Hydromorphone (Dilaudid, Exalgo)

Hydromorphoneis used to relieve moderate to severe pain. Hydromorphone is anopioid(narcotic) pain reliever. It acts on certain centers in the brain to give you pain relief.

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

Adult and Pediatric Dosage Forms and Strengths

Tablet: Schedule II

• 2mg
• 4mg
• 8mg

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

• 8mg
• 12mg
• 16mg
• 32mg

Injection solution

• 1mg/mL
• 2mg/mL
• 4mg/mL

Injection solution, preservative free: Schedule II (adult only)

10mg/mL

Oral liquid: Schedule II

5mg/5mL

Suppository: Schedule II

3mg

Prefilled syringe: Schedule II (adult only)

• 0.2 mg/mL
• 0.6 mg/mL

Dosage Considerations – Should be Given as Follows:

Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of 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

Subcutaneous/Intramuscular(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 variable absorption and 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-controlledanalgesia

Usual concentration, 0.2 mg/mL; demand dose, 0.1-0.2 mg; dose range is 0.05-0.4 mg Lockout interval: 5-10 minutes

Rectal

3 mg as needed every 6-8 hours

Geriatric: 2-4 mg orally every 4-6 hours as needed; a gradual increase in dose may be required

Chronic Severe Pain

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

阿片宽容的病人只有(延长释放:)8-64 mg orally once/day; may administer a starting dose equivalent to patient's total daily oral hydromorphone dose administered once daily with or without 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 ofrespiratory depression和死亡

Converting to Exalgo

Conversion from other oral hydromorphone formulations: Start with equivalent total daily dose of immediate release formulation and administer once daily; may titrate every 3-4 days until adequate pain relief with tolerable adverse effects achieved Conversion from other opioids: Start Exalgo dose at 50% of calculated daily dose every 24 hours; titrate until adequate pain relief with tolerable adverse effects achieved Conversion from transdermalfentanylto Exalgo: Start Exalgo 18 hours after removal of transdermal fentanyl patch at 50% of calculated total daily dose given over 24 hours; for a 25 mcg/hour fentanyl patch the equianalgesic dose is 12 mg orally every 24 hours Discontinuation of Exalgo 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 fatal respiratory depression Patients who are opioid tolerant are those receiving, for 1 week or longer, at least 60 mg/day orallymorphine, 25 mcg/hour transdermal fentanyl, 30 mg/day orallyoxycodone, 8 mg/day orally hydromorphone, 25 mg/day orallyoxymorphone, or an equianalgesic dose of another opioid

Limitations of use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve for patients whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain Not indicated foracute painor as a as neededanalgesic

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

Children: 0.015 mg/kg intravenously (IV) every 4-6 hours as needed

Adolescents: 1-2 mg/dose intravenously/intramuscularly/subcutaneously (IV/IM/SC) every 4-6 hours

Patient ControlledAnesthesia, Pediatric (Off-label)

Loading dose: 8 mcg/kg intravenous (IV) bolus

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

Dosing Considerations

Geriatric

Titrate dose to effect; oral andparenteraldoses 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
• Biliarytract spasm
• Bloating (abdominaldistention)
• Bronchospasm
• Cardiac arrest
• Chest pain (angina pectoris)
• Circulatorydepression
• Coma
• Constipation
• Decreased intestinal motility
• Depression
• Diarrhea
• Dizziness
• Drowsiness
• Dry mouth
• Euphoria
• Fainting
• Fast heart rate
• Feeling uneasy
• 流感样症状(Exalgo)
• Flushing (warmth, redness, or tingly feeling)
• Gastroesophageal refluxdisease (GERD)
• Hives
• Increased sweating
• Itching
• Lightheadedness
• Loss of appetite
• Low blood oxygen (hypoxia)
• Mental clouding
• Heart attack(myocardial infarction)
• Mental/mood changes (such as agitation, hallucinations, confusion)
• Nausea
• Nervousness
• Palpitations
• Paralytic ileus
• QT-interval prolongation
• Respiratory arrest
• Respiratory depression
• Restlessness
• Runny orstuffy nose
• Sedation
• Seizures
• Severe cardiac arrhythmias
• Shock
• Shortness of breath
• Skin rash
• Sleep problems (insomnia)
• Slow heart rate
• ST-segment elevation
• Stomach or abdominal pain (may be severe) Strangedreams
• Sweating
• Urinary retention/difficulty urinating
• Ventricular tachycardia
• Visual disturbances (blurred vision, double vision)
• Vomiting
• Warmness of face/neck/upperthorax
• Weakness

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

If your doctor has directed you to use this medication, your doctor or pharmacist 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, health care 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
  • naloxone
  • 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

Hydromorphone high-potency formulation:

• 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
• Use caution to avoid confusing the highly concentrated (Dilaudid-HP) injection with the less concentrated (Dilaudid) injectable product
• Schedule II opioid agonists (e.g., morphine, oxymorphone, oxycodone, fentanyl,methadone) have highest potential for abuse and risk of producing respiratory depression
• Alcohol, other opioids, andcentral nervous system(CNS) depressants (e.g.,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
• Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions

Life-threatening respiratory depression:

• Serious, life-threatening, or fatal respiratory depression may occur
• Monitor for respiratory depression, especially during initiation or following a dose increase
• 指导病人吞下平板电脑/胶囊整体;crushing, chewing, or dissolving can cause rapid release and absorption of a potentially fatal dose

Accidental exposure:

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

Neonatalopioid withdrawal syndrome:

• Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts
• Syndrome presents as irritability,hyperactivityand abnormal sleep pattern, high pitched cry,tremor, vomiting, diarrhea and failure to gain weight
• Onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn
• If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available

This medication contains hydromorphone. Do not take 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 a Poison Control Center immediately.

Contraindications

Hypersensitivity

Dilaudid Liquid and Tablets

• Obstetrical analgesia

Suppository

• Increased intracranial pressure resulting from intracraniallesion; conditions resulting in depressed ventilatory function includingchronic obstructive pulmonary disease(COPD),emphysema, status asthmaticus, kyphoscoliosis,corpulmonale

Dilaudid injection

• Dilaudid HP: Paralyticileus, opioid non-tolerant patients, known or suspected pre-existinggastrointestinal(GI) surgery or diseases resulting in narrowing of GI tract loops in the GI tract or GI obstruction
• Dilaudid HP is contraindicated in non-opioid tolerant patients

Extended-release (Exalgo)

• Opioid non-tolerant patients
• Paralytic ileus, opioid non-tolerant patients, known or suspected pre-existing gastrointestinal (GI) surgery or diseases resulting in narrowing of GI tract loops in the GI tract or GI obstruction
• Significant respiratory depression
• Acute or severe bronchialasthma

Effects of Drug Abuse

High potential for abuse; use caution in patients with history of drug abuse oralcoholism.

Use of opioid agonists/antagonists my causewithdrawal symptoms.

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

Assess each 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?"

Long-Term Effects

Long-term opioid use may cause secondaryhypogonadism, which may lead to sexual dysfunction, 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.

Myoclonusand seizures reported with high doses; use caution in patients with history ofseizure disorders.

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

May causehypotensionespecially in patients withcardiovascular diseaseorhypovolemia; may cause severe hypotension, includingorthostatic hypotensionandsyncope; use caution in patients taking drugs that may exaggeratehypotensiveeffects, including phenothiazines or general anesthetics; avoid use in patients with circulatory shock; may reducecardiac outputand blood pressure.

May prevent diagnosis of patients with acute abdominal conditions.

Use caution in patients with biliary tract dysfunction.

Use caution in in patients with inflammatory or obstructive bowel disorder,acute pancreatitissecondary to biliary tract disease, and patients undergoing biliary surgery.

Use with caution in patients with adrenal insufficiency including Addison's disease.

Avoid use in patients susceptible to intracranial effects of CO2 retention including central nervous system (CNS) depression or coma.

Carbon dioxideretention from opioid-induced respiratory depression can exacerbate sedating effects of opioids.

Use caution in精神错乱的调节ens.

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

High potential for abuse; use caution in patients with history of drug abuse or alcoholism.

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

Use caution in renal/hepatic impairment,obesity, prostatichyperplasia/urinarystricture, psychoses, respiratory disease orthyroiddysfunction.

Use within 14 days ofmonoamine oxidase inhibitor(MAOI) 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.

Intramuscular (IM) formulation may result in variable absorption and a lag time to peak effect.

Tailor opioid-containing analgesic regimen to each patient's needs.

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

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

Use caution in patients who are morbidlyobese.

Some formulations may contain lactose; consider lactose content prior to initiating therapy in patients with hereditary disease of galactose intolerance.

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

Some dosage forms may contain trace amounts of sodium metabisulfite, which may cause allergic reactions.

Use of opioid agonists/antagonists my cause withdrawal symptoms.

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 family history ofsubstance abuseor mental illness (e.g.,major depression); the potential for these risks should not, however, prevent the prescribing of properpain 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 and Lactation

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

长期使用的孕期hydromorphone can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.

Hydromorphone is excreted in breast milk; use is not recommended while breastfeeding.