Medication info
Mianthopa Tablets 12.5/50 mg (Benserazide, Levodopa)

Mianthopa Tablets 12.5/50 mg (Benserazide, Levodopa)

Prescription medicationTabletOral
Ingredient · strength
Benserazide Hydrochloride›14.25mg / 1 tabletLevodopa›50mg / 1 tablet
Manufacturer / importer
Myungin Pharmaceuticals Co., Ltd.
Appearance
Pink round tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202301581 · Approved 2023.05.17 · Insurance code 651905340

Summary

Main use
Treatment of parkinsonian syndrome (excluding drug-induced cases)
Who takes it
Adults
Adult dose
○ As with conventional levodopa therapy, treatment with this medicine should be initiated at the lowest possible dose and increased slowly. The dosage and administration should be determined individually at every stage of the disease. To prevent the competitive effect of dietary protein on levodopa and promote a more rapid onset of action, it is recommended, if possible, to take this medicine 30 minutes before or 1 hour after a meal. Gastrointestinal adverse reactions may occur early in treatment, but can be managed by taking this medicine with a low-protein meal or beverage or by increasing the dose slowly. ○ The following dosage regimens may be used as a guide. 1. Initial therapy In patients with early-stage Parkinson's disease, it is advisable to initiate treatment with this medicine (levodopa 50mg/benserazide 12.5mg) at 1 tablet 3-4 times daily. In patients with more advanced disease, initiate treatment at twice the above dose (levodopa 100mg/benserazide 25mg per dose) 3-4 times daily. Once tolerability of the initial regimen has been confirmed, increase the number of daily doses by 1 at weekly intervals (e.g., 4 times daily instead of 3 times daily). If the patient can be closely monitored, the dose may also be adjusted at intervals of 2-3 days. Optimal effects are generally achieved with a total daily dose of 4~8 tablets of levodopa 100mg/benserazide 25mg, divided into 3-4 doses. If the daily dose needs to be increased further, increase it at intervals of 1 month. It may take 4-6 weeks to reach the optimal dose. 2. Maintenance therapy The average maintenance dose is 1 tablet of levodopa 100mg/benserazide 25mg 4-6 times daily. The number of daily doses (at least 3 times daily) and the intervals between doses should be determined and adjusted according to the patient. 3. Special dosage and administration Medicines for Parkinson's disease other than levodopa may be continued until the therapeutic effect of this medicine is fully established; however, after this medicine begins to take effect, the doses of these medicines can often be gradually reduced. If marked fluctuations in therapeutic effect (on-off phenomenon) occur during treatment, it is recommended to reduce the dose per administration using this medicine (levodopa 50mg/benserazide 12.5mg) and increase the number of daily doses, or administer HBS capsules (levodopa/benserazide).

Ingredients

Manufacturer
Myungin Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of parkinsonian syndrome (excluding drug-induced cases)

  • Parkinson's syndrome
View approved original text

Parkinson's syndrome is a disorder characterized by slowed movement and tremors due to neurological impairment. This medication is used to alleviate the major symptoms of Parkinson's syndrome and improve the patient's ability to perform daily activities.

How to take

Adult dose

○ As with conventional levodopa therapy, treatment with this medicine should be initiated at the lowest possible dose and increased slowly. The dosage and administration should be determined individually at every stage of the disease. To prevent the competitive effect of dietary protein on levodopa and promote a more rapid onset of action, it is recommended, if possible, to take this medicine 30 minutes before or 1 hour after a meal. Gastrointestinal adverse reactions may occur early in treatment, but can be managed by taking this medicine with a low-protein meal or beverage or by increasing the dose slowly. ○ The following dosage regimens may be used as a guide. 1. Initial therapy In patients with early-stage Parkinson's disease, it is advisable to initiate treatment with this medicine (levodopa 50mg/benserazide 12.5mg) at 1 tablet 3-4 times daily. In patients with more advanced disease, initiate treatment at twice the above dose (levodopa 100mg/benserazide 25mg per dose) 3-4 times daily. Once tolerability of the initial regimen has been confirmed, increase the number of daily doses by 1 at weekly intervals (e.g., 4 times daily instead of 3 times daily). If the patient can be closely monitored, the dose may also be adjusted at intervals of 2-3 days. Optimal effects are generally achieved with a total daily dose of 4~8 tablets of levodopa 100mg/benserazide 25mg, divided into 3-4 doses. If the daily dose needs to be increased further, increase it at intervals of 1 month. It may take 4-6 weeks to reach the optimal dose. 2. Maintenance therapy The average maintenance dose is 1 tablet of levodopa 100mg/benserazide 25mg 4-6 times daily. The number of daily doses (at least 3 times daily) and the intervals between doses should be determined and adjusted according to the patient. 3. Special dosage and administration Medicines for Parkinson's disease other than levodopa may be continued until the therapeutic effect of this medicine is fully established; however, after this medicine begins to take effect, the doses of these medicines can often be gradually reduced. If marked fluctuations in therapeutic effect (on-off phenomenon) occur during treatment, it is recommended to reduce the dose per administration using this medicine (levodopa 50mg/benserazide 12.5mg) and increase the number of daily doses, or administer HBS capsules (levodopa/benserazide).

Precautions

This medication should not be used in patients with severe endocrine disorders or severe liver, kidney, or heart diseases. Additionally, it should not be administered to patients with mental disorders or severe psychiatric conditions, patients under 25 years of age with incomplete skeletal development, pregnant women or those planning to become pregnant, patients with a history of malignant melanoma, patients with closed-angle glaucoma, and patients allergic to this drug or its components. Patients taking non-selective MAO inhibitors should also avoid using this medication. Patients with mild liver or kidney impairment, those with open-angle glaucoma, a history of heart disease, history of osteomalacia or peptic ulcers, and diabetic patients should use this medication with caution and require regular check-ups. Blood tests and liver and kidney function tests should be conducted regularly while taking this medication for a long time, as various side effects such as loss of appetite, depression, anxiety, hallucinations, drowsiness, arrhythmias, hypotension, gastrointestinal disturbances, and skin rashes may occur. Patients scheduled for surgery should stop administering this medication during anesthesia, and abrupt discontinuation may cause serious symptoms, therefore it should be tapered off gradually. Caution is required as drowsiness or somnolence may occur when driving or operating machinery, and behavioral changes such as impulse control disorders can arise, so both patients and caregivers should be aware and observe closely. This medication may interact with various drugs, so it is important to consult with healthcare professionals if taking other medications. Women who are pregnant or breastfeeding should not use this medication, and women who could become pregnant should take a pregnancy test before treatment and employ appropriate contraception. Serious side effects may occur with overdose, so dosage must be strictly adhered to, and it should be stored in a place out of reach of children, avoiding moisture and stored tightly in its original container.

Side effects

  • Hemolytic anemia
  • transient leukopenia
  • thrombocytopenia
  • loss of appetite
  • depression
  • agitation
  • anxiety
  • insomnia
  • hallucinations
  • delusions
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  • transient loss of proprioception
  • dopamine dysregulation syndrome
  • loss of taste
  • taste disturbances
  • dyskinesia
  • drowsiness
  • daytime drowsiness
  • somnolence
  • deep vein thrombosis
  • orthostatic hypotension
  • nausea
  • vomiting
  • diarrhea
  • pruritus
  • rash
  • gastrointestinal bleeding
  • flushing
  • sweating
  • elevated serum uric acid
  • elevated BUN
  • mild elevation of transaminases
  • increased ALP
  • increased gamma-glutamyltransferase
  • red discoloration of urine
  • staining of saliva
  • tongue
  • teeth
  • or oral mucosa
  • confusion
  • insomnia
  • abnormal involuntary movements

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light, so it should be stored in a dark place. It is important to store it in a sealed container as moisture in the air may affect the quality of the medication. Additionally, to maintain the drug's effectiveness, it should be stored at a cool temperature below 25 degrees Celsius.

Appearance and packaging

Appearance

Pink round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.