MADOPAR ® - Levodopa + Benserazide

MADOPAR ® is a medicinal product based on Levodopa and Benserazide hydrochloride.

THERAPEUTIC GROUP: Dopaminergic substances

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications MADOPAR ® - Levodopa + Benserazide

MADOPAR ® is indicated for the treatment of Parkinson's disease and Parkinson's syndromes characterized by alterations such as tremor, bradykinesia and muscle stiffness.

MADOPAR ® is not indicated for the treatment of Parkinsonism with iatrogenic medicinal origin.

Mechanism of action MADOPAR ® - Levodopa + Benserazide

MADOPAR ® is a medicinal product 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 to reach the central nervous system after being taken orally and with gastro-enteric absorption, and is thus 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 effectiveness of the therapy itself and increasing the risk of potential side effects.

The aforementioned mechanisms allow to rebalance the activity of the nuclei of the base, counteracting the typical motor deficit that is observed in these conditions.

Studies carried out and clinical efficacy

LEVODOPA / BENSERAZIDE: PHARMACOKINETIC CHARACTERISTICS

Clin Neuropharmacol. 2012 May-Jun; 35 (3): 111-7. doi: 10.1097 / WNF.0b013e31825645d1.

Interesting pharmacokinetic study that tests the pharmacokinetic characteristics of the association between Levodopa and Carbidopa in microtavolette, trying to intensify the best and most effective clinical association.

LEVODOPA / BENSERAZIDE: NEW DELIVERY SYSTEMS

Neuroreport. 2010 Aug 23; 21 (12): 837-40. doi: 10.1097 / WNR.0b013e32833d40c8.

Experimental study that tests the effectiveness of new delivery systems for Levodopa and Benserazide, achieving great success in the treatment of dyskinesia in rats.

BENSERAZIDE LEVODOPA IN THE LEG SYNDROME WITHOUT REST

MMW Fortschr Med. 2004 Dec 9; 146 (Suppl 3-4): 87-93.

Study demonstrating that the combined treatment of Levodopa Benserazide can be effective in the treatment of restless legs syndrome, guaranteeing a marked improvement in symptoms with good tolerability.

Method of use and dosage

MADOPAR ®

Capsules of 100 mg of Levodopa and 25 mg of Benserazide;

Tablets of 200 mg of Levodopa and 50 mg of Benserazide;

Extended release capsules of 100 mg Levodopa and 25 mg of Benserazide.

The dosing schedule should be defined by the competent neurologist in the treatment of Parkinson's disease considering the patient's general health conditions, the severity of his / her clinical picture and therapeutic tolerability.

The defined doses could undergo adaptations based on the onset of side effects during therapy, therefore requiring continuous medical supervision.

Warnings MADOPAR ® - Levodopa + Benserazide

Therapy with MADOPAR ® must necessarily be preceded by a careful medical examination in order to clarify the origin of the symptomatology and the prescriptive appropriateness.

The doctor should also pay particular attention to the simultaneous presence of cardiovascular, pulmonary, hepatic, renal, 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 sleepiness or alteration of normal perceptual abilities suggests the usefulness of avoiding driving cars or using machinery during treatment.

During the entire treatment the main blood chemistry parameters should also be monitored, given Levodopa's ability to alter its values.

It is recommended to keep the medicine out of the reach of children.

PREGNANCY AND BREASTFEEDING

The aforementioned contraindications to the use of MADOPAR ® must also be extended to pregnancy and the subsequent period of breastfeeding, given the absence of studies able to fully characterize the safety profile of its active ingredients for fetal health and infant.

Interactions

The patient receiving MADOPAR ® ® should avoid the simultaneous intake of antihypertensive drugs due to the risk of postural hypotension, antidepressants, due to the potential side effects linked to the simultaneous intake of Levodopa, and other active ingredients capable of altering the normal pharmacokinetic properties of Levodopa like 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 suffering from severe liver and kidney diseases, in patients with narrow angle glaucoma, myocardial infarction, suspected melanoma lesions, in patients under the age of 18, during pregnancy and lactation.

Undesirable effects - Side effects

Therapy with MADOPAR ® could expose patients to numerous risks of widespread side effects among the various organs and systems.

Nausea, vomiting, dizziness, psychiatric disorders, tachycardia, drowsiness, fatigue, psychosis, anorexia, haematological alterations and hypotension are only some of the most frequently documented symptoms following the use of Levodopa.

Fortunately, the incidence of clinically relevant side effects for which the need to adjust the dosage or discontinue therapy may be rarer.