Madopar Dual Release indications
Treatment of Parkinson's disease.
Madopar Dual Release dispersible is a formulation which is suitable for patients with dysphagia (difficulties in swallowing) or who require a formulation with a more rapid onset of action eg, patients suffering from early morning and afternoon akinesia, or who exhibit "delayed on" or "wearing off" phenomena.
Madopar Dual Release HBS is indicated for patients presenting with all types of fluctuations (eg, "peak-dose dyskinesia" and "end of dose deterioration" eg, nocturnal immobility).
Madopar Dual Release description
Madopar Dual Release is a combination of Levodopa (Madopar Dual Release) and the decarboxylase inhibitor besnerazide (as hydrochloride) in a ratio of 4:1 for the treatment of Parkinson's disease..
Madopar Dual Release 62.5 is Levodopa (Madopar Dual Release) 50 mg and Benserazide (Madopar Dual Release) 12.5 mg; 125 is Levodopa (Madopar Dual Release) 100 mg and Benserazide (Madopar Dual Release) 25 mg; 250 is Levodopa (Madopar Dual Release) 200 mg and besenrazide 50 mg.
Madopar Dual Release 250: Each capsule contains Levodopa (Madopar Dual Release) 200 mg and Benserazide (Madopar Dual Release) HCl 50 mg.
Madopar Dual Release HBS (Hydrodynamically Balanced System): Each capsule contains Levodopa (Madopar Dual Release) 100 mg and Benserazide (Madopar Dual Release) HCl 25 mg.
Madopar Dual Release dosage
Standard
Dosage: Treatment with Madopar Dual Release should be introduced gradually, dosage should be assessed individually and titrated for optimal effect. The following dosage instructions should therefore be regarded as guidelines.
Initial Therapy: In the early stages of Parkinson's disease it is advisable to start treatment with 1 capsule of Madopar Dual Release '62.5' or half a tablet of Madopar Dual Release '125' 3-4 times daily. As soon as tolerability of the initial dosing schedule is confirmed, the dosage should be increased slowly in accordance with the patient's response.
An optimal effect is generally achieved with a daily dosage of Madopar Dual Release corresponding to Levodopa (Madopar Dual Release) 300-800 mg + Benserazide (Madopar Dual Release) 75-200 mg, to be divided into ≥3 doses. Between 4 and 6 weeks may be needed to achieve the optimal effect. If it proves necessary to further increase the daily dosage, this should be done on a monthly basis.
Maintenance Therapy: The average maintenance dosage is 1 capsule or tablet of Madopar Dual Release '125' 3-6 times daily. The number of individual doses (not <3) and their distribution throughout the day must be titrated for optimal effect. Madopar Dual Release HBS and Madopar Dual Release dispersible may substitute standard Madopar Dual Release to achieve an optimal effect.
Special Dosage Instructions: Dosage must be carefully titrated in all patients. Patients on other antiparkinsonian agents may receive Madopar Dual Release. However, as treatment with Madopar Dual Release proceeds and the therapeutic effect becomes apparent, the dosage of the other drugs may need to be reduced or these drugs gradually withdrawn.
Madopar Dual Release dispersible tablets are particularly suitable for patients with dysphagia (difficulties in swallowing) or in situations where a more rapid onset of action is required eg, in patients suffering from early morning and afternoon akinesia or who exhibit "delayed on" or "wearing off" phenomena.
Patients who experience large fluctuations in the drug's effect in the course of the day (on-off phenomena) should receive smaller, more frequent single doses or be switched to Madopar Dual Release HBS.
The switch from standard Madopar Dual Release to Madopar Dual Release HBS is preferably made from 1 day to the next, beginning with the morning dose. The daily dose and dosing interval should initially be the same as with standard Madopar Dual Release.
After 2-3 days, the dosage should be gradually increased by about 50%. Patients should be informed that their condition may temporarily deteriorate.
Due to the pharmacokinetic properties of Madopar Dual Release HBS, the onset of action is delayed. The clinical effect may be achieved more rapidly by administering Madopar Dual Release HBS together with standard Madopar Dual Release or Madopar Dual Release dispersible. This may prove especially useful for the 1st morning dose, which should preferably be higher than the subsequent daily doses. The individual titration for Madopar Dual Release HBS must be carried out slowly and carefully, allowing intervals of at least 2-3 days between dose changes.
In patients with nocturnal immobility, positive effects have been reported after gradually increasing the last evening dose to Madopar Dual Release HBS 250 mg on retiring.
Excessive responses to Madopar Dual Release HBS (dyskinesia) can be controlled by increasing the interval between doses rather than reducing the single doses.
Treatment with standard Madopar Dual Release or Madopar Dual Release dispersible should be resumed if the response to Madopar Dual Release HBS is inadequate.
Patients should be carefully observed for possible undesirable psychiatric symptoms.
Administration: When taking standard Madopar Dual Release capsules or Madopar Dual Release HBS, patients must always ensure to swallow the whole capsule without chewing it.
Standard Madopar Dual Release tablets are breakable to facilitate swallowing.
Madopar Dual Release dispersible tablets are to be dispersed in a quarter of a glass of water (approximately 25-50 mL). The tablets disintegrate completely, producing a milky-white dispersion within a few minutes. Because of rapid sedimentation, it is advisable to stir the dispersion before drinking. Madopar Dual Release dispersible tablets should be taken within ½ an hr of preparing the dispersion.
Madopar Dual Release should be taken 30 min before or 1 hr after meals where possible. Undesirable gastrointestinal effects, which may occur mainly in the early stages of the treatment, can largely be controlled by taking Madopar Dual Release with a small snack (eg, biscuits) or liquid or by increasing the dose slowly.
Madopar Dual Release interactions
Pharmacokinetic Interactions: Co-administration of the anticholinergic drug trihexyphenidyl with standard Madopar Dual Release reduces the rate, but not the extent of Levodopa (Madopar Dual Release) absorption. Trihexyphenidyl given concomitantly with Madopar Dual Release HBS does not affect the pharmacokinetics of Levodopa (Madopar Dual Release).
Co-administration of antacids with Madopar Dual Release HBS reduces the extent of Levodopa (Madopar Dual Release) absorption by 32%.
Ferrous sulphate decreases the maximum plasma concentration and the AUC of Levodopa (Madopar Dual Release) by 30-50%. The pharmacokinetic changes observed during co-treatment with ferrous sulphate appear to be clinically significant in some but not all patients.
Metoclopramide increases the rate of Levodopa (Madopar Dual Release) absorption.
Domperidone may increase the bioavailability of Levodopa (Madopar Dual Release) by stimulation of gastric emptying.
Pharmacodynamic Interactions: Neuroleptics, opioids and antihypertensive medications containing reserpine inhibit the action of Madopar Dual Release.
If Madopar Dual Release is to be administered to patients receiving irreversible nonselective MAO inhibitors, an interval of at least 2 weeks should be allowed between cessation of the MAO inhibitor and the start of Madopar Dual Release therapy. Otherwise unwanted effects eg, hypertensive crises are likely to occur. Selective MAO-B inhibitors eg, selegiline and rasagiline and selective MAO-A inhibitors eg, moclobemide, can be prescribed to patients on Madopar Dual Release therapy; it is recommended to readjust the Levodopa (Madopar Dual Release) dose to the individual patient's needs, in terms of both efficacy and tolerability. Combination of MAO-A and MAO-B inhibitors is equivalent to nonselective MAO inhibition and hence this combination should not be given concomitantly with Madopar Dual Release.
Madopar Dual Release should not be administered concomitantly with sympathomimetics (agents eg, epinephrine, norepinephrine, isoproterenol or amphetamine which stimulate the sympathetic nervous system) as Levodopa (Madopar Dual Release) may potentiate their effects. Should concomitant administration prove necessary, close surveillance of the cardiovascular system is essential, and the dose of the sympathomimetic agents may need to be reduced.
Combination with other agents eg, anticholinergics, amantadine, selegiline,bromocriptine and dopamine agonists is permissible, though both the desired and the undesired effects of treatment may be intensified. It may be necessary to reduce the dosage of Madopar Dual Release or the other substance. When initiating an adjuvant treatment with a COMT inhibitor, a reduction of the dosage of Madopar Dual Release may be necessary. Anticholinergics should not be withdrawn abruptly when Madopar Dual Release therapy is instituted, as Levodopa (Madopar Dual Release) does not begin to take effect for some time.
Levodopa (Madopar Dual Release) may affect the results of laboratory tests for catecholamines, creatinine, uric acid and glucose.
Coombs' tests may give a false-positive result in patients taking Madopar Dual Release.
Concomitant administration of antipsychotics with dopamine-receptor blocking properties, particularly D2-receptor antagonists might antagonize the antiparkinsonian effects of Levodopa (Madopar Dual Release)-Benserazide (Madopar Dual Release). Levodopa (Madopar Dual Release) may reduce antipsychotic effects of these drugs. These drugs should be co-administration with caution.
A diminution of effect is observed when the drug is taken with a protein-rich meal.
General Anesthesia with Halothane: Madopar Dual Release should be discontinued 12-48 hrs before surgical intervention requiring general anesthesia with halothane as fluctuations in blood pressure and/or arrhythmias may occur.
For general anesthesia with other anesthetics see Precautions.
Madopar Dual Release side effects
Post-Marketing: Blood and Lymphatic System Disorders: Hemolytic anemia, transient leukopenia and thrombocytopenia have been reported in rare cases. Therefore, as in any long-term Levodopa (Madopar Dual Release)-containing treatment, blood count and liver and kidney function should be monitored periodically.
Metabolic and Nutritional Disorders: Anorexia has been reported.
Psychiatric Disorders: Depression can be part of the clinical picture in patients with Parkinson's disease and may also occur in patients treated with Madopar Dual Release. Agitation, anxiety, insomnia, hallucinations, delusions and temporal disorientation may occur particularly in elderly patients and in patients with a history of such disorders.
Nervous System Disorder: Isolated cases of ageusia or dysgeusia have been reported. At later stages of the treatment, dyskinesia (eg, choreiform or athetotic) may occur. These can usually be eliminated or be made tolerable by a reduction of dosage. With prolonged treatment, fluctuations in therapeutic response may also be encountered.
They include freezing episodes, end-of-dose deterioration and the "on-off" effect. These can usually be eliminated or made tolerable by adjusting the dosage and by giving smaller single doses more frequently. An attempt at increasing the dosage again can subsequently be made in order to intensify the therapeutic effect. Madopar Dual Release is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Cardiac Disorders: Cardiac arrhythmias may occur occasionally.
Vascular Disorders: Orthostatic hypotension may occur occasionally. Orthostatic disorders commonly improve following reduction of the Madopar Dual Release dosage.
Gastrointestinal Disorders: Nausea, vomiting and diarrhea have been reported with Madopar Dual Release. Undesirable gastrointestinal effects, which may occur mainly in the early stages of the treatment, can largely be controlled by taking Madopar Dual Release with some food or liquid or by increasing the dose slowly.
Skin and Subcutaneous Tissue Disorders: Allergic skin reactions eg, pruritus and rash may occur in rare cases.
Investigations: Transient elevation of liver transaminase and alkaline phosphatase may occur. Increase of γ-glutamyltransferase has been reported.
Rises in blood urea nitrogen have been noted with Madopar Dual Release.
Urine may be altered in color, usually acquiring a red tinge which turns dark on standing. Other body fluids or tissues may also be discoloured or stained including saliva, the tongue, teeth or oral mucosa.
Laboratory Abnoramlities: See Post-Marketing as previously mentioned.
Madopar Dual Release contraindications
Hypersensitivity to Levodopa (Madopar Dual Release) or Benserazide (Madopar Dual Release).
In conjunction with nonselective monoamine oxidase (MAO) inhibitors. However, selective MAO-B inhibitors eg, selegiline and rasagiline or selective MAO-A inhibitors eg, moclobemide are not contraindicated. Combination of MAO-A and MAO-B inhibitors is equivalent to nonselective MAO inhibition and hence, this combination should not be given concomitantly with Madopar Dual Release.
Patients with decompensated endocrine, renal (except patients on dialysis) or hepatic function, cardiac disorders, psychiatric diseases with a psychotic component or closed angle glaucoma.
Pregnant women or to women of childbearing potential in the absence of adequate contraception. If pregnancy occurs in a woman taking Madopar Dual Release, the drug must be discontinued (as advised by the prescribing physician).
Patients <25 years (skeletal development must be complete).
Use in pregnancy: Madopar Dual Release is contraindicated during pregnancy and in women of childbearing potential in the absence of adequate contraception.
Active ingredient matches for Madopar Dual Release:
| Unit description / dosage (Manufacturer) | Price, USD |
| Tablet; Oral; Levodopa 200 mg; Benserazide Hydrochloride 50 mg | |
List of Madopar Dual Release substitutes (brand and generic names): | |
| Madopar T (Germany) | |
| Tablet; Oral; Levodopa 100 mg; Benserazide Hydrochloride 25 mg | |
| Tablet; Oral; Levodopa 200 mg; Benserazide Hydrochloride 50 mg | |
| Madopar/Madopar Dispersible/Madopar HBS (Hongkong) | |
| Madopar 125 cap 100's (Roche) | |
| Madopar Dispersible / dispersible tab 100's (Roche) | |
| Madopar HBS SR cap 100's (Roche) | |
| Madopar 250 tab 100's (Roche) | |
| Madopark (Sweden) | |
| Madopark Depot (Sweden) | |
| Madopark mite (Sweden) | |
| Madozide (Chile) | |
| Melitase (Chile, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua) | |
| Tablet; Oral; Benserazide 50 mg; Levodopa 200 mg (Tecnofarma) | |
| Menkart (Bulgaria) | |
| Modopar (France, Tunisia) | |
| Capsule; Oral; Benserazide Hydrochloride 12.5 mg; Levodopa 50 mg (Eureco) | |
| Capsule; Oral; Benserazide Hydrochloride 25 mg; Levodopa 100 mg (Eureco) | |
| Capsule; Oral; Benserazide Hydrochloride 50 mg; Levodopa 200 mg (Eureco) | |
| Capsule, Prolonged Release; Oral; Benserazide Hydrochloride 25 mg; Levodopa 100 mg (Eureco) | |
| Modopar Dispersible | |
| Modopar LP (France) | |
| Capsule, Prolonged Release; Oral; Benserazide Hydrochloride 25 mg; Levodopa 100 mg | |
| Neodopasol (Japan) | |
| Pardoz (Indonesia) | |
| Pardoz 5 x 10's (Kalbe) | $ 18.60 |
| PK-Levo (Germany) | |
| Tablet; Oral; Benserazide Hydrochloride 25 mg; Levodopa 100 mg (Merz) | |
| Prolopa (Belgium, Brazil, Canada, Chile, Luxembourg, Uruguay) | |
| Capsule; Oral; Benserazide Hydrochloride 12.5 mg; Levodopa 50 mg (Roche) | |
| Capsule; Oral; Benserazide Hydrochloride 25 mg; Levodopa 100 mg (Roche) | |
| Capsule; Oral; Benserazide Hydrochloride 50 mg; Levodopa 200 mg (Roche) | |
| Prolopa 125 (Belgium) | |
| Prolopa 250 (Belgium, Luxembourg) | |
| Prolopa HBS (Uruguay) | |
| Capsule; Oral; Benserazide Hydrochloride 25 mg; Levodopa 100 mg | |
| Prolopa HBS-125 (Luxembourg) | |
| Rekoveren (Bosnia & Herzegowina) | |
| Restex (Austria, Germany) | |
| Capsule, Retard; Oral; Benserazide Hydrochloride; Levodopa (Roche) | |
| Tablet; Oral; Benserazide Hydrochloride; Levodopa (Roche) | |
| Restex 100mg/25mg (Austria, Germany) | |
| Seler 125 (Paraguay) | |
| Seler 250 (Paraguay) | |
| Tonotil 125 (Uruguay) | |
| Tonotil 250 (Uruguay) | |
| Udopar (Thailand) | |
| Udopar-250 (Thailand) | |
| Vopar (Thailand) | |
| Vopar 100's (Unison) | |
| Vopar 10 x 10's (Unison) | |
| Vopar 250 mg tab 10 x 10's (Unison) | |
See 175 substitutes for Madopar Dual Release | |
References
- DailyMed. "CARBIDOPA; ENTACAPONE; LEVODOPA: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "levodopa". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- PubChem. "benserazide". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
