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Oxymorphone Dosage

Applies to the following strength(s): 5 mg ; 10 mg ; 20 mg ; 40 mg ; 7.5 mg ; 15 mg ; 30 mg ; 1 mg/mL ; 1.5 mg/mL

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Pain

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time; each patient should be managed individually.

ORAL:
Patients Who Are Not Opioid-Experienced:
-Initial dose: 10 to 20 mg orally every 4 to 6 hours; may consider 5 mg orally every 4 to 6 hours if deemed necessary
-Maintenance dose: Titrate cautiously to an acceptable level of analgesia taking into account the pain intensity and side effects experienced.

Conversion from Injection to Oral:
-Administering 10 times the total daily parenteral dose in 4 to 6 equally divided oral oxymorphone doses.

Conversion from Other Oral Opioids to Oral Oxymorphone:
-Determine equipotent dose using published potency tables; it is safest to start therapy by administering one-half the calculated total daily oxymorphone requirement in 4 to 6 equally divided oral doses every 4 to 6 hours and gradually adjust dose as needed.

Comments:
-The oxymorphone 5 mg tablet strength is available as both immediate-release and extended-release; it is important to clarify which product is being used.
-Initiation of therapy with oral doses higher than 20 mg is not recommended because of potential serious side effects.
-Dose conversion should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response.
-Upon cessation of therapy, taper gradually in physically dependent patient.

Use: For the relief of moderate to severe pain where the use of an opioid is appropriate.

PARENTERAL:
Initial dose: 0.5 mg IV or 1 mg to 1.5 mg IM/subcutaneously every 4 to 6 hours as needed
Maintenance dose: Titrate cautiously to an acceptable level of analgesia taking into account the pain intensity and side effects experienced.

Conversion from Oral to Injection
-Patients receiving oral oxymorphone may be converted to injection by administering one-tenth the total daily oral dose in 4 to 6 equally divided parenteral doses.

Comments:
-Doses are adjusted to an acceptable level of analgesia taking into account the pain intensity and side effects experienced.
-Dose conversion should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response.

Uses:
-For the relief of moderate to severe pain where the use of an opioid is appropriate.
-For relief of anxiety in patients with dyspnea associated with pulmonary edema secondary to acute left ventricular dysfunction.

Usual Adult Dose for Labor Pain

Initial dose: 0.5 mg to 1 mg intramuscularly

Comments: Use caution during labor as opioids are known to cross the placenta and may produce respiratory depression in neonates; monitor neonates closely for signs of respiratory depression.

Use: For obstetrical analgesia.

Usual Adult Dose for Chronic Pain

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time; each patient should be managed individually.

Use as the First Opioid Analgesic or for those who are NOT Opioid Tolerant:
Initial dose: Extended-release tablets: 5 mg orally every 12 hours

CONVERSION DOSES:
Immediate-Release Oxymorphone to Extended-Release Oxymorphone Tablets:
-Administer one-half the patient's total daily immediate-release requirement as extended-release tablet taken orally every 12 hours

Parenteral Oxymorphone to Extended-Release Oxymorphone:
-Give 10 times the patient's total daily parenteral oxymorphone dose as extended-release tablet taken in 2 equally divided doses orally every 12 hours.

From Other Oral Opioids to Oxymorphone Extended-Release Tablets:
-Discontinue all other around-the-clock opioid drugs when oxymorphone extended-release therapy is initiated.
-Published potency tables can be used to estimate a patient's 24-hour oral oxymorphone requirement; however, due to substantial inter-patient variability, the conversion should then underestimate a patient's 24-hour requirement and provide rescue medication as the dose is titrated.
-Alternatively, the following conversion factors (CF) may be used to convert selected oral opioids to the extended-release oxymorphone tablet: Oxymorphone, CF=1; Hydrocodone, CF=0.5; Oxycodone, CF=0.5; Methadone, CF= 0.5, Morphine, CF=0.333
-As an example: Sum the total daily dose of prior oral opioid; multiply that sum by the CF to obtain 24-hour oral oxymorphone requirement; divide by 2 to calculate approximate starting dose to be given every 12 hours, round down, if necessary.
-These CFs cannot be used to convert from oxymorphone extended-release tablets to the selected oral opioid as doing so will result in overestimation of the oral opioid dose and may result in fatal respiratory depression

TITRATION AND MAINTENANCE:
Maintenance Dose: Individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; dose adjustments may be made in 5 to 10 mg increments every 12 hours, every 3 to 7 days.
Breakthrough Pain: If the level of pain increases after dose stabilization, attempt to identify the source before increasing dose; rescue medication with appropriate immediate-release analgesia may be helpful

Comments:
-An opioid tolerant patient is one who has been receiving for 1-week or longer at least: oral morphine 60 mg/day, fentanyl transdermal patch 25 mcg per hour, oral oxycodone 30 mg/day, oral hydromorphone 8 mg/day, oral oxymorphone 25 mg/day, or an equianalgesic dose of another opioid
-When converting from methadone, close monitoring is of particular importance due to methadone's long half-life.
-Dose conversion should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response.
-Upon cessation of therapy, taper gradually in physically dependent patient.

Use: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Renal Dose Adjustments

Moderate to severe renal impairment: Use with caution starting at the lowest dose and titrate slowly while monitoring for signs and symptoms of respiratory and CNS depression.

Extended-release tablets:
Opioid-naive with CrCl less than 50 mL/min: Initial dose: 5 mg orally every 12 hours
Opioid-experienced with CrCl less than 50 mL/min: Initial dose: 50% lower than starting dose for patients with normal function, titrate slowly while monitoring for signs and symptoms of respiratory and CNS depression.

Liver Dose Adjustments

Moderate to severe hepatic impairment: Use is contraindicated
Mild hepatic impairment: titrate slowly while monitoring for signs and symptoms of respiratory and CNS depression.

Extended-release tablets:
Opioid-naive with mild hepatic impairment: Initial dose: 5 mg orally every 12 hours
Opioid-experienced with mild hepatic impairment: Initial dose: 50% lower than starting dose for patients with normal function, titrate slowly while monitoring for signs and symptoms of respiratory and CNS depression.

Dose Adjustments

Elderly:
Immediate-release: Use with caution starting at the lowest dose and titrate slowly while monitoring for side effects.
Extended-release tablets:
Initial dose: 5 mg orally every 12 hours; titrate slowly while monitoring for signs and symptoms of respiratory and CNS depression.

Use with CNS depressants:
-This drug should be started at one-third to one-half of the usual dose in patients concurrently receiving other CNS depressants.

Cessation of Therapy:
-In the physically dependent patient, a gradual downward dose titration every 2 to 4 days is recommended to prevent signs and symptoms of withdrawal.

Precautions

US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for EXTENDED-RELEASE (ER) AND LONG-ACTING (LA) OPIOID ANALGESICS including OPANA ER. This Shared System includes a medication guide and elements to assure safe use. For additional information: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

US BOXED WARNINGS: ADDICTION, ABUSE, and MISUSE: This drug exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing, and monitor all patients regularly for the development of these behaviors or conditions.
LIFE-THREATENING RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase. Instruct patients to swallow extended-release tablets whole; crushing, chewing or dissolving can cause rapid release and absorption of a potentially fatal dose of oxymorphone.
ACCIDENTAL INGESTION: Accidental ingestion of even 1 dose of the extended-release tablet, especially by children, can result in a fatal overdose of oxymorphone.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of this drug during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
INTERACTION WITH ALCOHOL: Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking this drug. The co-ingestion of alcohol with this drug may result in increased plasma levels and a potentially fatal overdose of oxymorphone.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

Administration advice: To avoid medication errors, prescribers and pharmacists must be aware that oxymorphone is available as both immediate-release 5 mg and 10 mg tablets and extended-release 5 mg and 10 mg tablets.
Oral:
-Take tablets on an empty stomach, at least 1 hour before or 2 hours after eating
-If a dose is missed, take it as soon as possible; if it is almost time for the next dose, skip the missed dose and return to the regular dosing schedule
-Extended-release tablets must be taken whole; do not cut, break, chew, dissolve, or crush
-Extended-release tablets should be taken 1 at a time with enough water to ensure complete swallowing; do not pre-soak, lick, or otherwise wet the tablet before placing in the mouth
Parenteral:
-May be administered IM, IV, or subcutaneously

Storage requirements: Protect injection from light

General:
-This drug should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
-Because of the greater risk of overdose and death with extended-release formulations, the extended-release tablet should only be used in patients for whom alternative treatment options are ineffective, not tolerated, or would otherwise be inadequate to provide sufficient pain management.
-For patients receiving other opioid analgesics and switching to this drug or the extended-release tablet formulation, it is safer to underestimate a patient's 24-hour oral requirement and provide rescue medication than overestimate and manage an adverse reaction; there is substantial inter-patient variation in the relative potency of different opioid drugs that conversion tables are not able to capture.
-During chronic therapy, periodically reassess the continued need for opioid analgesics.
-The extended-release tablet should not be used as an as-needed pain medication.

Monitoring:
-Monitor closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dose increases.
-Monitor regularly for the development of addiction, abuse, and misuse.
-Monitor for signs of hypotension upon initiating therapy and following dose increases, especially in those whose blood pressure is compromised.
-Monitor for constipation and decreased bowel motility in post-operative patients.

Patient advice:
-Advise patients to store this drug safely out of the sight and reach of children; accidental use by a child is a medical emergency and can result in death.
-Advise patients that this drug, even when taken as recommended can result in addiction, abuse, and misuse; instruct patients not to share their drug with others and protect their drug from theft or misuse.
-Patients should understand the risks of life-threatening respiratory depression, and be informed as to when this risk is greatest.
-Instruct patients not to consume alcoholic beverages, or prescription and non-prescription products that contain alcohol as this may result in increased oxymorphone levels.
-This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery until adverse effects are determined.
-Women of child bearing potential should understand that prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome and that prompt recognition and treatment will be necessary.
-Patients should be instructed in proper disposal.

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