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Epilepsy is a long-term, clinically recurrent neurological disorder, characterized by abnormal neuronal firing leading to transient brain dysfunction
.
In view of the limited clinical experience in the treatment of epilepsy in China, the Multidisciplinary Collaboration Group for Rare Diseases of Peking Union Medical College Hospital and the China Alliance for Rare Diseases, based on evidence-based medical evidence, organized clinical, pharmaceutical and methodological experts in the field of epilepsy to formulate the "Expert Consensus on the Treatment of Refractory Epilepsy (2022)" for the first time, aiming to improve the effectiveness and safety
of the clinical application of clobazam.
Let's
take a look at the main recommendations.
Clinical use of clobazam in refractory epilepsy
Recommendation 1: Patients aged ≥ 2 years with LGS (Lennox-Gastaut syndrome) who do not respond to valproic acid and lamotrigine can be added to clobazam as adjunctive therapy, especially for the treatment of fall episodes [level of evidence: 2b; Recommended intensity: B].
(Consensus: 100%)
Recommendation 2: If valproic acid is ineffective, the addition of clobazam can be adjunctive to children aged ≥ 3 years with DS (Dravet syndrome) [level of evidence: 4; Recommended intensity: C].
(Consensus: 100%)
Recommendation 3: For children aged ≥ 2 years with EMAS (myoclonus-atonic epilepsy), if valproic acid and lamotrigine do not respond to treatment, adjuvant therapy with clobazam may be tried [level of evidence: 5; Recommended intensity: D].
(Consensus: 100%)
Recommendation 4: For clobazam, it is recommended to give different doses according to the patient's body weight, starting with small doses [level of evidence: 5; Recommended strength: D]; It is recommended that the dose of clobazam be adjusted according to the patient's clinical presentation and tolerance, and the interval between adjustments should not be less than 1 week [level of evidence: 5; Recommended strength: D]; When combined with other commonly used ASMs (anti-epileptic drugs), clobazam dosing dose does not require routine adjustment [level of evidence: 2b; Recommended intensity: B].
(Consensus: 100%)
Blood concentration monitoring
Recommendation 5: Routine TDM (drug monitoring for treatment) is not required for clobazam in refractory epilepsy [level of evidence: 5; strength :D of recommendation].
; Once there is an obvious adverse reaction, genetic testing is required for patients suspected of CYP2C19 slow metabolism, and if it is determined to be CYP2C19 slow metabolism, TDM is required.
and consider the presence of other risk factors for aggravating adverse effects; If the patient is not a slow metabolizer of CYP2C19, the focus should be on the presence of co-etrovirin or other risk factors for aggravating adverse effects, and TDM, both of which require adjustment of the dose of cloba according to the monitoring results [evidence level: 5; Recommended intensity: D].
(Consensus: 100%)
Drug interactions
Recommendation 6: When combined with drugs that affect the activity of CYP3A4 and CYP2C19 or substrates of CYP2D6 and CYP3A4, attention should be paid to clobazam-related drug interactions and patient response to the combined drug should be monitored; When suspected adverse reactions occur, the dosing regimen should be adjusted in a timely manner in combination with clinical symptoms and TDM results [evidence level: 5; Recommended intensity: D].
(Consensus: 100%)
Medication for special populations
Recommendation 7: People with CYP2C19 slow metabolism, the elderly, and patients with mild to moderate hepatic insufficiency should start with clobazam in small doses, increase the dose slowly, and reduce the maintenance dose
.
Patients with mild to moderate renal insufficiency do not need to adjust the dose
.
At present, there is a lack of safety data on the drug in children aged < 2 years and patients with severe hepatic and renal insufficiency, and it is recommended to determine the dosing regimen<b22> after multidisciplinary discussion on an individualized basis.
Clobazam is not recommended for pregnant and lactating women [level of evidence: 5; Recommended intensity: D].
(Consensus: 100%)
Adverse reactions, overdose and poisoning treatment
Recommendation 8: Before and during clobazam, the risk of addiction and central sedation should be assessed, especially in the case of the combination of central inhibitory drugs, if necessary, start with a small dose or reduce the dose observation, overdose is not recommended
.
Immediate discontinuation of clobazam can induce withdrawal symptoms
such as persistent seizures and neuropsychiatric abnormalities.
If skin allergic reactions occur during use, there may be a risk of SJS/TEN (Steven Johnson syndrome/toxic epidermal necrolysis), and you should go to the nearest medical institution as soon as possible for diagnosis and treatment, stop the drug immediately under the guidance/supervision of the medical institution, and actively treat the symptoms, while avoiding reuse
.
Routine supportive care is recommended if symptoms of overdose or poisoning are present, and rescue with flumazenil is not recommended [level of evidence: 5; Recommended intensity: D].
(Consensus: 100%)
"Expert consensus on clobazam in the treatment of refractory epilepsy (2022)".
Peking Union Medical Journal.
2022.
13 (5): 768 -782.
