other dopaminergic treatments including levodopa-associated entacapone, particularly at high doses, reported cases of pathological gambling, increased libido, and hypersexuality. which are usually reversible after dose reduction or discontinuation of treatment.

Isolated cases of NMS have been reported following a decrease or abrupt cessation of entacapone and other dopaminergic drugs.

Isolated cases of rhabdomyolysis have been reported

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