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General: Hypersensitivity reactions may occur in susceptible individuals.
Regular measurement of intraocular pressure is advisable in patients with open-angle glaucoma, as levodopa theoretically has the potential to raise intraocular pressure.
Depression can be part of the clinical picture in patients with Parkinson's disease and may also occur in patients treated with Madopar.
If a patient on levodopa requires a general anesthetic, the normal Madopar regimen should be continued as close to the surgery as possible, except in the case of halothane.
In general anesthesia with halothane, Madopar should be discontinued 12-48 hours before surgical intervention as fluctuations in blood pressure and/or arrhythmias may occur in patients on Madopar therapy. Madopar therapy may be resumed following surgery; the dosage should be increased gradually to the preoperative level.
Madopar must not be withdrawn abruptly. Abrupt withdrawal of the preparation may result in a neuroleptic malignant-like syndrome (hyperpyrexia and muscular rigidity, possibly psychological changes and elevated serum creatinine phosphokinase) which may be life-threatening. Should a combination of such symptoms and signs occur, the patient should be kept under medical surveillance, if necessary, hospitalized and rapid and appropriate symptomatic treatment given. This may include resumption of Madopar therapy after an appropriate evaluation.
Levodopa has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore a reduction of dosage or termination of therapy may be considered (see Ability to Drive and Use Machines as follows).
Dopaminergic drugs: Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson's Disease. There is no established causal relationship between Madopar, which is not a dopamine agonist, and these events. However, caution is advised as Madopar is a dopaminergic drug.
Potential for Drug Dependence or Abuse: Dopamine dysregulation syndrome (DDS): small number of patients suffer from cognitive and behavioral disturbance that can be directly attributed to taking increasing quantities of medication against medical advice and well beyond the doses required to treat their motor disabilities.
Ability to Drive and Use Machines: Patients being treated with levodopa and presenting with somnolence and/or sudden sleep episodes must be informed 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 and somnolence have resolved (see General in the previous text).
Laboratory Tests: Checks of liver function and blood cell count should be performed during treatment.
Patients with diabetes should undergo frequent blood sugar tests, and the dosage of antidiabetic agents should be adjusted to blood sugar levels.
Renal Impairment: Levodopa and benserazide are both extensively metabolized and less than 10% of levodopa is excreted unchanged through the kidneys. No dose reduction is therefore necessary in case of mild or moderate renal insufficiency.
Pharmacokinetic (PK) data with levodopa in renal impaired patients are not available. Madopar is well tolerated by uremic patients undergoing hemodialysis.
Hepatic Impairment: Levodopa is mainly metabolized by the aromatic amino acid decarboxylase that is abundantly present in the intestinal tract, in kidney and heart in addition to the liver.
PK data with levodopa in hepatic impaired patients are not available.
Use in Children: See Contraindications.
