Dosage of Madopar Roche 100 mg/25 mg in details
Standard
Dosage: Treatment with Madopar 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 Roche 100 mg/25 mg '62.5' or half a tablet of Madopar 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 Roche 100 mg/25 mg corresponding to Levodopa (Madopar Roche 100 mg/25 mg) 300-800 mg + Benserazide (Madopar 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 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 Roche 100 mg/25 mg HBS and Madopar Roche 100 mg/25 mg dispersible may substitute standard Madopar 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 Roche 100 mg/25 mg. However, as treatment with Madopar 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the therapeutic effect becomes apparent, the dosage of the other drugs may need to be reduced or these drugs gradually withdrawn.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 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 Roche 100 mg/25 mg HBS.
The switch from standard Madopar Roche 100 mg/25 mg to Madopar 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 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 Roche 100 mg/25 mg HBS, the onset of action is delayed. The clinical effect may be achieved more rapidly by administering Madopar Roche 100 mg/25 mg HBS together with standard Madopar Roche 100 mg/25 mg or Madopar 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 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 Roche 100 mg/25 mg HBS 250 mg on retiring.
Excessive responses to Madopar 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 Roche 100 mg/25 mg or Madopar Roche 100 mg/25 mg dispersible should be resumed if the response to Madopar Roche 100 mg/25 mg HBS is inadequate.
Patients should be carefully observed for possible undesirable psychiatric symptoms.
Administration: When taking standard Madopar Roche 100 mg/25 mg capsules or Madopar Roche 100 mg/25 mg HBS, patients must always ensure to swallow the whole capsule without chewing it.
Standard Madopar Roche 100 mg/25 mg tablets are breakable to facilitate swallowing.
Madopar 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 Roche 100 mg/25 mg dispersible tablets should be taken within ½ an hr of preparing the dispersion.
Madopar 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 Roche 100 mg/25 mg with a small snack (eg, biscuits) or liquid or by increasing the dose slowly.
Madopar Roche 100 mg/25 mg interactions
Pharmacokinetic Interactions: Co-administration of the anticholinergic drug trihexyphenidyl with standard Madopar Roche 100 mg/25 mg reduces the rate, but not the extent of Levodopa (Madopar Roche 100 mg/25 mg) absorption. Trihexyphenidyl given concomitantly with Madopar Roche 100 mg/25 mg HBS does not affect the pharmacokinetics of Levodopa (Madopar Roche 100 mg/25 mg).
Co-administration of antacids with Madopar Roche 100 mg/25 mg HBS reduces the extent of Levodopa (Madopar Roche 100 mg/25 mg) absorption by 32%.
Ferrous sulphate decreases the maximum plasma concentration and the AUC of Levodopa (Madopar 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 Roche 100 mg/25 mg) absorption.
Domperidone may increase the bioavailability of Levodopa (Madopar Roche 100 mg/25 mg) by stimulation of gastric emptying.
Pharmacodynamic Interactions: Neuroleptics, opioids and antihypertensive medications containing reserpine inhibit the action of Madopar Roche 100 mg/25 mg.
If Madopar 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 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 Roche 100 mg/25 mg therapy; it is recommended to readjust the Levodopa (Madopar 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 Roche 100 mg/25 mg.
Madopar 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 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 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 Roche 100 mg/25 mg may be necessary. Anticholinergics should not be withdrawn abruptly when Madopar Roche 100 mg/25 mg therapy is instituted, as Levodopa (Madopar Roche 100 mg/25 mg) does not begin to take effect for some time.
Levodopa (Madopar 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 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 Roche 100 mg/25 mg)-Benserazide (Madopar Roche 100 mg/25 mg). Levodopa (Madopar 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 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.
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).
- FDA/SPL Indexing Data. "46627O600J: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Dopamine Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
