Madopar 125/Madopar 250/Madopar Dispersible 125/Madopar HBS 125

Madopar 125/Madopar 250/Madopar Dispersible 125/Madopar HBS 125

benserazide + levodopa

Manufacturer:

Roche

Marketer:

DKSH
Concise Prescribing Info
Contents
Per Madopar 125 cap Levodopa 100 mg, benserazide HCl 25 mg. Per Madopar 250 tab Levodopa 200 mg, benserazide HCl 50 mg. Per Madopar Dispersible 125 tab Levodopa 100 mg, benserazide HCl 25 mg. Per Madopar HBS 125 cap Levodopa 100 mg, benserazide HCl 25 mg
Indications/Uses
Parkinson's disease w/ the exception of drug-induced Parkinsonism. Madopar Dispersible 125 Patients w/ dysphagia or who require a formulation w/ a more rapid onset of action eg, patients suffering from early morning & afternoon akinesia, or who exhibit 'delayed on' or 'wearing off' phenomenon. Madopar HBS 125 Patients w/ all types of fluctuations (ie, 'peak dose dyskinesia' & 'end of dose deterioration' eg, nocturnal immobility).
Dosage/Direction for Use
Initially 62.5 mg or ½ tab of Madopar 125 tds-qds, may be increased slowly depending on patient's response. Optimal effect is achieved at levodopa 300-800 mg + benserazide 75-200 mg divided into ≥3 doses in 4-6 wk. Maintenance therapy: 1 cap or tab of Madopar 125 3-6 times daily. Madopar HBS & Madopar Dispersible 125 may substitute standard Madopar to achieve an optimal effect. Switch from Madopar to Madopar HBS should be made from 1 day to the next, beginning w/ the morning dose. Initially, daily dose & dosing interval should be the same as w/ Madopar; after 2-3 days, gradually increase by about 50%. Patient w/ nocturnal immobility Gradually increase the last evening dose to 250 mg of Madopar HBS.
Administration
Should be taken on an empty stomach: Best taken at least ½ hr before or 1 hr after meals. May be taken w/ meals to reduce GI discomfort. Cap & HBS cap: Swallow whole, do not chew/crush. Dispersible tab: Disperse in ¼ glass of water (approx 25-50 mL). Stir before drinking. Consume entire amount w/in ½ hr of dissolving the tab.
Contraindications
Hypersensitivity. Concomitant use w/ non-selective MAOIs. Combinations of MAO-A & MAO-B inhibitors. Patients w/ decompensated endocrine, renal or hepatic function, cardiac disorders, psychiatric diseases w/ a psychotic component or closed-angle glaucoma. Patients w/ decompensated hepatic function. Patients <25 yr. Women of childbearing potential in the absence of adequate contraception. Pregnancy.
Special Precautions
Do not w/draw abruptly. Observe for possible undesirable psychiatric symptoms. Depression may occur. Concomitant use w/ dopamine agonists for Parkinson's disease, antipsychotics w/ dopamine-receptor blocking properties ie, D2-receptor antagonists. Do not use concomitantly w/ sympathomimetics. Adjuvant treatment w/ catechol-O-methyltransferase (COMT). Regularly measure IOP in patients w/ open-angle glaucoma. Avoid general anesth w/ halothane. Perform liver function check & blood cell count during treatment; frequent blood sugar test in patients w/ diabetes. Potential dopamine dysregulation syndrome (DDS). Somnolence &/or sudden sleep episodes may affect ability to drive or operate machinery. Lactation.
Adverse Reactions
Potentially, haemolytic anaemia, transient leukopenia, thrombocytopenia; anorexia; depression, agitation, anxiety, insomnia, hallucinations, delusions, temporal disorientation, DDS; ageusia, dysgeusia, dyskinesia, fluctuations in therapeutic response, augmentation of restless legs syndrome, somnolence, excessive daytime sleepiness, sudden sleep onset episodes; cardiac arrhythmias; orthostatic hypotension; nausea, vomiting, diarrhea, discolouration of saliva, tongue, tooth & oral mucosa; pruritus, rash; increased liver transaminase, alkaline phosphatase & γ-glutamyltransferase; chromaturia, increased BUN.
Drug Interactions
Reduced absorption of Madopar HBS w/ antacids. Decreased levodopa max plasma conc by ferrous sulphate. Increased levodopa absorption w/ metoclopramide. Increased levodopa bioavailability w/ domperidone. Inhibited action by reserpine-containing neuroleptics, opioids & antihypertensive drugs. Risk of hypertensive crisis in concomitant use w/ non-selective MAOIs. Do not give concomitantly w/ combination of MAO-A & MAO-B inhibitors. May potentiate effects of sympathomimetics (eg, epinephrine, norepinephrine, isoproterenol or amphetamine). Dose reduction may be necessary when initiating adjuvant treatment w/ a COMT inhibitor. Do not abruptly w/draw anticholinergics. May reduce effects of antipsychotics w/ dopamine-receptor blocking properties, particularly D2-receptor antagonists. Fluctuations in BP &/or arrhythmias may occur during general anesth w/ halothane; discontinue 12-48 hr before surgical intervention requiring general anesth. May affect laboratory test results for catecholamines, creatinine, uric acid & glycosuria. False +ve result in urine tests for ketone bodies & Coombs' test. Diminution effects w/ protein-rich meal.
ATC Classification
N04BA02 - levodopa and decarboxylase inhibitor ; Belongs to the class of dopa and dopa derivative dopaminergic agents. Used in the management of Parkinson's disease.
Presentation/Packing
Form
Madopar 250 tab
Packing/Price
100's;30's
Form
Madopar Dispersible 125 tab
Packing/Price
100's;30's
Form
Madopar 125 cap
Packing/Price
100's;30's
Form
Madopar HBS 125 CR cap
Packing/Price
100's;30's
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