Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Hydromorphone Ext-rel Tabs Generic Name & Formulations
Legal Class
CII
General Description
Hydromorphone HCl 8mg, 12mg, 16mg, 32mg; ext-rel tabs; contains sulfites.
Pharmacological Class
Opioid agonist.
How Supplied
Contact supplier
Manufacturer
Hydromorphone Ext-rel Tabs Indications
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
Adult
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.
Children
≤17yrs: not established.
Hydromorphone Ext-rel Tabs Contraindications
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
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.
REMS
Hydromorphone Ext-rel Tabs Pharmacokinetics
See Literature
Hydromorphone Ext-rel Tabs Interactions
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
See Literature
Hydromorphone Ext-rel Tabs Note
Notes
Formerly known under the brand name Exalgo.
Hydromorphone Ext-rel Tabs Patient Counseling
See Literature
