Side effects of Madopar 100 mg/25 mg retard in details
Post-Marketing: Blood and Lymphatic System Disorders: Hemolytic anemia, transient leukopenia and thrombocytopenia have been reported in rare cases. Therefore, as in any long-term Levodopa (Madopar 100 mg/25 mg retard)-containing treatment, blood count and liver and kidney function should be monitored periodically.
Metabolic and Nutritional Disorders: Anorexia has been reported.
Psychiatric Disorders: Depression can be part of the clinical picture in patients with Parkinson's disease and may also occur in patients treated with Madopar 100 mg/25 mg retard. Agitation, anxiety, insomnia, hallucinations, delusions and temporal disorientation may occur particularly in elderly patients and in patients with a history of such disorders.
Nervous System Disorder: Isolated cases of ageusia or dysgeusia have been reported. At later stages of the treatment, dyskinesia (eg, choreiform or athetotic) may occur. These can usually be eliminated or be made tolerable by a reduction of dosage. With prolonged treatment, fluctuations in therapeutic response may also be encountered.
They include freezing episodes, end-of-dose deterioration and the "on-off" effect. These can usually be eliminated or made tolerable by adjusting the dosage and by giving smaller single doses more frequently. An attempt at increasing the dosage again can subsequently be made in order to intensify the therapeutic effect. Madopar 100 mg/25 mg retard is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Cardiac Disorders: Cardiac arrhythmias may occur occasionally.
Vascular Disorders: Orthostatic hypotension may occur occasionally. Orthostatic disorders commonly improve following reduction of the Madopar 100 mg/25 mg retard dosage.
Gastrointestinal Disorders: Nausea, vomiting and diarrhea have been reported with Madopar 100 mg/25 mg retard. Undesirable gastrointestinal effects, which may occur mainly in the early stages of the treatment, can largely be controlled by taking Madopar 100 mg/25 mg retard with some food or liquid or by increasing the dose slowly.
Skin and Subcutaneous Tissue Disorders: Allergic skin reactions eg, pruritus and rash may occur in rare cases.
Investigations: Transient elevation of liver transaminase and alkaline phosphatase may occur. Increase of γ-glutamyltransferase has been reported.
Rises in blood urea nitrogen have been noted with Madopar 100 mg/25 mg retard.
Urine may be altered in color, usually acquiring a red tinge which turns dark on standing. Other body fluids or tissues may also be discoloured or stained including saliva, the tongue, teeth or oral mucosa.
Laboratory Abnoramlities: See Post-Marketing as previously mentioned.
Madopar 100 mg/25 mg retard contraindications
Hypersensitivity to Levodopa (Madopar 100 mg/25 mg retard) or Benserazide (Madopar 100 mg/25 mg retard).
In conjunction with nonselective monoamine oxidase (MAO) inhibitors. However, selective MAO-B inhibitors eg, selegiline and rasagiline or selective MAO-A inhibitors eg, moclobemide are not contraindicated. Combination of MAO-A and MAO-B inhibitors is equivalent to nonselective MAO inhibition and hence, this combination should not be given concomitantly with Madopar 100 mg/25 mg retard.
Patients with decompensated endocrine, renal (except patients on dialysis) or hepatic function, cardiac disorders, psychiatric diseases with a psychotic component or closed angle glaucoma.
Pregnant women or to women of childbearing potential in the absence of adequate contraception. If pregnancy occurs in a woman taking Madopar 100 mg/25 mg retard, the drug must be discontinued (as advised by the prescribing physician).
Patients <25 years (skeletal development must be complete).
Use in pregnancy: Madopar 100 mg/25 mg retard is contraindicated during pregnancy and in women of childbearing potential in the absence of adequate contraception.
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).
- DTP/NCI. "levodopa: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Levodopa: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
