Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2021 Publisher: Roche Products (New Zealand) Limited, PO Box 109113, Newmarket, Auckland 1149, NEW ZEALAND, Medical enquiries: 0800 276 243
Madopar is indicated for the treatment of all forms of Parkinson’s syndrome with the exception of medicine-induced parkinsonism.
Madopar 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, e.g. patients suffering from early morning and afternoon akinesia, or who exhibit “delayed on” or “wearing off” phenomena.
Madopar HBS is indicated for patients presenting with all types of fluctuations in response, especially those related to fluctuations in plasma levels (i.e. “peak dose dyskinesia” and “end of dose deterioration”) and for better control of nocturnal symptoms.
Further experience is required to determine whether it is also advantageous to use Madopar HBS in new Parkinson patients.
Treatment with Madopar should be introduced gradually; dosage should be assessed individually and titrated for optimal effect. The following dosage instructions should therefore be regarded as guidelines.
In the early stages of Parkinson’s disease, it is advisable to start treatment with one capsule of Madopar 62.5 three to four 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 corresponding to 300-800 mg of levodopa + 75 – 200 mg benserazide, to be divided into 3 or more 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.
The average maintenance dosage is 1 capsule of Madopar 125 three to six times daily. The number of individual doses (not less than 3) and their distribution throughout the day must be titrated for optimal effect. Madopar HBS and Madopar dispersible may substitute standard Madopar to achieve an optimal effect.
Dosage must be carefully titrated in all patients (see section 4.1 Therapeutic Indications). Patients on other anti-parkinsonian agents may receive Madopar. However, as treatment with Madopar proceeds and the therapeutic effect becomes apparent, the dosage of the other medication may need to be reduced or these medicines gradually withdrawn.
Madopar dispersible tablets are particularly suitable for patients with dysphagia (difficulties in swallowing) or in situations where a more rapid onset of action is required, e.g. 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 medicine’s effect in the course of the day (on-off phenomena) should receive smaller, more frequent single doses or be switched to Madopar HBS.
The switch from standard Madopar to Madopar HBS is preferably made from one day to the next, beginning with the morning dose. The daily dose and dosing interval should initially be the same as with standard Madopar.
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 HBS, the onset of action is delayed. The clinical effect may be achieved more rapidly by administering Madopar HBS together with standard Madopar or Madopar dispersible. This may prove especially useful for the first morning dose, which should preferably be higher than the subsequent daily doses. The individual titration for Madopar 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 250 mg of Madopar HBS on retiring.
Excessive responses to Madopar HBS (dyskinesia) can be controlled by increasing the interval between doses rather than reducing the single doses.
Treatment with standard Madopar or Madopar dispersible should be resumed if the response to Madopar HBS is inadequate.
Patients should be carefully observed for possible undesirable psychiatric symptoms.
No dose reduction is considered necessary in case of mild or moderate renal insufficiency (see section 4.3 Contraindications).
The safety and efficacy of Madopar have not been established in patients with hepatic impairment (see section 4.3 Contraindications).
When taking standard Madopar capsules or Madopar HBS, patients must always ensure that they swallow the whole capsule without chewing it.
Madopar dispersible tablets are to be dispersed in a quarter of a glass of water (approx. 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 dispersible tablets should be taken within half an hour of preparing the dispersion.
Where possible, Madopar should be taken at least 30 minutes before or 1 hour after meals, so that the competitive effect of dietary protein on levodopa uptake can be avoided and to facilitate a more rapid onset of action. Undesirable gastrointestinal effects, which may occur mainly in the early stages of the treatment, can largely be controlled by taking Madopar with a low protein snack (e.g. biscuits) or liquid or by increasing the dose slowly.
Symptoms and signs of overdose are qualitatively similar to the side effects of Madopar in therapeutic doses but may be of greater severity. Overdose may lead to: cardiovascular side effects (e.g. cardiac arrhythmias), psychiatric disturbances (e.g. confusion and insomnia), gastro-intestinal effects (e.g. nausea and vomiting) and abnormal involuntary movements (see section 4.8 Undesirable effects).
If a patient has taken an overdose of a controlled release form of Madopar (i.e. Madopar HBS capsules), occurrence of symptoms and signs may be delayed due to delayed absorption of the active substances from the stomach.
Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular patients may require symptomatic treatment for cardiovascular effects (e.g. antiarrhythmics) or central nervous system effects (e.g. respiratory stimulants, neuroleptics).
In addition, for the controlled release formulation further absorption should be prevented using an appropriate method.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
All presentations: 36 months.
Madopar 62.5, 125, 250 capsules: Store below 30°C. Keep the bottle tightly closed.
Madopar 62.5 Rapid tablets: Store at or below 25°C. Protect from moisture.
Madopar HBS 125 capsules: Store at or below 30°C. Keep the bottle tightly closed.
Madopar 62.5, Madopar 125 and Madopar 250 capsules are supplied in amber glass bottles with HDPE cap with integral desiccant (bottle contains 100 capsules).
Madopar HBS 125 capsules are supplied in amber glass bottles with HDPE cap with integral desiccant (bottle contains 100 capsules).
Madopar Rapid 62.5 dispersible tablets are supplied in amber glass bottles with HDPE cap with integral desiccant (bottle contains 100 tablets).
Any unused medicine or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
