DILAUDID Dosage & Rx Info | Uses, Side Effects

Dilaudid Generic Name & Formulations

Legal Class

CII

General Description

Hydromorphone HCl 2mg, 4mg, 8mg; tabs; contains sulfites.

Pharmacological Class

Opioid agonist.

How Supplied

Tabs: 2mg, 8mg—100; 4mg—100, 500; Oral soln—473mL

Manufacturer

Rhodes Pharmaceuticals

Mechanism of Action

Hydromorphone is a full opioid agonist and is relatively selective for the mu receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of hydromorphone is analgesia. The precise mechanism of action is not known but the effects are thought to be mediated through opioid-specific receptors located in the CNS.

Dilaudid Indications

Indications

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Due to risks of addiction, abuse, and misuse with opioids (can occur at any dosage or duration), reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics, opioid combination products) are not tolerated or inadequate to provide analgesia. Should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Dilaudid Dosage and Administration

Adult

Use lowest effective dose for shortest duration. Individualize. Initially 2–4mg every 4–6 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 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 Boxed Warnings

Boxed Warning

Serious and life-threatening risks from use of Dilaudid: Risk of medication errors; Addiction, abuse, and misuse; Life-threatening respiratory depression; Accidental ingestion; Risks from concomitant use with benzodiazepines or other CNS depressants; Neonatal opioid withdrawal syndrome; Opioid analgesic risk evaluation and mitigation strategy (REMS).

Dilaudid 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 esp. during initiation or 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. Opioid-induced hyperalgesia (OIH) and allodynia; consider decreasing dose of current opioid or opioid rotation if OIH is suspected. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Monitor for signs of hypotension when initiating or titrating dose. 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

YES

Dilaudid Pharmacokinetics

Absorption

Peak plasma concentrations generally attained within ½ to 1 hour after oral administration. Hydromorphone is rapidly absorbed from the GI tract.

Distribution

Volume of distribution at steady state: 302.9 L (after IV bolus dose). Plasma protein bound: 8–19%.

Metabolism

Hepatic (glucuronidation).

Elimination

Renal. Half-life: ~2.3 hours (after IV dose). Systemic clearance: ~1.96 L/min.

Dilaudid 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 Adverse Reactions

Adverse Reactions

Lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, pruritus; respiratory depression, orthostatic hypotension, syncope, OIH and allodynia.

Dilaudid Clinical Trials

See Literature

Dilaudid Note

Not Applicable

Dilaudid Patient Counseling