Dopamine tablets

1. Dopamine is a compound preparation composed of levodopa and benserazide. Dopamine is a neurotransmitter in the brain. The basal ganglia of patients with Parkinson's disease have insufficient dopamine. Levodopa is an intermediate product of dopamine biosynthesis and a dopamine precursor. Dopamine is generated under the action of aromatic L-amino acid decarboxylase. Levodopa can pass through the blood-brain barrier, while dopamine itself cannot, so levodopa is used as a prodrug to increase dopamine levels. 2. After administration, levodopa undergoes rapid decarboxylation reaction outside the brain and in brain tissue to generate dopamine, so that most levodopa cannot reach the basal ganglia, and dopamine produced in the periphery often causes adverse reactions. Therefore, it is very necessary to inhibit the decarboxylation reaction of levodopa in tissues outside the brain. This purpose can be achieved by administering levodopa and the peripheral decarboxylase inhibitor benserazide at the same time. 3. Dopamine is a compound preparation of levodopa and benserazide in a 4:1 ratio. Clinical trials and therapeutic applications have shown that this ratio has the best therapeutic effect, which is equivalent to the effect of giving a large dose of levodopa alone.

This product is a compound preparation, and its components are: each tablet contains 200 mg of levodopa and 50 mg of benserazide (equivalent to 57 mg of benserazide hydrochloride).

This product is a light red tablet with added colorant.

For the treatment of Parkinson's disease, symptomatic parkinsonism (post-encephalitic, arteriosclerotic or toxic), but not including drug-induced parkinsonism.

The most appropriate daily dose of Madopar must be determined based on the individual patient's situation. The following dosage table can be used as a basic reference: 1. The first recommended dose for initial treatment is 1/2 tablet of Madopar each time, 3 times a day. The daily dose is increased by 1/2 tablet each week thereafter until the therapeutic dose suitable for the patient is reached. If the patient visits the doctor regularly, the dose can be increased more quickly, for example, the daily dose is increased twice a week, and 1/2 tablet of Madopar is added each week. In this way, the effective dose can be reached more quickly. The effective dose is usually between 2-4 tablets per day, taken 3-4 times a day. The daily dose rarely needs to exceed 5 tablets of Madopar. For example: If it is necessary to give more than 4 tablets of Madopar per day, the dose should be increased at monthly intervals. For a few patients, the initial recommended dose listed in the table is too large and should be gradually increased from 1/4 tablet to 1/2 tablet to the same total daily dose. 2. The daily dose of Madopar for maintenance therapy should be taken at least 3 times a day, and the average maintenance dose is 3 times a day, one tablet of Madopar each time. However, since improvement in symptoms may fluctuate, the daily dose allocation (in terms of the dose and the timing of each patient's medication) is determined on a patient-by-patient basis. If a patient begins to experience significant fluctuations in efficacy (e.g., an "on-off" phenomenon), this can often be significantly improved by taking 1/4 tablet of Madopar. In principle, the daily dose does not change, and 1/4 tablet of Madopar can replace part or, if necessary, the original Madopar allocation, but the intervals should be shortened: 1/2 tablet of Madopar previously taken can be replaced by two doses of 1/4 tablet each. 1 tablet of Madopar previously taken can be replaced by four doses of 1/4 tablet each. 3. Patients who were previously taking levodopa and are now switching to Madopar If a patient who was previously taking levodopa needs to switch to Madopar 1 tablet, the method of change is as follows: the number of tablets of Madopar taken per day is equal to half of the total number of levodopa 500 mg/tablet tablets or capsules currently taken by the patient minus 1/2 tablet. For example, if a patient takes 2 grams of levodopa per day (4 500 mg levodopa tablets or capsules per day), the doctor should prescribe him 2-1/2 = 1 + 1/2 tablets of Madopar per day. For all patients, the minimum initial dose is twice a day, 1/2 tablet each time. The patient should be closely observed for one week, and if necessary, the dose of Madopar should be increased until a satisfactory therapeutic effect is achieved (the dosage schedule is the same as for patients who have not been treated with levodopa before). If the patient's clinical condition deteriorates, the time for increasing the dose can be brought forward. 4. General precautions In a few cases, more serious adverse reactions occur at the beginning of treatment. At this time, the dose should not be further increased, and even should be reduced. However, it is rarely necessary to interrupt treatment. When the adverse reactions disappear or can be tolerated, the daily dose can be increased again, but it should be more slowly, such as increasing only 1/2 tablet of Madopar every 2 to 3 weeks. When the patient takes Madopar in excess of the usual effective dose (such as more than 3 tablets of Madopar per day), the interval between dose increases must be longer, because it takes a certain amount of time for the drug to achieve full therapeutic effect. Like all alternative treatments, treatment with Madopar is long-term. If symptoms improve after 4 weeks of treatment, Madopar should be continued to achieve the best results. Sometimes it is necessary to take Madopar for more than 6 months to achieve the best results.

1. Blood and lymphatic system: Hemolytic anemia, transient leukopenia and thrombocytopenia have been reported in very rare cases. Therefore, when using levodopa-containing drugs for long-term treatment, blood cells as well as liver and kidney function should be checked regularly. 2. Metabolism and nutrition: Anorexia has been reported. 3. Psychiatric symptoms: Patients treated with Madopar may experience depression, but this may also be a clinical manifestation of patients with Parkinson's disease and restless legs syndrome. Agitation, anxiety, insomnia, hallucinations, delusions and transient disorientation may occur in elderly patients or patients with similar medical histories. 4. Nervous system: Loss of taste or taste disorders have been reported in individual cases. In the later stages of treatment, movement disorders (such as chorea-like movements or athetosis) may occur, and reducing the dosage of the medication usually eliminates the symptoms.

1. Madopar is contraindicated in patients with known hypersensitivity to levodopa, benserazide or their excipients. 2. Madopar is contraindicated in combination with non-selective monoamine oxidase inhibitors, but selective monoamine oxidase B inhibitors (such as selegiline and rasagiline) and selective monoamine oxidase A inhibitors (such as moclobemide) are not prohibited. The combined use of monoamine oxidase A and monoamine oxidase B inhibitors is equivalent to non-selective monoamine oxidase inhibitors and should not be used in combination with Madopar (see [Drug Interactions]). 3. Madopar is contraindicated in patients with endocrine, renal (except dialysis patients), liver decompensation or heart disease, mental illness, and angle-closure glaucoma. 4. Madopar is contraindicated in patients under 25 years of age (must be patients with complete skeletal development). 5. Madopar is contraindicated in pregnant women and women with potential pregnancy potential (such as pregnant or lactating women) who are not taking effective contraceptive measures. If the patient becomes pregnant during medication, the medication should be stopped (as recommended by the prescribing physician).

Precautions for children: Not suitable for use by children under 25 years old. Precautions for pregnancy and lactation: 1. Animal experiments show that Madopar may affect the skeletal development of the embryo, so it is absolutely forbidden to use it in pregnant women or women who are pregnant but have not taken effective contraceptive measures. 2. Because it is unknown whether benserazide can enter breast milk, mothers taking Madopar are prohibited from breastfeeding because the possibility of skeletal deformities in infants cannot be ruled out. Precautions for the elderly: Same usage and dosage.

1. Pharmacokinetic Interactions 1.1 The anticholinergic drug benzhexol (Antan) can reduce the absorption rate of levodopa when used in combination with the standard preparation of Madopar, but it will not affect its absorption extent. Ferrous sulfate can reduce the maximum plasma concentration and AUC of levodopa by 30-50%. Significant changes in clinical pharmacokinetics can be observed in some patients when used in combination with ferrous sulfate, but not in all patients. 1.2 Metoclopramide can increase the absorption rate of levodopa. 1.3 There is no pharmacokinetic interaction between levodopa and the following compounds: bromocriptine, amantadine, selegiline and domperidone. 2. Pharmacodynamic Interactions 2.1 Neuroleptics, opioids and antihypertensive drugs containing reserpine can inhibit the effects of Madopar. 2.2 When Madopar is given to patients who are receiving irreversible non-selective monoamine oxidase inhibitors, the monoamine oxidase inhibitor should be discontinued for at least two weeks before starting Madopar, otherwise adverse reactions such as hypertensive crisis may occur (see [Contraindications]). However, patients who have been treated with Madopar can use selective monoamine oxidase B inhibitors (such as selegiline and rasagiline) and selective monoamine oxidase A inhibitors (such as moclobemide). In this case, it is recommended to adjust the dose of levodopa based on the efficacy and tolerability of each patient. The combined use of monoamine oxidase A and monoamine oxidase B inhibitors is equivalent to taking non-selective monoamine oxidase inhibitors and should not be used in combination with Madopar (see [Contraindications]). 2.3 Madopar should not be used simultaneously with sympathomimetic drugs (such as epinephrine, norepinephrine, isoproterenol or amphetamine that excite the sympathetic nervous system) because levodopa can enhance the effects of these drugs. If patients must use such drugs at the same time, the cardiovascular system response should be closely monitored and the dosage of sympathomimetic drugs should be reduced. 2.4 Madopar can be used in combination with other anti-Parkinson's disease drugs (such as anticholinergic drugs, amantadine, dopamine receptor agonists, etc.), although the therapeutic effect and adverse reactions may increase at the same time. The dosage of Madopar or other drugs should be reduced when used in combination. When COMT inhibitors are used for adjuvant therapy, the dose of Madopar should be appropriately lowered. Since levodopa cannot produce efficacy in a short period of time, anticholinergic drugs should not be stopped abruptly. 3. Levodopa can affect the test results of catecholamines, creatinine, uric acid and blood sugar. In patients using Madopar, the Coombs test may show false positive results. 4. Eating a high-protein meal at the same time will reduce the efficacy of the drug. 4.1 General anesthesia with halothane: Since halothane may cause blood pressure fluctuations and/or arrhythmias, if halothane is required for general anesthesia, Madopar should be discontinued 12-48 hours before surgery. 4.2 If other anesthetics are used for general anesthesia, see [Precautions].

Keep in a dark place, sealed, and stored in a cool (no more than 20°C) and dry place. The medicine should be kept out of reach of children.

0.25 g (levodopa 200 mg, benserazide 50 mg)

48 months

Shandong Xinhua Pharmaceutical Company Limited

• Founded in:

  1998-11-20

• Address:

  Chemical Industry Zone, Zibo High-tech Industrial Development Zone

• Tax NO.:

  91370300164103727C

• Registered Funds:

  682,407,635 yuan

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