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HYDROMORPHONE HYDROCHLORIDE, Vial U.S. Physician Prescribing Information (hydromorphone hydrochloride injection, USP) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION (HPF) safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION (HPF).

HYDROMORPHONE HYDROCHLORIDE INJECTION [high potency formulation (HPF)], for intravenous, intramuscular or subcutaneous use, CII

Initial U.S. Approval: January 1984

WARNING: RISK OF MEDICATION ERRORS, ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

See full prescribing information for complete boxed warning.

  • Do not confuse Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] with standard parenteral formulations of Hydromorphone Hydrochloride Injection or other opioids, as overdose and death could result. (5.1)
  • Hydromorphone hydrochloride exposes users to risks of addictions, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behaviors and conditions. (5.2)
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (5.3)
  • Prolonged use of hydromorphone hydrochloride injection [high potency formulation (HPF)] during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.4)
  • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.5, 7)

RECENT MAJOR CHANGES

Warnings & Precautions (5.3)10/2019

INDICATIONS AND USAGE

  • Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is an opioid agonist indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. (1)
  • Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg/hr of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when administering Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. (1)

Limitations of Use:

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] 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 (1)

DOSAGE AND ADMINISTRATION

  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (2.1)
  • Initial Dosage:
    -
    Intramuscular or 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)
  • Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is for opioid-tolerant patients only and should be used only if the amount of hydromorphone required can be delivered accurately with this formulation. (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 [high potency formulation (HPF)] abruptly in a physically-dependent patient. (2.6)

DOSAGE FORMS AND STRENGTHS

Hydromorphone Hydrochloride Injection, USP [high potency formulation (HPF)], 10 mg/mL available in 1 mL, 5 mL or 50 mL vials. (3)

CONTRAINDICATIONS

  • Significant respiratory depression. (4)
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. (4)
  • Known or suspected gastrointestinal obstruction, including paralytic ileus. (4)
  • Known hypersensitivity to hydromorphone, hydromorphone salts, or any other components of the product. (4)
  • Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]: Patients who are not opioid tolerant. (4)

WARNINGS AND PRECAUTIONS

  • Life-Threatening Respiratory Depression in Patients With Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.6)
  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.7)
  • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] in patients with circulatory shock. (5.8)
  • 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 [high potency formulation (HPF)] in patients with impaired consciousness or coma. (5.9)

ADVERSE REACTIONS

Most common adverse reactions are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] 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 [high potency formulation (HPF)] because they may reduce the analgesic effect of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] or precipitate withdrawal symptoms. (7)

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. (8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2020

What's New

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