Indications for ZOHYDRO ER:
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment (eg, non-opioid analgesics or immediate-release opioids) are inadequate.
Limitations of Use:
Reserve for use in patients for whom alternative treatment options are ineffective, not tolerated, or inadequate to manage pain. Not indicated as an as-needed (prn) analgesic.
Use lowest effective dose for shortest duration. Swallow whole. Individualize. ≥18yrs: Opioid-naïve or opioid non-tolerant: initially 10mg every 12hrs. May increase dose in increments of 10mg every 12hrs every 3–7 days as needed. Severe hepatic impairment: initially 10mg every 12hrs, titrate carefully and monitor. Renal impairment: use low initial dose. Use 50mg ER caps, a single dose >40mg, or a total daily dose >80mg in opioid-tolerant patients only. Conversion from other opioids: see full labeling. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.
<18yrs: not established.
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.
Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Cytochrome P450 3A4 interaction. Risks from concomitant use with benzodiazepines or other CNS depressants. Interaction with alcohol.
Abuse potential (monitor). Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Drug or alcohol abusers. Renal or severe hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.
Avoid alcohol or alcohol-containing products. Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.
Constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, peripheral edema, upper respiratory tract infection, muscle spasms, UTI, back pain, tremor; respiratory depression, severe hypotension, syncope.