Stalevo Special Precautions

Stalevo is not recommended for the treatment of drug-induced extrapyramidal reactions.
Stalevo therapy should be administered with caution to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease or convulsions.
In patients with a history of myocardial infarction who have residual atrial nodal or ventricular arrhythmias, cardiac function should be monitored with particular care during the period of initial dosage adjustments.
All patients treated with Stalevo should be monitored carefully for the development of mental changes (eg, hallucinoses and psychoses), depression with suicidal tendencies and serious antisocial behavior. Patients with previous or current psychosis should be treated with caution.
Concomitant administration of antipsychotics with dopamine receptor-blocking properties, particularly D₂ receptor antagonists, should be carried out with caution and the patient carefully observed for loss of antiparkinsonian effect or worsening of parkinsonian symptoms.
Patients with chronic wide-angle glaucoma may be treated with Stalevo with caution, provided the intraocular pressure is well controlled and the patient is monitored carefully for changes in intraocular pressure.
Stalevo may induce orthostatic hypotension. Therefore, caution is necessary when giving Stalevo to patients who are taking other medicinal products which may cause orthostatic hypotension.
Entacapone in combination with levodopa has been associated with somnolence and episodes of sudden sleep onset in patients with Parkinson's disease and caution should therefore be exercised when driving or operating machines (see Effects on ability to drive and use machines as follows).
In clinical studies, undesirable dopaminergic effects eg, dyskinesia, were more common in patients who received entacapone and dopamine agonists (eg, bromocriptine), selegiline or amantadine compared to those who received placebo with this combination. The doses of other antiparkinsonian medicinal products may need to be adjusted when Stalevo is introduced in a patient not previously treated with entacapone.
Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson's disease. Isolated cases of rhabdomyolysis have been reported with entacapone treatment. NMS, including rhabdomyolysis and hyperthermia, is characterized by motor symptoms (rigidity, myoclonus, tremor), mental status changes (eg, agitation, confusion, coma), hyperthermia, autonomic dysfunction (tachycardia, labile blood pressure) and elevated serum creatine phosphokinase. In individual cases, only some of these symptoms and/or findings may be evident. Early diagnosis is important for the appropriate management of NMS. A syndrome resembling NMS including muscular rigidity, elevated body temperature, mental changes and increased serum creatine phosphokinase has been reported with the abrupt withdrawal of antiparkinsonian agents. Isolated cases of NMS have been reported, especially following abrupt reduction or discontinuation of entacapone.
When considered necessary, withdrawal of Stalevo and other dopaminergic treatment should proceed slowly, and if signs and/or symptoms occur despite a slow withdrawal of Stalevo, an increase in levodopa dosage may be necessary.
Prescribers should exercise caution when switching patients from Stalevo to levodopa/DDC inhibitor therapy without entacapone. When considered necessary, the replacement of Stalevo with levodopa and DDC inhibitor without entacapone should proceed slowly and an increase in levodopa dosage may be necessary.
If general anesthesia is required, therapy with Stalevo may be continued for as long as the patient is permitted to take fluids and medication by mouth. If therapy has to be stopped temporarily, Stalevo may be restarted as soon as oral medication can be taken at the same daily dosage as before.
Periodic evaluation of hepatic, hematopoietic, cardiovascular and renal function is recommended during extended therapy with Stalevo.
For patients experiencing diarrhea, a follow-up of weight is recommended in order to avoid potential excessive weight decrease. Prolonged or persistent diarrhoea suspected to be related to Stalevo may be a sign of colitis. In the event of prolonged or persistent diarrhoea, the drug should be discontinued and appropriate medical therapy and investigations considered.
For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.
Dopamine dysregulation syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with levodopa/ carbidopa. Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS (see Adverse Reactions).
Patients should be regularly monitored for the development of impulse control disorders. Patients and caregivers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido and hypersexuality have been reported in Parkinson’s disease patients treated with dopamine agonists and other dopaminergic treatments including Stalevo. Review of treatment is recommended if such symptoms develop.
Levodopa/carbidopa may cause false positive result when a dipstick is used to test for urinary ketone; this reaction is not altered by boiling the urine sample. The use of glucose oxidase methods may give false negative results for glycosuria.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Effects on the Ability to Drive or Operate Machinery: Stalevo may have a major influence on the ability to drive and use machines. Patients being treated with Stalevo and presenting with somnolence and/or sudden sleep onset episodes must be instructed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes have resolved.
Levodopa, carbidopa and entacapone together may cause dizziness and symptomatic orthostatism. Therefore, caution should be exercised when driving or using machines.