Madopar 125/Madopar 250/Madopar Dispersible 125/Madopar HBS 125

Madopar 125/Madopar 250/Madopar Dispersible 125/Madopar HBS 125 Special Precautions

benserazide + levodopa

Manufacturer:

Roche

Marketer:

DKSH
Full Prescribing Info
Special Precautions
General: Warnings related to immunological reactions: Hypersensitivity reactions may occur in susceptible individuals.
Warnings related to neurological and psychiatric effects: Madopar must not be withdrawn abruptly.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 phospokinase) which may be life-threatening. Should a combination of such symptoms and signs occurs, 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.
Patients should be carefully observed for possible undesirable psychiatric symptoms.
Depression can be part of the clinical picture in patients with Parkinson's disease and may also occur in patients treated with Madopar.
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 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: Impulse control disorders such as pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Pakinson'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.
Warnings related to ocular effects: Regular measurement of intraocular pressure is advisable in patients with open-angle glaucoma, as levodopa theoretically has the potential to raise intraocular pressure.
Warnings related to Interactions: If a patient on levodopa requires general anaesthesia, the normal Madopar regimen should be continued as close to the surgery as possible, except in case of halothane. In general anaesthesia 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.
If Madopar is to be administered to patients receiving irreversible non-selective MAO inhibitors, an interval of at least 2 weeks should be allowed between cessation of the MAO inhibitor and the start of Madopar therapy. Otherwise unwanted effects such as hypertensive crisis are likely to occur (see Contraindications and Interactions).
Concomitant administration of antipsychotics with dopamine-receptor blocking properties, particularly D2-receptor antagonists might antagonize the antiparkinsonian effects of levodopa-benserazide. Levodopa may reduce antipsychotic effects of these drugs. These drugs should be co-administered with caution (see Interactions).
Madopar should not be administered concomitantly with sympathomimetics (such as epinephrine, norepinephrine, isoproterenol or amphetamine which stimulate the sympathetic nervous system) as levodopa may potentiate their effects. Should concomitant administration prove necessary, close surveillance of the cardiovascular system is essential, and the dose of the sympathomimetic agents may need to be reduced (see Interactions).
When initiating an adjuvant treatment with a COMT inhibitor, a reduction of the dosage of Madopar may be necessary.
Anticholinergics should not be withdrawn abruptly when Madopar therapy is instituted, as levodopa does not begin to take effect for some time.
Combination with anticholinergics, amantadine, selegiline, bromocriptine and dopamine agonists is permissible, though both the desired and the undesired effects of treatment may be intensified. It may be necessary to reduce the dosage of Madopar or the other substance (see Interactions).
Laboratory Tests: Checks of liver function and blood cell count should be performed during treatment (see Post Marketing Experience under Adverse Reactions). Patients with diabetes should undergo frequent blood sugar tests, and the dosage of antidiabetic agents should be adjusted to blood sugar levels.
Drug Dependence and Abuse: Dopamine dysregulation syndrome (DDS): a small number of patients have been known to suffer from cognitive and behavioural 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.
Renal impairment: Levodopa and benserazide are both extensively metabolized and less than 10% of levodopa is excreted unchanged through the kidneys. It is unlikely that dose adjustments are necessary in mild or moderate renal insufficiency (see Special Dosage Instructions under Dosage & Administration).
Pharmacokinetic data with levodopa in renal impaired patients are not available. Madopar must not be given to patients with decompensated renal function.
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 (see Special Dosage Instructions under Dosage & Administration).
Pharmacokinetic data with levodopa in hepatic impaired patients are not available. Madopar must not be given to patients with decompensated hepatic function.
Ability to Drive and Use Machines: Madopar may have a major influence on the 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 as previously mentioned).
Use in Children: Madopar is contraindicated in patients less than 25 years old (see Contraindications).
Use in the Elderly: See Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.
Renal impairment: Levodopa and benserazide are both extensively metabolized and less than 10% of levodopa is excreted unchanged through the kidneys. It is unlikely that dose adjustments are necessary in mild or moderate renal insufficiency (see Special Dosage Instructions under Dosage & Administration).
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