Comtan

Comtan

entacapone

Manufacturer:

Orion Pharma

Distributor:

Apex
Concise Prescribing Info
Contents
Entacapone
Indications/Uses
Adjunct to l-dopa/benserazide or l-dopa/carbidopa in patients w/ Parkinson's disease & end-of-dose motor fluctuations who cannot be stabilized on those combinations.
Dosage/Direction for Use
1 tab w/ each l-dopa/dopa decarboxylase inhibitor dose. Max: 2,000 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Pheochromocytoma; previous history of NMS &/or non-traumatic rhabdomyolysis. Concomitant use w/ non-selective (eg, phenelzine, tranylcypromine) & selective MAOIs. Hepatic impairment.
Special Precautions
Discontinue use if prolonged or persistent diarrhoea occurs. Rhabdomyolysis secondary to severe dyskinesias or NMS; ischaemic heart disease; somnolence, sudden sleep onset episodes. May aggravate l-dopa-induced orthostatic hypotension. Monitor/follow-up of wt in patients experiencing diarrhoea. Regularly monitor for development of impulse control disorders. Perform general medical evaluation including hepatic function in case of progressive anorexia, asthenia & decreased wt. Not to be taken by patients w/ fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Avoid abrupt discontinuation. Concomitant use w/ COMT-metabolized medicinal products eg, rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, α-methyldopa, apomorphine; medicinal products causing orthostatic hypotension; dopamine agonists (eg, bromocriptine), selegiline or amantadine. May impair ability to drive & use machines. Dialysis patients. Not to be used during pregnancy & lactation. Not recommended in childn <18 yr.
Adverse Reactions
Dyskinesia, nausea, urine discolouration. Insomnia, hallucinations, confusion, nightmares; aggravated parkinsonism, dizziness, dystonia, hyperkinesia; ischaemic heart disease events other than MI eg, angina pectoris; diarrhoea, abdominal pain, dry mouth, constipation, vomiting; fatigue, increased sweating, fall.
Drug Interactions
MAO-A inhibitors, TCAs, noradrenaline reuptake inhibitors eg, desipramine, maprotiline, venlafaxine, COMT-metabolized medicinal products (eg, catechol-structured compds ie, rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, α-methyldopa, apomorphine, paroxetine); selective MAO-B inhibitor eg, selegiline; diazepam, NSAIDs. Formation of chelates w/ Fe prep. Increased INR w/ warfarin.
MIMS Class
Antiparkinsonian Drugs
ATC Classification
N04BX02 - entacapone ; Belongs to the class of other dopaminergic agents used in the management of Parkinson's disease.
Presentation/Packing
Form
Comtan FC tab 200 mg
Packing/Price
100's
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