Oxymorphone (oral)

Oxymorphone (oral)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Overview

Oxymorphone (oral) is an analgesic opioid that is FDA approved for the {{{indicationType}}} of Anesthesia; AdjunctView additional information.

       Anxiety, Due to dyspnea associated with pulmonary edema caused by acute left ventricular dysfunctionView additional information.
       Obstetric pain
       Pain, acute (Moderate to Severe)
       Pain, chronic (Severe), in patients requiring daily long-term around-the-clock opioid analgesic
       Premedication for anesthetic procedure - Surgical procedure..   Common adverse reactions include Cardiovascular: Hypotension (less than 10% )
   Dermatologic: Pruritus (less than or equal to 15.2% ), Sweating symptom (1% to less than 10% )
   Gastrointestinal: Abdominal pain (1% to less than 10% ), Constipation (4.1% to 27.6% ), Nausea (2.9% to 33.1% ), Vomiting (less than or equal to 15.6% ), Xerostomia (1% to less than 10% )
   Neurologic: Confusion (1% to less than 10% ), Dizziness (5% to 17% ), Headache (4% to 12% ), Somnolence (2% to 19% )
   Respiratory: Dyspnea (1% to less than 10% ), Hypoxia (less than 10% )
   Other: Fatigue (1% to less than 10% ), Fever (1% to 14.2% ).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

be aware oxymorphone 5 mg and 10 mg tablets are available as both immediate- and extended-release formulations [1]. do not discontinue abruptly in the physically dependent patient [2] oral oxymorphone is approximately 10% bioavailable; to convert to parenteral therapy, administer one-tenth the patient's total daily oral oxymorphone dose as the total daily injection dose divided in 4 to 6 doses per day [2] Anesthesia; Adjunct: initially, 1 to 1.5 mg IM or subQ repeated every 4 to 6 hours as needed OR 0.5 mg IV [2] Anxiety, Due to dyspnea associated with pulmonary edema caused by acute left ventricular dysfunction: initially, 1 to 1.5 mg IM or subQ repeated every 4 to 6 hours as needed OR 0.5 mg IV [2] Obstetric pain: 0.5 to 1 mg IM during labor [2] Pain, acute (Moderate to Severe): (immediate release), initially, 5 to 20 mg ORALLY every 4 to 6 hours; MAX initial: 20 mg/dose; titrate based on patient response [3] Pain, acute (Moderate to Severe): initially, 1 to 1.5 mg IM or subQ repeated every 4 to 6 hours as needed OR 0.5 mg IV [2] Pain, chronic (Severe), in patients requiring daily long-term around-the-clock opioid analgesic: initial dose selection must take into account patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [1] Pain, chronic (Severe), in patients requiring daily long-term around-the-clock opioid analgesic: (extended-release) as first opioid analgesic and in patients who are not opioid-tolerant: initiate at 5 mg extended-release ORALLY every 12 hours [1] Pain, chronic (Severe), in patients requiring daily long-term around-the-clock opioid analgesic: (conversion from oral immediate-release oxymorphone) administer one-half total daily immediate-release dose ORALLY every 12 hours [1] Pain, chronic (Severe), in patients requiring daily long-term around-the-clock opioid analgesic: (conversion from parenteral oxymorphone) administer 5 times the patient's total daily parenteral dose ORALLY every 12 hours and monitor closely due to patient variability [1] Pain, chronic (Severe), in patients requiring daily long-term around-the-clock opioid analgesic: (conversion from other oral opioids) underestimate patient's 24-hour oral oxymorphone dose and administer one-half ORALLY every 12 hours while providing rescue medication as needed [1] Pain, chronic (Severe), in patients requiring daily long-term around-the-clock opioid analgesic: (extended-release) maintenance: adjust dose of extended-release tablets in increments of 5 to 10 mg ORALLY every 12 hours every 3 to 7 days [1] Premedication for anesthetic procedure - Surgical procedure: initially, 1 to 1.5 mg IM or subQ repeated every 4 to 6 hours as needed OR 0.5 mg IV [2]

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Oxymorphone in adult patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Oxymorphone in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

safety and efficacy have not been established in pediatric patients younger than 18 years

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Oxymorphone in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Oxymorphone in pediatric patients.

Contraindications

Oxymorphone hydrochloride tablets are contraindicated in patients with a known hypersensitivity to oxymorphone or to any of the other ingredients in oxymorphone hydrochloride tablets, or with known hypersensitivity to morphine analogs such as codeine.

   Oxymorphone hydrochloride tablets are contraindicated in patients with respiratory depression, except in monitored settings and in the presence of resuscitative equipment.
   Oxymorphone hydrochloride tablets are contraindicated in patients with acute or severe bronchial asthma or hypercarbia.
   Oxymorphone hydrochloride tablets are contraindicated in any patient who has or is suspected of having paralytic ileus [see Warnings and Precautions (5.8)].
   Oxymorphone hydrochloride tablets are contraindicated in patients with moderate or severe hepatic impairment [see Warnings and Precautions (5.6)].

Warnings

Respiratory Depression

Respiratory depression is the chief hazard of oxymorphone hydrochloride. Respiratory depression may occur more frequently in elderly or debilitated patients as well as in those suffering from conditions accompanied by hypoxia or hypercapnia, when even moderate therapeutic doses may dangerously decrease pulmonary ventilation.

Administer oxymorphone hydrochloride with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression, or coma. In these patients, even usual therapeutic doses of oxymorphone may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. Consider alternative non-opioid analgesics and use oxymorphone hydrochloride only under careful medical supervision at the lowest effective dose in such patients.

5.2 Misuse, Abuse, and Diversion of Opioids

Oxymorphone hydrochloride tablets contain oxymorphone, a mu opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. Opioid agonists are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This issue should be considered when prescribing or dispensing oxymorphone in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Oxymorphone hydrochloride tablets may be abused by crushing, chewing, snorting, or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death [see Drug Abuse and Dependence (9)].

Oxymorphone hydrochloride tablets may be targeted for theft and diversion. Healthcare professionals should contact their State Medical Board, State Board of Pharmacy, or State Control Board for information on how to detect or prevent diversion of this product, and security requirements for storing and handling of oxymorphone hydrochloride tablets.

Healthcare professionals should advise patients to store oxymorphone hydrochloride tablets in a secure place, preferably locked and out of the reach of children and other non-caregivers.

Concerns about abuse, misuse, diversion and addiction should not prevent the proper management of pain.

5.3 Additive CNS Depressant Effects

The concomitant use of other CNS depressants including other opioids, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, and alcohol with oxymorphone may produce increased depressant effects including hypoventilation, hypotension, profound sedation, coma and death [see Drug Interactions (7.1)].

5.4 Use in Patients With Head Injury and Increased Intracranial Pressure

In the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure, the respiratory depressant effects of opioid analgesics and their potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated. Furthermore, opioid analgesics can produce effects on papillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries.

Administer oxymorphone hydrochloride with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness. Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.

5.5 Hypotensive Effect

Oxymorphone hydrochloride, like all opioid analgesics, may cause severe hypotension in a patient whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents that compromise vasomotor tone. Administer oxymorphone hydrochloride with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

5.6 Hepatic Impairment

A study of extended-release oxymorphone tablets in patients with hepatic disease indicated greater plasma concentrations than in those with normal hepatic function [see Clinical Pharmacology (12.3)]. Use oxymorphone hydrochloride with caution in patients with mild impairment, starting with the lowest dose and titrating slowly while carefully monitoring for side effects [see Dosage and Administration (2.2, 2.5)]. Oxymorphone hydrochloride is contraindicated in patients with moderate or severe hepatic impairment.

5.7 Special Risk Groups

Use oxymorphone hydrochloride with caution in the following conditions: adrenocortical insufficiency (e.g., Addison’s disease), prostatic hypertrophy or urethral stricture, severe impairment of pulmonary or renal function, and toxic psychosis.

Opioids may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings.

5.8 Gastrointestinal Effects

Opioids diminish propulsive peristaltic waves in the gastrointestinal tract. Monitor for decreased bowel motility in post-operative patients receiving opioids. The administration of oxymorphone hydrochloride may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxymorphone hydrochloride is contraindicated in patients with paralytic ileus.

5.9 Use in Pancreatic/Biliary Tract Disease

Oxymorphone hydrochloride, like other opioids, may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.

5.10 Driving and Operating Machinery

Opioid analgesics impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.

Adverse Reactions

Clinical Trials Experience

The following serious adverse reactions are discussed elsewhere in the labeling:

   Respiratory depression [see Warnings and Precautions (5.1)]
   Misuse and abuse [see Warnings and Precautions (5.2) and Drug Abuse and Dependence (9)]
   CNS depressant effects [see Warnings and Precautions (5.3)]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

6.1 Clinical Trials Experience

A total of 591 patients were treated with oxymorphone hydrochloride in controlled clinical trials. The clinical trials consisted of patients with acute post-operative pain (n = 557) and cancer pain (n = 34) trials.

The following table lists adverse reactions that were reported in at least 2% of patients receiving oxymorphone hydrochloride in placebo-controlled trials (acute post-operative pain (N = 557)).

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This image is provided by the National Library of Medicine.

The common (≥ 1% to < 10%) adverse drug reactions reported at least once by patients treated with oxymorphone hydrochloride in the clinical trials organized by MedDRA’s (Medical Dictionary for Regulatory Activities) System Organ Class were and not represented in Table 1:

   Cardiac disorders: tachycardia

   Gastrointestinal disorders: dry mouth, abdominal distention, and flatulence

   General disorders and administration site conditions: sweating increased 

   Nervous system disorders: anxiety and sedation

   Respiratory, thoracic and mediastinal disorders: hypoxia 

   Vascular disorders: hypotension

Other less common adverse reactions known with opioid treatment that were seen < 1% in the oxymorphone hydrochloride trials include the following:

Abdominal pain, ileus, diarrhea, agitation, disorientation, restlessness, feeling jittery, hypersensitivity, allergic reactions, bradycardia, central nervous system depression, depressed level of consciousness, lethargy, mental impairment, mental status changes, fatigue, depression, clamminess, flushing, hot flashes, dehydration, dermatitis, dyspepsia, dysphoria, edema, euphoric mood, hallucination, hypertension, insomnia, miosis, nervousness, palpitation, postural hypotension, syncope, dyspnea, respiratory depression, respiratory distress, respiratory rate decreased, oxygen saturation decreased, difficult micturition, urinary retention, urticaria, vision blurred, visual disturbances, weakness, appetite decreased, and weight decreased.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of oxymorphone hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nervous system disorder: amnesia, convulsion, memory impairment

Drug Interactions

Use With CNS Depressants

The concomitant use of other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol may produce additive CNS depressant effects. Oxymorphone hydrochloride, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dose in patients who are concurrently receiving other central nervous system depressants because respiratory depression, hypotension, and profound sedation, coma and death may result and titrated slowly as necessary for adequate pain relief.

When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced [see Dosage and Administration (2.7) and Warnings and Precautions (5.3)].

7.2 Interactions With Mixed Agonist/Antagonist Opioid Analgesics

Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol, and buprenorphine) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxymorphone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of oxymorphone and/or may precipitate withdrawal symptoms in these patients.

7.3 Cimetidine

CNS side effects have been reported (e.g., confusion, disorientation, respiratory depression, apnea, seizures) following coadministration of cimetidine with opioid analgesics; a causal relationship has not been established.

7.4 Anticholinergics

Anticholinergics or other medications with anticholinergic activity when used concurrently with opioid analgesics may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

7.5 MAO Inhibitors

Oxymorphone hydrochloride is not recommended for use in patients who have received MAO inhibitors within 14 days, because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics. No specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, but caution in the use of any opioid in patients taking this class of drugs is appropriate.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C Pregnancy

The safety of using oxymorphone in pregnancy has not been established with regard to possible adverse effects on fetal development. The use of oxymorphone hydrochloride in pregnancy, in nursing mothers, or in women of child-bearing potential requires that the possible benefits of the drug be weighted against the possible hazards to the mother and the child.

Teratogenic Effects

Pregnancy Category C

There are no adequate and well-controlled studies of oxymorphone in pregnant women. In animal studies, oxymorphone caused decreased fetal and pup weights, an increase in stillbirth, and a decrease in postnatal pup survival at maternal oxymorphone doses equivalent to 0.4 to 4 times the human daily dose of 120 mg (based on body surface area). Oxymorphone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In embryo-fetal developmental toxicity studies, pregnant rats and rabbits received oxymorphone hydrochloride at doses up to about 2 times (rats) and 8 times (rabbits) total human daily dose of 120 mg (based on body surface area). No malformations occurred, but reduced fetal weights occurred at maternal doses of 0.8 (rat) and 4 (rabbit) times the total human daily dose of 120 mg (based on body surface area). There were no adverse developmental effects in rats that received 0.4 times or rabbits that received less than 4 times the total human dose. There were no effects of oxymorphone hydrochloride on intrauterine survival at doses in rats ≤ 2 times, or in rabbits at ≤ 8 times the human dose (see Nonteratogenic Effects, below). In a study conducted prior to the establishment of Good Laboratory Practices (GLP) and not according to current recommended methodology, a single subcutaneous injection of oxymorphone hydrochloride on gestation day 8 produced malformations in offspring of hamsters that received a dose equivalent to 10 times the total human daily dose of 120 mg (based on body surface area). This dose also produced 83% maternal lethality.

Nonteratogenic Effects

Oxymorphone hydrochloride administration to female rats during gestation in a pre- and postnatal developmental toxicity study reduced mean litter size (18%) at a dose of 25 mg/kg/day, attributed to an increase in the incidence of stillborn pups. An increase in neonatal death occurred at doses ≥ 5 mg/kg/day (0.4 times a total human daily dose of 120 mg, based on body surface area). Low pup birth weight, decreased post-natal weight gain, and reduced post-natal survival of pups occurred following treatment of the dams with 25 mg/kg/day (about 2 times a total human daily dose of 120 mg, based on body surface area).

Prolonged use of opioid analgesics during pregnancy may cause fetal-neonatal physical dependence. Neonatal withdrawal may occur. Symptoms usually appear during the first days of life and may include convulsions, irritability, excessive crying, tremors, hyperactive reflexes, fever, vomiting, diarrhea, sneezing, yawning, and increased respiratory rate.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Oxymorphone (oral) in women who are pregnant.

Labor and Delivery

Opioids cross the placenta and may produce respiratory depression in neonates. Oxymorphone hydrochloride is not recommended for use in women during and immediately prior to labor, when use of shorter acting analgesics or other analgesic techniques are more appropriate. Occasionally, opioid analgesics may prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Neonates whose mothers received opioid analgesics during labor should be observed closely for signs of respiratory depression. A specific opioid antagonist, such as naloxone or nalmefene, should be available for reversal of opioid-induced respiratory depression in the neonate.

Nursing Mothers

It is not known whether oxymorphone is excreted in human milk. Because many drugs, including some opioids, are excreted in human milk, caution should be exercised when oxymorphone hydrochloride tablets are administered to a nursing woman. Infants exposed to oxymorphone hydrochloride through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breast-fed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.

Pediatric Use

Safety and effectiveness of oxymorphone hydrochloride in pediatric patients below the age of 18 years have not been established.

Geriatic Use

Oxymorphone hydrochloride should be used with caution in elderly patients [see Clinical Pharmacology (12.3)].

Of the total number of subjects in clinical studies of oxymorphone hydrochloride, 31% were 65 and over, while 7% were 75 and over. No overall differences in effectiveness were observed between these subjects and younger subjects. There were several adverse events that were more frequently observed in subjects 65 and over compared to younger subjects. These adverse events included dizziness, somnolence, confusion, and nausea. In general, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Gender

There is no FDA guidance on the use of Oxymorphone (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Oxymorphone (oral) with respect to specific racial populations.

Renal Impairment

In a study of extended-release oxymorphone tablets, patients with moderate to severe renal impairment were shown to have an increase in bioavailability ranging from 57 to 65% [see Clinical Pharmacology (12.3)]. Such patients should be started cautiously with lower doses of oxymorphone hydrochloride and titrated slowly while monitoring for side effects [see Dosage and Administration (2.6)].

Hepatic Impairment

In a study of extended-release oxymorphone tablets, patients with mild hepatic impairment were shown to have an increase in bioavailability of 1.6 fold. Oxymorphone hydrochloride should be used with caution in patients with mild impairment. These patients should be started with the lowest dose and titrated slowly while carefully monitoring for side effects. Oxymorphone hydrochloride is contraindicated for patients with moderate and severe hepatic impairment [see Contraindications (4), Warnings and Precautions (5.6), and Dosage and Administration (2.5)].

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Oxymorphone (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Oxymorphone (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Oxymorphone (oral) Administration in the drug label.

Monitoring

There is limited information regarding Oxymorphone (oral) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Oxymorphone (oral) and IV administrations.

Overdosage

There is limited information regarding Oxymorphone (oral) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Oxymorphone (oral) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Oxymorphone (oral) Mechanism of Action in the drug label.

Structure

There is limited information regarding Oxymorphone (oral) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Oxymorphone (oral) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Oxymorphone (oral) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Oxymorphone (oral) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Oxymorphone (oral) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Oxymorphone (oral) How Supplied in the drug label.

Storage

There is limited information regarding Oxymorphone (oral) Storage in the drug label.

Images

Drug Images

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Patient Counseling Information

There is limited information regarding Oxymorphone (oral) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Oxymorphone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Oxymorphone (oral) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Oxymorphone (oral) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.