Description of the drug STALEVO
This combination should be used with caution in cases of severe cardiovascular and pulmonary insufficiency, bronchial asthma, liver disease, and kidney disease; diabetes mellitus and other decompensated endocrine diseases, erosive and ulcerative lesions of the gastrointestinal tract; convulsions (history), a history of myocardial infarction (with persistent heart rhythm disturbances), a history of psychosis and/or during treatment, depression with suicidal tendencies, antisocial behavior; open angle glaucoma. Caution should be exercised when using this combination concomitantly with drugs that can cause orthostatic hypotension; with antipsychotics that block dopamine (especially dopamine D2 receptor antagonists); with tricyclic antidepressants, desipramine, maprolitine, venlafaxine; with warfarin and drugs metabolized by COMT (paroxetine).
Not recommended for the treatment of drug-induced extrapyramidal reactions.
In patients who have suffered a myocardial infarction and have lesions of the atrial node or ventricular arrhythmias, it is necessary to monitor heart function, especially during the selection of the initial dose.
All patients taking this combination should be carefully monitored for mental changes, depression with suicidal tendencies, and other significant antisocial reactions.
Prescribe with caution to patients with psychosis (including a history).
When used together with antipsychotics (dopamine receptor blockers, especially D2 receptor antagonists), the patient must be carefully monitored for a decrease in the antiparkinsonian effect of the drug or a worsening of the symptoms of Parkinson's disease.
During the treatment period, careful monitoring of the patient's intraocular pressure and recording of all pressure changes is necessary.
Taking this combination may cause orthostatic hypotension. Use with caution in patients taking other medications that may also cause orthostatic hypotension.
When combined with levodopa, entacapone may cause drowsiness and episodic instantaneous sleep onset in patients with Parkinson's disease.
Clinical studies have confirmed an increased incidence of dopaminergic adverse reactions (eg, dyskinesia) in patients treated with entacapone and the dopamine agonists (bromocriptine), selegiline and amandatine, compared with patients treated with placebo with this combination of drugs. Dosage adjustments of other antiparkinsonian medications may be necessary when prescribing this combination to patients who have not previously received entacapone.
Rarely, rhabdomyolysis occurs in patients with Parkinson's disease due to dyskinesias or NMS. Abrupt dose reductions or sudden discontinuation of levodopa should be monitored, particularly in patients receiving antipsychotic treatment. NMS, rhabdomyolysis and hyperthermia are characterized by motor symptoms (muscle rigidity, myoclonus, tremor), changes in mental state (excitement, confusion, coma), increased body temperature, autonomic dysfunction (tachycardia, changes in blood pressure), as well as increased CPK levels in the blood serum . In some cases, only a few of the above symptoms and signs are observed. Early recognition of symptoms is essential for effective treatment of NMS. There are reports of a syndrome similar to NMS, characterized by muscle rigidity, elevated body temperature, changes in mental status and increased serum CPK, also associated with sudden withdrawal of antiparkinsonian drugs. There are isolated reports of the development of NMS with the use of entacapone, especially with sudden discontinuation or reduction of the dose of entacapone and concomitant dopaminergic drugs. Of the studies conducted in which entacapone was abruptly discontinued, there were no cases of NMS or rhabdomyolysis associated with withdrawal. If it is necessary to transfer a patient from therapy with this combination to levodopa and dopa decarboxylase inhibitors, the transition should occur gradually; an increase in the dose of levodopa will likely be required.
If anesthesia is necessary, this combination can be taken as long as the patient is allowed to take fluids and oral medications.
During long-term treatment, it is recommended to periodically monitor liver and hematological parameters, renal function, and the cardiovascular system.
It is recommended to monitor the patient's body weight during diarrhea to prevent excessive weight loss.
Prolonged, persistent diarrhea that occurs while taking entacapone may be a sign of colitis. In case of prolonged persistent diarrhea, the drug should be discontinued, appropriate treatment should be prescribed and the cause of diarrhea should be established.
Patients should be closely monitored for the development of impulse control disorders. Patients and those involved in their care should be warned about the possible occurrence of behavioral symptoms of impulse control disorders, such as gambling, increased libido, hypersexuality, pathological urge to spend money, gluttony, or compulsive hunger. These symptoms may occur during treatment with dopamine agonists and/or other dopaminergic drugs, including this combination. If these symptoms appear, it is recommended to reconsider the treatment regimen.
Patients with progressive anorexia, asthenia and weight loss, especially over a relatively short period of time, require a general medical examination and liver function testing.
Levodopa and carbidopa may cause a false positive result on urine acetone test strips. In this case, boiling urine does not change the resulting reaction. The glucose oxidase method may give a false negative result when testing for glycosuria.
Impact on the ability to drive vehicles and machinery
Taking this combination affects the ability to drive a car and operate machinery. In combination, levodopa, carbidopa and entacapone may cause dizziness and symptomatic orthostatic hypotension. When taking the drug, the patient should be careful when driving or operating machinery.
Patients taking this combination and experiencing drowsiness and/or episodic instantaneous sleep onsets should be advised to refrain (until symptoms resolve) from driving or performing tasks requiring increased alertness, as They may expose not only themselves but also those around them to the risk of serious injury or even death (for example, when operating machinery).
Stalevo, 200 mg/200 mg/50 mg, film-coated tablets, 30 pcs.
Stalevo® is not recommended for the treatment of drug-induced extrapyramidal reactions.
The drug Stalevo® is prescribed with caution to patients with coronary heart disease, severe forms of diseases of the cardiovascular system or lungs, bronchial asthma, kidney disease or endocrine system, with a history of stomach ulcers or convulsions.
In patients who have suffered a myocardial infarction and have lesions of the atrial node or ventricular arrhythmias, it is necessary to monitor heart function, especially during the selection of initial doses.
All patients taking Stalevo® should be carefully monitored for mental changes, depression with suicidal tendencies, and other significant antisocial reactions. The drug Stalevo® is prescribed with caution to patients with psychosis (including a history of psychosis).
Combined treatment with antipsychotics (dopamine receptor blockers, especially D2 receptor antagonists) should be prescribed with caution. Careful monitoring of the patient is necessary for loss of the antiparkinsonian effect of the drug or worsening of symptoms of Parkinson's disease.
The drug is prescribed with caution to patients with chronic open-angle glaucoma; It is necessary to carefully monitor the patient's intraocular pressure and record all changes in pressure.
Taking Stalevo® may cause orthostatic hypotension. The drug is prescribed with caution to patients taking other medications that can also cause orthostatic hypotension.
When combined with levodopa, entacapone may cause drowsiness and episodic instantaneous sleep onset in patients with Parkinson's disease.
When taking the drug, you must be careful when driving vehicles or working with machinery.
Clinical studies have confirmed an increased incidence of dopaminergic adverse reactions (eg, dyskinesia) in patients treated with entacapone and the dopamine agonists (bromocriptine), selegiline and amandatine, compared with patients receiving placebo with this combination of drugs. It may be necessary to adjust the doses of other antiparkinsonian drugs taken by the patient when prescribing Stalevo® to patients who have not previously received entacapone.
Rarely, rhabdomyolysis occurs in patients with Parkinson's disease associated with dyskinesias or neuroleptic malignant syndrome (NMS). Abrupt dose reductions or sudden discontinuation of levodopa should be monitored, particularly in patients receiving antipsychotic treatment. NMS, rhabdomyolysis and hyperthermia are characterized by motor symptoms (muscle rigidity, myoclonus, tremor), changes in mental status (agitation, confusion, coma), autonomic dysfunction (tachycardia, changes in blood pressure), as well as increased levels of creatine phosphokinase in the blood serum. In some cases, only a few of the above symptoms and signs are observed. Early detection of the disease is essential for effective treatment of NMS.
There are reports of a syndrome similar to neuroleptic malignant syndrome, characterized by muscle rigidity, elevated body temperature, changes in mental status and increased serum creatine phosphokinase, also associated with sudden withdrawal of antiparkinsonian drugs. Of the studies conducted in which entacapone was abruptly discontinued, there were no cases of NMS or rhabdomyolysis associated with withdrawal. Since the introduction of entacapone on the market, isolated cases of the development of NMS have been reported, especially when the dose of entacapone and concomitant dopaminergic drugs is suddenly discontinued or reduced. If it is necessary to change treatment with Stalevo® to levodopa and dopa decarboxylase inhibitors, the change should occur gradually; an increase in the dose of levodopa will likely be required.
If general anesthesia is necessary, Stalevo® can be taken as long as the patient is allowed to take fluids and take oral medications. Resumption of drug therapy at the previously prescribed dosage is possible after general anesthesia as soon as the patient is able to independently take the drug tablets.
During long-term treatment with the drug, it is recommended to periodically monitor the functions of the liver and kidneys, as well as monitor the hematological and cardiovascular systems.
It is recommended to monitor the patient's body weight during diarrhea to prevent excessive weight loss. Prolonged, persistent diarrhea that occurs while taking entacapone may be a sign of colitis. In case of prolonged persistent diarrhea, the drug should be discontinued, appropriate treatment should be prescribed and the cause of diarrhea should be established.
Patients should be closely monitored for the development of impulse control disorders. Patients and those involved in their treatment should be warned about the possible occurrence of behavioral symptoms of impulse control disorders, such as gambling, increased libido, hypersexuality, urge to spend money and buy, gluttony or compulsive hunger. These symptoms may occur during treatment with dopamine agonists and/or other dopaminergic drugs containing levodopa, including Stalevo®. If these symptoms appear, it is recommended to reconsider the treatment regimen.
Patients with progressive anorexia, asthenia and weight loss, especially over a relatively short period of time, require a general medical examination and testing of liver function.
Levodopa and carbidopa may cause a false positive result on urine acetone test strips. In this case, boiling the urine test does not change the resulting reaction. The glucose oxidase method may give a false negative result when testing for glycosuria.
The composition of the drug Stalevo® includes sucrose. Patients with rare hereditary diseases such as galactose intolerance, lactose intolerance or glucose-galactose malabsorption should not take this drug.
Stalevo tablet p/o film 150mg+37.5mg+200mg 30 pcs
Stalevo is not recommended for the treatment of drug-induced extrapyramidal reactions. The drug Stalevo is prescribed with caution to patients with coronary heart disease, severe forms of diseases of the cardiovascular system or lungs, bronchial asthma, kidney disease or endocrine system, with a history of stomach ulcers or convulsions. In patients who have suffered a myocardial infarction and have lesions of the atrial node or ventricular arrhythmias, it is necessary to monitor heart function, especially during the selection of initial doses. All patients taking Stalevo should be carefully monitored for mental changes, depression with suicidal tendencies, and other significant antisocial reactions. The drug Stalevo is prescribed with caution to patients with psychosis (including a history). Combined treatment with antipsychotics (dopamine receptor blockers, especially D-2 receptor antagonists) should be prescribed with caution. Careful monitoring of the patient is necessary for a decrease in the antiparkinsonian effect of the drug or worsening symptoms of Parkinson's disease. The drug is prescribed with caution to patients with chronic open-angle glaucoma; It is necessary to carefully monitor the patient's intraocular pressure and record all changes in pressure. Taking Stalevo may cause orthostatic hypotension. The drug is prescribed with caution to patients taking other medications that can also cause orthostatic hypotension. When combined with levodopa, entacapone may cause drowsiness and episodic instantaneous sleep onset in patients with Parkinson's disease. When taking the drug, you must be careful when driving or operating machinery. Clinical studies have confirmed an increased incidence of dopaminergic adverse reactions (eg, dyskinesia) in patients treated with entacapone and the dopamine agonists (bromocriptine), selegiline and amandatine, compared with patients receiving placebo with this combination of drugs. It may be necessary to adjust the doses of other antiparkinsonian drugs taken by the patient when prescribing Stalevo to patients who have not previously received entacapone.
Rarely, rhabdomyolysis occurs in patients with Parkinson's disease associated with dyskinesias or neuroleptic malignant syndrome (NMS). Abrupt dose reductions or sudden discontinuation of levodopa should be monitored, particularly in patients receiving antipsychotic treatment. NMS, rhabdomyolysis and hyperthermia are characterized by motor symptoms (muscle rigidity, myoclonus, tremor), changes in mental status (agitation, confusion, coma), increased body temperature, autonomic dysfunction (tachycardia, blood pressure changes), as well as increased serum creatine phosphokinase levels blood. In some cases, only a few of the above symptoms and signs are observed. Early recognition of symptoms is essential for effective treatment of NMS. There are reports of a syndrome similar to neuroleptic malignant syndrome, characterized by muscle rigidity, elevated body temperature, changes in mental status and increased serum creatine phosphokinase, also associated with sudden withdrawal of antiparkinsonian drugs.
Since the introduction of entacapone on the market, isolated cases of the development of NMS have been reported, especially when the dose of entacapone and concomitant dopaminergic drugs is suddenly discontinued or reduced. Of the studies conducted in which entacapone was abruptly discontinued, there were no cases of NMS or rhabdomyolysis associated with withdrawal. If it is necessary to change treatment with Stalevo to levodopa and dopa decarboxylase inhibitors, the change should occur gradually; an increase in the dose of levodopa will likely be required. If general anesthesia is necessary, Stalevo can be taken as long as the patient is allowed to take fluids and take oral medications. Resumption of drug treatment after a break occurs when the patient is again allowed to take drugs orally, including Stalevo in the prescribed dosage.
During long-term treatment with the drug, it is recommended to periodically monitor hepatic, hematological, renal function, as well as monitor the cardiovascular system. It is recommended to monitor the patient's body weight during diarrhea to prevent excessive weight loss. Prolonged, persistent diarrhea that occurs while taking entacapone may be a sign of colitis. In case of prolonged persistent diarrhea, the drug should be discontinued, appropriate treatment should be prescribed and the cause of diarrhea should be established. Patients should be closely monitored for the development of impulse control disorders. Patients and those involved in their treatment should be warned about the possible occurrence of behavioral symptoms of impulse control disorders, such as gambling, increased libido, hypersexuality, pathological desire to spend money, gluttony or compulsive hunger. These symptoms may occur during treatment with dopamine agonists and/or other dopaminergic drugs, including Stalevo. If these symptoms appear, it is recommended to reconsider the treatment regimen. Patients with progressive anorexia, asthenia and weight loss, especially over a relatively short period of time, require a general medical examination and testing of liver function.
Levodopa and carbidopa may cause a false positive result on urine acetone test strips. In this case, boiling the urine test does not change the resulting reaction. The glucose oxidase method may give a false negative result when testing for glycosuria. The composition of the drug Stalevo includes sucrose. Patients with rare hereditary diseases such as galactose intolerance, lactose intolerance or glucose-galactose malabsorption should not take this drug
Impact on the ability to drive a car and operate machinery
The drug Stalevo affects the ability to drive a car and operate machinery. In combination, levodopa, carbidopa and entacapone may cause dizziness and symptomatic orthostatic hypotension. When taking the drug, the patient should be careful when driving or operating machinery. Patients taking Stalevo who experience drowsiness and/or episodic instantaneous sleepiness should be advised to refrain from driving or performing tasks that require alertness until symptoms resolve, as they may put themselves at risk of serious injury or even death ( for example, when working with machinery). Due to the possibility of episodic instantaneous sleep, patients may put not only themselves but also those around them at risk of serious injury and even death.
