hydromorphone hydrochloride injection, USP (HIGH POTENCY) Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

•
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks.
•
Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5)]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.
•
Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available.
•
There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.2)].
•
Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. Consider this risk when selecting an initial dose and when making dose adjustments [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 [high potency formulation (HPF)] vials. No loss of potency has been demonstrated. Hydromorphone Hydrochloride Injection [high potency formulation (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.

500 mg/50 mL Vial

To use this single-dose presentation, withdraw the contents using aseptic technique for preparation of a single, large-volume parenteral solution. Discard any unused portion in an appropriate manner.

2.2 Initial Dosage

Use of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] as the First Opioid Analgesic:

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is for use in opioid tolerant patients only. Do not use Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] for patients who are not tolerant to the respiratory depressant or sedating effects of opioids.

Subcutaneous or Intramuscular Administration:

The usual starting dose is 1 mg to 2 mg every 2 to 3 hours as necessary for pain, and the lowest dose necessary to achieve adequate analgesia. Depending on the clinical situation, the initial starting dose may be lowered in patients who are opioid naïve. Titrate the dose based upon the individual patient’s response to their initial dose of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)].

Intravenous Administration:

The initial starting dose is 0.2 mg 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 [high potency formulation (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 [high potency formulation (HPF)]. It is safer to underestimate a patient's 24-hour Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] dosage than to overestimate the 24-hour Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] dosage and manage an adverse reaction due to overdose.

If the decision is made to convert to Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] 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 [high potency formulation (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.

Use Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] ONLY for patients who require the higher concentration and lower total volume of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. Because of its high concentration, the delivery of precise doses of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] may be difficult if low doses of hydromorphone are required. Therefore, use Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] only if the amount of hydromorphone required can be delivered accurately with this formulation.

Base the starting dose for Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] on the prior dose of Hydromorphone Hydrochloride Injection or on the prior dose of an alternate opioid.

2.3 Dosage Modifications in Patients With 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 [see Clinical Pharmacology (12.3)].

2.4 Dosage Modifications in Patients With 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 [see Clinical Pharmacology (12.3)].

2.5 Titration and Maintenance of Therapy

Titrate the dose based upon the individual patient’s response to their initial dose of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. Individually titrate Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and other adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.2, 5.13)]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] dosage. If after increasing the dosage, unacceptable opioid-related adverse reactions are observed (including an increase in pain after a dosage increase), consider reducing the dosage [see Warnings and Precautions (5)]. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

2.6 Safe Reduction or Discontinuation of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]

When a patient who has been taking Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] regularly and may be physically-dependent no longer requires therapy with Hydromorphone Hydrochloride Injection [high potency formulation (HPF)], taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] in a physically-dependent patient [see Warnings and Precautions (5.13), Drug Abuse and Dependence (9.3)].

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

•
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks.
•
Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5)]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.
•
Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available.
•
There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.2)].
•
Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. Consider this risk when selecting an initial dose and when making dose adjustments [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 [high potency formulation (HPF)] vials. No loss of potency has been demonstrated. Hydromorphone Hydrochloride Injection [high potency formulation (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.

500 mg/50 mL Vial

To use this single-dose presentation, withdraw the contents using aseptic technique for preparation of a single, large-volume parenteral solution. Discard any unused portion in an appropriate manner.

2.2 Initial Dosage

Use of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] as the First Opioid Analgesic:

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is for use in opioid tolerant patients only. Do not use Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] for patients who are not tolerant to the respiratory depressant or sedating effects of opioids.

Subcutaneous or Intramuscular Administration:

The usual starting dose is 1 mg to 2 mg every 2 to 3 hours as necessary for pain, and the lowest dose necessary to achieve adequate analgesia. Depending on the clinical situation, the initial starting dose may be lowered in patients who are opioid naïve. Titrate the dose based upon the individual patient’s response to their initial dose of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)].

Intravenous Administration:

The initial starting dose is 0.2 mg 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 [high potency formulation (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 [high potency formulation (HPF)]. It is safer to underestimate a patient's 24-hour Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] dosage than to overestimate the 24-hour Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] dosage and manage an adverse reaction due to overdose.

If the decision is made to convert to Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] 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 [high potency formulation (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.

Use Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] ONLY for patients who require the higher concentration and lower total volume of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. Because of its high concentration, the delivery of precise doses of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] may be difficult if low doses of hydromorphone are required. Therefore, use Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] only if the amount of hydromorphone required can be delivered accurately with this formulation.

Base the starting dose for Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] on the prior dose of Hydromorphone Hydrochloride Injection or on the prior dose of an alternate opioid.

2.3 Dosage Modifications in Patients With 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 [see Clinical Pharmacology (12.3)].

2.4 Dosage Modifications in Patients With 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 [see Clinical Pharmacology (12.3)].

2.5 Titration and Maintenance of Therapy

Titrate the dose based upon the individual patient’s response to their initial dose of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. Individually titrate Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and other adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.2, 5.13)]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] dosage. If after increasing the dosage, unacceptable opioid-related adverse reactions are observed (including an increase in pain after a dosage increase), consider reducing the dosage [see Warnings and Precautions (5)]. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

2.6 Safe Reduction or Discontinuation of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]

When a patient who has been taking Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] regularly and may be physically-dependent no longer requires therapy with Hydromorphone Hydrochloride Injection [high potency formulation (HPF)], taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] in a physically-dependent patient [see Warnings and Precautions (5.13), Drug Abuse and Dependence (9.3)].
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