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

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

Warnings

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

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Oxymorphone (oral) in women who are pregnant.
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

There is no FDA guidance on use of Oxymorphone (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Oxymorphone (oral) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Oxymorphone (oral) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Oxymorphone (oral) in geriatric settings.

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

There is no FDA guidance on the use of Oxymorphone (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Oxymorphone (oral) in patients with hepatic impairment.

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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Package and Label Display Panel

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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.