Levodopa / Benserazid-Teva is a combined anti-Parkinsonian drug.
Release form and composition
Available in the form of tablets, 20, 30, 50, 60 or 100 pcs. in bottles with a screw-on polypropylene cap, fitted with a first-opening control system, in a cardboard bundle one bottle.
1 tablet contains active ingredients:
- Levodopa - 100 mg;
- Benserazide - 25 mg.
- Levodopa - 200 mg;
- Benserazide - 50 mg.
Auxiliary components: Povidone K25, corn starch pregelatinized, microcrystalline cellulose, mannitol, calcium hydrophosphate (anhydrous), crospovidone (type A), silicon dioxide colloid, magnesium stearate, dye of iron red oxide (E172).
Indications for use
Levodopa / Benserazid-Teva is used to treat Parkinson's disease.
- Severe abnormal liver or kidney function;
- Endogenous and exogenous psychosis;
- Severe dysfunction of the organs of the endocrine system;
- Severe dysfunction of the cardiovascular system;
- Age up to 25 years;
- The lack of reliable methods of contraception in women of childbearing age;
- Simultaneous administration of non-selective monoamine oxidase inhibitors (MAO) or a combination of MAO inhibitors of type A and MAO of type B (since such a combination is equivalent to non-selective inhibition of MAO);
- Hypersensitivity to levodopa, benserazide or auxiliary components of the drug.
Dosing and Administration
The drug should be taken orally, preferably not earlier than 30 minutes before or 60 minutes after a meal.
Treatment begins with a minimum dose and gradually increase it individually for each patient until a therapeutic effect is achieved.
Below are general recommendations on the dosing regimen of Levodopa / Benserazid-Teva.
The initial dose for patients who have not previously received levodopa is 50 mg of levodopa and 12.5 mg of benserazide 2-4 times per day. In the case of good tolerability of the drug every 3 days, the dose is increased by 50-100 mg of levodopa / 12.5-25 mg benserazide to achieve the desired effect.
In the future, dose selection is carried out 1 time per month. Usually, a dose of 200-400 mg of levodopa / 50-100 mg of benserazide per day is sufficient. The maximum allowable daily dose of 800 mg / 200 mg (respectively, levodopa and benserazida).
To ensure the optimal therapeutic effect, the total daily dose should be divided into at least 4 doses. In case of occurrence of undesirable reactions, it is necessary to stop increasing the dose or reduce the received dose.
Patients who have previously received levodopa, start taking Levodopa / Benserazid-Teva should be 12 hours after its last dose. To maintain the effect already achieved, the dose of this drug should be approximately 20% of the previous dose of levodopa. If necessary, in the future it is increased according to the scheme described above.
Patients who received combination treatment with levodopa with an aromatic L-amino acid decarboxylase inhibitor should begin taking Levodopa / Benserazid-Teva 12 hours after the last dose of the specified combination. In order to minimize the decrease in therapeutic efficacy already achieved, it is recommended to stop the previous therapy at night, and start taking this drug the next morning. If necessary, further dose is increased as described above.
Dosing regimens in special cases:
- Patients who experience strong motor fluctuations are advised to divide the daily dose by more than 4 doses;
- In old age, the dose should be increased at long intervals;
- In the event of spontaneous movements of athetosis or chorea in the later stages of treatment, the dose of Levodopa / Benserazid-Tev should be reduced;
- In the event of a weakening of the effect by the end of the period of the dose, the occurrence of episodes of "freezing" or the phenomenon of "on-off" with prolonged use of the drug, you should reduce the dose or increase the number of doses. Subsequently, to enhance the effect, the dose can be increased again;
- With the appearance of adverse reactions from the cardiovascular system, it is necessary to reduce the dose.
The frequency of side effects is classified according to the following criteria: very often - ≥10% of cases; often - ≥1% and ≤10%; sometimes ≥0.1% and ≤1%; rarely, ≥0.01% and ≤0.1%; very rarely - ≤0.01%, including isolated cases.
Possible adverse reactions from various organs and body systems:
- Mental disorders: rarely - insomnia, aggression, depressed mood, delirium, anxiety, depression, mild enthusiasm, anorexia, pathological gambling addiction, agitation, increased libido, hypersexuality; very rarely - temporary disorientation, hallucinations;
- Nervous system: often - “freezing” episodes, spontaneous movement disorders (such as chorea and athetosis), dizziness, headache, on-off phenomenon, weakening effect by the end of the dose validity period, increased manifestations of “restless legs” syndrome, convulsions; very rarely - episodes of sudden sleep, severe drowsiness;
- Hematopoietic system: very rarely - thrombocytopenia, transient leukopenia, hemolytic anemia;
- Digestive system: very rarely - dryness of the oral mucosa, diarrhea, nausea, vomiting; sometimes loss or change in taste; frequency unknown - gastrointestinal bleeding;
- Cardiovascular system: very rarely - increased blood pressure, orthostatic hypotension (weakens after reducing the dose of the drug), arrhythmias; frequency unknown - tides;
- Skin and subcutaneous tissue: rarely - pruritus, rash;
- Laboratory indicators: infrequently - change of color of urine to red (when standing darkens), increase in urea and creatinine in the blood, concentration of bilirubin, alkaline phosphatase, activity of hepatic transaminases;
- Other: frequency is unknown - excessive sweating, febrile fever.
Side effects from the digestive system are possible at the initial stage of treatment. You can almost completely eliminate them if you take the drug with a small amount of liquid or food, and also if you increase the dose gradually. Levodopa / Benserazid-Teva is not recommended for use in iatrogenic extrapyramidal syndrome and trophy Huntington.
During the period of treatment, monitoring of indicators of the function of the kidneys and liver, blood formulas is necessary. Patients with a history of convulsions, osteomalacia and ulcers of the gastrointestinal tract, in addition, should regularly monitor the relevant indicators. Patients with myocardial infarction, coronary heart disease and heart rhythm disorders in history, also showed electrocardiogram monitoring.
Patients with a history of orthostatic hypotension should be under special medical supervision, especially at the beginning of treatment.
Patients with diabetes mellitus often need to determine the concentration of glucose in the blood and correct the dose of oral hypoglycemic agents. Patients should be warned that when taking Levodopa / Benserazid-Tev, episodes of sudden sleep can occur.
With the use of Levodopa / Benserazid-Teva, the risk of developing malignant melanoma increases, so it is not recommended to prescribe this drug in patients with this disease, including a history.
When taking Levodopa / Benserazid-Teva in high doses increases the risk of developing compulsive disorders.
In the case of the appointment of a planned operation with the use of halothane anesthesia 12-24 hours prior to surgical intervention, the drug should be canceled, since there is a likelihood of arrhythmia and fluctuations in blood pressure. Treatment is resumed after surgery, gradually increasing the dose.
The consequence of taking Levodopa / Benserazid-Teva can be depression, but it can also be a clinical manifestation of parkinsonism. Such patients should be under special medical supervision.
If Levodopa / Benserazid-Tev is abruptly discontinued, it is possible that withdrawal syndrome develops (muscle stiffness, fever, serum creatinine phosphokinase activity) or akinestic crises that may threaten the patient's life. For this reason, discontinue the drug should be a gradual decrease in dose.
Levodopa / benserazide may affect the results of some laboratory tests, in particular, the determination of the concentration of glucose, uric acid, creatinine, bilirubin, catecholamines, alkaline phosphatase. It is possible to obtain a false-positive result of the Coombs test, a false-negative reaction to glucose in the urine when it is determined by the method of glucose oxidase, data on the increased content of creatinine and urea in the blood.
If pregnancy is suspected, the drug should be immediately canceled.
Some patients while taking Levodopa / Benserazid-Teva may experience excessive daytime sleepiness or episodes of sudden sleep. In this case, it is necessary to refrain from driving and performing work that requires reaction speed and concentration. You may need a lower dose of the drug.
Trihexyphenidyl (m-holinoblokator) reduces the rate of absorption of levodopa, metoclopramide - increases.
Antacids reduce the degree of absorption of levodopa / benserazide by 32%.
Iron sulfate reduces the maximum and total concentration of levodopa by 30-50%. In some cases, these changes are clinically significant.
With simultaneous use of Levodopa / Benserazid-Tev with antihypertensive drugs, orthostatic hypotension may develop.
The drug potentiates the action of sympathomimetics (amphetamine, epinephrine, isoproterenol, norepinephrine), so this combination is not recommended. If simultaneous reception is mandatory, you need to carefully monitor the state of the cardiovascular system, if necessary, reduce the dose of sympathomimetics.
Anti-hypertensive drugs based on reserpine, opioids and antipsychotics suppress the effects of levodopa / benserazide. If such a combination is necessary, use the lowest possible dose of these drugs.
Pyridoxine may reduce the anti-parkinsonian efficacy of the drug.
With simultaneous use of the catechol-O-methyltransferase inhibitor, it may be necessary to reduce the dose of levodopa / benserazide.
Levodopa / Benserazid-Teva should not be taken simultaneously with non-selective MAO inhibitors and within 2 weeks after their withdrawal. Premature use may cause hypertensive crisis.
Selective inhibitors of MAO type A (for example, moclobemide) and type B (including rasagiline and selegilin) can be used during treatment with levodopa / benserazide. However, it should be borne in mind that selegilin may enhance the effect of this drug, therefore, a dose adjustment of Levodopa / Benserazid-Teva may be required depending on its efficacy and tolerability.
Levodopa / Benserazid-Teva can be used in combination with other anti-Parkinsonian drugs (amantadine, anticholinergics, agnoists dopamine receptors), but it should be borne in mind that both desirable and undesirable effects may increase, which may require adjustments in the doses of both drugs.
Protein-rich foods can reduce the therapeutic efficacy of levodopa / benserazide.
Terms and conditions of storage
Store at a temperature up to 25 ºС in a place protected from moisture and inaccessible to children.
Shelf life - 2 years.