OPANA ER CII
Generic Name and Formulations:
Oxymorphone HCl 5mg, 7.5mg, 10mg, 15mg, 20mg, 30mg, 40mg; ext-rel tabs.
Indications for OPANA ER:
Moderate-to-severe pain when the use of a continuous, around-the-clock opioid is required for an extended period of time. Not for use: as an as-needed (prn) analgesic, for pain that is mild or not expected to persist for an extended period of time, for acute pain, or for postoperative pain unless already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate-to-severe and persist for an extended period of time.
Adult Dose for OPANA ER:
Individualize. Take on empty stomach. May give Opana as needed on an every 4–6 hrs schedule; Opana ER is given on a continuous basis every 12hrs. ≥18yrs: Opioid-naive: Opana: 5–20mg every 4–6 hrs as needed. Opana ER: Swallow whole; 5mg every 12 hrs, titrate by 5–10mg every 12 hours every 3–7 days; if breakthrough pain occurs: adjust dose or use a small-dose rescue medication (eg, immediate-release oxymorphone). Converting from Opana to Opana ER: Give half the total daily Opana dose as Opana ER every 12 hrs. Converting from parenteral oxymorphone, or other opioids to Opana or Opana ER: see full labeling. Mild hepatic impairment, renal impairment (CrCl <50mL/min), or elderly (≥65yrs): opioid-naive: initiate with 5mg dose; opioid-experience: initiate at 50% lower than normal starting dose and titrate slowly. Concomitant other CNS depressants: reduce initial dose.
Children's Dose for OPANA ER:
<18yrs: not established.
Significant respiratory depression. Acute or severe bronchial asthma. Hypercarbia. Known or suspected paralytic ileus. Moderate-to-severe hepatic impairment.
Abuse potential. Life-threatening respiratory depression; monitor first 24–72hrs after initiating therapy and during dose increases. Accidental ingestion may cause fatal overdose (esp. in children). Head injury. Increased intracranial pressure. CNS depression. Impaired consciousness or coma. Convulsive disorders. Shock. Impaired pulmonary, hepatic, or renal function. GI obstruction. COPD. Cor pulmonale. Biliary tract disease. Acute pancreatitis. Acute alcoholism. Avoid abrupt cessation. Re-evaluate periodically. Drug abusers. Elderly. Cachectic. Debilitated. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended.
Co-ingestion of alcohol may cause fatal overdose; avoid. Potentiates CNS depression with benzodiazepines, barbiturates, other CNS depressants and other psychoactive substances (avoid). Possible withdrawal symptoms with mixed agonist/antagonist opioids (eg, pentazocine, nalbuphine, butorphanol); avoid. Paralytic ileus with anticholinergics. Potentiated by cimetidine; monitor.
Constipation, GI upset, dizziness, somnolence, pruritus, headache, sweating increased, dry mouth, sedation, insomnia, fatigue, appetite decreased, abdominal pain; hypotensive effects, CNS and respiratory depression, seizures.
Opana ER—60; Opana—100
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