Hydromorphone HCl Injection (HPF) Dosage & Rx Info

Hydromorphone Hcl Injection (hpf) Generic Name & Formulations

Legal Class

CII

General Description

Hydromorphone HCl 10mg/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

Various generic manufacturers

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.

Hydromorphone Hcl Injection (hpf) Indications

Indications

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in opioid-tolerant patients who require higher doses.

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.

Hydromorphone Hcl Injection (hpf) Dosage and Administration

Adult

Use in opioid-tolerant patients only. Individualize; base starting dose on prior Dilaudid inj or prior dose of alternate opioid: see full labeling.

Children

Not established.

Hydromorphone Hcl Injection (hpf) 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.

Hydromorphone Hcl Injection (hpf) Boxed Warnings

Boxed Warning

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

Hydromorphone Hcl Injection (hpf) 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.

Hydromorphone Hcl Injection (hpf) 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.

Hydromorphone Hcl Injection (hpf) 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 Hcl Injection (hpf) Adverse Reactions

Adverse Reactions

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

Hydromorphone Hcl Injection (hpf) Clinical Trials

See Literature

Hydromorphone Hcl Injection (hpf) Note

Not Applicable

Hydromorphone Hcl Injection (hpf) Patient Counseling