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Hydromorphone (rectal) is an analgesic that is FDA approved for the treatment of pain. Common adverse reactions include anxiety, fear, dysphoria, dizziness, Orthostatic hypotension,urinary retention, nausea, vomiting and pruritus.
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 Suppositories (3 mg) may provide longer duration of relief which could obviate additional medication during the sleeping hours. The usual adult dose is one (1) suppository inserted rectally every 6 to 8 hours or as directed by physician.
Off-Label Use and Dosage (Adult)
There is limited information regarding Off-Label Guideline-Supported Use of Hydromorphone (rectal) in adult patients.
There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydromorphone (rectal) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Hydromorphone (rectal) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
There is limited information regarding Off-Label Guideline-Supported Use of Hydromorphone (rectal) in pediatric patients.
There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydromorphone (rectal) in pediatric patients.
- 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).
- 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.
Clinical Trials Experience
Central Nervous System:
- Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes.
- Nausea, and vomiting occur infrequently; they are more frequent in ambulatory than in recumbent patients. The antiemetic phenothiazines are useful in suppressing these effects; however, some phenothiazine derivatives seem to be antianalgesic and to increase the amount of narcotic required to produce pain relief, while other phenothiazines reduce the amount of narcotic required to produce a given level of analgesia. Prolonged administration of hydromorphone hydrochloride may produce constipation. Opiate agonist-induced increase in intraluminal pressure may endanger surgical anastomosis.
- Circulatory depression, peripheral circulatory collapse and cardiac arrest have occurred after rapid intravenous injection. Orthostatic hypotension and fainting may occur if a patient stands up suddenly after receiving an injection of hydromorphone hydrochloride.
- Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported.
- 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. If significant respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride. The usual adult dose of 0.4 to 0.8 mg given intramuscularly or intravenously, promptly reverses the effects of morphine-like opioid agonists such as hydromorphone hydrochloride. In patients who are physically dependent, small doses of naloxone may be sufficient not only to antagonize respiratory depression, but also to precipitate withdrawal phenomena. The dose of naloxone should therefore be adjusted accordingly in such patients. SInce the duration of action of hydromorphone hydrochloride may exceed that of the antagonist, the patient should be kept under continued surveillance; repeated doses of the antagonist may be required to maintain adequate respiration. Apply other supportive measures when indicated.
There is limited information regarding Postmarketing Experience of Hydromorphone (rectal) in the drug label.
- 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.
Use in Specific Populations
Pregnancy Category (FDA): 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.
- 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.
- 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.
- Safety and effectiveness in children have not been established.
There is no FDA guidance on the use of Hydromorphone (rectal) with respect to geriatric patients.
There is no FDA guidance on the use of Hydromorphone (rectal) with respect to specific gender populations.
There is no FDA guidance on the use of Hydromorphone (rectal) with respect to specific racial populations.
There is no FDA guidance on the use of Hydromorphone (rectal) in patients with renal 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.
There is no FDA guidance one the use of Hydromorphone (rectal) in patients who are immunocompromised.
Administration and Monitoring
There is limited information regarding Monitoring of Hydromorphone (rectal) in the drug label.
There is limited information regarding IV Compatibility of Hydromorphone (rectal) in the drug label.
Signs and Symptoms:
- Serious overdosage with hydromorphone hydrochloride is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, particularly the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur.
- Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including hydromorphone hydrochloride. Therefore, naloxone hydrochloride should be administered as described under adverse reactions in conjunction with ventilatory assistance.
- Since the duration of action of hydromorphone hydrochloride may exceed that of the antagonist, the patient should be kept under continued surveillance; repeated doses of the antagonist may be required to maintain adequate respiration. An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated.
|Systematic (IUPAC) name|
|Solubility in water||HCl: 333 mg/mL (20 °C)|
|Bioavailability||Oral: 30–35%, Intranasal: 52–58%|
|Half life||2–3 hours|
|Dependence Liability||Very High|
|Routes||oral, intramuscular, intravenous, subcutaneous, intranasal, rectal, sublingual, transmucosal, buccal, transdermal (experimental)|
Mechanism of Action
- The precise mechanism of action of hydromorphone hydrochloride and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system.
- Hydromorphone hydrochloride , a hydrogenated ketone of morphine, is a narcotic analgesic. It is available in:
- Suppositories (for rectal administration) containing:
- 3 mg hydromorphone hydrochloride in a cocoa butter base with silicone dioxide.
- The structural formula of hydromorphone hydrochloride is:
There is limited information regarding Pharmacodynamics of Hydromorphone (rectal) in the drug label.
There is limited information regarding Pharmacokinetics of Hydromorphone (rectal) in the drug label.
There is limited information regarding Nonclinical Toxicology of Hydromorphone (rectal) in the drug label.
There is limited information regarding Clinical Studies of Hydromorphone (rectal) in the drug label.
- Rectal Suppositories: 3 mg Suppositories
- Boxes of 6 NDC 0574-7224-06
- Hydromorphone Hydrochloride Suppositories should be stored in a refrigerator. Protect from light.
|This pill image is provided by the National Library of Medicine's PillBox.|
Package and Label Display Panel
|This image of the FDA label is provided by the National Library of Medicine.|
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Hydromorphone (rectal) in the drug label.
Precautions with Alcohol
- Alcohol-Hydromorphone (rectal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
- HYDROMORPHONE HYDROCHLORIDE®
Look-Alike Drug Names
- A® — B®
The contents of this FDA label are provided by the National Library of Medicine.
- Coda BA, Rudy AC, Archer SM, Wermeling DP (July 2003). "Pharmacokinetics and bioavailability of single-dose intranasal hydromorphone hydrochloride in healthy volunteers". Anesth. Analg. 97 (1): 117–23, table of contents. doi:10.1213/01.ANE.0000066311.40978.4F. PMID 12818953.
- Vallner JJ, Stewart JT, Kotzan JA, Kirsten EB, Honigberg IL (April 1981). "Pharmacokinetics and bioavailability of hydromorphone following intravenous and oral administration to human subjects". J Clin Pharmacol. 21 (4): 152–6. doi:10.1002/j.1552-4604.1981.tb05693.x. PMID 6165742.
- "hydromorphone hydrochloride suppository".
- "http://www.ismp.org". External link in