Stalevo

Stalevo

carbidopa + levodopa + entacapone

Manufacturer:

Novartis Indonesia

Marketer:

Wellesta
Concise Prescribing Info
Contents
Per 75/18.75/200 mg FC tab Levodopa 75 mg, carbidopa 18.75 mg, entacapone 200 mg. Per 100/25/200 mg FC tab Levodopa 100 mg, carbidopa 25 mg, entacapone 200 mg. Per 125/31.25/200 mg FC tab Levodopa 125 mg, carbidopa 31.25 mg, entacapone 200 mg
Indications/Uses
Parkinson's disease & end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
Dosage/Direction for Use
1 tab/dose administration. Individualize dose. Max: 10 tab daily; 7 tab daily (200/50/200 mg tab).
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Narrow-angle glaucoma, pheochromocytoma, concomitant use of selective & non-selective MAO-A & MAO-B inhibitor, history of neuroleptic malignant syndrome &/or non-traumatic rhabdomyolysis. Severe hepatic impairment.
Special Precautions
Not recommended for drug-induced extrapyramidal reactions. Ischemic heart disease, severe CV or pulmonary disease, bronchial asthma, endocrine disease; history of peptic ulcer or convulsions; past or current psychosis; chronic wide-angle glaucoma; progressive anorexia, asthenia. Monitor cardiac function in patients w/ a history of MI who have residual atrial nodal or ventricular arrhythmias. Monitor for development of mental changes, depression w/ suicidal tendencies & serious antisocial behaviour. Concomitant use w/ dopamine receptor-blockers eg, D2-receptor antagonists; medicinal products causing orthostatic hypotension; general anaesth. May induce orthostatic hypotension. Patients not previously treated w/ entacapone. Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome. Avoid abrupt w/drawal. Switching to levodopa/DDC inhibitor therapy w/o entacapone. Periodic evaluation of hepatic, haematopoietic, CV & renal function on extended therapy. Follow-up of wt in order to avoid excessive wt decrease in patients w/ diarrhoea. Discontinue when prolonged or persistent diarrhoea occurs. Perform a general medical evaluation including liver function. Potential risk of developing dopamine dysregulation syndrome. Monitor for the development of impulse control disorders regularly. False +ve urinary ketone test result; glycosuria. Not to be taken by patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. May affect ability to drive or operate machinery. Mild to moderate hepatic impairment. Severe renal impairment; dialysis patients. Not to be used during pregnancy & lactation. Not recommended in childn & adolescents <18 yr.
Adverse Reactions
Dyskinesia; diarrhoea, nausea; muscle, musculoskeletal & connective tissue pain; chromaturia. Anaemia; decreased wt & appetite; depression, hallucination, confusional state, abnormal dreams, anxiety, insomnia; aggravated parkinsonism (eg, bradykinesia), tremor, on & off phenomenon, dystonia, mental impairment (eg, memory impairment, dementia), somnolence, dizziness, headache; blurred vision; ischemic heart disease events other than MI (eg, angina pectoris), irregular heart rhythm; orthostatic hypotension, HTN; dyspnoea; constipation, vomiting, dyspepsia, abdominal pain & discomfort, dry mouth; rash, hyperhidrosis; muscle spasms, arthralgia; UTI; chest pain, peripheral oedema, fall, gait disturbance, asthenia, fatigue.
Drug Interactions
Not to be used concurrently w/ entacapone. Symptomatic postural hypotension w/ antihypertensives. MAO-A inhibitors, TCAs, noradrenaline reuptake inhibitors (eg, desipramine, maprotiline, venlafaxine), COMT-metabolised medicinal products (eg, catechol-structured compds ie, rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, α-methyldopa, apomorphine, paroxetine). Reduced therapeutic effect w/ dopamine-receptor antagonists (eg, some antipsychotics, antiemetics), phenytoin, papaverine. Increased INR w/ warfarin. Impaired absorption in patients on high-protein diet. Formation of chelates w/ Fe prep (take 2-3 hr apart).
MIMS Class
Antiparkinsonian Drugs
ATC Classification
N04BA03 - levodopa, decarboxylase inhibitor and COMT inhibitor ; Belongs to the class of dopa and dopa derivative dopaminergic agents. Used in the management of Parkinson's disease.
Presentation/Packing
Form
Stalevo 100/25/200 mg FC tab
Packing/Price
10's;30's (Rp514,000/pak)
Form
Stalevo 125/31.25/200 mg FC tab
Packing/Price
10's;30's
Form
Stalevo 75/18.75/200 mg FC tab
Packing/Price
10's;30's
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