ZOHYDRO ER CII
Generic Name and Formulations:
Hydrocodone bitartrate 10mg, 15mg, 20mg, 30mg, 40mg, 50mg; ext-rel caps; with BeadTek.
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 every 2–4 days.
<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.
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). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). 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 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.
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