
(ox i mor’ fone)
Opana, Opana ERDNC
PREGNANCY CATEGORY C
CONTROLLED SUBSTANCE C-II
Drug Class
Opioid agonist analgesic
Therapeutic Actions
Semisynthetic derivative of morphine. Acts as agonist at specific opioid receptors in the CNS to produce analgesia, euphoria, sedation; the receptors mediating these effects are thought to be the same as those mediating the effects of endogenous opioids (enkephalins, endorphins).
Indications
Relief of moderate to moderately severe acute pain (immediate-release form)
Parenterally (injection only) for preoperative medication, support of anesthesia, obstetric analgesia
Relief of moderate to severe pain in patients who need around-the-clock opioid treatment for extended time (ER form)
Relief of anxiety in patients with pulmonary edema associated with left ventricular dysfunction (parenteral)
Relief of moderate to severe pain
Contraindications and Cautions
Contraindicated with hypersensitivity to opioids, diarrhea caused by poisoning (before toxins are eliminated), pregnancy (readily crosses placenta; neonatal withdrawal), labor or delivery (opioids given to the mother can cause respiratory depression of neonate; premature infants are at special risk; may prolong labor), bronchial asthma, COPD, cor pulmonale, respiratory depression, anoxia, kyphoscoliosis, acute alcoholism, increased intracranial pressure, lactation.
Use cautiously with acute abdominal conditions, CV disease, supraventricular tachycardias, myxedema, seizure disorders, delirium tremens, cerebral arteriosclerosis, ulcerative
colitis, fever, Addison disease, prostatic hypertrophy, urethral stricture, recent GI or GU surgery, toxic psychosis, renal or hepatic impairment.
Available Forms
Injection—1 mg/mL; tablets—5, 10 mg; ER tabletsDNC—5, 7.5, 10, 20, 30, 40 mg
Dosages
Adults
Oral
For immediate-release form, 10–20 mg PO every 4–6 hr. For ER tablets, 5 mg PO every 12 hr; may be increased in 5- to 10-mg increments every 3–7 days to cover pain.
IV
Initially, 0.5 mg IV.
Subcutaneous or IM
Initially, 1–1.5 IM or subcutaneously mg every 4–6 hr as needed. For analgesia during labor, 0.5–1 mg IM.
Pediatric patients
Safety and efficacy not established for children younger than 18 yr.
Geriatric patients or impaired adults
Use caution; respiratory depression may occur in the elderly, the very ill, and those with respiratory problems. Start at low end of dosage range and titrate slowly.
Patients with renal impairment
For CrCl of less than 50 mL/min, use ER tablets at lowest possible dose.
Pharmacokinetics
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