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Dilaudid Oral Solution Generic Name & Formulations
Legal Class
CII
General Description
Hydromorphone HCl 5mg/5mL; contains sulfites.
Pharmacological Class
Opioid agonist.
See Also
How Supplied
Tabs: 2mg, 8mg—100; 4mg—100, 500; Oral soln—473mL
Manufacturer
Dilaudid Oral Solution Indications
Indications
Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Reserve for use in patients for whom alternative treatment options have not been tolerated or not provided adequate analgesia.
Dilaudid Oral Solution Dosage and Administration
Adult
Use lowest effective dose for shortest duration. Avoid dosing errors. Obtain a calibrated measuring cup/syringe. Individualize. Initially 2.5–10mg (2.5–10mL) every 3–6 hours as needed. Elderly: start at lower dose. Renal or hepatic impairment: initially ¼ to ½ the usual dose. Conversion from other opioids: see full labeling. Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.
Children
Not established.
Dilaudid Oral Solution Contraindications
Contraindications
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.
Dilaudid Oral Solution Boxed Warnings
Boxed Warning
Risk of medication errors. 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.
Dilaudid Oral Solution Warnings/Precautions
Warnings/Precautions
Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Risk of accidental overdose and death due to medication errors; ensure accuracy when prescribing, dispensing, and administering (oral soln). 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. 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: not recommended. Nursing mothers: monitor infants.
REMS
Dilaudid Oral Solution Pharmacokinetics
See Literature
Dilaudid Oral Solution 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 closely; consider prescribing naloxone if concomitant use is warranted. 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.
Dilaudid Oral Solution Adverse Reactions
Adverse Reactions
Lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, pruritus; respiratory depression, severe hypotension, syncope.
Dilaudid Oral Solution Clinical Trials
See Literature
Dilaudid Oral Solution Note
Not Applicable
Dilaudid Oral Solution Patient Counseling
See Literature
