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Hydromorphone Dosage

Applies to the following strength(s): 2 mg/mL ; 4 mg/mL ; 1 mg/mL ; 3 mg/mL ; 10 mg/mL ; 2 mg ; 4 mg ; 8 mg ; 3 mg ; 250 mg ; 10 mg-0.9%/50 mL ; 0.2 mg/mL-NaCl 0.9% ; 1 mg/mL-NaCl 0.9% ; 12 mg ; 16 mg ; 32 mg ; 0.5 mg/mL-NaCl 0.9% ; 1.4 mg/mL-NaCl 0.9% ; 24 mg ; 2 mg/10 mL-NaCl 0.9% ; 0.1 mg/mL-NaCl 0.9% ; 0.4 mg/mL-NaCl 0.9% ; 25 mg-0.9%/50 mL ; 0.5 mg/5 mL-D5% ; 3 mg/30 mL-D5% ; 100 mg/50 mL-D5% ; 0.6 mg/0.6 mL-NaCl 0.9%

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Pain

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time; each patient should be managed individually.

ORAL:
Immediate-release tablets: Initial dose: 2 to 4 mg orally every 4 to 6 hours
Immediate-release oral liquid: Initial dose: 2.5 to 10 mg orally every 3 to 6 hours
Maintenance dose: Gradually increase dose if analgesia is inadequate, as tolerance develops, or if pain severity increases.

PARENTERAL: Multiple concentrations are available: Standard: 1 mg/mL, 2 mg/mL, 4 mg/mL
-High Potency (HP): for opioid tolerant patients only and should be used only if the amount of hydromorphone can be delivered accurately: 10 mg/mL
IM or Subcutaneous: Initial dose: 1 mg to 2 mg IM or subcutaneously ever 2 to 3 hours as needed
-Adjust dose according to the severity of pain, the severity of adverse events, and the patients underlying disease and age.
IV: Initial dose: 0.2 mg to 1 mg IV; administer slowly over at least 2 to 3 minutes.
-Dose should be titrated to achieve acceptable analgesia and tolerable adverse events.

CONVERSION FROM PRIOR OPIOIDS:
Initial daily dose should be 50% of the 24-hour calculated hydromorphone requirement divided by the number of doses permitted based on dosing interval.
-Dose should be titrated to achieve acceptable analgesia and tolerable adverse events.

-The following may be used as a guide to determine conversion to hydromorphone. A hydromorphone IM or subcutaneous dose of 1.3 to 2 mg is approximately equianalgesic to a hydromorphone oral dose of 6.5 to 7.5 mg.
-Hydromorphone IM or subcutaneous doses of 1.3 to 2 mg are approximately equianalgesic to the following parenteral doses: Morphine 10 mg; Oxymorphone 1 to 1.1 mg; Levorphanol 2 to 2.3 mg; Meperidine 75 to 100 mg; Methadone 10 mg; Nalbuphine 10 to 12 mg; Butorphanol 1.5 to 2.5 mg
-Hydromorphone oral doses of 6.5 to 7.5 mg are approximately equianalgesic to the following oral doses: Morphine 40 to 60 mg; Oxymorphone 6.6 mg; Levorphanol 4 mg; Meperidine 300 to 400 mg; Methadone 10 to 20 mg

Comments:
-Dose titration should be guided by need for analgesia rather than by dose.
-Due to risk of respiratory depression, Hydromorphone-HP injection is reserved for use in opioid tolerant patients only; opioid tolerant patients are those patients taking for one week or longer, at least: oral morphine 60 mg/day, fentanyl transdermal 25 mcg/hour, oral oxycodone 30 mg/day, oral hydromorphone 8 mg/day, oral oxymorphone 25 mg/day, or an equianalgesic dose of another opioid.

Use: Management of pain in patients where an opioid analgesic is appropriate.

SUPPOSITORY: Insert 3 mg suppository rectally every 6 to 8 hours

Comments: The labeling for this product has not been approved by FDA

Use: For the relief of moderate to severe pain such as that due to surgery, trauma, burns, cancer, biliary colic, myocardial infarction, or renal colic.

Usual Adult Dose for Chronic Pain

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time; each patient should be managed individually. Discontinue all other around-the-clock opioid drugs when initiating therapy with extended-release hydromorphone.

-Due to risk of respiratory depression, EXTENDED-RELEASE tablets are reserved for use in opioid tolerant patients only; opioid tolerant patients are those patients taking for one week or longer, at least: oral morphine 60 mg/day, fentanyl transdermal 25 mcg/hour, oral oxycodone 30 mg/day, oral hydromorphone 8 mg/day, oral oxymorphone 25 mg/day, or an equianalgesic dose of another opioid.

Initial doses:
Conversion from Immediate-Release Oral Hydromorphone to Extended-Release tablets: Starting dose should be equivalent to the total daily oral immediate-release dose taken as extended-release tablet orally once a day.

Conversion from Other Oral Opioids to Extended-Release tablets: Starting dose should be equivalent to 50% of the calculated daily hydromorphone requirement taken as extended-release tablet orally once a day.
-Published potency tables can be used to estimate a patient's 24-hour oral hydromorphone requirement, however, if used it is best to underestimate the 24-hour requirement due to substantial inter-patient variability; rescue medication can be provided as the dose is titrated
-Alternatively, the following conversion factors (CFs) may be used to convert selected oral opioids to hydromorphone extended-release tablets: Hydromorphone, CF=1; Codeine, CF=0.06; Hydrocodone, CF=0.4; Oxycodone, CF=0.4; Methadone, CF= 0.6, Morphine, CF=0.2, Oxymorphone, CF=0.6.
-Example: Sum the total daily dose of prior oral opioid; multiply that sum by the CF to obtain 24-hour oral requirement; the starting dose should be 50% of this 24-hour oral requirement, round down if necessary.
-These CFs cannot be used to convert from hydromorphone extended-release tablets to oral opioids as doing so will result in overestimation of the opioid dose and may result in fatal respiratory depression.

Conversion from Transdermal Fentanyl to Oral Hydromorphone Extended-Release: Initiate therapy 18 hours following removal of the transdermal fentanyl patch, starting dose should be determined using the conversion: 25 mcg fentanyl patch=12 mg oral extended-release hydromorphone; this 24-hour requirement should then be reduced by 50%, round down if necessary; calculated initial dose taken orally once a day.

TITRATION AND MAINTENANCE:
Maintenance dose: Individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; dose adjustments may be made in 4 to 8 mg increments every 24 hours, every 3 to 4 days.
Breakthrough Pain: If the level of pain increases after dose stabilization, attempt to identify the source before increasing dose; rescue medication with appropriate immediate-release analgesia may be helpful.

Comments:
-When converting from methadone, close monitoring is of particular importance due to methadone's long half-life.
-Dose conversion should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response.
-Extended-release tablets are not indicated as an as-needed analgesic.
-Upon cessation of therapy, gradually taper dose in physically dependent patient.

Use: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Renal Dose Adjustments

Closely monitor for respiratory and CNS depression during initiation and dose escalation

Oral:
Immediate-release: Consider use of oral liquid to allow for dose adjustments
-Moderate renal impairment; Start on a lower dose
-Severe renal impairment: Starting dose should be even lower
Extended-release tablets:
-Moderate renal impairment: Initial dose: give 50% of the normal initial dose
-Severe renal impairment: Initial dose: give 25% of the normal initial dose; consider alternative analgesic that may permit more flexibility in dosing.

Parenteral:
-Depending on the extent of impairment: Initial dose should be one-fourth to one-half the usual dose

Liver Dose Adjustments

Closely monitor for respiratory and CNS depression during initiation and dose escalation

Oral:
Immediate-release: Consider use of oral liquid to allow for dose adjustments
-Moderate renal impairment; Start on a lower dose; no specific doses suggested
-Severe renal impairment: Starting dose should be even lower; no specific doses suggested
Extended-release tablets:
-Moderate hepatic impairment: Initial dose: give 25% of the normal initial dose; closely monitor for respiratory and CNS depression during initiation and dose escalation
-Severe hepatic impairment: Alternative analgesics are recommended.

Parenteral:
-Depending on the extent of impairment: Initial dose should be one-fourth to one-half the usual dose

Dose Adjustments

Elderly patients: Closely monitor for respiratory and CNS depression during initiation and dose escalation

In general, opioids used regularly should not be abruptly discontinued.

Cessation of therapy in the opioid-tolerant patient:
-Taper extended-release gradually by 25% to 50% every 2 or 3 days down to a dose of 8 mg per day before discontinuation to prevent signs and symptoms of withdrawal.

Precautions

US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for EXTENDED-RELEASE (ER) AND LONG-ACTING (LA) OPIOID ANALGESICS including EXALGO and Hydromorphone Hydrochloride Extended-Release Tablets. This Shared System includes a medication guide and elements to assure safe use. For additional information: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

US BOXED WARNINGS: ADDICTION, ABUSE, and MISUSE: This drug 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, and monitor all patients regularly for the development of these behaviors or conditions.
LIFE-THREATENING RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase. Instruct patients to swallow extended-release tablets whole; crushing, chewing or dissolving can cause rapid release and absorption of a potentially fatal dose.
ACCIDENTAL INGESTION: Accidental ingestion of even 1 dose of the extended-release tablet, especially by children, can result in a fatal overdose.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of this drug 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.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

To avoid medication errors, prescribers and pharmacists must be aware that hydromorphone is available as both immediate-release 8 mg and extended-release 8 mg tablets.

Administration advice:
Parenteral:
-May be administered IM, IV, or subcutaneously; if administered IV, give slowly over at least 2 to 3 minutes.
-High-Potency (HP) injection should be used in opioid tolerant patients only.
Oral:
-May take with or without food;
-Extended-release tablets:
-Must be taken whole; do not cut, break, chew, dissolve, or crush
-The non-dissolvable shell of the extended-release product may appear in the stool
-If a dose is missed, take your next dose at your usual time the next day.

Storage requirements: Protect from light (injection and suppository)

General:
-The extended-release tablets should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of pain.
-Because of the greater risk of overdose and death with extended-release formulations, the extended-release tablet should only be used in patients for whom alternative treatment options are ineffective, not tolerated, or would otherwise be inadequate to provide sufficient pain management.
-For patients receiving other opioid analgesics and switching to this drug or the extended-release tablet formulation, it is safer to underestimate a patient's 24-hour oral requirement and provide rescue medication than overestimate and manage an adverse reaction; there is substantial inter-patient variation in the relative potency of different opioid drugs that conversion tables are not able to capture.
-During chronic therapy, periodically reassess the continued need for opioid analgesics.
-The extended-release tablet should not be used as an as-needed pain medication.

Monitoring:
-Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dose increases.
-Monitor all patients regularly for the development of addiction, abuse, and misuse.
-Monitor patients for signs of hypotension upon initiating therapy and following dose increases, especially those whose blood pressure is compromised.
-Monitor for constipation and decreased bowel motility in post-operative patients

Patient advice:
-Advise patients to store this drug safely out of the sight and reach of children; accidental use by a child is a medical emergency and can result in death.
-Advise patients that this drug, even when taken as recommended can result in addiction, abuse, and misuse; instruct patients not to share their drug with others and protect their drug from theft or misuse.
-Patients should understand the risks of life-threatening respiratory depression, and be informed as to when this risk is greatest.
-This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery until adverse effects are determined.
-Women of child bearing potential should understand that prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome and that prompt recognition and treatment will be necessary.
-Patients should be instructed in proper disposal.

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