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MADOPAR is a brand name for Benserazide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Parkinsonism - idiopathic, post-encephalitic. Previous neurosurgery is not a contra-indication to Madopar. Patients requiring a more rapid onset of action, e.g. patients suffering from early morning or afternoon akinesia, or who exhibit “delayed on” or “wearing off” phenomena, are more likely to benefit from Madopar…
Verbatim from this product's MHRA label. Tap a section to expand.
Dosage and frequency of administration are variable and no more than a guide can be given. 5 mg three or four times daily. If the disease is at an advanced stage, the starting dose should be one capsule or dispersible tablet of Madopar 100 mg/25 mg three times daily.
The daily dosage should then be increased by one capsule or dispersible tablet of Madopar 100 mg/25 mg, or their equivalent, once or twice weekly until a full therapeutic effect is obtained, or side-effects supervene. 5 mg once or twice daily, increasing by one capsule or dispersible tablet every third or fourth day.
The effective dose usually lies within the range of four to eight capsules or dispersible tablets of Madopar 100 mg/25 mg (two to four capsules of Madopar 200 mg/50 mg) daily in divided doses, most patients requiring no more than six capsules or dispersible tablets of Madopar 100 mg/25 mg daily.
Optimal improvement is usually seen in one to three weeks but the full therapeutic effect of Madopar may not be apparent for some time. It is advisable, therefore, to allow several weeks to elapse before contemplating dosage increments above the average dose range.
If satisfactory improvement is still not achieved, the dose of Madopar may be increased but with caution. It is rarely necessary to give more than ten capsules or dispersible tablets of Madopar 100 mg/25 mg (five capsules of Madopar 200 mg/50 mg) per day.
Treatment should be continued for at least six months before failure is concluded from the absence of a clinical response. 5 mg capsules or dispersible tablets may be used to facilitate adjustment of dosage to the needs of the individual patient.
5 mg capsules or dispersible tablets without, however, altering the total daily dose. Madopar 200 mg/50 mg capsules are only for maintenance therapy once the optimal dosage has been determined using Madopar 100 mg/25 mg capsules or dispersible tablets.
Patients previously treated with levodopa The following procedure is recommended:
Levodopa alone should be discontinued and Madopar started on the following day. The patient should be initiated on a total of one less Madopar 100 mg/25 mg capsule or dispersible tablet daily than the total number of 500 mg levodopa tablets or capsules previously taken (for example, if the patient had previously taken 2g levodopa daily, then he should start on three capsules or dispersible tablets Madopar 100 mg/25 mg daily on the following day).
The following undesirable effects have been identified from post-marketing experience with Madopar (frequency not known, cannot be estimated from the available data) based on spontaneous case reports and literature cases.
Frequency categories are as follows:
Very common: ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1,000 to <1/100 Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Blood and Lymphatic System Disorders Haemolytic anaemia Leukopenia frequency not known Thrombocytopenia Metabolic and nutritional disorders frequency not known Decreased appetite Psychiatric Disorders Dopamine dysregulation syndrome Confusional state Depression Agitation * Anxiety* Insomnia* Hallucination* Delusion* Disorientation* Pathological gambling Increased libido Hypersexuality Compulsive shopping Binge eating frequency not known Eating disorder symptom Nervous System Disorders Ageusia Dysgeusia Dyskinesia (choreiform and athetotic) Fluctuations in therapeutic response Freezing phenomenon End-of-dose deterioration On and off phenomenon Restless legs syndrome Somnolence frequency not known Sudden onset of sleep Cardiac disorders frequency not known Arrhythmia Vascular Disorders frequency not known Orthostatic hypotension Gastrointestinal disorders Nausea Vomiting Diarrhoea Saliva discolouration Tongue discolouration Tooth discolouration frequency not known Oral mucosa discolouration Liver and Biliary disorders Transaminases increased Alkaline phosphatase increased frequency not known Gamma-glutamyltransferase increased Skin and subcutaneous tissue disorders Pruritusfrequency not known Rash Renal and urinary disorders Blood urea increasedfrequency not known Chromaturia *These events may occur particularly in elderly patients and in patients with a history of such disorders.
Impulse Control Disorders:
When other drugs must be given in conjunction with Madopar, the patient should be carefully observed for unusual side-effects or potentiating effects. Hypersensitivity reactions may occur in susceptible individuals. Regular measurement of intraocular pressure is advisable in patients with open-angle glaucoma, as levodopa theoretically has the potential to raise intraocular pressure.
g. g. bronchial asthma), due to possible potentiation of the cardiovascular effects of levodopa; where antihypertensive drugs are being used, due to possible increased hypotensive action. 3). Cardiac function should be monitored with particular care in such patients during the period of treatment initiation and regularly thereafter throughout treatment.
g. elderly patients, concomitant antihypertensives or other medication with orthostatic potential) or a history of orthostatic hypotension is recommended especially at the beginning of treatment or at dose increases. g. haemolytic anaemia, thrombocytopenia and leukopenia).
In a few instances agranulocytosis and pancytopenia have been reported in which the association with Madopar could neither be established, nor be completely ruled out. Therefore, periodical evaluation of blood cell count should be performed during treatment.
Depression can be part of the clinical picture in patients with Parkinson’s disease and may also occur in patients treated with Madopar. All patients should be carefully monitored for psychological changes and depression with or without suicidal ideation.
Madopar may induce dopamine dysregulation syndrome resulting in excessive use of the product. A small subgroup of PD patients suffer from cognitive and behavioural disturbance that can be directly attributed to taking increasing quantities of medication against medical advice and well beyond the doses required to treat their motor disabilities.
1. 4). However, selective MAO-B inhibitors, such as selegiline and rasagiline or selective MAO-A inhibitors, such as moclobemide, are not contraindicated. 5). g. g. severe cardiac arrhythmias and cardiac failure), psychiatric diseases with a psychotic component or closed angle glaucoma (it may be used in wide-angle glaucoma provided that the intra-ocular pressure remains under control).
- patients less than 25 years old (skeletal development must be complete). - pregnant women or women of childbearing potential in the absence of adequate contraception. If pregnancy occurs in a woman taking Madopar, the drug must be discontinued (as advised by the prescribing physician).
Suspicion has arisen that levodopa may activate a malignant melanoma. Therefore, Madopar should not be used in persons who have a history of, or who may be suffering from, a malignant melanoma.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Observe the patient for one week and then, if necessary, increase the dosage in the manner described for new patients. Patients previously treated with other levodopa/decarboxylase inhibitor combinations Previous therapy should be withdrawn for 12 hours.
In order to minimise the potential for any effects of levodopa withdrawal, it may be beneficial to discontinue previous therapy at night and institute Madopar therapy the following morning. 5 mg three or four times daily. This dose may then be increased in the manner described for patients not previously treated with levodopa.
Other anti-Parkinsonian drugs may be given with Madopar. g. anticholinergics or amantadine, should be continued during initiation of Madopar therapy. However, as treatment with Madopar proceeds and the therapeutic effect becomes apparent, the dosage of the other drugs may need to be reduced or the drugs gradually withdrawn.
Elderly Although there may be an age-related decrease in tolerance to levodopa in the elderly, Madopar appears to be well-tolerated and side effects are generally not troublesome. Children Not to be given to patients under 25 years of age, therefore, no dosage recommendations are made for the administration of Madopar to children.
Method of administration Madopar capsules and dispersible tablets are for oral administration. They should be taken 30 minutes before or one hour after meals. Madopar dispersible tablets are particularly suitable for patients who are unable to take capsules or have difficulty in swallowing solid dosage forms.
They should be dispersed in at least 25ml water per tablet. If preferred, they may be taken in dilute orange squash (at least 25ml per tablet). However, orange juice should not be used. The tablets disintegrate completely, producing a milky-white dispersion within few minutes.
Stir before administration and use within 30 minutes of preparation.
Impulse control disorders such as pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Madopar.
4).
Nervous System Disorder:
Psychiatric disturbances are common in Parkinsonian patients, including those treated with levodopa, including mild elation, anxiety, agitation, insomnia, drowsiness, depression, aggression, delusions, hallucinations, temporal disorientation and “unmasking” of psychoses.
g. 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.
Levodopa- benserazide is associated with somnolence and has been associated very rarely with excessive daytime sleepiness and sudden sleep onset episodes.
Restless Legs Syndrome:
The development of augmentation (time shift of symptoms from the evening/night into the early afternoon and evening before taking the next nightly dose, is the most common adverse effect of dopaminergic long-term treatment. Gastrointestinal disorders: - 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 or liquid or by increasing the dose slowly.
- Gastro-intestinal bleeding has been reported with levodopa therapy. - Isolated cases of loss or alterations of taste.
Vascular Disorders:
Orthostatic disorders commonly improve following reduction of the Madopar dosage. Others: - Flushing and sweating have been reported with levodopa.
Investigations:
Urine may be altered in colour; usually acquiring a red-tinge, which turns dark on standing. These changes are due to metabolites and are no cause for concern. Other body fluids or tissues may also be discoloured or stained including saliva, the tongue, teeth or oral mucosa.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Madopar must not be withdrawn abruptly. Abrupt withdrawal of the preparation may result in a neuroleptic malignant-like syndrome (hyperpyrexia and muscular rigidity, possibly psychological changes and elevated serum creatinine phosphokinase, additional signs in severe cases may include myoglobinuria, rhabdomyolysis – and acute renal failure) which may be life- threatening.
Should a combination of such symptoms and signs occur, the patient should be kept under medical surveillance, if necessary, hospitalized and rapid and appropriate symptomatic treatment given. This may include resumption of Madopar therapy after an appropriate evaluation.
Pyridoxine (vitamin B6) may be given with Madopar since the presence of a decarboxylase inhibitor protects against the peripheral levodopa transformation facilitated by pyridoxine. Levodopa has been associated with somnolence and episodes of sudden sleep onset.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa.
Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. 7). Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders.
Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa, including Madopar.
Review of treatment is recommended if such symptoms develop. Malignant melanoma Epidemiological studies have shown that patients with Parkinson's disease have a higher risk of developing melanoma than the general population (approximately 2-6 fold higher).
It is unclear whether the increased risk observed was due to Parkinson's disease, or other factors such as levodopa used to treat Parkinson's disease. Therefore, patients and providers are advised to monitor for melanomas on a regular basis when using Madopar for any indication.
g. dermatologists). Warnings related to Interactions If a patient requires a general anaesthesia, the normal Madopar regimen should be continued as close to the surgery as possible, except in the case of halothane. In general anaesthesia with halothane, Madopar should be discontinued 12 - 48 hours before surgical intervention as fluctuations in blood pressure and/or arrhythmias may occur in patients on Madopar therapy.
Madopar therapy may be resumed following surgery; the dosage should be increased gradually to the preoperative level. If a patient has to undergo emergency surgery, when Madopar has not been withdrawn, anaesthesia with halothane should be avoided.
If Madopar is to be administered to patients receiving irreversible non- selective MAO inhibitors, an interval of at least 2 weeks should be allowed between cessation of the MAO inhibitor and the start of Madopar therapy. 3). Concomitant […]