oxymorphone hydrochloride

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oxymorphone hydrochloride

Opana, Opana ER, Oxynorm (UK)

Pharmacologic class: Opioid agonist

Therapeutic class: Narcotic analgesic

Controlled substance schedule II

Pregnancy risk category C

FDA Box Warning

• Drug is morphine-like opioid agonist and Schedule II controlled substance, with abuse potential similar to other opioids. This potential must be considered when prescribing or dispensing drug.

• Drug is indicated for managing moderate to severe pain when continuous, around-the-clock opioid is needed for extended period. It isn't intended for as-needed analgesia.

• Instruct patients to swallow extended-release tablets whole. Caution them not to break, chew, dissolve, or crush them, as this causes rapid release and absorption of potentially fatal dose.

• Caution patient not to consume alcoholic beverages or take prescription or nonprescription medications containing alcohol during therapy, as this may increase drug blood levels and cause potentially fatal overdose.


Unknown. Thought to interact with opioid receptor sites primarily in limbic system, thalamus, and spinal cord, blocking pain impulse transmission.


Injection: 1 mg/ml, 1.5 mg/ml

Tablets: 5 mg, 10 mg

Tablets (extended-release): 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg

Indications and dosages

Moderate to severe pain

Adults: 1 to 1.5 mg I.M. or subcutaneously q 4 to 6 hours p.r.n.; or initially, 0.5 mg I.V., increased cautiously until pain relief is satisfactory

To reduce labor pain

Adults: 0.5 to 1 mg I.M.

Initiation of therapy for moderate to severe acute pain in opioid-naïve patients

Adults: 10 to 20 mg (Opana) P.O. q 4 to 6 hours depending on initial pain intensity. If deemed necessary to initiate therapy at lower dose, start with 5 mg. Adjust dosage based on patient's response to initial dose. Dose can then be adjusted to acceptable level of analgesia taking into account pain intensity and adverse effects experienced. For chronic around-the-clock opioid therapy, give 5 mg (Opana ER) q 12 hours; thereafter, individually adjust dosage, preferably at increments of 5 to 10 mg q 12 hours every 3 to 7 days to level that provides adequate analgesia and minimizes side effects; give under close supervision of prescribing physician.

Moderate to severe acute pain when converting from parenteral to oral form in patients requiring continuous, around-the-clock opioid treatment for extended period

Adults: 10 times patient's total daily parenteral oxymorphone dose as Opana, in four or six equally divided doses (for example, approximately 10 mg Opana may be needed to provide pain relief equivalent to total daily I.M. dose of 4 mg oxymorphone); titrate dosage to optimal pain relief or combine with acetaminophen/nonsteroidal anti-inflammatories for optimal pain relief. Or 10 times patient's total daily parenteral oxymorphone dose as Opana ER, in two equally divided doses (for example, approximately 20 mg Opana ER q 12 hours may be needed to provide pain relief equivalent to total daily parenteral dose of 4 mg oxymorphone.

Moderate to severe acute pain when converting from other oral opioids to Opana or Opana ER

Adults: Refer to published relative potency information, keeping in mind that conversion ratios are only approximate. In general, it's safest to start Opana therapy by administering half of calculated total daily dose of Opana in four to six equally divided doses P.O. q 4 to 6 hours. Or, for patients requiring continuous, around-the-clock opioid treatment for extended period, give Opana ER in two divided doses P.O. q 12 hours. Gradually adjust initial dosage of Opana or Opana ER until adequate pain relief and acceptable adverse effects have been achieved.

Moderate to severe acute pain in opioid-experienced patients when converting from Opana to Opana ER

Adults: Administer half patient's total daily oral Opana dose as Opana ER P.O. q 12 hours.

Dosage adjustments

• Mild hepatic impairment (Opana, Opana ER)

• Severe hepatic impairment (Numorphan)

• Moderate to severe renal impairment (Opana, Opana ER)

• Concurrent use of other CNS depressants (Opana, Opana ER)

• Elderly or debilitated patients


• Hypersensitivity to drug or its components, or morphine analogs

• Any situation in which opioids are contraindicated, such as respiratory depression (in absence of resuscitative equipment or in unmonitored settings) and acute or severe bronchial asthma or hypercarbia

• Pulmonary edema secondary to chemical respiratory irritant (Numorphan)

• Suspected or existing paralytic ileus

• Moderate and severe hepatic impairment (Opana, Opana ER)


Use cautiously in:

• head trauma, increased intracranial pressure, severe renal disease, hypothyroidism, adrenal insufficiency, urethral stricture, undiagnosed abdominal pain or prostatic hyperpla-sia, biliary tract disease, pancreatitis, extensive burns, alcoholism

• history of substance abuse

• prolonged or high-dose therapy

• elderly or debilitated patients

• labor and delivery

• pregnant or breastfeeding patients

• Pain in immediate postoperative period (first 12 to 24 hours), or if pain is mild or not expected to persist for extended period (Opana ER)

• Children younger than age 18.


• Give oral on empty stomach at least 1 hour before or 2 hours after eating.

• Tell patient to swallow extended-release tablets whole and not to break, chew, dissolve, or crush tablets.

• Be aware that extended-release tablets are not for p.r.n. use.

• Be aware that extended-release tablets are indicated only for postoperative use if patient had already been receiving drug before surgery or if postoperative pain is expected to be moderate or severe and persist for extended period.

Be aware that administration from any source (such as beverages or drugs) may result in increased plasma drug levels and potentially fatal overdose of oxymorphone.

Keep naloxone available to reverse respiratory depression, if necessary.

• Give I.V. dose by direct injection over 2 to 3 minutes.

Adverse reactions

CNS: somnolence (Opana, Opana ER), sedation, headache, drowsiness, confusion, dysphoria, euphoria, dizziness, hallucinations, lethargy, impaired mental and physical performance, depression, restlessness, insomnia, paradoxical stimulation, seizures

CV: hypotension, orthostatic hypotension, palpitations, bradycardia, tachycardia

EENT: blurred vision, miosis, diplopia, visual disturbances, tinnitus

GI: abdominal distention, flatulence (Opana), abdominal pain, dyspepsia (Opana ER), nausea, vomiting, constipation, biliary tract spasm, cramps, dry mouth, anorexia, paralytic ileus, toxic megacolon

GU: urinary hesitancy or retention, urethral spasm, antidiuretic effect

Respiratory: suppressed cough reflex, hypoxia (Opana), atelectasis, respiratory depression, allergic bronchospastic reaction, allergic laryngeal edema or laryngospasm, apnea

Skin: rash, urticaria, pruritus, facial flushing, diaphoresis

Other: pyrexia (Opana, Opana ER), physical or psychological drug dependence, drug tolerance, allergic reaction, injection site reaction (Numorphan)


Drug-drug. Agonist/antagonist analgesia (such as buprenorphine, butorphanol, nalbuphine, or pentazocine): reduced oxymorphone effect; may precipitate withdrawal symptoms (Opana, Opana ER)

Anticholinergics: increased risk of urinary retention or severe constipation

Antihistamines (first-generation), antipsychotics, barbiturates, general anesthetics, MAO inhibitors, sedative-hypnotics, skeletal muscle relaxants, tricyclic antidepressants: increased risk of respiratory depression

Propofol: increased risk of bradycardia (Numorphan)

Drug-diagnostic tests. Amylase, lipase: increased levels

Drug-behaviors. Alcohol use or abuse, opiate abuse: increased risk of respiratory depression

Patient monitoring

Closely monitor respiratory status. Stay alert for respiratory depression and allergic responses affecting bronchi and larynx.

• Monitor vital signs and ECG.

• With prolonged use, watch for signs and symptoms of drug dependence.

• Assess neurologic status carefully. Institute protective measures as needed.

• Monitor patient receiving Opana or Opana ER for breakthrough pain and adverse reaction (especially severe constipation).

Patient teaching

Instruct patient to immediately report seizures or difficulty breathing.

• Tell patient to rise slowly when changing position, to avoid dizziness from blood pressure decrease.

• Instruct patient taking Opana or Opana ER to report episodes of breakthrough pain and adverse reactions (especially severe constipation that may lead to paralytic ileus).

Advise patient not to drink alcohol from any source because doing so may result in fatal overdose.

• Caution patient not to drive or perform other hazardous activities.

• Tell patient not to stop taking drug suddenly after several weeks, because withdrawal symptoms may occur.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved

oxymorphone hydrochloride

A semisynthetic opioid drug used to treat moderate to severe pain.
The American Heritage® Medical Dictionary Copyright © 2007, 2004 by Houghton Mifflin Company. Published by Houghton Mifflin Company. All rights reserved.
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References in periodicals archive ?
Officials at the agency made the decision after reviewing all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product's reformulation.
The US Food and Drug Administration (FDA) has asked United States-based Endo Pharmaceuticals to withdraw its Opana ER (oxymorphone hydrochloride) from the market, it was reported yesterday.
However, the FTC has refiled its suit against Watson Pharmaceuticals Inc., which made the generic versions of Opana ER and Lidoderm.
Opana ER or oxymorphone is a semisynthetic opioid introduced in 1955 by Endo Pharmaceuticals [1].
Endo International, a global specialty healthcare company, has decided to withdraw its supplemental New Drug Application relating to specific abuse deterrent labelling for OPANA ER without prejudice to re-filing, it is reported today.
As the formulator of OPANA ER, GrA1/4nenthal indemnified Endo for certain intellectual property matters, including Depomed's ongoing patent infringement lawsuit against Endo.
LA/ER OPR were defined as those that should be taken only 2 to 3 times a day, such as methadone, OxyContin, and Opana ER. High-dose OPR were defined as the largest formulations available for each type of OPR that resulted in a total daily dosage of [greater than or equal to] 100 morphine milligram equivalents when taken at the usual frequency, for example, every 4-6 hours.
The Food and Drug Administration (FDA) announced Friday that it will allow the continued sale of generic forms of the prescription pain drug Opana ER, after the agency found that a new form of the drug was not significantly more successful at preventing abuse.
A crush-resistant formulation of hydromorphone (Opana ER) was approved in September 2012.
Release date- 21072011 - Actavis has begun shipping Oxymorphone Hydrochloride Extended-Release Tablets, CII 7.5mg and 15mg, a generic equivalent of Opana ER in the United States.
Oramorph, oxycodone (OxyContin), hydromorphone (Exalgo), transdermal fentanyl (Duragesic), buprenorphine (Butrans), and oxymorphone (Opana ER).