Generic Name and Formulations:
Morphine sulfate 10mg/mL, 25mg/mL; soln for continuous microinfusion devices for intrathecal or epidural infusion; preservative-free.
West-Ward Pharmaceutical Corp.
Indications for INFUMORPH:
Management of intractable chronic pain severe enough to require an opioid analgesic and for which less invasive means of controlling pain are inadequate. Limitations of use: not for single-dose IV, IM, SC or neuraxial administration.
Use lowest effective dose for shortest duration. Should be administered by or under the direct supervision of an experienced physician. ≥18yrs: Individualize. Epidural: opioid-naive: 3.5–7.5mg/day; opioid-tolerant: 4.5–10mg/day, may increase to 20–30mg/day. Intrathecal: limit to the lumbar region. Opioid-naive: 0.2–1mg/day; opioid-tolerant: 1–10mg/day. Caution with doses >20mg/day.
<18yrs: not recommended.
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. During or within 14 days of MAOIs. Known or suspected GI obstruction, including paralytic ileus. Neuraxial administration: infection at injection site, concomitant anticoagulant therapy, uncontrolled bleeding diathesis, presence of any other concomitant therapy or medical condition which would render epidural/intrathecal administration especially hazardous.
Risks with neuraxial administration. Have resuscitative equipment and reversal agent (eg, naloxone HCl) immediately available. Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Indwelling intrathecal catheter: monitor for inflammatory masses that may result in neurologic impairment. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Pupillary changes (miosis). Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Urinary system disorders. Volume-depleted. Impaired myocardial function. Drug abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery: not recommended. Nursing mothers: monitor infants.
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, psychotropic drugs, antihistamines, neuroleptics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. 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. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. Possible orthostatic hypotension with sympatholytic drugs.
Sedation, lightheadedness, dizziness, nausea, vomiting, constipation; severe hypotension, syncope, myoclonic activity, urinary retention, respiratory depression/arrest, apnea, circulatory depression, shock, cardiac arrest.
Single-use ampuls (20mL)—1
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