High Alert Medication: This medication bears a heightened risk of causing significant patient harm when it is used in error.
- Opana ER
Controlled Substance Schedule: II
Moderate to severe pain in patients who require opioid treatment. Extended-release tablets should only be used in patients who require continuous 24–hr management of chronic pain.
Binds to opioid receptors in the CNS. Alters the perception of and the response to pain, while producing generalized CNS depression.
Absorption: 10% absorbed following oral administration. Food and alcohol significantly ↑absorption (38%).
Distribution: Crosses the placenta.
Metabolism and Excretion: Mostly metabolized by the liver; at least 2 metabolites are pharmacologically active, <1% excreted unchanged in urine.
Half-life: 7–9.5 hr.
- Concurrent alcohol
- Moderate/severe hepatic impairment
- Respiratory depression (unless monitoring and resuscitative equipment are readily available)
- Known/suspected paralytic ileus.
Use Cautiously in:
- Acute alcoholism or delirium tremens or other toxic psychoses
- Mild hepatic impairment
- Head injury/increased intracranial pressure (may obscure neurologic signs and further increase pressure)
- Volume depletion or drugs that may cause hypotension including diuretics and phenothiazines (may increase the risk of severe hypotension)
- Geri: Blood levels are ↑; dose accordingly
- Circulatory shock (may increase the risk of severe hypotension)
- Adrenocortical insufficiency
- Prostatic hyperplasia or ureteral stricture
- Sever pulmonary or renal impairment
- Biliary tract disease or pancreatitis
- OB: Use only in pregnancy if maternal benefit outweighs fetal risk; may enter breast milk and increase the risk of sedation/respiratory depression in infant.
Exercise Extreme Caution in:
Conditions association with hypoxia, hypercapnea, decreased respiratory reserve (including asthma, COPD, cor pulmonale, morbid obesity, sleep apnea, myxedema, kyphoscoliosis, CNS depression and coma).
Adverse Reactions/Side Effects
CNS: drowsiness, confusion, dizziness, headache
Resp: RESPIRATORY DEPRESSION, hypoxia
CV: , hypotension, tachycardia
GI: nausea, abdominal distention, constipation, dry mouth, flatulence, ileus, vomiting
Derm: itching, ↑ sweating
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
- Concurrent use of alcohol may ↑ blood levels and effects and should be avoided.
- ↑ risk of CNS depression, hypotension and respiratory depression with alcohol, other opioids or CNS depressants including sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, or sedating antihistamines; may initiate therapy with 1/2 to 1/2 usual starting dose.
- Drugs that may cause volume depletion or hypotension including diuretics, phenothiazines may ↑ risk of severe hypotension.
- Concurrent use of mixed agonist/antagonist opioid analgesics may ↓ analgesia and ↑ risk of opioid withdrawal.
PO: (Adults) Opioid-naive patients– 10–20 mg every 4–6 hr, some patients may require initial dose of 5 mg, not to exceed 20 mg. Once optimal analgesia is obtained, chronic pain patients may be converted to an equivalent 24 hour dose given as extended release tablets every 12 hr.
Tablets (Opana): 5 mg, 10 mg
Extended-release tablets (Opana ER): 5 mg, 10 mg, 20 mg, 40 mg
- Assess type, location, and intensity of pain prior to and 1 hr (peak) after administration. When titrating opioid doses, increases of 25–50% should be administered until there is either a 50% reduction in the patient's pain rating on a numerical or visual analog scale or the patient reports satisfactory pain relief. A repeat dose can be safely administered at the time of the peak if previous dose is ineffective and side effects are minimal.
- Patients taking controlled-release tablets should also be given supplemental short-acting opioid doses for breakthrough pain.
- An equianalgesic chart (see equianalgesic dosing guidelines) should be used when changing routes or when changing from one opioid to another.
- Assess BP, pulse, and respirations before and periodically during administration. If respiratory rate is <10/min, assess level of sedation. Physical stimulation may be sufficient to prevent significant hypoventilation. Dose may need to be decreased by 25–50%. Initial drowsiness will diminish with continued use.
- Prolonged use may lead to physical and psychological dependence and tolerance. This should not prevent patient from receiving adequate analgesia. Most patients who receive oxymorphone for pain do not develop psychological dependence. Progressively higher doses may be required to relieve pain with long-term therapy.
- Assess bowel function routinely. Prevention of constipation should be instituted with increased intake of fluids and bulk, and laxatives to minimize constipating effects. Stimulant laxatives should be administered routinely if opioid use exceeds 2–3 days, unless contraindicated.
Lab Test Considerations:
May increase↑ plasma amylase and lipase levels.Toxicity Overdose:
If an opioid antagonist is required to reverse respiratory depression or coma, naloxone (Narcan) is the antidote. Dilute the 0.4-mg ampule of naloxone in 10 mL of 0.9% NaCl and administer 0.5 mL (0.02 mg) by direct IV push every 2 min. For children and patients weighing <40 kg, dilute 0.1 mg of naloxone in 10 mL of 0.9% NaCl for a concentration of 10 mcg/mL and administer 0.5 mcg/kg every 2 min. Titrate dose to avoid withdrawal, seizures, and severe pain.
- High Alert:Accidental overdosage of opioid analgesics has resulted in fatalities. Before administering, clarify all ambiguous orders; have second practitioner independently check original order and dose calculations.
- Explain therapeutic value of medication prior to administration to enhance the analgesic effect.
- Regularly administered doses may be more effective than PRN administration. Analgesic is more effective if given before pain becomes severe.
- Coadministration with nonopioid analgesics may have additive analgesic effects and may permit lower doses.
- Medication should be discontinued gradually after long-term use to prevent withdrawal symptoms.
- PO: Administer at least 1 hr prior to or 2 hrs after eating.
- Controlled-release tablets should be swallowed whole; do not crush, break, or chew.
- Controlled Release: Patients should be titrated to mild to no pain with the regular use of no more than 2 doses of supplemental analgesia (rescue) per 24 hrs. Dose should be based on 24-hr opioid requirement determined with short-acting opioids then converted to controlled-release form.
- If patient is opioid-naive, start with 5 mg every 12 hrs, then titrate in increments of 5–10 mg every 12 hrs every 3–7 days to a level that provides adequate analgesia with minimal side effects.
- If converting from Opana to Opana ER, administer half the patient's total daily dose of Opana as Opana ER every 12 hrs.
- If converting from parenteral oxymorphone, administer 10 times the patient's total daily parenteral oxymorphone dose as Opana ER in two equally divided doses every 12 hrs.
- If converting from other opioids, 10 mg of oral oxymorphone is equianalgesic to hydrocodone 20 mg, oxycodone 20 mg, methadone 20 mg, and morphine 30 mg orally.
- Instruct patient on how and when to ask for pain medication.
- Instruct patient to take oxymorphone as directed and not to adjust dose without consulting health care professional. Take missed doses as soon as possible. If almost time for next dose, skip dose and return to regular schedule. Do not double doses unless advised by health care professional. Do not stop taking oxymorphone abruptly, may cause withdrawal symptoms. Discontinue gradually under supervision of health care professional. Caution patient to keep medication out of reach of children and pets.
- Caution patient not to share this medication; may cause harm or death and is against the law.
- Medication may cause drowsiness or dizziness. Advise patient to call for assistance when ambulating or smoking. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
- Advise patient to make position changes slowly to minimize orthostatic hypotension.
- Advise patient to avoid concurrent use of alcohol or other CNS depressants with this medication.
- Caution patient not to take any new Rx, OTC, or herbal products without notifying health care professional.
- Encourage patient to turn, cough, and breathe deeply every 2 hr to prevent atelectasis.
- Advise patient to notify health care professional if pregnancy is planned or suspected.
Decrease in severity of pain without a significant alteration in level of consciousness or respiratory status.
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