hydromorphone

ROUTE	ONSET	PEAK	DURATION
PO-IR	30 min	30–90 min	4–5 hr
PO-ER	unknown	unknown	unknown
SUBQ	15 min	30–90 min	4–5 hr
IM	15 min	30–60 min	4–5 hr
IV	10–15 min	15–30 min	2–3 hr
Rect	15–30 min	30–90 min	4–5 hr

Contraindicated in:

Hypersensitivity;
Some products contain bisulfites and should be avoided in patients with known hypersensitivity;
Severe respiratory depression (in absence of resuscitative equipment) (extended release only);
Acute or severe bronchial asthma (extended release only);
Paralytic ileus (extended release only);
Acute, mild, intermittent, or postoperative pain (extended release only);
Prior GI surgery or narrowing of GI tract (extended release only);
Opioid-intolerant patients (extended release only);
Severe hepatic impairment (extended release only).

Use Cautiously in:

Personal or family history of substance use disorder or mental illness;
Head trauma;
↑intracranial pressure;
Severe pulmonary disease;
Moderate or severe renal impairment (extended release only) (dose ↓ recommended);
Moderate hepatic impairment (extended release only) (dose ↓ recommended);
Hypothyroidism;
Seizure disorder;
Adrenal insufficiency;
Undiagnosed abdominal pain;
Prostatic hypertrophy;
Biliary tract disease (including pancreatitis);
OB: Avoid chronic use during pregnancy. Has been used during labor but may cause respiratory depression in the newborn;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Geri: Older adults may have risk of respiratory depression; dose suggested.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypotension, bradycardia

Derm: flushing, sweating

EENT: blurred vision, diplopia, miosis

Endo: adrenal insufficiency

GI: constipation, dry mouth, nausea, vomiting

GU: urinary retention

Neuro: confusion, sedation, dizziness, dysphoria, euphoria, floating feeling, hallucinations, headache, unusual dreams

Resp: RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA)

Misc: allodynia, opioid-induced hyperalgesia, physical dependence, psychological dependence, tolerance

Interactions ⬆ ⬇

Drug-drug:

Exercise extreme caution with MAO inhibitors (may produce severe, unpredictable reactions—reduce initial dose of hydromorphone to 25% of usual dose; discontinue MAO inhibitors 2 wk prior to hydromorphone).
Use with benzodiazepines or other CNS depressants, including other opioids, nonbenzodiazepine sedative/hypnotics, anxiolytics, general anesthetics, muscle relaxants, antipsychotics, and alcohol, may cause profound sedation, respiratory depression, coma, and death; reserve concurrent use for when alternative treatment options are inadequate.
Mixed agonist/antagonist analgesics, including nalbuphine or butorphanol, and partial agonist analgesics, including buprenorphine, may ↓ hydromorphone's analgesic effects and/or precipitate opioid withdrawal in physically dependent patients.
Drugs that affect serotonergic neurotransmitter systems, including tricyclic antidepressants, SSRIs, SNRIs, MAO inhibitors, TCAs, tramadol, trazodone, mirtazapine, 5-HT3 receptor antagonists, linezolid, methylene blue, and triptans, ↑ risk of serotonin syndrome.

Drug-Natural Products:

Concomitant use of kava-kava, valerian, chamomile, or hops can ↑ CNS depression.

Route/Dosage ⬆ ⬇

Doses depend on level of pain and tolerance. Larger doses may be required during chronic therapy
PO (Adults ≥50 kg): Immediate release: 4–8 mg every 3–4 hr initially (some patients may respond to doses as small as 2 mg initially); or once 24-hr opioid requirement is determined, convert to extended release by administering total daily oral dose once daily.
PO (Adults and Children <50 kg): 0.06 mg/kg every 3–4 hr initially, younger children may require smaller initial doses of 0.03 mg/kg. Maximum dose 5 mg.
IV IM SC (Adults ≥50 kg): 1.5 mg every 3–4 hr as needed initially; may be ↑.
IV IM SC (Adults and Children <50 kg): 0.015 mg/kg every 3–4 hr as needed initially; may be ↑.
IV (Adults ): Continuous infusion (unlabeled): 0.2–3 mg/hr depending on previous opioid use. An initial bolus of twice the hourly rate in mg may be given with subsequent breakthrough boluses of 50–100% of the hourly rate in mg.
(Adults ): 3 mg every 6–8 hr initially as needed.

Hepatic Impairment

PO (Adults ): Moderate hepatic impairment (extended release):↓ initial dose by 75%.

Renal Impairment

PO (Adults ): Moderate renal impairment (extended release):↓ initial dose by 50%; Severe renal impairment (extended release):↓ initial dose by 75%.

Availability ⬆ ⬇

(Generic available)

Immediate-release tablets: 2 mg; 4 mg; 8 mg
Extended-release capsules: 3 mg; 4.5 mg; 6 mg; 9 mg; 12 mg; 18 mg; 24 mg; 30 mg
Extended-release tablets (abuse deterrent): 8 mg; 12 mg; 16 mg; 32 mg
Oral solution: 1 mg/mL
Solution for injection: 0.2 mg/mL; 1 mg/mL; 2 mg/mL; 4 mg/mL; 10 mg/mL
Rectal suppositories: 3 mg

Assessment ⬆ ⬇

Assess type, location, and intensity of pain prior to and 1 hr following IM or PO and 5 min (peak) following IV administration. When titrating opioid doses, ↑ of 25–50% should be administered until there is either a 50% ↓ in the patient's pain rating on a numerical or visual analogue scale or the patient reports satisfactory pain relief. When titrating doses of short-acting hydromorphone, a repeat dose can be safely administered at the time of the peak if previous dose is ineffective and side effects are minimal.
Patients on a continuous infusion should have additional bolus doses provided every 15–30 min as needed for breakthrough pain. The bolus dose is usually set to the amount of drug infused each hour by continuous infusion.
Patients taking extended-release hydromorphone may require additional short-acting or rapid-onset opioid doses for breakthrough pain. Doses of short-acting opioids should be equivalent to 10–20% of 24 hr total and given every 2 hr as needed.
An equianalgesic chart (see Equianalgesic Dosing Guidelines) should be used when changing routes or when changing from one opioid to another.
Assess level of consciousness, BP, pulse, and respirations before and periodically during administration. If respiratory rate is <10/min, assess level of sedation. Physical stimulation may be sufficient to prevent significant hypoventilation. Subsequent doses may need to be ↓ by 25–50%. Initial drowsiness will ↓ with continued use. Monitor for respiratory depression, especially during initiation or following dose ↑; serious, life-threatening, or fatal respiratory depression may occur. May cause sleep-related breathing disorders (central sleep apnea, sleep-related hypoxemia).Geri: Assess geriatric and pediatric patients frequently; more sensitive to the effects of opioid analgesics and may experience side effects and respiratory complications more frequently.
Assess for opioid-induced hyperalgesia, which can appear as ↑ levels of pain upon increasing the dose of the opioid, ↓ levels of pain upon decreasing the dose of the opioid, or pain from ordinarily nonpainful stimuli (allodynia). This condition is different from tolerance. If a patient is suspected to be experiencing opioid-induced hyperalgesia, consider ↓ the dose of the current opioid or switching to a different opioid analgesic.
Prolonged use may lead to physical and psychological dependence and tolerance. This should not prevent patient from receiving adequate analgesia. Patients who receive hydromorphone for pain rarely develop psychological dependence. Progressively higher doses may be required to relieve pain with long-term therapy; may ↑ risk of overdose. Prolonged use of opioids should be reserved for patients whose pain remains severe enough to require them and alternative treatment options continue to be inadequate. Many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
Assess bowel function routinely. Institute prevention of constipation with increased intake of fluids and bulk, and laxatives to minimize constipating effects. Administer stimulant laxatives routinely if opioid use exceeds 2–3 days, unless contraindicated. Consider drugs for opioid induced constipation.
Assess risk for opioid addiction, abuse, or misuse prior to administration. Abuse or misuse of extended-release preparations by crushing, chewing, snorting, or injecting dissolved product will result in uncontrolled delivery of morphine and can result in overdose and death.

Lab Test Considerations:

May ↑ plasma amylase and lipase levels.

Toxicity and Overdose:

If an opioid antagonist is required to reverse respiratory depression or coma, naloxone (Narcan) is the antidote. Dilute the 0.4-mg ampule of naloxone in 10 mL of 0.9% NaCl and administer 0.5 mL (0.02 mg) by IV push every 2 min. For children and patients weighing <40 kg, dilute 0.1 mg of naloxone in 10 mL of 0.9% NaCl for a concentration of 10 mcg/mL and administer 0.5 mcg every 2 min. Titrate dose to avoid withdrawal, seizures, and severe pain.

Implementation ⬆ ⬇

Accidental overdose of opioid analgesics has resulted in fatalities. Before administering, check infusion pump settings.
Pedi: Medication errors with opioid analgesics are common in pediatric patients; calculate doses carefully. Use appropriate measuring devices.
Do not confuse hydromorphone with buprenorphine, hydralazine, hydroxyzine, morphine, or oxymorphone; fatalities have occurred. Do not confuse high-potency dose forms with regular dose forms.
Explain therapeutic value of medication prior to administration to enhance the analgesic effect.
- Regularly administered doses may be more effective than prn administration. Analgesic is more effective if given before pain becomes severe.
- Coadministration with nonopioid analgesics may have additive analgesic effects and permit lower opioid doses.
- When converting from immediate-release to extended-release hydromorphone, administer total daily oral hydromorphone dose once daily; dose of extended-release product can be titrated every 3–4 days (see Equianalgesic Dosing Guidelines). To convert from another opioid to extended-release hydromorphone, convert to total daily dose of hydromorphone and then administer 50% of this dose as extended-release hydromorphone once daily; can then titrate dose every 3–4 days. When converting from transdermal fentanyl, initiate extended-release hydromorphone 18 hr after removing transdermal fentanyl patch; for each 25 mcg/hr fentanyl transdermal dose, the equianalgesic dose of extended-release hydromorphone is 12 mg once daily (should initiate at 50% of this calculated total daily dose given once daily).
Medication should be discontinued gradually after long-term use to prevent withdrawal symptoms. For patients on long-acting agents who are physically opioid-dependent, initiate the taper by a small enough increment (not >10% to 25% of total daily dose) to avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2–4 wk. May be necessary to provide patient with a lower dose strength for a successful taper. Monitor frequently to manage pain and withdrawal symptoms (restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate). If withdrawal symptoms occur, pause taper for a period of time or raise the dose of opioid analgesic to the previous dose, and then proceed with a slower taper. Monitor patients for changes in mood, emergence of suicidal thoughts, or use of other substances. A multimodal approach to pain management may optimize the treatment of chronic pain and assist with the successful tapering of the opioid analgesic.
FDA strongly encourages health care professionals to complete a REMS-compliant education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain, available at www.fda.gov/OpioidAnalgesicREMSBlueprint. Information on programs can be found at 1-800-503-0784 or www.opioidanalgesicrems.com
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Discuss availability of naloxone for emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing therapy, especially if patient has household members (including children) or other close contacts at risk for accidental exposure or overdose. Consider prescribing naloxone based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. However, the presence of risk factors for overdose should not prevent the proper management of pain in any patient.
PO: May be administered with food or milk to minimize GI irritation.
- DNC: Swallow extended-release tablets whole; do not break, crush, dissolve, or chew.

IV Administration:

Administer undiluted. Inspect solution for particulate matter. Slight yellow color does not alter potency. Store at room temperature.
Rate: Administer slowly over 2–3 min.
Rapid administration may lead to increased respiratory depression, hypotension, and circulatory collapse.
- For other clinical situations (sedation in mechanically ventilated patient), a continuous infusion may also be administered.

Patient/Family Teaching ⬆ ⬇

Instruct patient on how and when to ask for pain medication. Do not stop taking without discussing with health care professional; may cause withdrawal symptoms if discontinued abruptly after prolonged use. Do not ↑ doses without discussing with health care professional, may lead to overdose. Discuss safe use, risks, and proper storage and disposal of opioid analgesics with patients and caregivers with each Rx. The Patient Counseling Guide is available at www.fda.gov/OpioidAnalgesicREMSPCG.
Advise patient that hydromorphone is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed. Store out of sight and reach of children, and in a location not accessible by others.
Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose. Inform patients and caregivers about ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (by prescription, directly from a pharmacist, or as part of a community-based program).
May cause drowsiness or dizziness. Advise patient to call for assistance when ambulating or smoking. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Advise patient to notify health care professional if pain control is not adequate or if side effects occur.
Advise patient to change positions slowly to minimize orthostatic hypotension.
Instruct patient to avoid concurrent use of alcohol or other CNS depressants.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Encourage patient to turn, cough, and breathe deeply every 2 hr to prevent atelectasis.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Inform patient of potential for neonatal opioid withdrawal syndrome with prolonged use during pregnancy. Monitor neonate for signs and symptoms of withdrawal symptoms (irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, and/or failure to gain weight); usually occur the first days after birth. Monitor infants exposed to hydromorphone through breast milk for excess sedation and respiratory depression. Chronic use may fertility in females and males.
Home Care Issues:
Explain to patient and family how and when to administer hydromorphone; discuss safe storage of medication and proper care of infusion equipment. Teach parents or caregivers how to accurately measure liquid medication and to use only measuring device dispensed with medication
.
- Emphasize the importance of aggressive prevention of constipation with the use of hydromorphone.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Contr. Subst. Schedule ⬆