Cenobamate is a novel antiepileptic drug that combines voltage-gated sodium channel inhibition and positive allosteric regulation of gamma aminobutyric acid type A (GABAA) receptors.

1、 Drug name

1. Common name: Cenobamate

2. Product Name: XCOPRI ®

2、 Indications

Used to treat focal (partial) epilepsy in adults.

3、 Specifications and characteristics

200 milligrams. Improved oval light orange pill with film coating, engraved with "200".

4、 Main components

Active ingredient: Benzodiazepine ester.

5、 Usage and dosage

1. Initial dose: The recommended initial dose is once daily, 12.5 milligrams per dose.

2. Maximum dose: If necessary for clinical efficacy and tolerability, the maximum dose can be reached by adding 50 milligrams every two weeks, once daily at 400 milligrams each time.

3. Administration method: This product can be taken with or without meals. It can be taken as a whole tablet, or the tablet can be crushed and taken orally with water to form a suspension, or administered through a nasogastric tube.

6、 Dose adjustment

1. Patients with liver dysfunction: For patients with mild or moderate (Child Pugh A or B) liver dysfunction, the maximum recommended dose is once daily, 200 milligrams per dose, and further dose reduction may need to be considered. Not recommended for patients with severe (Child Pugh C grade) liver dysfunction.

2. Patients with renal insufficiency: For patients with mild to moderate and severe renal insufficiency, caution should be exercised and dose reduction should be considered. Not recommended for end-stage renal disease patients undergoing dialysis.

7、 Medication precautions

1. Before and after meals: taking benazepril is not affected by food.

2. Leakage treatment: It is recommended to consult a doctor. Double doses should not be taken to compensate for missed doses.

3. Vomiting: If vomiting occurs after taking the medication and it is uncertain whether the medication has been absorbed, it is recommended to consult a doctor.

4. General warning:

Prohibited from use in patients known to have familial short QT syndrome or allergies to benzodiazepine or any ingredients in this product.

Drug reactions with eosinophilia and systemic symptoms (DRESS) may occur. If there are signs of fever, rash, facial swelling, lymph node enlargement, or other organ dysfunction, seek medical attention immediately and discontinue medication.

This product may shorten the QT interval and should be avoided in combination with drugs that also shorten the QT interval. If the patient experiences prolonged palpitations or fainting, they should inform the doctor promptly.

All antiepileptic drugs, including benazepril, increase the risk of suicidal ideation and behavior, and patients should be closely monitored.

Clinically significant liver injury may occur. Before and during treatment, liver function tests should be performed as needed.

May cause drowsiness, fatigue, dizziness, gait disorders, cognitive impairment, and visual changes. Before determining the impact of this product, patients should not drive or operate machinery, and should avoid using other central nervous system inhibitors or alcohol simultaneously.

Do not suddenly stop taking medication unless it is necessary for safety reasons. Normally, medication should be gradually reduced and stopped within at least 2 weeks to minimize the risk of increased seizure frequency.

8、 Medication for special populations

1. Pregnant women: Animal data shows potential harm to the fetus. Pregnant women should consult a doctor and it is recommended to join the North American antiepileptic drug pregnancy registry during pregnancy.

2. Breastfeeding women: There is currently no data on the presence of benazepril in human milk, and the benefits of breastfeeding should be balanced against the potential risks of medication for infants.

3. Women and men of childbearing age: Pembarate can reduce the efficacy of oral hormonal contraceptives, and it is recommended to use additional or alternative non hormonal contraceptive methods at the same time.

4. Children: The safety and efficacy in pediatric patients have not yet been determined.

5. Elderly patients: Elderly patients may have decreased liver and kidney function, and caution should be exercised in dosage selection.

6. Patients with renal insufficiency: As mentioned earlier, caution should be exercised and dosage may need to be adjusted.

7. Patients with liver dysfunction: As mentioned earlier, the dosage should be adjusted.

9、 Adverse reactions

1. The most common adverse reactions (with an incidence rate of ≥ 10% and higher than the placebo group) are drowsiness, dizziness, fatigue, diplopia, and headache.

2. Other high incidence adverse reactions (with higher incidence in different dose groups than in the placebo group) include nausea, balance disorders, gait disorders, nystagmus, articulation disorders, attention disorders, memory disorders, etc.

3. Serious adverse reactions: Possible occurrence of DRESS, liver injury (including liver failure), shortened QT interval, suicidal thoughts and behaviors, etc.

4. Adverse reactions that may lead to discontinuation of medication include ataxia, dizziness, drowsiness, diplopia, nystagmus, and vertigo.

10、 Contraindications

1. Known to be allergic to benzoate or any inactive ingredient in this product.

2. Suffering from familial short QT syndrome.

11、 Drug interactions

Effects and recommendations on the following drugs:

1. Phenytoin: This product can significantly increase the blood concentration of phenytoin. During the titration of this product, the dosage of phenytoin should be gradually reduced by up to 50%.

2. Phenobarbital/Chlorpromazine: This product can increase its blood drug concentration, and it may be necessary to consider reducing the dosage of phenobarbital or chlorpromazine.

3. Lamotrigine/Carbamazepine: This product can reduce its blood drug concentration, and its dosage may need to be increased based on clinical reactions.

4. Oral contraceptive pills: This product can reduce its blood drug concentration and efficacy. During use, women should use additional or alternative non hormonal contraceptive methods.

5. Other drugs: This product will reduce the blood drug concentration of CYP2B6 and CYP3A substrates (dosage may need to be increased); It will increase the blood drug concentration of CYP2C19 substrate (which may require reducing the dose).

6. Combination therapy with other drugs that shorten the QT interval: caution should be exercised as there may be a synergistic effect that increases the risk of QT interval shortening.

7. Combined use with other central nervous system inhibitors or alcohol: may increase neurological adverse reactions and should be avoided.

12、 Storage method

1. It should be stored at room temperature of 20 ° C to 25 ° C (68 ° F to 77 ° F), allowing for brief exposure to an environment of 15 ° C to 30 ° C (59 ° F to 86 ° F).

2. Please keep this product out of reach of children.

cenobamateinformation