苯巴那酯(cenobamate)的用法用量:用药指南,剂量调整,特殊人群用药,用药注意事项

Long-term use requires the guidance of a doctor to gradually determine the initial appropriate dosage and reasonable combination with other drugs based on the actual situation.

Indications of cenobamate

It is used to treat partial-onset epilepsy.

The pictures come from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Regular dose of cenobamate for adults with epileptic seizures

1. Initial dose

‌ Weeks 1-2‌ Take 12.5 mg orally once a day.

‌2. Titration phase:

Take 25 mg orally once a day in weeks 3-4; 50 mg orally once a day in weeks 5-6; 100 mg orally once a day in weeks 7-8; 150 mg orally once a day in weeks 9-10; Maintenance dose (starting from week 11): 200 mg orally once a day; maximum dose: 400 mg orally once a day.

3. Precautions

This drug can be used as a single drug or as an adjuvant treatment.

‌Older patients‌ should start at the lower end of the dosage range with caution.

In order to avoid serious adverse reactions caused by excessive titration, we strictly prohibit excessive titration operations.

Based on the patient’s clinical response and drug tolerance, the principle of dose adjustment is to gradually increase the initial maintenance dose of the drug to 50 mg/day every 2 weeks, and the adjustment of the exceeded maintenance dose is more flexible.

Cenobamate (cenobamate) dose adjustment for special groups

1. Renal insufficiency

Patients with mild to severe renal impairment (especially those with CrCl indicators less than 90mL/min) need to reduce the dose accordingly while taking the drug to prevent adverse pharmacokinetic effects due to further damage to renal function.

Not recommended for patients with end-stage renal disease (ESRD) on dialysis.

2. Hepatic insufficiency

‌ Mild to moderate liver damage (Child-Pugh A/B grade)‌ The recommended maximum dose is 200 mg/day, and further reduction may be required.

This drug should be contraindicated in patients with Child-Pugh class C severe hepatic impairment.

3. Medication discontinuation method

Gradually reduce and discontinue the medication within at least 2 weeks (unless safety risks require immediate discontinuation).

‌4. Contraindications‌

Allergy to this product or any excipients.

Familial short QT syndrome.

‌Patients under 18 years of age‌Safety and effectiveness have not been established.

5. Dosing recommendations

‌Oral or nasogastric administration‌: It can be taken with food or on an empty stomach.

‌Tablet handling‌: The tablets can be swallowed whole or crushed and mixed with water to form an oral suspension/nasogastric tube administration.

Monitoring items for cenobamate

‌Skin reactions‌; ‌Central nervous system depression‌ (such as drowsiness, sedation, especially when combined with other sedative drugs); Psychiatric symptoms‌ (such as worsening of depression and suicidal tendencies).

Instructions for other patients when taking the drug:

Avoid sudden discontinuation of the drug; report any fever, rash, palpitations or loss of consciousness immediately; patients should avoid driving or operating machinery while taking phenobarnate; women of childbearing age need to use non-hormonal contraceptive measures.

Storage conditions of cenobamate

Cenobamate tablets should be stored in a cool place at 20°C-25°C (68°F-77°F) and can also be placed at 15°C-30°C (59°F-86°F) for short periods of time.

‌Suspension‌: Use immediately, do not store.