Stalevo

Stalevo

carbidopa + levodopa + entacapone

Manufacturer:

Orion Pharma

Distributor:

Apex
Concise Prescribing Info
Contents
Per 50 mg/12.5 mg/200 mg FC tab Levodopa 50 mg, carbidopa 12.5 mg, entacapone 200 mg. Per 100 mg/25 mg/200 mg FC tab Levodopa 100 mg, carbidopa 25 mg, entacapone 200 mg. Per 150 mg/37.5 mg/200 mg FC tab Levodopa 150 mg, carbidopa 37.5 mg, entacapone 200 mg. Per 200 mg/50 mg/200 mg FC tab Levodopa 200 mg, carbidopa 50 mg, entacapone 200 mg
Indications/Uses
Idiopathic Parkinson's disease: Substitute for IR carbidopa/l-dopa & entacapone; replace IR carbidopa/l-dopa therapy (w/o entacapone) when patients experience the signs & symptoms of end-of-dose "wearing-off".
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. History of NMS &/or non-traumatic rhabdomyolysis. Narrow-angle glaucoma, pheochromocytoma. Concomitant use w/ selective & nonselective MAOIs. Severe hepatic impairment.
Special Precautions
Discontinue use if prolonged or persistent diarrhoea occurs. Not recommended for drug-induced extrapyramidal reactions. Ischemic heart disease, severe CV or pulmonary disease, bronchial asthma, endocrine disease; history of PUD or convulsions, MI w/ residual atrial nodal, ventricular arrhythmias, cardiac function; past or current psychosis; chronic wide-angle glaucoma; rhabdomyolysis secondary to severe dyskinesias or NMS; progressive anorexia, asthenia. Potential risk of developing dopamine dysregulation syndrome. Patients not previously treated w/ entacapone. Perform periodic evaluation of hepatic, haematopoietic, CV & renal function during extended therapy. Monitor for development of mental changes (eg, hallucinoses, psychoses), depression w/ suicidal tendencies, serious antisocial behaviour, impulse control disorders. Follow-up of wt in order to avoid excessive wt decrease in patients w/ diarrhoea. False +ve urinary ketone test result; glycosuria. Avoid abrupt w/drawal. Not to be taken by patients w/ fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency. Concomitant use w/ dopamine receptor-blockers eg, D2-receptor antagonists; medicinal products causing orthostatic hypotension; general anaesth. May affect ability to drive & use machines. 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
Symptomatic postural hypotension w/ antihypertensives. 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. 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).
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 mg/25 mg/200 mg FC tab
Packing/Price
100's
Form
Stalevo 150 mg/37.5 mg/200 mg FC tab
Packing/Price
100's
Form
Stalevo 200 mg/50 mg/200 mg FC tab
Packing/Price
100's
Form
Stalevo 50 mg/12.5 mg/200 mg FC tab
Packing/Price
100's
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