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These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION [high potency formulation (HPF)] safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION [high potency formulation (HPF)]. HYDROMORPHONE HYDROCHLORIDE INJECTION [high potency formulation (HPF)], for intravenous, intramuscular, or subcutaneous use, CII Initial U.S. Approval: January 1984
Medication labelWhy this: Advisory · dailymed-prescription
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is 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. Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg oral morphine per day, or at least 25 mcg transdermal fentanyl per hour, or at least 30 mg oral oxycodone per day, or at least 8 g oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid for one week or longer. Patients must remain on around-the-clock opioids while administering Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- generic_name
- hydromorphone hydrochloride
- product_names
- HYDROMORPHONE HYDROCHLORIDE
- ndc
- 0703-0018, 0703-0110, 0703-0113, 0703-0110-01, 0703-0110-03, 0703-0113-01, 0703-0113-03, 0703-0018-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en