Hydromorphone Hydrochloride Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)

Limitations of Use (1)

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Hydromorphone Hydrochloride Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

• Have not been tolerated, or are not expected to be tolerated,
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. (2.1)
• Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (2.1)
• Intramuscular and Subcutaneous Use: The usual starting dose is 1 mg to 2 mg every 2 to 3 hours as necessary. (2.2)
• Intravenous Use: The usual starting dose is 0.2 mg to 1 mg every 2 to 3 hours. The injection should be given slowly, over at least 2 to 3 minutes. (2.2)
• Hepatic Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of hepatic impairment. (2.3)
• Renal Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of renal impairment. (2.4)
• Do not stop Hydromorphone Hydrochloride Injection abruptly in a physically dependent patient. (2.6)

Injection: 0.5 mg/0.5 mL, 1 mg/mL, 2 mg/mL and 4 mg/mL is available in ampuls, Carpuject™ cartridges, iSecure™ syringes, and single-dose vials for parenteral administration. (3)

• Significant respiratory depression. (4)
• Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4)
• Known or suspected gastrointestinal obstruction, including paralytic ileus. (4)
• Known hypersensitivity to hydromorphone. (4)

• Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.5)
• Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.6)
• Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Hydromorphone Hydrochloride Injection in patients with circulatory shock. (5.7)
• Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Hydromorphone Hydrochloride Injection in patients with impaired consciousness or coma. (5.8)

Most common adverse reactions are light-headedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus.

Serious adverse reactions include respiratory depression and apnea, circulatory depression, respiratory arrest, shock and cardiac arrest. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov.medwatch.

• Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Hydromorphone Hydrochloride Injection if serotonin syndrome is suspected. (7)
• Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of hydromorphone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping treatment with an MAOI. (7)
• Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Hydromorphone Hydrochloride Injection because they may reduce analgesic effect of Hydromorphone Hydrochloride Injection or precipitate withdrawal symptoms. (7)

Pregnancy: May cause fetal harm. (8.1)