Hydromorphone (Dilaudid, Exalgo)

Hydromorphoneis used to relieve moderate to severe疼痛. Hydromorphone is anopioid(narcotic) pain reliever. It acts on certain centersinthebrainto give you pain relief.

Hydromorphone is available under the following different brand names:Dilaudid,Dilaudid-HP, andExalgo.

成人和Pediatric剂型和优势

药片: Schedule II

• 2mg
• 4mg
• 8mg

药片, extended-release: Schedule II (adult only)

• 8mg
• 12mg
• 16mg
• 32mg

Injection solution

• 1mg/mL
• 2mg/ml
• 4mg/mL

注射解决方案，免费防腐剂：附表II（仅成人）

10mg/mL

Oralliquid: Schedule II

5mg/5mL

栓剂: Schedule II

3mg

Prefilledsyringe：附表II（仅成人）

• 0.2mg/mL
• 0.6 mg/mL

剂量考虑 - 应如下给出：

Risk of opioidaddiction, abuse, and misuse, which can lead to overdose anddeath评估每个patient's risk prior to prescribing and monitor all patients regularly for thedevelopmentof these behaviors or conditions

Moderate-to-Severe Pain

Indicated for moderate-to-severe pain

Oral

Immediate-release: 2-4 mg every 4-6 hours as needed; a gradual increase in dose may be required Oral liquid (usual dose): 2.5-10 mg (2.5-10 mL) every 3-6 hours as needed

皮下/肌内(SC / IM)

1-2 mg every 2-3 hours as needed; adjust dose according to pain and adverse effects IM dose not recommended for use as it may result in variableabsorptionand lag time to peak effect

Intravenous(IV)

Opioid naive: 0.2-1 mg IV every 2-3 hours as needed; may require higher doses in patients with prior opioid exposure Critically ill patients (opiate-naive patients): 0.2-0.6 mg every 1-2 hours as needed given slowly over 2-3 minutes; patients with previous opiate exposure may tolerate higher doses Continuous infusion: 0.5-3 mg/hour, titrated to response

Patient-controlled analgesia

通常的浓度为0.2 mg/ml；需求剂量为0.1-0.2 mg;剂量rangeis 0.05-0.4 mg Lockout interval: 5-10 minutes

Rectal

3 mg as needed every 6-8 hours

老年病：根据需要每4-6小时口服2-4毫克；可能需要逐渐增加剂量

Chronic严重的疼痛

Long-acting (Exalgo) is indicated for the management of pain in opioid tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

仅每天口服阿片类药物耐受性患者（延长释放:) 8-64 mg；可以使用或不使用或不用的情况food

Should address pain relief and adverse events frequently; increase dose no more frequently than every 3-4 days; may titrate with increases of 25-50% of current daily dose; consider increasing dose if more than 2 doses of rescue medications are needed within 24 hours within 2 consecutive days

Extented-release tablets should be swallowed whole; crushing, dividing, or dissolving will release opioid content all at once and increase risk of呼吸抑郁和死亡

Converting to Exalgo

从其他口服氢键配方进行转换：从同等的每日总剂量立即释放配方开始，每天一次管理；可以每3-4天滴定一次，直到有足够的疼痛缓解效果，并从其他阿片类药物中依靠的不良反应：从每日计算的每日剂量的50％开始，每24小时开始exalgo剂量；滴定直到足够的疼痛缓解效果并忍受不良影响，从经皮芬太尼转变为Exalgo：在去除经皮芬太尼斑块后18小时以24小时内给定的每日总剂量的50％开始Exalgo；对于25 mcg/小时的芬太尼贴片therapy: Taper gradually by decreasing dose by 25-50% every 2-3 days to a dose of 8 mg orally every 24 hours before discontinuing

Opioid-tolerant definition

Use of higher starting doses in patients who are not opioid tolerant may cause fatalrespiratorydepressionPatients who are opioid tolerant are those receiving, for 1 week or longer, at least 60 mg/day orally吗啡, 25 mcg/hour transdermal fentanyl, 30 mg/day orally羟考酮, 8 mg/day orally hydromorphone, 25 mg/day orallyoxymorphone，或另一种阿片类药物的含量剂量

使用的局限性

由于阿片类药物的成瘾，滥用和滥用的风险，即使是推荐剂量，并且由于延长释放的阿片类药物配方的过量和死亡的风险更大，因此为其他治疗方案（例如非阿皮奥德镇痛学的患者保留）储备或立即释放的阿片类药物）无效，不容忍，或者以其他方式不足以提供对未指示的疼痛的足够的治疗acute painor as a as needed镇痛

Cough(Off-label)

1 mg orally every 3-4 hours as needed

Pain, Pediatric (Off-label)

Moderate-to-severe pain

Children: 0.03-0.08 mg/kg orally every 4-6 hours as needed; not to exceed 5 mg/dose

Adolescents: 1-4 mg/dose orally every 4-6 hours as needed

儿童：每4-6小时静脉注射0.015 mg/kg（iv）

青少年：每4-6小时静脉/肌肉内/皮下（IV/IM/SC）1-2 mg/剂量

患者受控麻醉, Pediatric (Off-label)

加载剂量：8 mcg/kg静脉注射（IV）推注

Demand dose (initial): 2 mcg/kg IV with a lockout time of 10 minutes

Dosing Considerations

Geriatric

Titrate dose to effect; oral andparenteral剂量s are not equivalent; because parenteral dose 5 times more potent than oral dose, administer one fifth of oral dose when changing to parenteral route

Oral dose: Initiate at low end of dosage range; consider lowering dose by 25-50% in patients over 70 years

Intravenous (IV): Reduce initial dose to 0.2 mg every 2-3 hours

Side effects of hydromorphone include:

• Agitation
• Biliarytractspasm
• Bloating (腹部distention)
• Bronchospasm
• Cardiacarrest
• 胸痛(angina pectoris)
• 循环depression
• 昏迷
• Constipation
• Decreased intestinal motility
• 沮丧
• Diarrhea
• Dizziness
• Drowsiness
• Dry mouth
• Euphoria
• Fainting
• Fastheart rate
• Feeling uneasy
• Flu-like symptoms (Exalgo)
• Flushing (warmth, redness, or tingly feeling)
• 胃食管反流疾病(GERD)
• 麻疹
• Increasedsweating
• Itching
• Lightheadedness
• Loss of appetite
• Lowbloodoxygen(hypoxia)
• Mental clouding
• 心脏病发作(myocardial infarction)
• Mental/mood changes (such as agitation, hallucinations, confusion)
• 恶心
• Nervousness
• Palpitations
• Paralytic ileus
• QT-interval prolongation
• Respiratory arrest
• 呼吸抑郁
• 不安
• Runny orstuffy nose
• 镇静
• Seizures
• 严重的心律不齐
• 震惊
• 气促
• Skinrash
• 睡觉problems (insomnia)
• Slowheartrate
• ST-segment elevation
• 胃or腹部疼痛（可能很严重）奇怪dreams
• Sweating
• 尿保留/排尿困难
• Ventricular tachycardia
• Visual disturbances (blurred vision, double vision)
• Vomiting
• 脸的温暖/neck/上thorax
• Weakness

This document does not contain all possible side effects and others may occur. Check with yourphysicianfor additional information about side effects.

If yourdoctorhas directed you to use thismedication, your doctor or药剂师may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor,healthcare provider or pharmacist first.

• Severe interactions of hydromorphone include:
  • Alvimopan
• Hydromorphone has serious interactions with at least 34 different drugs.
• Hydromorphone has moderate interactions with at least 210 different drugs.
• Mild interactions of hydromorphone include:
  • brimonidine
  • dextroamphetamine
  • eucalyptus
  • lidocaine
  • 纳洛酮
  • sage
  • ziconotide

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

水电性高效公式：

• Hydromorphone high-potency injection is highly concentrated solution of hydromorphone, a potent Schedule II controlled opioidagonistintended for use in opioid-tolerant patients; it is not to be confused with standard parenteral formulations of hydromorphone or other opioids; overdose and death could result
• 请谨慎避免将高度浓缩（Dilaudid-HP）注入与浓缩（Dilaudid）的可注射产品混淆
• Schedule II opioid agonists (e.g., morphine, oxymorphone, oxycodone, fentanyl,methadone) have highest potential for abuse and risk of producing respiratory depression
• 酒精, other opioids, and中央nervous system(CNS）抑郁剂（例如sedative-hypnotics) potentiate respiratory depressant effects of hydromorphone, increasing risk of respiratory depression that might result in death
• Accidental intake may lead to fatal overdose, especially in children High potential for abuse

Addiction, abuse, and misuse:

• Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death
• 评估每个patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions

Life-threatening respiratory depression:

• 可能发生严重，威胁生命或致命的呼吸抑郁症
• 监测呼吸道抑郁症，尤其是在启动期间或剂量增加之后
• Instruct patients to swallow tablet/胶囊所有的;压碎，咀嚼或溶解可能会导致潜在致命剂量的快速释放和吸收

Accidental exposure:

• Accidental ingestion of even 1 dose, especially by children, can result in a fatal overdose

Neonatalopioid withdrawalsyndrome:

• Prolonged use duringpregnancycan result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed byneonatology专家
• 综合征表现为烦躁，hyperactivityand异常sleep pattern, high pitched cry,tremor, vomiting, diarrhea and failure to gain weight
• 发作, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last母亲use, and rate of elimination of the drug by the newborn
• If opioid use is required for a prolonged period in apregnantwoman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available

这种药物含有hydromorphone。不德e Dilaudid, Dilaudid-HP, or Exalgo if you are allergic to hydromorphone or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact aPoison Control Center立即地。

禁忌症

Hypersensitivity

Dilaudid Liquid and Tablets

• 产科镇痛

栓剂

• Increasedintracranialpressure resulting from intracraniallesion;导致抑郁通气功能的条件，包括chronic obstructive pulmonary disease(COPD),emphysema, status asthmaticus,kyphoscoliosis,cor pulmonale

Dilaudid injection

• Dilaudid HP：麻痹ileus, opioid non-tolerant patients, known or suspected pre-existing胃肠道(GI)surgeryor diseases resulting in narrowing of胃肠道loops in the GI tract or GIobstruction
• Dilaudid HP is contraindicated in non-opioid tolerant patients

扩展释放（Exalgo）

• 阿片类药物非耐受性患者
• 麻痹性肠病，阿片类药物非耐受性患者，已知或怀疑已有的胃肠道（GI）手术或疾病，导致GI区或GI阻塞中的GI区域变窄
• Significant respiratory depression
• Acuteor severe bronchialasthma

Effects of Drug Abuse

滥用的高潜力；在有病史的患者中谨慎行事drug abuse or酗酒.

使用阿片类药物激动剂/拮抗剂我的原因withdrawal symptoms.

Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death.

评估每个patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions.

Short-Term Effects

• See "What Are Side Effects Associated with Using Hydromorphone?"

长期影响

Long-term opioid use may cause secondaryhypogonadism, which may lead to sexualdysfunction,infertility, mood disorders, andosteoporosis.

• See "What Are Side Effects Associated with Using Hydromorphone?"

Cautions

May impair physical or mental abilities; use caution when performing work that require mental alertness such as operating machinery or driving.

Myoclonus并以高剂量报告的癫痫发作；在有病史的患者中谨慎行事seizure disorders.

Use with caution in patients with hypersensitivity reactions to other phenanthrene derivative opioid agonists, including可待因,hydrocodone, levorphanol, oxycodone, oxymorphone.

May causehypotensionespecially in patients withcardiovascular diseaseorhypovolemia;可能引起严重的低血压，包括orthostatic hypotensionandsyncope;use caution in patients taking drugs that may exaggeratehypotensiveeffects, including phenothiazines or general anesthetics; avoid use in patients with circulatory shock; may reducecardiac outputandblood pressure.

May preventdiagnosisof patients with acute abdominal conditions.

Use caution in patients with biliary tract dysfunction.

Use caution in in patients with inflammatory or obstructive肠disorder,acute pancreatitis继发于胆道疾病，以及接受胆道手术的患者。

在包括艾迪生氏病在内的肾上腺功能不全的患者中谨慎使用。

避免使用敏感的病人颅内effects of CO2 retention including中央神经系统（CNS）抑郁或昏迷。

Carbon dioxide从阿片类药物诱导的呼吸抑制中保留exacerbatesedating effects of opioids.

Use caution in震颤性谵妄.

Long-term opioid use may cause secondary hypogonadism, which may lead to sexual dysfunction, infertility, mood disorders, and osteoporosis.

滥用的高潜力；在有药物滥用或酗酒史的患者中谨慎行事。

Caution when coadministered with other central nervous system (CNS) depressants (e.g.,barbiturates,benzodiazepines, alcohol).

Use caution inrenal/hepaticimpairment,obesity, prostatic增生/urinarystricture，精神病，呼吸道疾病或甲状腺dysfunction.

Use within 14 days ofmonoamine oxidase inhibitor(毛伊) intake not recommended.

Controlled-release formulation should only be used when continuous analgesia is required over an extended period of time; not for use as needed.

肌肉内（IM）制剂可能会导致吸收变化和滞后时间的峰值效应。

量身定制的含阿片类药物的镇痛药regimen满足每个患者的需求。

May cause constipation; consider preventive measures to reduce potential of constipation; use with caution in patients with chronic constipation.

Use caution in patients withhead injury, intracranial lesions, or elevated intracranial pressure; exaggerated intracranial pressure may occur with treatment.

Use caution in patients who are morbidlyobese.

Some formulations may containlactose;consider lactose content prior to initiating therapy in patients with hereditary disease of半乳糖不宽容。

Vial stoppers of single-dose injectable vials may contain latex.

Some dosage forms may contain trace amounts ofsodiummetabisulfite, which may cause allergic reactions.

使用阿片类药物激动剂/拮抗剂我的戒断症状。

Long-acting opioids:

• Schedule II opioid analgesics expose users to the risks of addiction, abuse, and misuse; there is a greater risk for overdose and death with extended-release opioids due to the larger amount of active opioid present (see Warnings)
• Addiction, abuse, and misuse risks are increased in patients with a personal or家史ofsubstance abuseor mental illness (e.g.,major depression); the potential for these risks should not, however, prevent the prescribing of proper疼痛managementin any given patient; intensive monitoring is necessary (see Warnings)
• Serious, life-threatening, or fatal respiratory depression reported (see Warnings)
• Accidental exposure reported, including fatalities (see Warnings)
• Neonatal opioid withdrawal syndrome reported with long-term use during pregnancy (see Warnings)
• Interactions with central nervous system (CNS) depressants (e.g., alcohol, sedatives, anxiolytics, hypnotics, neuroleptics, other opioids) can cause additive effects and increase risk for respiratory depression, profound sedation, and hypotension
• Life-threatening respiratory depression is more likely to occur in elderly,cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients

Pregnancy andLactation

Use hydromorphone with caution during pregnancy if benefits outweigh risks. Animal studies展示risk and human studies are not available or neither animal nor human studies were done.

怀孕期间长时间使用氢电路可能会导致新生儿阿片类药物戒断综合征，如果不认可和治疗，这可能会威胁生命，并且需要根据新生儿学专家开发的方案进行管理。

Hydromorphone is excreted in母乳;use is not recommended whilebreastfeeding.