Epidiolex

Epidiolex (cannabidiol) is an oral prescription liquid CBD medicine that may be used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in adults and children aged 1 year and older.

• Epidiolex may help reduce the frequency and severity of seizures.
• Some people may see significant improvements with Epidiolex, while others might not.

Epidiolex contains cannabidiol (CBD), a compound derived from cannabis plants. Scientists are not exactly sure how it works but it does not seem to exert its anticonvulsant effects through interaction with cannabinoid receptors. Unlike tetrahydrocannabinol (THC), which is another compound found in cannabis, Epidiolex does not make people feel 'high.'

Epidiolex first gained FDA approval on June 25, 2018, and was the first medicine to be approved that was derived from cannabis. It is only available with a doctor's prescription.

Active ingredient: cannabidiol 100 mg

Inactive ingredients: dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose.

Epidiolex is gluten-free, it does not contain wheat, barley, or rye.

Epidiolex is available in 60 mL and 100 mL bottles. The strength of Epidiolex is 100 mg/ mL

最常见的Epidiolex副作用包括：

• 嗜睡
• 食欲下降
• 腹泻
• 肝酶升高
• 感觉非常疲倦和虚弱
• 皮疹
• 睡眠问题（失眠）
• 发热
• 呕吐
• 感染。

严重副作用和警告

Epidiolex 可能引起以下严重的副作用。

肝脏问题。Epidiolex 可以导致肝酶升高，这可能会导致住院治疗。这种升高通常在治疗的前两个月内发生，但有些病例是在患者服用 Epidiolex 达到 18 个月后报告的。在开始使用 Epidiolex 和治疗期间，您的医疗保健提供者可能会要求进行血液检查以检查您的肝脏。在某些情况下，可能需要停止治疗。如果您在服用 Epidiolex 期间出现任何这些肝脏问题的症状和体征，请立即联系您的医疗保健提供者：

• 食欲不振、恶心、呕吐
• 发热、感到不适、异常疲倦
• 皮肤或眼白发黄（黄疸）
• 瘙痒
• 尿液颜色异常加深
• 右上腹部疼痛或不适。

嗜睡。Epidiolex 可能会使您感到困倦，随着时间推移可能会有所改善。与 Epidiolex 一起使用某些药物，如氯巴占或酒精，可能会增加困倦感。在了解 Epidiolex 对您的影响之前，不要驾驶、操作重型机械或从事其他危险活动。

和其他抗癫痫药物一样，Epidiolex 可能会导致 自杀的想法或行为，这种情况大约每 500 人中会有 1 人出现。如果您出现以下症状，请立即联系医疗保健提供者，特别是如果这些症状是新出现的、更严重的或让您担忧的：

• 自杀或死亡的想法
• 试图自杀
• 抑郁加重或恶化
• 焦虑加重或恶化
• 坐立不安或焦躁不安
• 恐慌发作
• 睡眠困难（失眠）
• 易怒加重或恶化
• 表现出攻击性、愤怒或暴力行为
• 采取危险冲动的行为
• 活动和说话显著增加（躁狂）
• 其他行为或情绪的异常变化。

注意任何变化，尤其是情绪、行为、思想或感觉的突然变化。按计划进行所有随访预约。

不要突然停用 Epidiolex，除非先与您的医疗保健提供者讨论。突然停用抗癫痫药物如 Epidiolex 可能会导致您更频繁地出现癫痫发作，或者癫痫发作无法停止（称为癫痫持续状态）。

有些人可能对 Epidiolex 过敏。如果您出现对 Epidiolex 过敏反应的迹象，如荨麻疹、呼吸困难或面部、嘴唇、舌头或喉咙肿胀，请立即寻求紧急医疗帮助。

这不是副作用的完整列表，其他副作用也可能发生。关于副作用，请向医生咨询医疗建议。您可以向 FDA 报告副作用，电话：1-800-FDA-1088。

Using Epidiolex with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• other seizure medications (especially clobazam or valproate); or
• cannabis-based products.

This list is not complete. Many other drugs can interact with cannabidiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using. Click the link below to check for interactions with this medicine.

Take Epidiolex exactly as prescribed by your doctor. Follow all directions on the Epidiolex Package Insert, especially the Instructions for Use. Your doctor may occasionally change your dose.

• Epidiolex is usually taken 2 times a day.
• Take the medicine at the same time each day.

Food can affect Epidiolex levels.

• You may take Epidiolex with or without food, but take it the same way each time.
• If you are not consistent with food then levels of Epidiolex will fluctuate significantly.

Each dose of Epidiolex must be measured exactly.

• Use the bottle adapter and the appropriate dosing syringes that come with Epidiolex.
• This medicine is supplied with 1 mL and 5 mL oral dispensing syringes.
• If your dose of Epidiolex is 1 mL or less, use the 1 mL syringes to take your medicine. Otherwise, use the 5 mL syringe.
• Use a dry syringe each time you take Epidiolex. If water is inside the syringe, it could cause the oil-based medicine to look cloudy.
• Epidiolex may be given through a feeding tube not made of polyvinyl chloride (PVC).
• Epidiolex is strawberry-flavored.

Epidiolex contains cannabidiol which can harm your liver.

• Your liver function may need to be checked before and during treatment.
• You may need to stop taking Epidiolex based on the results.

尽快服用药物，但如果接近下次服药的时间，则跳过漏服的剂量。不要一次服用两剂。

立即寻求紧急医疗救助。

• 将Epidiolex存放在室温下，介于68°F至77°F（20°C至25°C）之间。
• 始终将瓶子直立存放。
• 不要冷冻。
• 确保儿童安全盖紧闭。
• 首次打开瓶子后12周内使用。
• 12周后丢弃任何未使用的药物。
• 将此药和所有药物放在儿童接触不到的地方。

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