Hydromorphone Hydrochloride

HYDROMORPHONE HYDROCHLORIDE- hydromorphone hydrochloride injection
Akorn, Inc.

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

Risk of Medication Errors

Hydromorphone hydrochloride injection (high potency formulation) is a more concentrated solution of hydromorphone than hydromorphone hydrochloride injection, and is for use in opioid-tolerant patients only. Do not confuse hydromorphone hydrochloride injection (high potency formulation) with standard parenteral formulations of hydromorphone hydrochloride injection or other opioids, as overdose and death could result [see Warnings and Precautions (5.1)].

Addiction, Abuse, and Misuse

Hydromorphone hydrochloride injection (high potency formulation) exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing hydromorphone hydrochloride injection (high potency formulation) and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.2)].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of hydromorphone hydrochloride injection (high potency formulation). Monitor for respiratory depression, especially during initiation of hydromorphone hydrochloride injection (high potency formulation) or following a dose increase [see Warnings and Precautions (5.3)].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of hydromorphone hydrochloride injection (high potency formulation) during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.4)].

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

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 [see Warnings and Precautions (5.5), Drug Interactions (7)].

  • Reserve concomitant prescribing of hydromorphone hydrochloride (high potency formulation) and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

1 INDICATIONS AND USAGE

Hydromorphone hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

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 (HPF).

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)] , reserve hydromorphone hydrochloride injection (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

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

  • Always initiate dosing in opioid-naïve patients using hydromorphone hydrochloride injection. Never administer hydromorphone hydrochloride injection (HPF) to opioid-naïve patients.
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
  • Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.2)].
  • Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with hydromorphone hydrochloride injection (HPF) and adjust the dosage accordingly [see Warnings and Precautions (5.3)].
  • 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). No loss of potency has been demonstrated. Hydromorphone hydrochloride injection (HPF) is physically compatible and chemically stable for at least 24 hours at 25°C, protected from light in most common large-volume parenteral solutions.
  • Discard any unused portion in an appropriate manner.

2.2 Initial Dosage

Use of Hydromorphone Hydrochloride Injection (HPF) as the First Opioid Analgesic

Hydromorphone hydrochloride injection (HPF) is 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.

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.

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. The initial dose should be reduced in the elderly or debilitated and may be lowered to 0.2 mg.

Conversion From Other Opioids to Hydromorphone Hydrochloride Injection (HPF)

There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of hydromorphone hydrochloride injection (HPF). It is safer to underestimate a patient’s 24-hour hydromorphone hydrochloride injection (HPF) dosage than to overestimate the 24-hour hydromorphone hydrochloride injection (HPF) dosage and manage an adverse reaction due to overdose.

If the decision is made to convert to hydromorphone hydrochloride injection from another opioid analgesic using publicly available data, convert the current total daily amount(s) of opioid(s) received to an equivalent total daily dose of hydromorphone hydrochloride injection 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.

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.

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