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| {{DrugProjectFormSinglePage
| | #REDIRECT[[Hydromorphone]] |
| |authorTag={{KS}}
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| |genericName=hydromorphone hydrochloride
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| |aOrAn=an
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| |drugClass=[[opioid]] [[analgesic]]
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| |indicationType=treatment
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| |indication=[[pain]]
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| |hasBlackBoxWarning=Yes
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| |adverseReactions=[[lightheadedness]], [[dizziness]], [[sedation]], [[nausea]], [[vomiting]], [[sweating]], [[flushing]], [[dysphoria]], [[euphoria]], [[dry mouth]], and [[pruritus]]
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| |blackBoxWarningTitle=WARNING: RISK OF RESPIRATORY DEPRESSION, ABUSE, AND MEDICATION ERRORS
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| |blackBoxWarningBody='''HYDROMORPHONE HCl INJECTION (high potency formulation) IS FOR USE IN OPIOID-TOLERANT PATIENTS ONLY'''
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| * 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.
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| * 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.
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| * 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.
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| * 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.
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| |fdaLIADAdult===Indications==
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| * Hydromorphone Hydrochloride Injection, USP is indicated for the management of [[pain]] in patients where an [[opioid]] [[analgesic]] is appropriate.
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| * 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]].
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| ==Dosage==
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| '''General Dosing Considerations'''
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| * '''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'''.
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| * 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.
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| * 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.
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| '''Individualization of Dosing'''
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| * Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment. Give attention to the following:
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| :*The age, general condition, and medical status of the patient;
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| :*The patient's degree of opioid tolerance;
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| :*The daily dose, potency, and specific characteristics of the opioid the patient has been taking previously;
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| :*Concurrent medications
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| :*The type and severity of the patient's pain
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| :*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;
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| :*The balance between pain control and adverse reactions.
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| * 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.
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| '''Initiation of Therapy in Opioid-Naïve Patients'''
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| * '''Always initiate dosing in opioid-naïve patients using hydromorphone hydrochloride injection. Never administer hydromorphone hydrochloride injection (HPF) to opioid-naïve patients'''.
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| '''Subcutaneous or Intramuscular Administration'''
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| * 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.
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| '''Intravenous Administration'''
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| * 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.
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| '''Hepatic Impairment'''
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| * Start patients with hepatic impairment on one-fourth to one-half the usual hydromorphone hydrochloride injection starting dose depending on the extent of impairment.
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| '''Renal Impairment'''
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| * Start patients with renal impairment on one-fourth to one-half the usual hydromorphone hydrochloride injection starting dose depending on the degree of impairment.
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| '''Conversion From Prior Opioid'''
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| * 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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| [[File:Hydromorphone hydrochloride inj tabe1.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
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| * Hydromorphone Hydrochloride Injection (HPF) (for use in opioid-tolerant patients only)
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| * Do not use Hydromorphone Hydrochloride Injection (HPF) for patients who are not tolerant to the respiratory depressant or sedating effects of opioids.
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| * 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.
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| * Use Hydromorphone Hydrochloride Injection (HPF) ONLY for patients who require the higher concentration and lower total volume of Hydromorphone Hydrochloride Injection (HPF).
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| * 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.
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| * 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
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| |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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| |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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| |fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
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| |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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| |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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| |clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
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| |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
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| |useInPregnancyFDA=* '''Pregnancy Category'''
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| |useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
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| There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
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| |useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
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| |useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
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| |useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
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| |useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
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| |useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
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| |useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
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| |useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
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| |useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
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| |useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
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| |useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
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| <!--Administration and Monitoring-->
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| |administration=* Oral
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| * Intravenous
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| |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
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| * Description
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| <!--IV Compatibility-->
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| |IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
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| <!--Overdosage-->
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| |overdose====Acute Overdose===
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| ====Signs and Symptoms====
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| * Description
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| ====Management====
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| * Description
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| ===Chronic Overdose===
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| There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
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| <!--Pharmacology-->
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| <!--Drug box 2-->
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| |drugBox=<!--Mechanism of Action-->
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| |mechAction=*
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| <!--Structure-->
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| |structure=*
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| : [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
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| <!--Pharmacodynamics-->
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| |PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
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| <!--Pharmacokinetics-->
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| |PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
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| <!--Nonclinical Toxicology-->
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| |nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
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| <!--Clinical Studies-->
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| |clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
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| <!--How Supplied-->
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| |howSupplied=*
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| |packLabel=<!--Patient Counseling Information-->
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| |fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
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| <!--Precautions with Alcohol-->
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| |alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
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| <!--Brand Names-->
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| |brandNames=*HYDROMORPHONE HYDROCHLORIDE®<ref>{{Cite web | title =hydromorphone hydrochloride injection | url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4d33b072-0755-4b8c-9558-2551306756a3 }}</ref>
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| |lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
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| <!--Drug Shortage Status-->
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| |drugShortage=
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| }}
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| {{PillImage
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| |fileName=No image.jpg
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| }}
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| {{LabelImage
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| |fileName={{PAGENAME}}11.png
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| }}
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| {{LabelImage
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| |fileName={{PAGENAME}}11.png
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| }}
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| <!--Pill Image-->
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| <!--Label Display Image-->
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| <!--Category-->
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| [[Category:Drug]]
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