Parenteral Administration
Oxymorphone hydrochloride is administered by subcutaneous, IM, or IV injection. An opiate antagonist and facilities for administration of oxygen and control of respiration should be available during and immediately following IV administration of the drug.
Oral Administration
Oxymorphone hydrochloride is administered orally as conventional tablets and extended-release tablets. Because food affects oral absorption of oxymorphone administered as conventional tablets or extended-release tablets, these preparations should be taken on an empty stomach (i.e., at least 1 hour before or 2 hours after meals). Patients receiving oxymorphone should avoid alcohol; concomitant use may result in profound sedation, respiratory depression, coma, or death.700
Oxymorphone hydrochloride extended-release tablets should be swallowed whole and should not be broken, chewed, or crushed; intake of a broken, crushed, or chewed tablet may result in too rapid a release of the drug from the preparation and absorption of a potentially toxic dose of oxymorphone hydrochloride. Patients receiving oxymorphone hydrochloride extended-release tablets must not consume alcoholic beverages or prescription or nonprescription preparations containing alcohol; intake of alcohol may result in rapid release of the drug from the tablet and intake of a potentially toxic dose of oxymorphone.
Dosage 
Oxymorphone hydrochloride should be given at the lowest effective dosage and for the shortest duration of therapy consistent with the treatment goals of the patient.411,413,431,432,435 Reduced dosage is indicated in poor-risk patients and in geriatric patients. If concomitant therapy with other CNS depressants is required, the lowest effective dosages and shortest possible duration of concomitant therapy should be used.700,703
The manufacturer recommends that initial dosages of 33-50% of the usual dosage be employed when therapy with oxymorphone hydrochloride is initiated in patients receiving other CNS depressants.
For acute pain not related to trauma or surgery, the prescribed quantity should be limited to the amount needed for the expected duration of pain severe enough to require opiate analgesia (generally 3 days or less and rarely more than 7 days).411,433,434,435 When opiate analgesics are used for the management of chronic noncancer pain, the US Centers for Disease Control and Prevention (CDC) recommends that primary care clinicians carefully reassess individual benefits and risks before prescribing dosages equivalent to 50 mg or more of morphine sulfate daily (approximately 17 mg or more of oxymorphone hydrochloride daily) and avoid dosages equivalent to 90 mg or more of morphine sulfate daily (approximately 30 mg or more of oxymorphone hydrochloride daily) or carefully justify their decision to titrate the dosage to such levels.411 Other experts recommend consulting a pain management specialist before exceeding a dosage equivalent to 80-120 mg of morphine sulfate daily.423,431 For further information on the management of opiate analgesic therapy, see Dosage and Administration: Dosage, in the Opiate Agonists General Statement 28:08.08.
Parenteral Administration
The usual initial adult subcutaneous or IM dosage of oxymorphone hydrochloride is 1-1.5 mg every 4-6 hours as necessary. The usual initial IV dose is 0.5 mg. In nondebilitated patients, the dose may be increased cautiously until satisfactory analgesia is attained. The usual dose for analgesia during labor is 0.5-1 mg by IM injection.
Conventional Tablets
For opiate-naive adults, the usual initial dosage of conventional oxymorphone hydrochloride tablets is 10-20 mg every 4-6 hours. Alternatively, therapy can be initiated with 5 mg every 4-6 hours. Dosage should be adjusted according to patient tolerance and response. Therapy should not be initiated with an oxymorphone hydrochloride dose exceeding 20 mg.
Extended-release Tablets
For opiate-naive adults, the usual initial dosage of oxymorphone hydrochloride extended-release tablets is 5 mg every 12 hours. The dosage can be titrated in increments of 5-10 mg every 12 hours every 3-7 days. Dosage should be adjusted according to patient tolerance and response.
Pharmacology
Oxymorphone hydrochloride has little antitussive activity and may be less constipating than morphine. In equianalgesic doses, oxymorphone hydrochloride may cause more nausea, vomiting, and euphoria than does morphine sulfate.
Pharmacokinetics
Oxymorphone is well absorbed following subcutaneous, IM, or IV administration. Onset of action usually occurs within 5-10 minutes after IV administration and 10-15 minutes after subcutaneous or IM administration. Analgesia is maintained for 3-6 hours following parenteral administration.
Following oral administration of oxymorphone hydrochloride, bioavailability is approximately 10%. Following oral administration of oxymorphone hydrochloride conventional tablets with a high-fat meal, peak plasma concentrations and area under the concentration-time curve (AUC) were increased 38%. Following oral administration of oxymorphone hydrochloride extended-release tablets with food, peak plasma concentrations were increased 50%; AUC reportedly was unchanged in one study and increased 18% in another study. Bioavailability of oxymorphone was increased in patients with renal impairment, those with hepatic impairment, and in geriatric individuals following administration as extended-release tablets.
Concomitant administration of oxymorphone hydrochloride extended-release tablets with alcohol has resulted in variable effects on peak plasma concentrations of the drug. Changes in peak plasma concentrations of oxymorphone have ranged from a 50% decrease to a 270% increase. Concomitant administration of oxymorphone with alcohol must be avoided.
Oxymorphone hydrochloride is metabolized primarily in the liver. Like morphine, it probably undergoes conjugation with glucuronic acid and is excreted primarily in urine as oxymorphone glucuronide.
Chemistry and Stability
Chemistry
Oxymorphone hydrochloride is a semisynthetic phenanthrene-derivative opiate agonist. Oxymorphone hydrochloride occurs as a white or slightly off-white powder and is freely soluble in water and sparingly soluble in alcohol. Oxymorphone hydrochloride injection has a pH of 2.7-4.5.
Stability
Oxymorphone hydrochloride injection should be protected from light and stored at 15-30°C; freezing should be avoided. Oxymorphone hydrochloride conventional tablets and extended-release tablets should be stored at 15-30°C.
Additional Information
For further information on the chemistry, pharmacology, pharmacokinetics, uses, cautions, chronic toxicity, acute toxicity, drug interactions, and dosage and administration of oxymorphone hydrochloride, see the Opiate Agonists General Statement 28:08.08.
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