Dosing regimen
Treatment should be started gradually, individually selecting doses until the optimal therapeutic effect is achieved.
Capsules Madopar® “125” should be swallowed whole, without chewing.
Capsules Madopar® GSS “125” should be swallowed whole without chewing; they must not be opened before use in order to avoid the loss of the effect of the modified release of the active substance.
Madopar® “250” tablets can be crushed for easier swallowing.
Madopar® “125” fast-acting tablets (dispersible) should be dissolved in 25-50 ml of water. The tablet completely dissolves in a few minutes with the formation of a milky white solution, which should be taken no later than 30 minutes after the tablet is dissolved. Since a precipitate can quickly form, it is recommended to mix the solution before taking.
Parkinson’s disease
Standard dosing regimen
Inside, at least 30 minutes before or 1 hour after a meal.
Initial Therapy
At an early stage of Parkinson’s disease, it is recommended to start treatment with Madopar at a dose of 62.5 mg (50 mg levodopa + 12.5 mg benserazide 3-4 times / day). With good tolerance, the dose should be gradually increased, depending on the response of the patient.
The optimal effect is achieved, as a rule, with a daily dose containing 300-800 mg of levodopa + 75-200 mg of benserazide, taken in 3 or more doses. It may take 4 to 6 weeks to achieve the optimal effect. Further increases in the daily dose, if necessary, should be carried out at intervals of 1 month.
Supportive care
The average maintenance dose is 125 mg (100 mg levodopa + 25 mg benserazide) Madopar 3-6 times / day. The frequency of administration (at least 3 times) during the day should be distributed so as to ensure optimal effect. To optimize the effect, it may be necessary to replace Madopar “125” in the form of conventional capsules and Madopar “250” in the form of conventional tablets with Madopar® “125” fast-acting tablets (dispersible) or Madopar® GSS “125”.
Restless legs syndrome
The drug should be taken 1 hour before bedtime, with a small amount of food. The maximum daily dose is 500 mg of Madopar (400 mg of levodopa + 100 mg of benserazide).
Idiopathic Restless Leg Syndrome with Sleep Disorders
It is recommended to prescribe Madopar® “125” capsules or Madopar® “250” tablets.
The initial dose is 62.5-125 mg. With insufficient effect, the dose of Madopar should be increased to 250 mg (200 mg of levodopa + 50 mg of benserazide).
Idiopathic restless legs syndrome with sleep disorders
The initial dose is 1 capsule of Madopar® GSS “125” and 1 capsule of Madopar® “125” 1 hour before bedtime. With insufficient effect, the dose of Madopar GSS “125” should be increased to 250 mg (2 capsules).
Idiopathic restless legs syndrome with disturbances in falling asleep and sleep, as well as with disturbances during the day
Additionally: 1 dispersible tablet or 1 capsule Madopar® “125”, the maximum daily dose of Madopar is 500 mg (400 mg of levodopa and 100 mg of benserazide).
Restless legs syndrome in dialysis patients with chronic renal failure
The drug is prescribed at a dose of 125 mg (1 dispersible tablet or 1 capsule Madopar® “125”) 30 minutes before dialysis.Side effect
From the side of the central nervous system and peripheral nervous system: agitation, anxiety, insomnia, hallucinations, delirium, temporary disorientation (especially in elderly patients and in patients with a history of these symptoms), depression, headache, dizziness, in the later stages of treatment sometimes – spontaneous movements (such as chorea or athetosis), episodes of “freezing”, weakening of the effect by the end of the dose period (the “exhaustion” phenomenon), the “on-off” phenomenon, severe drowsiness, episodes of sudden drowsiness, increased manifestations of restless legs syndrome “.
From the digestive system: nausea, vomiting, diarrhea; in some cases – loss or change in taste sensations, dryness of the oral mucosa.
From the side of the cardiovascular system: arrhythmias, orthostatic hypotension (weakens after a decrease in the dose of Madopar), arterial hypertension.
From the respiratory system: rhinitis, bronchitis.
From the hematopoietic system: rarely – hemolytic anemia, transient leukopenia, thrombocytopenia.
Dermatological reactions: rarely – itching, rash.
On the part of laboratory parameters: sometimes – a transient increase in the activity of hepatic transaminases, alkaline phosphatase, an increase in gamma-glutamyl transpeptidase, an increase in blood urea nitrogen, a change in the color of urine to red, darkening when standing.
On the part of the organism as a whole: anorexia.
Other: febrile infection.Use during pregnancy and lactation
Madopar® is contraindicated in pregnancy and in women of childbearing age who do not use reliable methods of contraception, due to a possible violation of the development of the skeleton in the fetus.
If pregnancy occurs during treatment with Madopar, the drug should be immediately discontinued in accordance with the recommendations of the attending physician.
It is not known whether benserazide is excreted in breast milk. If it is necessary to use Madopar during lactation, breastfeeding should be discontinued, since skeletal developmental disorders in the child cannot be excluded.
Application for violations of liver function
Contraindicated in decompensated liver dysfunction.
Application for violations of kidney function
Contraindicated in decompensated renal dysfunction.
Use in children
Contraindication: age up to 25 years.
special instructions
Individuals with hypersensitivity to the drug may develop appropriate reactions.
Adverse reactions from the digestive system, possible at the initial stage of treatment, are largely eliminated if Madopar® is taken with a small amount of food or liquid, as well as by slowly increasing the dose.
Patients with open-angle glaucoma should regularly measure intraocular pressure, since theoretically levodopa can increase intraocular pressure.
In patients taking levodopa, it is recommended to periodically monitor the blood count, liver and kidney function.
Patients with diabetes should frequently monitor blood glucose levels and adjust the dose of hypoglycemic drugs.
If possible, Madopar should be continued as long as possible before general anesthesia, with the exception of halothane anesthesia. Since fluctuations in blood pressure and arrhythmias may occur in a patient receiving Madopar during halothane anesthesia, Madopar should be discontinued 12-48 hours before surgery. After the operation, treatment is resumed, gradually increasing the dose to the previous level.
Madopar® cannot be canceled abruptly. Abrupt withdrawal of the drug can lead to the development of a malignant neuroleptic syndrome (fever, muscle rigidity, as well as possible mental changes and an increase in serum CPK), which can take a life-threatening form. If such symptoms occur, the patient should be under medical supervision (hospitalization if necessary) and receive appropriate symptomatic therapy, which may include re-appointment of Madopar after an appropriate assessment of the patient’s condition.
Depression may be a clinical manifestation of the underlying disease (parkinsonism, restless legs syndrome) and may also occur during treatment with Madopar. Patients taking Madopar® should be carefully monitored for the possible occurrence of psychiatric adverse reactions.
Some patients with Parkinson’s disease have observed the appearance of behavioral and cognitive disorders as a result of uncontrolled use of increasing doses of the drug, despite the recommendations of the doctor and a significant excess of therapeutic doses of the drug.
Influence on the ability to drive vehicles and mechanisms
If drowsiness, sudden episodes of drowsiness occur, the patient should refuse to drive a car or work with machines and mechanisms. If these symptoms occur, dose reduction or discontinuation of therapy should be considered.
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