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[Indications for Entacapone Doubledopa Tablets]
This product is used to treat adult patients with Parkinson's disease who have uncontrolled or "end-of-dose" motor function fluctuations that cannot be controlled by levodopa/dopa decarboxylase (DDC) inhibitor therapy
[Specifications of Entacapone Doubledopa Tablets]
Endecapone-Dopa Tablets (II) 100mg/25mg/200mg: Levodopa 100mg, Carbidopa 25mg and Entacapone 200mg
[Entacapone-Doubledopa Tablets Dosage and Use]
The medicine can be taken on an empty stomach or after meals. One tablet contains a therapeutic dose. Tablets should be swallowed whole
Patients should take only one tablet at a time. Patients taking less than 70-100 mg of carbidopa per day are more likely to experience nausea and vomiting. Clinical experience with daily doses of carbidopa exceeding 300 mg is limited, whereas the recommended maximum daily dose of entacapone is 1600 mg. Therefore, the maximum daily dose of this product is 8 tablets per day
This product is usually used in patients who have been treated with corresponding doses of levodopa/dopa deaminase inhibitors and entacapone in standard release dosage forms.
Convert from levodopa/dopa deaminase inhibitors (carbidopa or benserazide) and entacapone tablets to this product.
a. Patients who are receiving the same dose of entacapone and standard-release levodopa/carbidopa as this product can be directly switched to receive the corresponding dose of this product.
b. If the patient is receiving entacapone and levodopa/carbidopa at doses that are not equal to the dose of this product (50mg/12.5mg/200mg. 100mg/25mg/200mg or 150mg/37.5mg/200mg). When initiating treatment with this product, the dose must be carefully titrated to achieve optimal clinical efficacy. At the beginning of treatment, the dose of levodopa should be adjusted as close as possible to the total daily dose of levodopa currently used.
c. If the patient is currently receiving entacapone and standard-release levodopa/benserazide, levodopa/benserazid should be discontinued the night before starting treatment with this product. Start taking this product the next morning. The levodopa content in the first dose of this product should be equal to or slightly exceed (5 to 10%) the currently used levodopa dose.
Patients who are not currently receiving entacapone will be switched to this product.
Some patients with Parkinson's disease and "off-dose" motor function fluctuations who are being treated with standard-release levodopa/dopa deaminase inhibitors but have unstable symptoms may be considered for treatment with corresponding doses of this product. However, direct conversion from levodopa/dopa deaminase inhibitors to treatment with this product is not recommended for patients with dyskinesia or whose daily levodopa dosage exceeds 600 mg. It is recommended that these patients first join entacapone (entacapone tablets) combination therapy before switching to this product for treatment. And it is necessary to adjust the levodopa dose as needed.
Entacapone may enhance the effects of levodopa. Therefore, the dose of levodopa may need to be reduced by 10 to 30% during the first days and weeks of treatment with this product. Especially patients with movement disorders. Based on the patient's clinical condition. Reduce the total daily dose of levodopa by extending the dosing interval and/or reducing the dose per dose.
Dose adjustment during treatment
When the condition requires more levodopa. Within the recommended dosage range, consideration should be given to increasing the frequency of dosing or using other doses of this product.
Reduce levodopa dosage if necessary. The total daily dose may be reduced by reducing the number of daily doses or extending the interval between doses or using a smaller strength of this product.
If other levodopa preparations are used concurrently with treatment with this product, the recommended maximum dose should be followed.
Discontinue treatment with this product
If you want to interrupt treatment with this product (levodopa/carbidopa/entacapone). Switch to levodopa/dopa deaminase inhibitor therapy. If entacapone is not used concomitantly, the dosage of other anti-Parkinson drugs, especially the dosage of levodopa, must be adjusted to achieve sufficient blood concentrations to achieve effective control of symptoms in patients with Parkinson's disease.
Hepatic Impairment
Patients with hepatic impairment should be careful when receiving this product and may need to reduce the dose
Renal Impairment
Renal impairment will not affect the pharmacokinetic characteristics of entacapone. There are currently no reported trials specifically investigating the pharmacokinetics of levodopa and carbidopa in renal insufficiency. Therefore, patients with severe renal impairment, including those receiving dialysis, must be careful when using this product.
[Adverse reactions of entacapone doubledopa tablets]
Carbidopa-levodopa
The most commonly reported adverse reactions of carbidopa-levodopa include movement disorders, such as chorea, dystonia and other involuntary movements, and nausea.
Entacapone
The most common adverse reactions (>5%) related to entacapone observed in double-blind, placebo-controlled clinical trials of entacapone (n=1003) were: dyskinesia/hyperkinesis, nausea, urine discoloration, diarrhea, and abdominal pain.
[Contraindications for Entacapone Didopa Tablets]
1. Allergy to the active ingredients of this product (carbidopa, levodopa or entacapone) or any of the excipients
2. Monoamine oxidase (MAO) and COMT are the two main enzyme systems in catecholamine metabolism. As with levodopa/carbidopa, non-selective monoamine oxidase inhibitors are contraindicated for use with this product.
3. Narrow-angle glaucoma
4. Since levodopa may activate malignant melanoma, patients with suspicious and undiagnosed skin lesions or patients with a history of melanoma are prohibited from taking this product.
[Precautions for Entacapone Doubledopa Tablets]
General Precautions
1. Similar to taking levodopa, when using this product for long-term treatment, it is recommended to evaluate liver, hematopoietic, cardiovascular and renal functions four years ago.
2. Patients with chronic open-angle glaucoma should pay attention when treating this product. Before starting to use this product, the patient's intraocular pressure should be well controlled, and changes in intraocular pressure should be carefully monitored.
[Storage of Entacapone and Doubledopa Tablets]
Save at room temperature (10-30 degrees). Prevent children from accidentally taking it.