Overdose of Madopar in details
Symptoms and Signs: Symptoms and signs of overdose are qualitatively similar to the adverse effects of Madopar in therapeutic doses but may be of greater severity. Overdose may lead to cardiovascular adverse effects (eg, cardiac arrhythmias), psychiatric disturbances (eg, confusion and insomnia), gastrointestinal effects (eg, nausea and vomiting) and abnormal involuntary movements.
If a patient has taken an overdose of a controlled-release form of Madopar (ie, Madopar HBS capsules), occurrence of symptoms and signs may be delayed due to delayed absorption of the active substances from the stomach.
Treatment: Monitor the patient's vital signs and institute supportive measures as indicated by the patient's clinical state. In particular patients may require symptomatic treatment for cardiovascular effects (eg, antiarrhythmics) or CNS effects (eg, respiratory stimulants, neuroleptics).
In addition, for the controlled-release formulations further absorption should be prevented using an appropriate method.
Madopar warnings
Stopping this medication suddenly can cause Parkinsons disease to worsen quickly. Report bothersome or unexpected side effects. Unless prescribed, do not take Madopar in addition to this drug. Avoid pyridoxine (vitamin B6) if you are taking Madopar alone, although it can be taken with carbidopa/Madopar. Avoid high-protein meals for maximum absorption. If you are taking the sustained-release tablet, swallow a whole or one-half tablet without chewing or crushing it. Onset of effect of the first morning dose of the sustained release product could be delayed up to 1 hour compared with the quick-release product. A dark color (red, brown, or black) might appear in saliva, urine, or sweat and can stain clothing.
Madopar precautions
General: Hypersensitivity reactions may occur in susceptible individuals.
Regular measurement of intraocular pressure (IOP) is advisable in patients with open-angle glaucoma, as Madopar theoretically has the potential to raise IOP.
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 Madopar 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 hrs 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.
Madopar 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 Madopar. 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.
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 casual 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: A small subgroup of Parkinson's disease 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.
Laboratory Tests: Checks of liver function and blood 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: Madopar and Benserazide (Madopar) are both extensively metabolized and <10% of Madopar is excreted unchanged through the kidneys. No dose reduction is therefore necessary in case of mild or moderate renal insufficiency.
Pharmacokinetic data with Madopar in renal impaired patients are not available. Madopar is well tolerated by uremic patients undergoing hemodialysis.
Hepatic Impairment: Madopar 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.
Pharmacokinetic data with Madopar in hepatic impaired patients are not available.
Effects on the Ability to Drive or Operate Machinery: Patients being treated with Madopar 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 (eg, operating machines) until such recurrent episodes and somnolence have resolved.
Use in lactation: Since it is not known whether Benserazide (Madopar) passes into breast milk, mothers requiring Madopar treatment should not nurse their infants, since the occurrence of skeletal malformations in the infants cannot be excluded.
Use in children: See Contraindications.
References
- DailyMed. "CARBIDOPA; ENTACAPONE; LEVODOPA: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "Benserazide". http://www.drugbank.ca/drugs/DB12783 (accessed September 17, 2018).
- DrugBank. "levodopa". http://www.drugbank.ca/drugs/DB01235 (accessed September 17, 2018).
Reviews
Consumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
