DILAUDID INJECTION Dosage & Rx Info

Dilaudid Injection Generic Name & Formulations

Legal Class

CII

General Description

Hydromorphone HCl 0.2mg/mL, 0.5mg/0.5mL, 1mg/mL, 2mg/mL; soln for IV, IM or SC inj; preservative-free; contains sulfites.

Pharmacological Class

Opioid agonist.

How Supplied

Prefilled syringes—10; HPF Injection—contact supplier

Manufacturer

Fresenius Kabi USA

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 Injection 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 Injection Dosage and Administration

Adult

Use lowest effective dose for shortest duration. Individualize. Initially 1–2mg SC or IM, or 0.2–1mg by slow IV (at least 2–3mins) every 2–3 hours as needed. Elderly, debilitated: initially 0.2mg IV. Renal or hepatic impairment: initially ¼ to ½ the usual dose. Conversion from other opioids: see full labeling. Withdraw gradually by 25–50% every 2–4 days.

Children

Not established.

Dilaudid Injection 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. Hydromorphone-HPF: opioid non-tolerant.

Dilaudid Injection Boxed Warnings

Boxed Warning

Serious and life-threatening risks from use of Dilaudid Injection: Addiction, abuse, and misuse; Life-threatening respiratory depression; Risks from concomitant use with benzodiazepines and other CNS depressants; Neonatal opioid withdrawal syndrome.

Dilaudid Injection Warnings/Precautions

Warnings/Precautions

Abuse potential (monitor). Life-threatening respiratory depression esp. during initiation or following dose increases. 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. Opioid-induced hyperalgesia (OIH) and allodynia; consider decreasing dose of current opioid or opioid rotation if OIH is suspected. 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.

Dilaudid Injection Pharmacokinetics

Distribution

Plasma protein bound: 8–19%. Steady state volume of distribution: 302.9 L.

Metabolism

Hepatic (glucuronidation).

Elimination

Renal. Half-life: ~2.3 hours. Systemic clearance: ~1.96 L/min.

Dilaudid Injection 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.

Dilaudid Injection 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 Injection Clinical Trials

See Literature

Dilaudid Injection Note

Not Applicable

Dilaudid Injection Patient Counseling