Confundus Trio tablets are indicated for Parkinson's disease. Movement disorders (instability) caused by dosage inefficiency during treatment with levodopa/dopa decarboxylase inhibitors.
Composition
Active ingredients: levodopa, carbidopa, entacapone;
1 film-coated tablet contains:
50 mg levodopa, 12.5 mg carbidopa, 200 mg entacapone,
or 100 mg levodopa, 25 mg carbidopa, 200 mg entacapone,
or 150 mg levodopa, 37.5 mg carbidopa, 200 mg entacapone,
or 200 mg levodopa, 50 mg carbidopa, 200 mg entacapone;
Excipients: corn starch, mannitol (E 421), croscarmellose sodium, povidone, magnesium stearate, hypromellose, sucrose, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), polysorbate 80, glycerol 85%.
Contraindication
Hypersensitivity to levodopa, carbidopa, entacapone or any other component of the drug. Severe hepatic insufficiency. Narrow-angle glaucoma. Pheochromocytoma. Concomitant use of Confundus® Trio with non-selective monoamine oxidase inhibitors (MAO-A and MAO-B) (e.g. phenelzine, tranylcypromine). Concomitant use of selective MAO-A and MAO-B inhibitors with Confundus® Trio. History of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis. History of undiagnosed skin diseases or melanoma. Severe heart failure. Severe cardiac arrhythmia. Severe psychosis.
Method of application
The tablets should be taken orally, regardless of meals. Each tablet contains one dose of the drug, so it is necessary to take the whole tablet.
The optimal daily dose of Confundus® Trio for each patient should be carefully selected. The daily dose of this medicinal product should be optimized by using one of the following dosages: 50/12.5/200 mg, 100/25/200 mg, 150/37.5/200 mg or 200/50/200 mg levodopa/carbidopa/entacapone.
Patients should be advised to take only one tablet of Confundus® Trio at the selected dosage. Nausea and vomiting may occur in patients taking less than 70-100 mg of carbidopa per day. Since experience with total daily doses of carbidopa greater than 200 mg is limited and the maximum recommended daily dose of entacapone is 2000 mg, the maximum daily dose of Confundus® Trio is 10 tablets for the dosages of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg and 7 tablets for the dosage of 200/50/200 mg.
Confundus® Trio is usually used in patients who are currently taking appropriate doses of levodopa or standard-release dopa decarboxylase inhibitors and entacapone.
Application features
Pregnant women
Should not be used during pregnancy.
Children
The use of the drug in this category of patients is not indicated.
Drivers
Taking the drug is associated with drowsiness and cases of sudden sleep onset, so caution should be exercised when driving and operating other machinery.
Overdose
Symptoms: early signs - muscle twitching, blepharospasm, hypertension, increased heart rate, decreased appetite, confusion, anxiety, insomnia, restlessness.
There are reports of daily doses of levodopa and entacapone of 10,000 mg and 40,000 mg, respectively. Acute symptoms in such cases include agitation, psychosis, coma, bradycardia, ventricular tachyarrhythmia, Cheyne-Stokes respiration, discoloration of the skin, tongue, conjunctiva, and chromaturia.
Treatment of acute overdose with Confundus® Trio is similar to that of acute overdose with levodopa. However, pyridoxine is ineffective in reversing the effects of Confundus® Trio. Hospitalization is recommended; general supportive measures should be administered with immediate gastric lavage and administration of activated charcoal. This may accelerate the elimination of entacapone, in particular by reducing absorption/reabsorption from the gastrointestinal tract.
Close monitoring of the respiratory, cardiovascular and urinary systems is necessary, and appropriate supportive measures should be taken. ECG monitoring should be initiated and the patient should be closely monitored for the possible development of arrhythmias. Appropriate antiarrhythmic therapy should be administered if necessary. It should be taken into account that the patient may have been taking other medications in addition to Confundus® Trio. The role of dialysis in the treatment of overdose is unknown.
Side effects
The most common adverse reactions are dyskinesia (19% of patients); gastrointestinal disorders, including nausea and diarrhea (15% and 12%, respectively); musculoskeletal pain and pain in muscles and connective tissue (12%); urine discoloration to red-brown (10%). In clinical trials of Confundus® Trio or entacapone in combination with levodopa/DDC inhibitor, cases of gastrointestinal bleeding and Quincke's edema were identified. Hepatitis with signs of cholestasis, rhabdomyolysis and neuroleptic malignant syndrome may occur when taking Confundus® Trio, although no such cases were identified during clinical trials.
Other antiparkinsonian drugs. There is no information on the interaction of other antiparkinsonian drugs and the drug Confundus® Trio. High doses of entacapone may affect the absorption of carbidopa. However, at the recommended dosage, no interaction with carbidopa was observed (200 mg entacapone up to 10 times a day). No interaction between entacapone and selegiline was observed in patients with Parkinson's disease who were taking levodopa/DDC inhibitor. When using the drug Confundus® Trio, the daily dose of selegiline should not exceed 10 mg.
Caution should be exercised when using Confundus® Trio and the following medications simultaneously.
Antihypertensive drugs: When levodopa is used together with antihypertensive drugs, symptomatic orthostatic hypotension may develop and the dose of the antihypertensive drug may need to be adjusted.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 3 years.
