Uses of Madopar 250mg

1. Uses of Madopar 250mg

Madopar 250mg contains 200mg of levodopa and 50mg of benserazide. It is indicated for the treatment of idiopathic Parkinson’s disease. However, this medication is contraindicated in the following cases:

• Patients with hypersensitivity to levodopa, benserazide, or any other components of the drug;
• Concurrent use of Madopar with non-selective monoamine oxidase (MAO) inhibitors is not allowed;
• Patients with endocrine disorders, decompensated liver or kidney diseases (except for patients undergoing dialysis), psychiatric disorders with psychosis, cardiovascular disorders, or closed-angle glaucoma;
• Patients under 25 years of age;
• Pregnant women or women of childbearing potential who are not using contraception. The medication should be discontinued immediately if pregnancy occurs during treatment with Madopar;
  Patients with a history of or at risk for malignant melanoma;
• Concurrent use of Madopar with antipsychotic drugs that have antiemetic effects is contraindicated.

2. How to Use Madopar 250mg

Madopar is administered orally. When using the capsule form or Madopar HBS, patients should swallow the entire capsule without removing the shell. For the regular tablet form of Madopar, the tablet can be split for easier swallowing.

Madopar dispersible tablets dissolve in approximately 25–50ml of water, breaking down completely into a milky solution within a few minutes. As the solution tends to settle quickly, it should be stirred well before drinking. Dispersible tablets should be consumed within 30 minutes of preparing the solution.

For Parkinson’s Disease:

• Madopar should be taken at least 30 minutes before meals or 1 hour after meals.
• Gastrointestinal side effects, which are common during the early stages of treatment, can be managed by taking Madopar with light food (such as biscuits), using the liquid form, or gradually increasing the dosage.

3. Dosage of Madopar 250mg

The treatment with Madopar 250mg should be initiated with a gradual increase in dosage. The dose should be carefully evaluated and individualized for each patient, adjusting to achieve the most effective therapeutic response. The dosage guidelines below are for general reference only.

3.1 Initial treatment dosage

• During the early stages of Parkinson's disease, patients should start treatment with one Madopar 62.5 capsule or half a Madopar 125 tablet, taken 3–4 times per day.
• Once the initial treatment regimen is well-tolerated, the dosage should be gradually increased based on the patient’s response.
• Optimal effects are generally achieved when the daily dose of Madopar corresponds to 300–800 mg of levodopa and 75–200 mg of benserazide, divided into 3 or more doses per day.
• It usually takes 4–6 weeks to achieve the optimal effect. If a further increase in the daily dosage is necessary, it should be done at monthly intervals.

3.2 Maintenance dosage

• The average maintenance dose is one Madopar 125mg capsule or tablet, taken 3–6 times per day.
• Each patient should take the medication at least 3 times daily, and the timing of doses should be adjusted to achieve the best therapeutic outcome.
• Madopar HBS or dispersible forms of Madopar can be used as substitutes for conventional Madopar to optimize treatment outcomes.

3.3 Special dosage considerations

• The dosage of Madopar should be carefully adjusted for all patients.
• Patients taking other Parkinson's medications may still use Madopar. However, as the effects of Madopar treatment become evident, the doses of other drugs may be gradually reduced or discontinued.
• Dispersible Madopar tablets are suitable for patients with swallowing difficulties or when rapid onset of action is required.
• For patients with significant fluctuations in drug efficacy during the day, the dosage should be divided into smaller, more frequent doses or switched to Madopar HBS.
• When transitioning from standard Madopar to Madopar HBS, this should be done overnight, starting with the morning dose. The  dose and frequency daily should match that of the conventional Madopar. After 2–3 days, the dosage should be gradually increased by approximately 50%. Patients should be informed that their condition may fluctuate temporarily during this transition. Due to the pharmacological properties of Madopar HBS, the onset of action is often delayed.
• Faster clinical effects may be achieved by combining Madopar HBS with dispersible or conventional Madopar, especially for the first morning dose, which should be slightly higher than subsequent doses.
• Dosage adjustments for patients on Madopar HBS should be made gradually and cautiously, with at least 2–3 days between dose changes.
• In patients with nighttime immobility, positive effects have been observed when gradually increasing the final evening dose to 250mg of Madopar HBS taken before bedtime.
• Over-responsiveness to Madopar HBS (dyskinesia) can be managed by increasing the interval between doses.
• If the patient shows poor response to Madopar HBS, they should be reverted to treatment with standard or dispersible Madopar formulations.
• Patients receiving Madopar treatment should be closely monitored for psychiatric side effects.

3.4 Management of overdose and missed doses

Overdose: Symptoms of overdose resemble the side effects of Madopar at therapeutic doses but are more severe. Overdose may lead to arrhythmias, confusion, insomnia, nausea, vomiting, and abnormal involuntary movements. Treatment includes monitoring vital signs, implementing supportive measures, and providing symptomatic treatment.
Missed dose: If a dose is missed, the patient should take it as soon as possible. If it is close to the next scheduled dose, the missed dose should be skipped, and the next dose taken as planned.

4. Side Effects of Madopar 250mg

Some side effects that patients may experience when using Madopar 250mg include:

• Blood and Lymphatic System Disorders: Hemolytic anemia, leukopenia, thrombocytopenia.
• Psychiatric Disorders: Dopamine dysregulation syndrome, depression, agitation, anxiety, insomnia, hallucinations, delusions, disorientation, pathological gambling, increased libido, hypersexuality.
• Nervous System Disorders: Loss or alteration of taste, dyskinesia (chorea and dystonia), fluctuations in treatment response, treatment resistance, on-off phenomenon, stupor, sudden onset of sleepiness.
• Cardiac Disorders: Arrhythmias.
• Vascular Disorders: Orthostatic hypotension.
• Gastrointestinal Disorders: Nausea, vomiting, diarrhea, discoloration of saliva, teeth, or oral mucosa, gastrointestinal bleeding, loss or change in taste.
• Hepatobiliary Disorders: Elevated transaminases, alkaline phosphatase, or gamma-glutamyl transferase.
• Skin and Subcutaneous Tissue Disorders: Itching, rash.
• Musculoskeletal and Connective Tissue Disorders: Restless legs syndrome.
• Renal and Urinary Disorders: Increased blood urea levels.

5. Precautions When Using Madopar 250mg

Here are some key points users need to remember before and during treatment with Madopar:

• When Madopar is used concurrently with other medications, patients must be carefully monitored for unusual side effects or enhanced drug effects.
• Madopar may cause hypersensitivity reactions in sensitive individuals.
  Regular intraocular pressure monitoring is required for patients with open-angle glaucoma, as levodopa (the main component of Madopar) may increase intraocular pressure.
• Caution should be exercised when using Madopar in patients with a history of coronary artery disease, heart failure, or arrhythmias.
• Special care must be taken to monitor and support cardiac function during the initial phase of treatment and periodically throughout the treatment period with Madopar.
• Patients at risk, such as the elderly, those taking antihypertensive medications, or medications that may cause orthostatic hypotension, and those with a history of orthostatic hypotension, should be closely monitored—especially during the early treatment phase or when the dosage is increased.
• Madopar may lead to a reduction in blood cell counts (thrombocytopenia, leukopenia, hemolytic anemia). Rare cases of agranulocytosis and pancytopenia have been reported. Blood counts should be regularly monitored throughout treatment.
• Patients treated with Madopar may experience depression or restless leg syndrome. Mental health changes and symptoms of depression should be closely observed.
• If general anesthesia is required, Madopar should be continued as close to the surgery date as possible (except in the case of halothane anesthesia). For halothane anesthesia, Madopar should be discontinued 12–48 hours before surgery to prevent blood pressure fluctuations and arrhythmias. Madopar may be resumed post-surgery with a gradual dose increase to the pre-surgery dosage.
• Abrupt discontinuation of Madopar is prohibited, as it may result in high fever, muscle rigidity, mental changes, increased serum creatinine and phosphokinase levels, myoglobinuria, acute renal failure, and rhabdomyolysis. If such symptoms occur, close monitoring is necessary.If  hospitalize the patient is need and provide prompt symptomatic treatment, including resuming Madopar after a full assessment.
• Levodopa in Madopar may cause drowsiness or sudden sleep episodes. Patients should be informed of this risk and cautioned when driving or operating machinery. 
  Patients who have experienced such episodes should refrain from driving or operating machinery. Dose adjustments or discontinuation of treatment may also be considered.
• Patients should be regularly monitored for impulse control disorders. Patients and caregivers should be informed of symptoms such as pathological gambling, hypersexuality, increased libido, compulsive shopping, binge eating, or compulsive drinking. Treatment should be reviewed if these symptoms occur.
• Patients with Parkinson's disease are at a higher risk of developing melanoma. Regular health check-ups, including skin examinations, are recommended for patients using Madopar.
• Dopaminergic medications like Madopar may lead to pathological gambling, increased libido, and hypersexuality in patients.
• Madopar is contraindicated in pregnant women and women who could become pregnant without using contraceptive methods. Breastfeeding mothers should not use Madopar to avoid the risk of skeletal deformities in infants.
• No dosage adjustment is needed for patients with mild to moderate renal impairment when using Madopar.
  There is insufficient data on the use of Madopar in patients with hepatic impairment; therefore, caution should be exercised, and all physician instructions should be strictly followed.

6. Drug Interactions of Madopar 250mg

6.1 Pharmacokinetic Interactions

• Concurrent use of standard Madopar with the anticholinergic drug trihexyphenidyl reduces the rate of levodopa absorption but does not decrease its extent of absorption. Concurrent use of trihexyphenidyl with Madopar HBS does not affect the pharmacokinetics of levodopa.
• Co-administration of Madopar HBS with antacids reduces the extent of levodopa absorption. Iron sulfate can decrease the maximum plasma concentration and AUC (Area Under the Curve) of levodopa.
• Metoclopramide may increase the rate of levodopa absorption.

6.2 Pharmacodynamic Interactions

• Opioids, sedatives, and antihypertensive drugs containing reserpine inhibit the effects of Madopar.
• For patients on non-selective, irreversible MAO inhibitors, these should be discontinued at least two weeks before starting treatment with Madopar. Otherwise, adverse effects such as hypertensive crises may occur.
• Selective MAO-B inhibitors (e.g., selegiline, rasagiline) and selective MAO-A inhibitors (e.g., moclobemide) can be prescribed to patients on Madopar. The levodopa dose should be adjusted individually based on therapeutic response and tolerance.
• Combining MAO-A and MAO-B inhibitors produces an effect equivalent to non-selective MAO inhibition and should not be used with Madopar.
• Madopar should not be co-administered with sympathomimetic agents such as epinephrine, norepinephrine, isoproterenol, or amphetamine, as levodopa may enhance their effects. If co-administration is unavoidable, cardiovascular monitoring is required, and the sympathomimetic dosage should be reduced.
• Concurrent use of antipsychotics with dopamine receptor-blocking properties may counteract the anti-Parkinson effects of Madopar. Levodopa may reduce the antipsychotic effects of such drugs, so caution is advised when combining these medications.

6.3 Other Drug Interactions

• Madopar 250mg can be used in combination with other medications such as anticholinergics, selegiline, amantadine, bromocriptine, and dopamine agonists. However, this may increase both desired effects and side effects, requiring a dose reduction of either Madopar or the other drugs. When initiating treatment with COMT inhibitors, the Madopar dose should also be reduced.
• Anticholinergic drugs should not be abruptly discontinued when starting Madopar, as levodopa requires time to exert its effects.
• Levodopa may interfere with test results for catecholamines, creatinine, uric acid, and glucose. Urinalysis may yield false-positive results for ketones. Coombs tests may also show false-positive results in patients on Madopar.
• The effectiveness of Madopar is reduced when taken with protein-rich meals.
• Madopar should be discontinued 12–48 hours before general anesthesia with halothane to prevent risks of blood pressure fluctuations and cardiac arrhythmias.

Madopar 250mg is a brand-name drug used to treat Parkinson's disease. Patients must strictly follow the doctor's prescription when using this medication. If any adverse side effects occur, the patient should promptly inform their doctor.

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