Hydromorphone Ext-rel Tabs

  • Narcotic analgesics

Hydromorphone Ext-rel Tabs Generic Name & Formulations

General Description

Hydromorphone HCl 8mg, 12mg, 16mg, 32mg; ext-rel tabs; contains sulfites.

Pharmacological Class

Opioid agonist.

How Supplied

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Hydromorphone Ext-rel Tabs Indications


Management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative therapies are inadequate.

Limitations of Use

Not for use as an as-needed (prn) analgesic. Use only if alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate to provide sufficient management of pain.

Hydromorphone Ext-rel Tabs Dosage and Administration


Not for initial opioid use. Swallow whole. Take once daily. Use lowest effective dose for shortest duration. >17yrs: Individualize based on prior analgesic treatment experience. May adjust by increments of 4–8mg every 3–4 days. Conversion from other opioids: see full labeling. Moderate hepatic impairment: initiate with 25% of normal dose; severe hepatic impairment: consider alternatives. Moderate renal impairment: initiate with 50% of normal dose; severe renal impairment: consider alternatives. Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.


≤17yrs: not established.

Hydromorphone Ext-rel Tabs Contraindications


Opioid non-tolerant patients. Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus. Surgical procedures and/or underlying disease resulting in GI narrowing, obstruction, or have "blind loops."

Hydromorphone Ext-rel Tabs Boxed Warnings

Boxed Warning

Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Risks from concomitant use with benzodiazepines or other CNS depressants.

Hydromorphone Ext-rel Tabs Warnings/Precautions


Abuse potential (monitor). Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Sulfite sensitivity. Drug abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.



Hydromorphone Ext-rel Tabs Pharmacokinetics

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Hydromorphone Ext-rel Tabs Interactions


Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.

Hydromorphone Ext-rel Tabs Adverse Reactions

Adverse Reactions

Constipation, nausea, vomiting, somnolence, headache, dizziness; respiratory depression, severe hypotension, syncope.

Hydromorphone Ext-rel Tabs Clinical Trials

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Hydromorphone Ext-rel Tabs Note


Formerly known under the brand name Exalgo.

Hydromorphone Ext-rel Tabs Patient Counseling

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