MADOPAR ® is a medicinal product based on Levodopa and Benserazide hydrochloride.
THERAPEUTIC GROUP: Dopaminergic substances
Indications MADOPAR ® - Levodopa + Benserazide
MADOPAR ® is indicated in the treatment of Parkinson's disease and Parkinsonian syndromes characterized by alterations such as tremor, bradykinesia and muscle stiffness.
MADOPAR ®, on the other hand, is not indicated for the treatment of Parkinsonism of medicinal iatrogenic origin.
Mechanism of action MADOPAR ® - Levodopa + Benserazide
MADOPAR ® is a medicinal specialty consisting of Levodopa and Benserazide, different active ingredients but both valuable in the management of the Parkinsonian patient.
More precisely :
- Levodopa, is the most effective active ingredient in the control of akinesia, being able, following oral intake and gastro-enteric absorption, to reach the central nervous system and thus be decarboxylated by dopaminergic neurons in Dopamine, raising the deficient concentrations of this neurotransmitter at the striatal level.
- Benserazide, on the other hand, is an inhibitor of peripheral decarboxylases, thus preventing these enzymes from decarboxylating Levodopa into Dopamine, reducing the efficacy of the therapy itself and at the same time increasing the risk of potential side effects.
The aforesaid mechanisms allow to rebalance the activity of the nuclei of the base, counteracting the typical motor deficit observed in such conditions.
Studies carried out and clinical efficacy
LEVODOPA / BENSERAZIDE: PHARMACOKINETIC CHARACTERISTICS
Clin Neuropharmacol. 2012 May-Jun; 35: 111-7. doi: 10.1097 / WNF.0b013e31825645d1.
Pharmacokinetics of levodopa / carbidopa microtablets versus levodopa / benserazide andlevodopa / carbidopa in healthy volunteers.
Nyholm D, Lewander T, Gomes-Trolin C, Bäckström T, Panagiotidis G, Ehrnebo M, Nyström C, Aquilonius SM.
Interesting pharmacokinetic study that tests the pharmacokinetic characteristics of the association between Levodopa and Carbidopa in microtablets, trying to intensify the best and most clinically effective association.
LEVODOPA / BENSERAZIDE: NEW DELIVERY SYSTEMS
Neuroreport. 2010 Aug 23; 21: 837-40. doi: 10.1097 / WNR.0b013e32833d40c8.
Levodopa / benserazide-loaded biodegradable microspheres reduce dyskinesia in rats.
Yang X, Yuan W, Ren T, Song L, Wu N, Liu Z.
Experimental study that tests the effectiveness of new delivery systems for Levodopa and Benserazide, with excellent success in the treatment of dyskinesia in rats.
LEVODOPA BENSERAZIDE IN THE SYNDROME OF THE LEGS WITHOUT REST
MMW Fortschr Med. 2004 Dec 9; 146 (Suppl 3-4): 87-93.
[Six months treatment of restless legs syndrome with levodopa / benserazide in domiciliary practice].
Mühlau G.
Study that demonstrates how the combined treatment Levodopa Benserazide can be effective in the treatment of restless legs syndrome, guaranteeing a clear improvement of symptoms in the face of good tolerability.
Method of use and dosage
MADOPAR ®
100 mg capsules of Levodopa and 25 mg of Benserazide;
200 mg tablets of Levodopa and 50 mg of Benserazide;
Prolonged-release capsules of 100 mg of Levodopa and 25 mg of Benserazide.
The dosing schedule should be defined by the neurologist competent in the treatment of Parkinson's disease considering the patient's general health conditions, the severity of his clinical picture and therapeutic tolerability.
Defined doses may be adjusted based on the occurrence of side effects during therapy, thus requiring continued medical supervision.
MADOPAR ® warnings - Levodopa + Benserazide
Treatment with MADOPAR ® must necessarily be preceded by a careful medical examination aimed at clarifying the origin of the symptoms and the appropriateness of prescribing.
The doctor should also pay particular attention to the simultaneous presence of cardiovascular, pulmonary, liver, kidney, psychotic and psychiatric disorders, given the increased risk of side effects related to the use of MADOPAR ® in these categories of patients.
The ability of Levodopa to induce drowsiness or alteration of normal perceptive abilities suggests the usefulness of avoiding driving cars or using machines during treatment.
During the entire treatment the main blood chemistry parameters should also be monitored, given the ability of Levodopa to alter their values.
It is recommended to store the drug out of the reach of children.
PREGNANCY AND BREASTFEEDING
The aforementioned contraindications to the use of MADOPAR ® should also be extended to pregnancy and the subsequent period of breastfeeding, given the absence of studies capable of fully characterizing the safety profile of its active ingredients for the health of the fetus and the suckling.
Interactions
The patient treated with MADOPAR ® ® should avoid the simultaneous intake of antihypertensive drugs due to the risk of postural hypotension, antidepressants, for the potential side effects related to the simultaneous intake of Levodopa, and other active ingredients capable of altering the normal pharmacokinetic properties of Levodopa such as iron, phenytoin and papaverine.
Contraindications MADOPAR ® - Levodopa + Benserazide
The use of MADOPAR ® is contraindicated in patients hypersensitive to the active substance or to one of its excipients and in patients with severe liver and kidney diseases, in patients with narrow angle glaucoma, myocardial infarction, suspected lesions of melanoma, in patients under the age of 18, during pregnancy and breastfeeding.
Undesirable Effects - Side Effects
The therapy with MADOPAR ® could expose the patient to numerous risks of side effects widespread among the various organs and systems.
Nausea, vomiting, dizziness, psychiatric disorders, tachycardia, somnolence, fatigue, psychosis, anorexia, haematological alterations and hypotension, are just some of the most frequently documented symptoms following the use of Levodopa.
Fortunately, the incidence of clinically relevant side effects is rarer, for which the need to adjust the dosage or discontinue therapy may arise.
Note
MADOPAR ® ® is a drug subject to mandatory medical prescription.
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