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Black Box Warning
WARNING: RISK OF RESPIRATORY DEPRESSION, ABUSE, AND MEDICATION ERRORS
See full prescribing information for complete Boxed Warning.
HYDROMORPHONE HCl INJECTION (high potency formulation) IS FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
Hydromorphone HCl Injection (high potency formulation) is a more concentrated solution of hydromorphone than Hydromorphone HCl Injection, and is for use in opioid-tolerant patients only. Do not confuse Hydromorphone HCl Injection (high potency formulation) with standard parenteral formulations of Hydromorphone Hydrochloride or other opioids, as overdose and death could result.
Hydromorphone HCl Injection (high potency formulation) contain hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Hydromorphone HCl Injection (high potency formulation) can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing Hydromorphone HCl Injection (high potency formulation) in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion.
Schedule II opioid agonists, including morphine, oxymorphone, hydromorphone, oxycodone, fentanyl, and methadone, have the highest potential for abuse and risk of producing fatal overdose due to respiratory depression. Ethanol, other opioids, and other central nervous system depressants (e.g., sedative-hypnotics, skeletal muscle relaxants) can potentiate the respiratory-depressant effects of hydromorphone and increase the risk of adverse outcomes, including death.
Hydromorphone Hydrochloride Injection, USP is indicated for the management of pain in patients where an opioidanalgesic is appropriate.
Hydromorphone Hydrochloride Injection, USP [high potency formulation (HPF)] is indicated for the management of moderate-to-severe pain in opioid-tolerant patients who require higher doses of opioids.
Dosage
General Dosing Considerations
Take care when prescribing and administering Hydromorphone Hydrochloride Injection (HPF) to avoid dosing errors due to confusion between the different concentrations and between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total volume of the dose.
Selection of patients and administration of hydromorphone hydrochloride injection (HPF) should be governed by the same principles that apply to the use of similar opioid analgesics to treat patients with acute or chronic pain, and depends upon a comprehensive assessment of the patient. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.
The nature of the pain (severity, frequency, etiology, and pathophysiology), as well as the medical status of the patient, will affect selection of the starting dosage. Opioid analgesics, including hydromorphone hydrochloride injection (HPF), have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks.
Individualization of Dosing
Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment. Give attention to the following:
The age, general condition, and medical status of the patient;
The patient's degree of opioid tolerance;
The daily dose, potency, and specific characteristics of the opioid the patient has been taking previously;
Concurrent medications
The type and severity of the patient's pain
Risk factors for abuse or addiction; including whether the patient has a previous or Current substance abuse problem, a family history of substance abuse, or a history of Mental illness or depression;
The balance between pain control and adverse reactions.
Periodic reassessment after the initial dosing of hydromorphone hydrochloride injection (HPF) is required. If pain management is not satisfactory, and opioid-induced adverse events are tolerable, the hydromorphone dose may be increased gradually. If excessive opioid side effects are observed early in the dosing interval, reduce the hydromorphone hydrochloride dose. If this results in breakthrough pain at the end of the dosing interval, the dosing interval may need to be shortened. Dose titration should be guided more by the need for analgesia and the severity of adverse events than the absolute dose of opioid employed.
Initiation of Therapy in Opioid-Naïve Patients
Always initiate dosing in opioid-naïve patients using hydromorphone hydrochloride injection. Never administer hydromorphone hydrochloride injection (HPF) to opioid-naïve patients.
Subcutaneous or Intramuscular Administration
The usual starting dose of hydromorphone hydrochloride injection is 1 mg to 2 mg every 2 to 3 hours as necessary. Depending on the clinical situation, the initial starting dose may be lowered in patients who are opioid naïve. Adjust the dose according to the severity of pain, the severity of adverse events, as well as the patient's underlying disease and age.
Intravenous Administration
The initial starting dose is 0.2 to 1 mg every 2 to 3 hours. Intravenous administration should be given slowly, over at least 2 to 3 minutes, depending on the dose. Titrate the dose to achieve acceptable analgesia and tolerable adverse events. The initial dose should be reduced in the elderly or debilitated and may be lowered to 0.2 mg.
Hepatic Impairment
Start patients with hepatic impairment on one-fourth to one-half the usual hydromorphone hydrochloride injection starting dose depending on the extent of impairment.
Renal Impairment
Start patients with renal impairment on one-fourth to one-half the usual hydromorphone hydrochloride injection starting dose depending on the degree of impairment.
Conversion From Prior Opioid
Use the equianalgesic dose table below (table1) as a guide to determine the appropriate dose of hydromorphone hydrochloride injection (HPF). Convert the current total daily amount(s) of opioid(s) received to an equivalent total daily dose of hydromorphone hydrochloride injection (HPF) and reduce by one-half due to the possibility of incomplete cross tolerance. Divide the new total amount by the number of doses permitted based on dosing interval (e.g., 8 doses for every-three-hour dosing). Titrate the dose according to the patient's response. For opioids not in table 1, first estimate the daily amount of morphine that is equivalent to the current total daily amount of other opioid(s) received, then use Table1 to find the approximate equivalent total daily dose of hydromorphone hydrochloride injection (HPF).
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Hydromorphone Hydrochloride Injection (HPF) (for use in opioid-tolerant patients only)
Do not use Hydromorphone Hydrochloride Injection (HPF) for patients who are not tolerant to the respiratory depressant or sedating effects of opioids.
Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
Use Hydromorphone Hydrochloride Injection (HPF) ONLY for patients who require the higher concentration and lower total volume of Hydromorphone Hydrochloride Injection (HPF).
Because of its high concentration, the delivery of precise doses of hydromorphone hydrochloride injection (HPF) may be difficult if low doses of hydromorphone are required. Therefore, use hydromorphone hydrochloride injection (HPF) only if the amount of hydromorphone required can be delivered accurately with this formulation.
Base the starting dose for hydromorphone hydrochloride injection (HPF) on the prior dose of hydromorphone hydrochloride injection or on the prior dose of an alternate opioid as described above in Section 2.4 Conversion From Prior Opioid and
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Hydromorphone hydrochloride (injection) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydromorphone hydrochloride (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Hydromorphone hydrochloride (injection) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Hydromorphone hydrochloride (injection) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydromorphone hydrochloride (injection) in pediatric patients.
Contraindications
There is limited information regarding Hydromorphone hydrochloride (injection) Contraindications in the drug label.
Warnings
WARNING: RISK OF RESPIRATORY DEPRESSION, ABUSE, AND MEDICATION ERRORS
See full prescribing information for complete Boxed Warning.
HYDROMORPHONE HCl INJECTION (high potency formulation) IS FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
Hydromorphone HCl Injection (high potency formulation) is a more concentrated solution of hydromorphone than Hydromorphone HCl Injection, and is for use in opioid-tolerant patients only. Do not confuse Hydromorphone HCl Injection (high potency formulation) with standard parenteral formulations of Hydromorphone Hydrochloride or other opioids, as overdose and death could result.
Hydromorphone HCl Injection (high potency formulation) contain hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Hydromorphone HCl Injection (high potency formulation) can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing Hydromorphone HCl Injection (high potency formulation) in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion.
Schedule II opioid agonists, including morphine, oxymorphone, hydromorphone, oxycodone, fentanyl, and methadone, have the highest potential for abuse and risk of producing fatal overdose due to respiratory depression. Ethanol, other opioids, and other central nervous system depressants (e.g., sedative-hypnotics, skeletal muscle relaxants) can potentiate the respiratory-depressant effects of hydromorphone and increase the risk of adverse outcomes, including death.
There is limited information regarding Hydromorphone hydrochloride (injection) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Hydromorphone hydrochloride (injection) in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Hydromorphone hydrochloride (injection) in the drug label.
Drug Interactions
There is limited information regarding Hydromorphone hydrochloride (injection) Drug Interactions in the drug label.
There is limited information regarding Patient Counseling Information of Hydromorphone hydrochloride (injection) in the drug label.
Precautions with Alcohol
Alcohol-Hydromorphone hydrochloride (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
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