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Levodopa and Benserazide is indicated for the treatment of all forms of Parkinson's syndrome with the exception of medicine-induced parkinsonism. Levodopa and Benserazide 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. Levodopa and Benserazide 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.
Dopamine, which acts as a neurotransmitter in the brain, is not present in sufficient quantities in the basal ganglia of parkinsonian patients. Levodopa or L-DOPA (3,4-dihydroxy phenylalanine) is an intermediate in dopamine biosynthesis. Levodopa (dopamine precursor) is used as a prodrug to increase dopamine levels since it is able to cross the blood-brain barrier whereas dopamine itself cannot. Once levodopa has entered the central nervous system, it is metabolised to dopamine by aromatic L-amino acid decarboxylase After administration, levodopa is rapidly decarboxylated to dopamine in extracerebral as well as cerebral tissues. As a result, most of the levodopa administered is not available to the basal ganglia, and the dopamine produced peripherally frequently causes unwanted effects. It is therefore particularly desirable to inhibit extracerebral decarboxylation of levodopa. This can be achieved by simultaneous administration of levodopa and benserazide, a peripheral decarboxylase inhibitor.
Standard dosage
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.
Initial therapy
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.
Maintenance therapy
The average maintenance dosage is 1 capsule of this combinations 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. It dispersible may substitute standard Madopar to achieve an optimal effect.
Levodopa + Benserazide may interact with other medicines used to treat Parkinson’s disease (amantadine, selegiline, orphenadrine, pergolide, ropinirole, and entacapone), a medicine used to treat low levels of iron (ferrous sulfate), antacids, a medicine used to aid digestion (metoclopramide), medicines used to treat mental illness (chlorpromazine, promazine, prochlorperazine, haloperidol, benperidol, flupentixol, and zuclopenthixol), a medicine used to treat anxiety (diazepam), a medicine used to control muscle movements (tetrabenazine), a medicine used to improve blood flow (papaverine), a medicine used to treat high blood pressure (reserpine), a medicine used to treat asthma (epinephrine, norepinephrine, and isoproterenol), a medicine used to control appetite and weight gain (amphetamines), strong pain killer (codeine and morphine), and medicine used to treat nausea and vomiting (domperidone).
Madopar is contraindicated in:
It is contraindicated during pregnancy and in women of childbearing potential in the absence of adequate contraception. If pregnancy occurs in a woman taking Madopar, the medicine must be discontinued (as advised by the prescribing physician).
The safe use of levodopa-benserazide during lactation has not been established. It is not known whether benserazide is excreted in human breast milk., Mothers requiring Madopar treatment should not nurse their infants, as the occurrence of skeletal malformations in the infants cannot be excluded.
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)
Store in a cool and dry place away from sunlight