Madopar CR Roche 100 mg/25 mg indications
Treatment of Parkinson's disease.
Madopar CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg HBS is indicated for patients presenting with all types of fluctuations (eg, "peak-dose dyskinesia" and "end of dose deterioration" eg, nocturnal immobility).
Madopar CR Roche 100 mg/25 mg description
Madopar CR Roche 100 mg/25 mg is a combination of Levodopa (Madopar CR Roche 100 mg/25 mg) and the decarboxylase inhibitor besnerazide (as hydrochloride) in a ratio of 4:1 for the treatment of Parkinson's disease..
Madopar CR Roche 100 mg/25 mg 62.5 is Levodopa (Madopar CR Roche 100 mg/25 mg) 50 mg and Benserazide (Madopar CR Roche 100 mg/25 mg) 12.5 mg; 125 is Levodopa (Madopar CR Roche 100 mg/25 mg) 100 mg and Benserazide (Madopar CR Roche 100 mg/25 mg) 25 mg; 250 is Levodopa (Madopar CR Roche 100 mg/25 mg) 200 mg and besenrazide 50 mg.
Madopar CR Roche 100 mg/25 mg 250: Each capsule contains Levodopa (Madopar CR Roche 100 mg/25 mg) 200 mg and Benserazide (Madopar CR Roche 100 mg/25 mg) HCl 50 mg.
Madopar CR Roche 100 mg/25 mg HBS (Hydrodynamically Balanced System): Each capsule contains Levodopa (Madopar CR Roche 100 mg/25 mg) 100 mg and Benserazide (Madopar CR Roche 100 mg/25 mg) HCl 25 mg.
Madopar CR Roche 100 mg/25 mg dosage
Standard
Dosage: Treatment with Madopar CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg '62.5' or half a tablet of Madopar CR Roche 100 mg/25 mg '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 CR Roche 100 mg/25 mg corresponding to Levodopa (Madopar CR Roche 100 mg/25 mg) 300-800 mg + Benserazide (Madopar CR Roche 100 mg/25 mg) 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 CR Roche 100 mg/25 mg '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 CR Roche 100 mg/25 mg HBS and Madopar CR Roche 100 mg/25 mg dispersible may substitute standard Madopar CR Roche 100 mg/25 mg to achieve an optimal effect.
Special Dosage Instructions: Dosage must be carefully titrated in all patients. Patients on other antiparkinsonian agents may receive Madopar CR Roche 100 mg/25 mg. However, as treatment with Madopar CR Roche 100 mg/25 mg proceeds and the therapeutic effect becomes apparent, the dosage of the other drugs may need to be reduced or these drugs gradually withdrawn.
Madopar CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg HBS.
The switch from standard Madopar CR Roche 100 mg/25 mg to Madopar CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg.
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 CR Roche 100 mg/25 mg HBS, the onset of action is delayed. The clinical effect may be achieved more rapidly by administering Madopar CR Roche 100 mg/25 mg HBS together with standard Madopar CR Roche 100 mg/25 mg or Madopar CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg HBS 250 mg on retiring.
Excessive responses to Madopar CR Roche 100 mg/25 mg HBS (dyskinesia) can be controlled by increasing the interval between doses rather than reducing the single doses.
Treatment with standard Madopar CR Roche 100 mg/25 mg or Madopar CR Roche 100 mg/25 mg dispersible should be resumed if the response to Madopar CR Roche 100 mg/25 mg HBS is inadequate.
Patients should be carefully observed for possible undesirable psychiatric symptoms.
Administration: When taking standard Madopar CR Roche 100 mg/25 mg capsules or Madopar CR Roche 100 mg/25 mg HBS, patients must always ensure to swallow the whole capsule without chewing it.
Standard Madopar CR Roche 100 mg/25 mg tablets are breakable to facilitate swallowing.
Madopar CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg dispersible tablets should be taken within ½ an hr of preparing the dispersion.
Madopar CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg with a small snack (eg, biscuits) or liquid or by increasing the dose slowly.
Madopar CR Roche 100 mg/25 mg interactions
Pharmacokinetic Interactions: Co-administration of the anticholinergic drug trihexyphenidyl with standard Madopar CR Roche 100 mg/25 mg reduces the rate, but not the extent of Levodopa (Madopar CR Roche 100 mg/25 mg) absorption. Trihexyphenidyl given concomitantly with Madopar CR Roche 100 mg/25 mg HBS does not affect the pharmacokinetics of Levodopa (Madopar CR Roche 100 mg/25 mg).
Co-administration of antacids with Madopar CR Roche 100 mg/25 mg HBS reduces the extent of Levodopa (Madopar CR Roche 100 mg/25 mg) absorption by 32%.
Ferrous sulphate decreases the maximum plasma concentration and the AUC of Levodopa (Madopar CR Roche 100 mg/25 mg) 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 CR Roche 100 mg/25 mg) absorption.
Domperidone may increase the bioavailability of Levodopa (Madopar CR Roche 100 mg/25 mg) by stimulation of gastric emptying.
Pharmacodynamic Interactions: Neuroleptics, opioids and antihypertensive medications containing reserpine inhibit the action of Madopar CR Roche 100 mg/25 mg.
If Madopar CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg therapy; it is recommended to readjust the Levodopa (Madopar CR Roche 100 mg/25 mg) 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 CR Roche 100 mg/25 mg.
Madopar CR Roche 100 mg/25 mg should not be administered concomitantly with sympathomimetics (agents eg, epinephrine, norepinephrine, isoproterenol or amphetamine which stimulate the sympathetic nervous system) as Levodopa (Madopar CR Roche 100 mg/25 mg) 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 CR Roche 100 mg/25 mg or the other substance. When initiating an adjuvant treatment with a COMT inhibitor, a reduction of the dosage of Madopar CR Roche 100 mg/25 mg may be necessary. Anticholinergics should not be withdrawn abruptly when Madopar CR Roche 100 mg/25 mg therapy is instituted, as Levodopa (Madopar CR Roche 100 mg/25 mg) does not begin to take effect for some time.
Levodopa (Madopar CR Roche 100 mg/25 mg) 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 CR Roche 100 mg/25 mg.
Concomitant administration of antipsychotics with dopamine-receptor blocking properties, particularly D2-receptor antagonists might antagonize the antiparkinsonian effects of Levodopa (Madopar CR Roche 100 mg/25 mg)-Benserazide (Madopar CR Roche 100 mg/25 mg). Levodopa (Madopar CR Roche 100 mg/25 mg) 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 CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg)-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 CR Roche 100 mg/25 mg. 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 CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg dosage.
Gastrointestinal Disorders: Nausea, vomiting and diarrhea have been reported with Madopar CR Roche 100 mg/25 mg. Undesirable gastrointestinal effects, which may occur mainly in the early stages of the treatment, can largely be controlled by taking Madopar CR Roche 100 mg/25 mg 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 CR Roche 100 mg/25 mg.
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 CR Roche 100 mg/25 mg contraindications
Hypersensitivity to Levodopa (Madopar CR Roche 100 mg/25 mg) or Benserazide (Madopar CR Roche 100 mg/25 mg).
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 CR Roche 100 mg/25 mg.
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 CR Roche 100 mg/25 mg, the drug must be discontinued (as advised by the prescribing physician).
Patients <25 years (skeletal development must be complete).
Use in pregnancy: Madopar CR Roche 100 mg/25 mg is contraindicated during pregnancy and in women of childbearing potential in the absence of adequate contraception.
Active ingredient matches for Madopar CR Roche 100 mg/25 mg:
Benserazide/Levodopa in Austria.
List of Madopar CR Roche 100 mg/25 mg substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| 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 CR Roche 100 mg/25 mg | |
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
