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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).
This image is provided by the National Library of Medicine.
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.
Administration and Reconstitution
Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. A slight yellowish discoloration may develop in hydromorphone hydrochloride injection (HPF) ampules. No loss of potency has been demonstrated. Hydromorphone hydrochloride injection (HPF) are physically compatible and chemically stable for at least 24 hours at 25°C, protected from light in most common large-volume parenteral solutions.
500 mg/50 mL Vial
To use this single dose presentation, do not penetrate the stopper with a syringe. Instead, remove both the aluminum flipseal and rubber stopper in a suitable work area, such as under a laminar flow hood (or equivalent clean air compounding area). The contents may then be withdrawn for preparation of a single, large-volume parenteral solution. Discard any unused portion in an appropriate manner.
DOSAGE FORMS AND STRENGTHS
Hydromorphone Hydrochloride Injection (high potency formulation) (for use in opioid-tolerant patients only): Each amber ampule and amber single-dose vial contains 10 mg/mL of hydromorphone hydrochloride in a sterile, aqueous solution and is available in 1 mL or 5 mL ampules or in 50 mL single-dose vials†.
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
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is contraindicated:
In patients with known hypersensitivity to hydromorphone, hydromorphone salts, any other components of the product, or sulfite-containing medications.
In any situation where opioids are contraindicated, e.g., in patients with respiratory depression in the absence of resuscitative equipment or in unmonitored settings; or patients with acute or severe bronchial asthma.
In patients with, or at risk of developing, gastrointestinal obstruction, especially paralytic ileus because hydromorphone diminishes the propulsive peristaltic wave in the gastrointestinal tract and may prolong the obstruction.
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is contraindicated in patients who are not opioid tolerant.
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.
Risk of Medication Errors
Hydromorphone HCl Injection (HPF) is a 10 mg/mL concentrated solution of hydromorphone, and is intended 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.
Do not confuse Hydromorphone HCl Injection (HPF) with standard parenteral formulations of Hydromorphone HCl Injection (1 mg/mL, 2 mg/mL, 4 mg/mL) or other opioids, as overdose and death could result.
Morphine does not convert to hydromorphone on a mg per mg basis. Use TABLE 1 when converting a patient from morphine to hydromorphone to avoid errors that can lead to overdose or death.
Respiratory Depression
Respiratory depression is the chief hazard of Hydromorphone HCl injection (HPF). Respiratory depression occurs most frequently in the elderly, in the debilitated, and in those suffering from conditions accompanied by hypoxia or hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may dangerously decrease pulmonary ventilation. Respiratory depression is also a particular problem following large initial doses in non opioid-tolerant patients or when opioids are given in conjunction with other agents that depress respiration.
Use Hydromorphone HCl Injection (HPF) with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale, patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression. In such patients, even usual therapeutic doses of opioid analgesics may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. Consider using non-opioid analgesics, and administer Hydromorphone HCl Injection only under careful medical supervision at the lowest effective dose in such patients.
Misuse, Abuse and Diversion of Opioids
Hydromorphone HCl Injection (HPF) contain hydromorphone, an opioid agonist with an abuse liability similar to morphine, and a Schedule II, controlled substance. Hydromorphone has the potential for being abused, is sought by drug abusers and people with addiction disorders, and is subject to criminal diversion. Diversion of Schedule II products is an act subject to criminal penalty.
Abuse of Hydromorphone HCl Injection (HPF), poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol or other substances. Schedule II opioid agonists have the highest potential for abuse and risk of fatal respiratory depression.
Hydromorphone HCl Injection (HPF) can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Hydromorphone HCl Injection (HPF) in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.
Interactions with Alcohol and other CNS Depressants
The concurrent use of Hydromorphone HCl Injection (HPF) with other central nervous system (CNS) depressants, including but not limited to, other opioids, illicit drugs, sedatives, hypnotics, general anesthetics, phenothiazines, muscle relaxants, other tranquilizers, and alcohol, increases the risk of respiratory depression, hypotension, and profound sedation, potentially resulting in coma or death. Use with caution and in reduced dosages in patients taking CNS depressants.
Neonatal Withdrawal Syndrome
Infants born to mothers physically dependent on Hydromorphone HCl Injection (HPF) will also be physically dependent and may exhibit signs of withdrawal. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. Neonatal opioid withdrawal syndrome may be life threatening and should be treated according to protocols developed by neonatology experts .
Use in Increased Intracranial Pressure or Head Injury
The respiratory depressant effects of Hydromorphone HCl Injection (HPF) promote carbon dioxide retention which results in elevation of cerebrospinal fluid pressure. This increase in intracranial pressure may be markedly exaggerated in the presence of head injury, intracranial lesions, or other conditions that predispose patients to increased intracranial pressure.
Hydromorphone HCl Injection (HPF) may produce effects on pupillary response and consciousness which can obscure the clinical course and neurologic signs of further increase in pressure in patients with head injuries.
Hypotensive Effect
Hydromorphone HCl Injection (HPF) may cause severe hypotension in patients whose ability to maintain blood pressure is compromised by a depleted blood volume, or a concurrent administration of drugs such as phenothiazines, general anesthetics, or other agents which compromise vasomotor tone.
Hydromorphone HCl Injection (HPF) may produce orthostatic hypotension in ambulatory patients.
Administer Hydromorphone HCl Injection (HPF) with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.
Sulfites
Hydromorphone HCl Injection (HPF) contain sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Use in Pancreatic/Biliary Tract Disease and Other Gastrointestinal Conditions
The administration of Hydromorphone HCl Injection (HPF) may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
Use Hydromorphone HCl Injection (HPF) with caution in patients who are at risk of developing ileus.
Use Hydromorphone HCl Injection (HPF) with caution in patients with biliary tract disease, including acute pancreatitis, as hydromorphone may cause spasm of the sphincter of Oddi and diminish biliary and pancreatic secretions.
Special Risk Patients
Give Hydromorphone HCl Injection (HPF) with caution and the initial dose should be reduced in the elderly or debilitated and those with severe impairment of hepatic, pulmonary or renal function; myxedema or hypothyroidism; adrenocortical insufficiency (e.g., Addison's Disease); CNS depression or coma; toxic psychoses; prostatic hypertrophy or urethral stricture; acute alcoholism; delirium tremens; or kyphoscoliosis associated with respiratory depression.
The administration of opioid analgesics including Hydromorphone HCl Injection (HPF) may aggravate preexisting convulsions in patients with convulsive disorders.
Hydromorphone HCl Injection (HPF), as with other opioids, may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings.
Reports of mild to severe seizures and myoclonus have been reported in severely compromised patients, administered high doses of parenteral hydromorphone.
Use in Drug and Alcohol Dependent Patients
Use Hydromorphone HCl Injection (HPF) with caution in patients with alcoholism and other drug dependencies due to the increased frequency of opioid tolerance, dependence, and the risk of addiction observed in these patient populations. Abuse of Hydromorphone HCl Injection (HPF) in combination with other CNS depressant drugs can result in serious risk to the patient.
Hydromorphone HCl Injection (HPF) contain hydromorphone, an opioid with no approved use in the management of addiction disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia.
Use in Ambulatory Patients
Hydromorphone HCl Injection (HPF) may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery). Patients should be cautioned accordingly. Hydromorphone HCl Injection (HPF) may produce orthostatic hypotension in ambulatory patients.
Parenteral Administration
Hydromorphone HCl Injection may be given intravenously, but the injection should be given very slowly. Rapid intravenous injection of opioid analgesics increases the possibility of side effects such as hypotension and respiratory depression.
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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