Zubsolv

Zubsolv 舌下片含有布托啡诺和纳洛酮的组合。[布托啡诺] 是一种阿片类药物，有时被称为麻醉药。[纳洛酮] 可以阻断阿片类药物的效果，包括止痛或产生欣快感，这些效果可能导致阿片类药物滥用。

Zubsolv 用于治疗 [阿片类使用障碍]。

Zubsolv 不适用于作为止痛药。

Zubsolv可能会减缓或停止你的呼吸，而且有可能会产生依赖性。滥用Zubsolv可能导致成瘾、过量用药，甚至是死亡，尤其是儿童或其他未经处方使用该药物的人。

怀孕期间使用Zubsolv可能会导致新生儿出现危及生命的戒断症状。

如果你将Zubsolv与酒精，或者其他会导致嗜睡或减缓呼吸的药物一同使用，可能会发生致命的副作用。

如果您出现对Zubsolv的过敏反应迹象，请立即寻求紧急医疗帮助：荨麻疹；呼吸困难；脸部、嘴唇、舌头或喉咙肿胀。

阿片类药物可能会减缓或停止您的呼吸，导致死亡。如果您呼吸缓慢且有长时间停顿、嘴唇发青或难以唤醒，照顾您的人应给予纳洛酮并/或寻求紧急医疗救助。

如果您出现以下情况，请立即联系医生或寻求紧急医疗救助：

• 牙齿或牙龈问题；

• 呼吸浅或睡眠中呼吸暂停；

• 感觉头晕，好像要昏倒；

• 意识模糊、协调能力差、极度虚弱；

• 视力模糊、言语不清；

• 肝功能问题 - 上腹痛、食欲不振、尿色深、粪便颜色淡如粘土、黄疸（皮肤或眼睛发黄）；

• 体内血清素水平过高 - 激动不安、幻觉、发热、出汗、颤抖、心跳加快、肌肉僵硬、抽搐、协调能力丧失、恶心、呕吐、腹泻；

• 低皮质醇水平 - 恶心、呕吐、食欲不振、头晕、疲倦或无力加重；或

• 阿片类戒断症状 - 寒战、鸡皮疙瘩、多汗、感觉冷热交替、流鼻涕、流泪、腹泻、肌肉疼痛。

老年人和体质虚弱者或患有消耗综合征或慢性呼吸系统疾病的人更容易出现严重的呼吸问题。

Zubsolv的常见副作用可能包括：

• 头晕、昏昏欲睡、视力模糊、感觉像醉了、难以集中注意力；

• 戒断症状；

• 舌痛、口腔内红斑或麻木；

• 恶心、呕吐、便秘；

• 头痛、背痛；

• 心跳加快、多汗；或

• 睡眠障碍（失眠）。

这并非所有可能的副作用列表，其他副作用也可能发生。关于副作用，请咨询医生以获取医疗建议。

如果您对丁丙诺啡或纳洛酮（纳曲酮）过敏，则不应使用Zubsolv。

为了确保Zubsolv对您是安全的，请告知您的医生是否曾有以下情况：

• 牙齿问题，包括蛀牙史；

• 呼吸问题，睡眠呼吸暂停；

• 前列腺肥大，排尿困难；

• 肝病或肾病；

• 影响呼吸的脊柱异常弯曲；

• 胆囊、肾上腺或甲状腺问题；

• 头部受伤，脑肿瘤，或癫痫；或者

• 酒精依赖症或药物滥用。

如果您在怀孕期间使用阿片类药物，宝宝可能会对该药物产生依赖。这可能导致婴儿出生后出现危及生命的戒断症状。 出生时对阿片类药物依赖的婴儿可能需要数周的医疗治疗。

如果您正在哺乳，请在使用阿片类药物前咨询医生。 如果您发现哺乳婴儿出现严重的嗜睡或呼吸缓慢，请告知您的医生。

在开始或停止使用某些其他药物时，您可能会出现呼吸问题或戒断症状。请告知您的医生，如果您还使用了以下药物：

• 抗生素、抗真菌药物、治疗心脏或血压的药物、抗癫痫药物或治疗艾滋病或丙型肝炎的药物。

• 感冒或过敏药、支气管扩张剂用于治疗哮喘/慢阻肺的药物或利尿剂（“水丸”）；

• 用于治疗晕动病、肠易激综合症或膀胱过度活动症的药物；

• 其他阿片类药物 - 阿片类止痛药或处方止咳药；

• 镇静剂如安定 - 地西泮、阿普唑仑、劳拉西泮、阿普唑仑、氯硝西泮、劳拉西泮等；

• 使您昏昏欲睡或减缓呼吸的药物 - 安眠药、肌肉松弛剂、治疗情绪障碍或精神疾病的药物；

• 影响体内血清素水平的药物 - 兴奋剂或治疗抑郁症、帕金森病、偏头痛、严重感染或恶心和呕吐的药物。

此列表并不完整。其他药物可能与丁丙诺啡和纳洛酮相互作用，包括处方药和非处方药、维生素和草药产品。这里没有列出所有可能的相互作用。

Use Zubsolv exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use Zubsolv in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Zubsolv comes in a blister pack with 10 blister units. Each blister unit contains one Zubsolv tablet. Remove one single blister unit by tearing along the perforations until it is fully separated. Then fold the single unit along the dotted line. Do not push the Zubsolv tablets through the foil as this could cause the tablet to break.

Use dry hands when handling Zubsolv sublingual tablets. Place the sublingual tablet under your tongue. Allow the tablet to dissolve slowly. Do not chew or swallow the tablet whole.

If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.

Do not stop using Zubsolv suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

You will need frequent blood tests to check your liver function.

All your medical care providers should know that you are being treated for opioid addiction, and that you take Zubsolv. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.

Rinse your mouth with water after the Zubsolv tablet dissolves. Wait one hour after the medicine dissolves to brush your teeth to prevent damage to the teeth and gums. You should receive regular dental checkups while using Zubsolv..

Never crush or break a Zubsolv sublingual tablet and inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

Store Zubsolv securely in its original blister packaging at room temperature, away from moisture and heat. Discard an empty blister in a place children and pets cannot get to. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using Zubsolv accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, remove any unused tablets from the blister pack and flush the tablets down the toilet. Throw the empty blister pack into the trash.

Usual Adult Dose for Opiate Dependence - Induction:

INDUCTION: For those Dependent on Heroin or Other Short-acting Opioid Products:
-INITIAL DOSES should begin when objective signs of moderate opioid withdrawal appear and not less than 6 hours after the patient last used opioids to avoid precipitating an opioid withdrawal syndrome:

Zubsolv Sublingual Tablets:
Day 1: up to 5.7 mg/1.4 mg sublingually; administer as an initial dose of 1.4 mg/0.36 mg and then up to 4.2 mg/1.08 mg should be divided into doses 1.4 mg/0.36 mg or 2.8 mg/0.72 mg and administered in 1.5 to 2 hour intervals (some patients with recent exposure to buprenorphine may tolerate a single second dose of 4.2 mg/1.08 mg)
Day 2: 11.4 mg/2.9 mg sublingually as a single dose

Comments:
-Patients dependent on heroin or other short-acting opioid products may be inducted with combination buprenorphine/naloxone or buprenorphine monotherapy; to avoid precipitating withdrawal during induction, initiation should occur when clear signs of withdrawal are evident, preferably when moderate objective signs of opioid withdrawal appear, and no sooner than 6 hours after last use of heroin or other short-acting opioid.
-In some studies, too-gradual induction over several days has led to a high dropout; it is recommended that an adequate treatment dose, titrated to clinical effectiveness, be achieved as rapidly as possible.
-For patient's dependent on methadone or long-acting opioid products, buprenorphine monotherapy should be used during the induction phase as naloxone may be absorbed in small amounts and could precipitate or prolong withdrawal during induction.
-Maintenance treatment begins on day 3.

Usual Adult Dose for Opiate Dependence - Maintenance:

MAINTENANCE Treatment:
-Doses of buprenorphine/naloxone should be adjusted to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms; doses should be titrated to clinical effectiveness as rapidly as possible as gradual titration may lead to higher drop-out rates.

Zubsolv Sublingual Tablets:
-Progressively adjust in increments/decrements of 1.4 mg/0.36 mg or 2.9 mg/0.71 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms
-Recommended target dose: 11.4 mg/2.9 mg sublingually once a day; dose range 2.9 mg/0.71 mg to 17.2 mg/4.2 mg
-Maximum dose: 17.2 mg/4.2 mg per day

Comments:
-Following induction, maintenance therapy is provided to hold a patient in treatment and suppress opioid withdrawal signs and symptoms; there is no maximum recommended duration for maintenance treatment and some patients may require treatment indefinitely.
-There are multiple buprenorphine/naloxone products available for maintenance treatment; these products are not bioequivalent and dose adjustments may be necessary when switching products; e.g., Zubsolv 4.2 mg/0.7 mg buccal film provides equivalent buprenorphine exposure as Suboxone 8 mg/2 mg sublingual tablet.

Use: For the treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.

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

立即寻求紧急医疗救助。阿片类药物过量可能导致死亡，尤其是儿童或未获处方而使用该药物的其他人。过量症状可能包括严重嗜睡、瞳孔极度缩小、呼吸缓慢或无呼吸。