|fdaLIADAdult=Hydromorphone hydrochloride is indicated for the relief of moderate to severe pain such as that due to:
* Dosing Information
:*[[Surgery]]
:*[[Trauma]]
(Soft tissue and bone)
:*[[Burns]]
:*[[Cancer]]
:*[[Biliary Colic]]
:*[[Myocardial Infarction]]
:*[[Renal Colic]]
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
:* Dosage
=====Condition2=====
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
* Dosing Information
:* Dosage
=====Condition3=====
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
* Dosing Information
:* Dosage
=====Condition4=====
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
* Dosing Information
:* Dosage
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Adult)-->
<!--Guideline-Supported Use (Adult)-->
|contraindications=* Hydromorphone hydrochloride is contraindicated in patients with a known [[hypersensitivity]] to hydromorphone; in the presence of an intracranial lesion associated with increased intracranial pressure; and whenever ventilatory function is depressed ([[chronic obstructive pulmonary disease]], [[cor pulmonale]], [[emphysema]], [[kyphoscoliosis]], [[status asthmaticus]]).
|offLabelAdultGuideSupport======Condition1=====
|warnings='''Respiratory Depression''':
* Developed by:
* Hydromorphone hydrochloride produces dose-related respiratory depression by acting directly on brain stem respiratory centers. Hydromorphone hydrochloride also affects centers that control respiratory rhythm, and may produce irregular and periodic breathing.
* Class of Recommendation:
'''Head Injury and Increased Intracranial Pressure''':
* Strength of Evidence:
* The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce effects which may obscure the clinical course of patients with head injuries.
* Dosing Information
'''Acute Abdominal Conditions''':
:* Dosage
* The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=* Condition1
<!--Warnings-->
|warnings=* Description
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
|drugInteractions=* Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, tranquilizers, sedative-hypnotics, [[tricyclic antidepressants]] or other [[CNS depressants]] (including [[alcohol]]) concomitantly with hydromorphone hydrochloride may exhibit an additive [[CNS depression]]. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
|useInPregnancyFDA='''Pregnancy Category C'''
* Hydromorphone hydrochloride has been shown to be teratogenic in hamsters when given in doses 600 times the human dose. There are no adequate and well-controlled studies in pregnant women. Hydromorphone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
=====Urogenital=====
'''Nonteratogenic Effects''':
* Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritablity 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. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7 to 1.0 mg/kg q6h, phenobarbital 2 mg/kg q6h, and paregoric 2 to 4 drops/kg q4h, have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, with the dosages decreased as tolerated.
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=* As with all narcotics, administration of hydromorphone hydrochloride to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=* It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydromorphone hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=* Safety and effectiveness in children have not been established.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
Line 324:
Line 141:
<!--Brand Names-->
<!--Brand Names-->
|brandNames=* HYDROMORPHONE HYDROCHLORIDE®<ref>{{Cite web | title =hydromorphone hydrochloride suppository|url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1bfbba46-1979-4797-a29e-d67718131686 }}</ref>
|brandNames=* HYDROMORPHONE HYDROCHLORIDE®<ref>{{Cite web | title =hydromorphone hydrochloride suppository|url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1bfbba46-1979-4797-a29e-d67718131686 }}</ref>
|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>
|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>
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Hydromorphone (rectal) is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Hydromorphone hydrochloride is indicated for the relief of moderate to severe pain such as that due to:
Hydromorphone hydrochloride produces dose-related respiratory depression by acting directly on brain stem respiratory centers. Hydromorphone hydrochloride also affects centers that control respiratory rhythm, and may produce irregular and periodic breathing.
Head Injury and Increased Intracranial Pressure:
The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce effects which may obscure the clinical course of patients with head injuries.
Acute Abdominal Conditions:
The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Hydromorphone (rectal) in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Hydromorphone (rectal) in the drug label.
Drug Interactions
Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, tranquilizers, sedative-hypnotics, tricyclic antidepressants or other CNS depressants (including alcohol) concomitantly with hydromorphone hydrochloride may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
Hydromorphone hydrochloride has been shown to be teratogenic in hamsters when given in doses 600 times the human dose. There are no adequate and well-controlled studies in pregnant women. Hydromorphone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects:
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritablity 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. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7 to 1.0 mg/kg q6h, phenobarbital 2 mg/kg q6h, and paregoric 2 to 4 drops/kg q4h, have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, with the dosages decreased as tolerated.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hydromorphone (rectal) in women who are pregnant.
Labor and Delivery
As with all narcotics, administration of hydromorphone hydrochloride to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydromorphone hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in children have not been established.
Geriatic Use
There is no FDA guidance on the use of Hydromorphone (rectal) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Hydromorphone (rectal) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Hydromorphone (rectal) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Hydromorphone (rectal) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Hydromorphone (rectal) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Hydromorphone (rectal) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Hydromorphone (rectal) in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Hydromorphone (rectal) in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Hydromorphone (rectal) in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Hydromorphone (rectal) in the drug label.
Pharmacology
There is limited information regarding Hydromorphone (rectal) Pharmacology in the drug label.
01.png){kind=link}