Stalevo

Stalevo

carbidopa + levodopa + entacapone

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 50/12.5/200 mg tab Levodopa 50 mg, carbidopa 12.5 mg, entacapone 200 mg. Per 100/25/200 mg tab Levodopa 100 mg, carbidopa 25 mg, entacapone 200 mg. Per 150/37.5/200 mg tab Levodopa 150 mg, carbidopa 37.5 mg, entacapone 200 mg. Per 200/50/200 mg tab Levodopa 200 mg, carbidopa 50 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. Max: 10 tab/day.
Administration
May be taken with or without food.
Contraindications
Concomitant use of MAOIs (discontinue use at least 2 wk prior to initiating therapy). Severe hepatic impairment. Narrow-angle glaucoma. Pheochromocytoma. History of neuroleptic malignant syndrome (NMS) &/or nontraumatic rhabdomyolysis.
Special Precautions
Not for drug-induced extrapyramidal reactions. Severe CV or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of PUD or convulsions. History of MI w/ residual atrial nodal or ventricular arrhythmias. Monitor patients for development of mental changes, depression w/ suicidal tendencies & serious antisocial behaviour. Past or current psychosis. Chronic wide-angle glaucoma. May induce orthostatic hypotension. May affect ability to drive or operate machinery. Abrupt dose reductions or w/drawal of levodopa in patients who are also receiving neuroleptics. Periodic evaluation of hepatic, haematopoietic, CV & renal function on extended therapy. Pregnancy & lactation.
Adverse Reactions
Levodopa/Carbidopa: Dyskinesias including choreiform, dystonic & other involuntary movements, muscle twitching & blepharospasm, nausea, mental changes. Entacapone: GI symptoms, insomnia, hallucinations, confusion, paranoia, dyskinesia, aggravated parkinsonism, dizziness, dystonia, hyperkinesia, fatigue, increased sweating, fall.
Drug Interactions
Not to be used concurrently w/ entacapone. Antihypertensives, antidepressants, MAO-A inhibitors, TCA, desipramine, maprotiline & venlafaxine, rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, α-methyldopa, apomorphine & paroxetine. Dopamine receptor antagonists, phenytoin & papaverine, S-warfarin, high-protein diet, Fe prep (take at least 2-3 hr apart).
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
100's
Form
Stalevo 150/37.5/200 mg FC tab
Packing/Price
100's
Form
Stalevo 50/12.5/200 mg FC tab
Packing/Price
100's
Form
Stalevo 200/50/200 mg FC tab
Packing/Price
100's
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