Masopen 250/25 Hasan Treatment of Parkinson's symptoms (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Carbidopa, Levodopa

Ingredient

Composition information	Content
Carbidopa	25mg
Levodopa	250mg

Uses

indications

Masopen 250/25 drugs are used to treat Parkinson's symptoms and syndrome (Parkinson's syndrome after encephalitis, after carbon monon monbon and manganese poisoning).

Pharmacology

Pharmacological group: Parkinson treatment.

ATC code: n04ba02.

Mechanism of action:

Levodopa is a direct precursor of dopamine, used as alternative therapy in the treatment of Parkinson's disease.

Carbidopa is an inhibitor of peripheral decarboxylase enzyme, preventing levodopa conversion into peripheral dopamin, increasing the amount of levodopa into the brain blood barrier. Therefore, Levodopa is used in lower doses, reducing the rate and severity of unwanted effects. Masopen is effective in reducing Parkinson's symptoms, especially spasms and slow movement and other symptoms such as tremor, difficulty swallowing, posture instability related to Parkinson and syndrome.

When responding to Levodopa unevenly uneven solidarity, Parkinson's signs and symptoms are not well controlled, replacement with Levodopa/Carbidopa often gives improved results. By reducing some Levodopa's adverse reactions, Levodopopa/Carbidopa combination allows patients to effectively control Parkinson's symptoms.

pharmacokinetics

levodopa

absorption: levodopa is quickly absorbed in the digestive tract.

Distribution: Levodopa competes with neutral amino acids when passing through the brain blood barrier, then decadboxylated into dopamine, reserves and release in nerve cells. Because Levodopa has rapid decarboxylation in the gastrointestinal tract and liver, only a small amount of doses in the form of unchanged into the brain barrier.

metabolism and elimination: levodopa has a half -time sale time and mainly decadboxylated into dopamine, partly converted into noradrenalin. About 30% of Levodopa is converted into 3-O-Methyldopa, which has the time to sell from 9 to 22 hours. About 80% of Levodopa is excreted in the urine within 24 hours in the form of homovanillic acid and hydroxyphenylactic acid, less than 1% are eliminated in a constant form.

carbidopa

absorption: Carbidopa after drinking is absorbed quickly but not completely in the digestive tract.

Distribution: carbidopa through the placenta and excretion through breast milk.

Metabolism and elimination: About 50% of the carbidopa dose is found in urine with about 3% in constant form. Carbidopa metabolizes and eliminated quickly, most of the constant form of drugs found in urine within 7 hours.

Carbidopa inhibits the peripheral decarboxylation process of levodopa into dopamine, increasing the amount of levodopa into the brain. Carbidopa does not affect the metabolism of Levodopa in the brain due to the failure to cross the bloodstream barrier. The lower dopamine concentration reduces the unwanted effects in the periphery such as nausea, vomiting, arrhythmia and treatment effect is still achieved at lower doses of levodopa.

pharmacokinetics in special subjects

Elderly

A study in healthy subjects with 8 people aged 21-22 and 8 people from 69 - 76 years old shows the absolute use of Levodopa similar in two groups after using Levodopa/Carbidopa. However, the body exposure (AUC) of Levodopa increased by 55% in the elderly group compared to the young group. Another study in 40 Parkinson patients showed a correlation between the patient's age and the increase in the AUC of Levodopa after taking Levodopa and the peripheral dopa decarboxylase. Levodopa's AUC increased by 28% in the elderly (≥65 years old) compared to young patients (Carbidopa's

AUC in the elderly (calculated over 10 people, 65-76 years old) increased by 29% compared to young people (calculated over 24 people, aged 23 - 64) after intravenous injection of 50 mg Levodopa with Carbidopa (50 mg). This increase does not cause a significant impact on clinical.

Before taking Masopen 250/25 Hasan Treatment of Parkinson's symptoms (3 blisters x 10 tablets)

How to use

Take oral use, should take medicine for a fixed time of the day, should be avoided with medicine with high protein meals.

If you forget to take the medication once, skip the dose and continue the treatment as usual, do not use double the dose.

There is no special requirement on drug treatment after use.

Dosage

studies show that the periphery dopa -decboxylase is completely inhibited by Carbidopa dose of 70 - 100 mg/day. Patients taking lower carbidopa dose may experience nausea and vomiting. Parkinson's treatment can be treated with other drug groups except Levodopa while using masopen, but need to adjust the dose appropriately.

Because the effectiveness of treatment and adverse reactions when using Masopen appear earlier than the single Levodopa, the patient should be closely monitored during the dose adjustment period. When unintentional movements appear, especially bronchospasm, an early sign shows an overdose in the patient.

Patients do not use Levodopa

Starting dose: 1 tablet of Masopen 100/25 × 3 times/day, equivalent to the dose of 75 mg Carbidopa/day. When necessary, a dose of 1 tablet of Masopen 50/12.5 or Masopen 100/25 daily until the maximum daily dose is 800 mg Levodopa/200 mg Carbidopa.

If using a Masopen 100/10 or Masopen 50/12.5, may start at a dose of 1 tablet x 3 or 4 times/day. Determining the level of carbidopa may be required in some patients to achieve the optimal dosage. The dosage can be increased by 1 tablet/day until the maximum dose is reached.

The drug response has been observed after 1 day, and sometimes after 1 dose. The optimal efficiency is usually achieved within 7 days compared to a few weeks to a few months when using a single levodopa.

Masopen 50/12.5 or Masopen 100/10 can be used for convenient dose adjustment according to each patient's needs.

Patients are taking Levodopa

Stop using Levodopa at least 12 hours before starting treatment with masopen.

The easiest way is to use Masopen in the morning after 1 night without using Levodopa. Masopen dose should be approximately 20% of the daily levodopa dose before.

For patients with dose of less than 1500 mg of levodopa/day, should start with Masopen 100/25 use 3 or 4 times daily depending on the patient response. The starting dose is recommended for most patients taking a dose greater than 1500 mg of levodopa/day is Masopen 250/25 use 3 or 4 times daily.

maintenance dose

Masopen treatment should be personalized and gradually adjusted according to the drug response. When the higher dose of Carbidopa is needed, it is necessary to replace the 100/10 Masopen tablet with Masopen 100/25 or 50/12.5.

When the levodopa dose is needed, Masopen 250/25 should be used for replacement at 1 tablet 3 or 4 times daily. If necessary, an increase of 1 tablet to a maximum dose of 8 Masopen 250/25 tablets. Treatment experience with a total daily dose greater than 200 mg of Carbidopa is limited.

Patients who are treating Levodopa with another decarboxylase inhibitor

When patients switch to using masopen from Levodopa in combination with decarboxylase inhibitors, it is necessary to stop taking the drug at least 12 hours before starting with Masopen. Lieu Masopen started with Levodopa content equivalent to Levodopa dose in Levodopa/Decarboxylase combination.

Patients are taking other Parkinson treatments

The current evidence indicates that other Parkinson's medications can be continued when starting to use Masopen, although the dosage can be adjusted in accordance with the manufacturer's recommendations.

used in children

The safety of masopen in patients under 18 years of age has not been set up, so it is not recommended to use drugs in this group.

Using drugs in the elderly

There is a lot of experience using drugs in elderly patients. The recommendation of drugs should be reflected from these experiences.

What to do when overdose? ECG monitoring should be monitored and carefully observed the ring of arrhythmia, if it is necessary to use appropriate anti -arrhythmia therapy. The possibility of the patient may have taken other drugs with Levodopa/Carbidopa tablets. Do not know the value of the separation when overdose levodopa/carbidopa.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using the drug, there are common unwanted effects (ADR) such as:

Harmful reactions are grouped by frequency: Very common (ADR ≥1/10), common (1/100≤adr

Unwanted effects occur often with Masopen are side effects due to Dopamin's central nerve activity. These reactions will usually be limited after reducing the dose. The most common is movement disorders including jerking, muscle tone disorders and other non -self -moving movements, nausea. Muscle convulsions, spontaneous muscle convulsions can appear as an early sign to consider reducing the dose.

Common:

Central nervous system: anxiety, confusion, stimulating state, depression, dementia, insomnia, fatigue, hallucinations, loss of air conditioning, tone disorders, dynamic disorders.

Cardiovascular: Hypotension, nervousness, arrhythmia.

Digestive: Nausea, vomiting, gastrointestinal bleeding, difficulty swallowing.

Eyes: blurred vision.

Uncommon:

Digestive: duodenum ulcer.

Respiratory: fast breathing, abnormal breathing, runny nose.

Urinary trend: urinary retention, urination, opaque urine.

Eyes: blurred vision, one -sided look, shrinking or dilating pupils.

Blood: leukemia, hemolytic anemia or no hemolysis.

Neurosa: headache, cramps, muscle weakness, sweat, skin and black teeth, gain or weight loss, edema, hair loss, penis erection, postmenopausal bleeding.

Other unwanted effects are reported in clinical trials or after circulation:

Systemic reaction: fainting, chest pain, anorexia.

Cardiovascular: heart abnormalities and/or chest drums, vertical effects include hypotension, hypertension, venous inflammation.

Gastrointestinal tract: Vomiting, stomach bleeding, duodenal ulcer, diarrhea, dark saliva.

Hematopoietic system: leukemia, hemolytic anemia and non -hemolytic anemia, thrombocytopenia, granulocytosis.

Hypersensitivity: Evala, urticaria, itching, Henoch-Schonlein bleeding.

Nervous/mental system: Malignant neurological syndrome, slow movements, dizziness, paresthesia, and revival of the miracles including illusion, hallucinations, paranoia, depression with or without suicide, memory loss, nightmares, agitation, confusion, increased libido. Levodopa is related to drowsiness and excessive sleepiness during the day or sudden (very rare) drowsiness.

Respiratory: Difficulty breathing.

Skin: hair loss, rash, dark sweat.

Urinary tract system: dark urine.

rarely occur, however, the relationship with Masopen has not been set up.

Other undesirable effects have been reported or likely to occur when treated with levodopa or coordinate Levodopa/Carbidopa:

Digestive: indigestion, dry mouth, bitter mouth, difficulty swallowing, grinding teeth, hiccups, abdominal pain, constipation, flatulence, burning sensation.

Metabolism: Increase or weight loss, edema.

Nervous/mental system: weakness, disorientation, loss of air conditioning, numbness, tremor, muscle spasm, jaw stiff, stimulating hidden horny syndrome, insomnia, anxiety, excitement, dopamine disorder syndrome.

Dopamine disorders (DDS) is an observed addictive disorder in patients with Carbidopa/Levodopa treatment patients. The affected patient shows that the enforcement of drug abuse on the dose controls the movement symptoms, which can lead to serious movement disorders in some cases.

Conduct disorders such as gambling, increased libido, shopping addiction and eating may occur in patients treated with dopamine resistance and/or other dopamine treatments containing levodopa, including masopen.

Skin: flushed, increased sweating.

senses: nearsightedness, blurred vision, dilated pupils, long -term attacks.

Urology-Sex: Urinary retention, non-autonomous urine, penis erection.

Other: weak, fainting, fatigue, headache, noise, hot burst, u Melanin.

Instructions on how to handle ADR:

Notify the physician with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Masopen 250/25 contraindications in the following cases:

Hypersensitivity to any ingredients of the drug. It is necessary to stop using inhibitors at least 2 weeks before starting with masopen. Masopen can be used simultaneously with Mao -B Selective inhibitors (such as Selegilin Hydrochorid) in the recommended dose of the manufacturer. severe mental disorders.

Be cautious when using

masopen is not recommended to treat extracurricular reactions due to drugs.

Be careful in patients with serious cardiovascular disease or lung disease, bronchial asthma, kidney disease, liver or endocrine system, history of stomach ulcer (due to the ability to cause gastric - intestinal bleeding).

Be cautious when using masopen in patients with a history of myocardial infarction with atrial arrhythmia or ventricular arrhythmia. Heart function should be specially monitored in these patients during the initial dose adjustment.

Levodopa can cause drowsiness and sudden drowsiness. Sudden drowsiness in daily activity may not be aware or without warning signs (rarely occur). Patients should be warned about this and should be cautious when driving or operating machinery. Patients with a history of drowsiness and drowsiness should avoid driving or operating machinery. Can consider reducing dose or stop treatment.

Patients should be carefully monitored about mental changes, depression tends to kill suicide and other serious social opposition behaviors. Caution should be treated in patients with mental disorders.

Mobility disorders can occur in patients who single -treatment with levodopa earlier, because Carbidopa helps Levodopa through more bloody brain barriers increase dopamine levels. May be required to reduce the dose.

Like Levodopa, Masopen can cause arbitrary movements and mental disorders. Patients with a history of non -arbitrary movements and severe psychosis when single -rise with Levodopa should be carefully monitored when using Masopen. These reactions are thought to be due to an increase in dopamine in the brain after using levodopa and using masopen may cause recurrence. A syndrome similar to malignant neurological syndrome including muscle stiffness, body temperature, mental change and increased creatinine phosphokinase have been reported when suddenly stopped using Parkinson's anti -Parkinson drugs. Therefore, the reduction of the dose or stopping the use of the drug suddenly should be carefully observed, especially in patients who are taking neuroleptic.

Simultaneous treatment of psychotropic drugs such as phenothiazin or butyrophenon should be cautious and patients need to be careful to observe the loss of anti -Parkinson drugs. Patients with a history of convulsions should be treated carefully. Like Levodopa, periodic liver function assessment, hematopoietic, cardiovascular and renal function are recommended during prolonged treatment.

Patients with wide -angle glaucoma can be treated with masopen carefully but need to carefully monitor eye pressure changes during treatment.

In case of body anesthesia, it is possible to continue treatment with masopen as long as the patient is allowed to drink water and take medicine. If temporarily stopped treatment, Masopen can be continued right after being able to take the medicine, with daily doses as before.

Epidemiological studies show that Parkinson patients are at higher risk of developing melanin tumors than the general population (about 2-6 times higher). The increased risk is not known to be due to Parkinson's disease or other factors such as Parkinson's treatment. Therefore, patients and suppliers need to monitor regular tumors when using Masopen for any indications. Ideally is periodic skin examination in dermatologists.

Testing

Normally, blood nitrogen levels in the blood, creatinine, uric acid are lower when using masopen than single -rise levodopa. Extraordinary abnormalities include increased blood urea, AST (SGOT), ALT (SGPT), LDH, Bilirubin and alkaline phosphate.

Reduce hemoglobin, hematocrite, serum and high blood cell glucose, bacteria and blood in the urine have been reported.

Positive Coomb test has been reported, both when using Levodopopa/Carbidopa and Levodopa.

masopen can cause false positive results when the exploration stick is used for ceton test and this reaction is not changed when boiling urine.

The use of glucose oxidation methods can give fake negative results.

Dopamine disorders (DDS) is an addictive disorder that leads to excessive use of Carbidopa/Levodopa. Before starting treatment, patients and relatives should be warned about this risk.

Conduct disorder

Patients should be monitored for the increase in behavioral disorders. Patients and people

Care should be aware of the behavioral symptoms of behavioral disorders including gambling, increased libido, shopping addiction and eating can occur in patients treated with dopamine resistance and/or other dopamine treatments containing levodopa, including masopen.

Considering treatment is recommended when symptoms show more serious signs.

The effect of the drug on the ability to drive and operate machinery

The drug response in each individual may vary and some side effects have been reported to Masopen about the effect of the drug on the sun's driving and operating machinery. Patients treated with Levodopa should be notified of the possibility of drowsiness and/or sudden drowsiness to avoid driving and operating machinery.

Using drugs for women during pregnancy and lactation

Using drugs for pregnant women

Although the effects of masopen on pregnancy are unknown, both the single Levodopa and the Levodopa/Carbidopa combination form causes internal and bone deformities in rabbits. Therefore, using masopen in pregnant women or possibly pregnancy requires consideration of benefits and risks that may occur in mother and fetus.

Using medicine for breastfeeding women

Do not know if Carbidopa is excreted through breast milk or not. In a study in a nursing mother, Parkinson's disease showed that Levodopa was excreted through the mother's milk that was reported. Because there are many drugs excreted through breast milk and have the ability to seriously harm babies, so it is necessary to consider the benefits and risks that may occur when taking the drug.

Drug interaction

Be careful when using the last drugs with masopen.

Hematoplasty drugs

Hypotension may occur when masopen is added in patients being treated with antihypertensive drugs. Adjusting the dose of antihypertensive drugs may be required.

antidepressants

The reactions including hypertension and dysfunction have been reported when used simultaneously with three -round antidepressants.

anti -cholinergic drugs

anti -cholinergic drugs may affect the absorption that leads to the patient's response change.

iron

Studies prove that the bioavailability of carbidopa and/or levodopa decreases when treated simultaneously with sulfate iron or gluconate iron.

Other drugs

So far has not yet shown that interactions will prevent the use of typical anti -Parkinson.

Dopamine D2 receptor resistant drugs (Phenothiazin, Butyrophenon, Risperidon) and Isoniazid can reduce Levodopa's treatment effect. The beneficial effects of Levodopa in the treatment of Parkinson's treatment have been reported to be reversed by Phenytoin and Papaverin. Patients using Masopen should be carefully monitored about the reduction of drug response.

It is not recommended to treat masopen with agents that reduce dopamine levels (such as tetrabenazine) or other drugs that significantly reduce monoamine.

Simultaneous treatment of Selegilin and Carbidopa-Levodopa may be related to serious vertical hypotension not only due to carbiodopa-levodopa.

Levodopa competes with some amino acids that can reduce masopen absorption in patients with a protein -rich diet.

The effect of Levodopa's bioavailability when treated simultaneously antacid with masopen has not been studied.

Masopen can be treated in Parkinson's patients using preparations containing pyridoxin hydrochloride (vitamin B6).

Tyeum of drugs

Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.

Storage

In dry place, below 30 degrees Celsius. Avoid light.

Other drugs

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