Madopar 250/Madopar HBS/Madopar Dispersible 125

Madopar 250/Madopar HBS/Madopar Dispersible 125

benserazide + levodopa

Manufacturer:

Roche

Distributor:

DKSH
Concise Prescribing Info
Contents
Per Madopar 250 tab Levodopa 200 mg, benserazide base 50 mg (as HCl). Per Madopar HBS CR cap Levodopa 100 mg, benserazide base 25 mg (as HCl). Per Madopar Dispersible 125 tab Levodopa 100 mg, benserazide base 25 mg (as HCl)
Indications/Uses
Parkinson's disease. Madopar Dispersible 125 Patients w/ dysphagia or patients w/ early morning & afternoon akinesia, or those who exhibit "delayed on" or "wearing off" phenomenon. Madopar HBS Patients w/ all types of fluctuations (eg, peak-dose dyskinesia" & "end of dose deterioration" eg, nocturnal immobility).
Dosage/Direction for Use
Initially 62.5 mg tid to qid. Increase to 300-800 mg levodopa + 75-200 mg benserazide divided into ≥3 doses in 4-6 wk to achieve optimal effect. Increase daily dosage mthly, if necessary. Maintenance therapy: 125 mg 3-6 times daily. Madopar HBS & Madopar Dispersible 125 may substitute standard Madopar to achieve an optima 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% every 2-3 days. Patients 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 30 min before or 1 hr after meals. May be taken w/ a low protein snack to reduce GI discomfort. HBS cap: Swallow whole, do not chew/crush. Tab: May be broken into small pieces to facilitate swallowing. Dispersible tab: Disperse in ¼ glass of water (approx 25-50 mL). Stir before drinking & consume entire amount w/in 30 min.
Contraindications
Hypersensitivity. Decompensated endocrine, renal (except patients on dialysis) or hepatic functions, cardiac disorders, psychiatric diseases w/ a psychotic component or closed-angle glaucoma. Concomitant use w/ non-selective MAOIs. Avoid MAO-AI & MAO-BI combinations. Patients <25 yr. Pregnancy & lactation.
Special Precautions
Regularly measure IOP in patients w/ open-angle glaucoma. Depression may occur. Avoid anesth w/ halothane. Discontinue 12-48 hr before surgery requiring general anesth. Do not w/draw abruptly. Caution while driving or operating machines during treatment. Concomitant use w/ dopamine agonists for Parkinson's disease. Perform liver function check & blood cell count during treatment. Renal & hepatic impairment. Lactation.
Adverse Reactions
Anorexia; depression, agitation, anxiety, insomnia, hallucinations, delusion & temporal disorientation, dopamine dysregulation syndrome; ageusia or dysgeusia, dyskinesia, somnolence; cardiac arrhythmias; orthostatic hypotension; nausea, vomiting & diarrhea; allergic skin reactions eg, pruritus & rash; increased liver transaminase & alkaline phosphatase, increased γ-glutamyltransferase, rise in BUN, altered urine color.
Drug Interactions
Reduced absorption of Madopar HBS w/ antacids. Increased absorption w/ metoclopramide. Increased bioavailability w/ domperidone. Madopar action inhibited by neuroleptics, opioids & antihypertensive drugs. Irreversible non-selective MAOIs. May potentiate effects of sympathomimetics (eg, epinephrine, norepinephrine, isoproterenol or amphetamine). False +ve result in Coombs' test. May reduce effects of antipsychotics w/ dopamine-receptor blocking properties, particularly D2-receptor antagonists. Diminution effects w/ protein-rich meal.
MIMS Class
Antiparkinsonian Drugs
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 HBS CR cap
Packing/Price
100's
Form
Madopar Dispersible 125 tab
Packing/Price
100's
Form
Madopar 250 tab
Packing/Price
100's
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