Generic Name and Formulations:
Morphine sulfate 0.5mg/mL, 1mg/mL; soln for intravenous, epidural or intrathecal infusion; preservative-free.
West-Ward Pharmaceutical Corp.
Indications for DURAMORPH:
Management of pain severe enough to require an opioid analgesic by intravenous (IV) administration, and for which alternative treatments are not expected to be adequate. Epidural or intrathecal management of pain without attendant loss of motor, sensory, or sympathetic function.
Limitations Of use:
Not for use in continuous microinfusion devices.
Use lowest effective dose for shortest duration. Should be administered by or under the direct supervision of an experienced physician. ≥18yrs: Individualize. IV: initially 2–10mg/70kg of body wt. Epidural: initially 5mg in lumbar region; if pain relief not achieved within 1hr, may administer additional incremental doses of 1–2mg at intervals sufficient to assess effectiveness; max 10mg/24hrs. Intrathecal: 0.2–1mg once in lumbar region; do not inject >2mL of the 5mg/10mL ampul or >1mL of the 10mg/10mL ampul. Repeat doses not recommended; if pain recurs, consider alternative routes. May use continuous IV infusion of naloxone 0.6mg/hr for 24hrs after intrathecal inj to reduce potential adverse effects.
<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). Risk of chest wall rigidity with rapid IV administration. 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.
GI upset, constipation, CNS effects, skin reactions; respiratory depression/arrest, severe hypotension, syncope, myoclonic activity, urinary retention.
Single-use ampuls (10mL)—10