DURAMORPH Dosage & Rx Info | Uses, Side Effects

Duramorph Generic Name & Formulations

Legal Class

CII

General Description

Morphine sulfate 0.5mg/mL, 1mg/mL; soln for intravenous, epidural or intrathecal infusion; preservative-free.

Pharmacological Class

Opioid agonist.

How Supplied

Single-use ampuls (10mL)—10

Manufacturer

Hikma Pharmaceuticals

Mechanism of Action

Morphine is a full opioid agonist and is relatively selective for the mu receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of morphine is analgesia.

Duramorph Indications

Indications

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. Due to risks of addiction, abuse, and misuse with opioids (can occur at any dosage or duration), reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics, opioid combination products) are not tolerated or inadequate to provide analgesia. Should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Duramorph Dosage and Administration

Adult

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.

Children

<18yrs: not recommended.

Duramorph Contraindications

Contraindications

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.

Duramorph Boxed Warnings

Boxed Warning

Serious and life-threatening risks from use of Duramorph: Risks with neuraxial administration; Addiction, abuse, and misuse; Life-threatening respiratory depression; Risks from concomitant use with benzodiazepines or other CNS depressants; Neonatal opioid withdrawal syndrome.

Duramorph Warnings/Precautions

Warnings/Precautions

Risks with neuraxial administration. Have resuscitative equipment and reversal agent (eg, naloxone HCl) immediately available. Abuse potential (monitor). Life-threatening respiratory depression; monitor during initiation or following a dose increase. Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. Opioid-induced hyperalgesia (OIH) and allodynia; consider decreasing dose of current opioid or opioid rotation if OIH is suspected. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Risk of chest wall rigidity with rapid IV administration. Adrenal insufficiency. Monitor for signs of hypotension when initiating or titrating dose. 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.

Duramorph Pharmacokinetics

Absorption

Peak plasma concentration: 33–40 ng/mL within 10–15 mins after administration (epidural); <1–7.8 ng/mL after 5–10 mins after administration (intrathecal). Maximum CSF concentration: 60–90 mins after administration (epidural).

Distribution

Apparent volume of distribution: 1–4.7 L/kg (IV); 22 ± 8 mL (intrathecal). Plasma protein bound: ~36% (IV).

Metabolism

IV: hepatic glucuronidation.

Elimination

IV: Renal, fecal (~10%). Total plasma clearance: 0.9–1.2 L/kg/h (IV). Half-life: 1.5–4.5 hours (IV); 39–249 minutes (epidural).

Duramorph Interactions

Interactions

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, cyclobenzaprine, metaxalone, 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. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. May delay the effects of oral P2Y₁₂ inhibitors (eg, clopidogrel, prasugrel, ticagrelor); consider IV form instead. Possible orthostatic hypotension with sympatholytic drugs.

Duramorph Adverse Reactions

Adverse Reactions

GI upset, constipation, CNS effects, skin reactions; respiratory depression/arrest, orthostatic hypotension, syncope, myoclonic activity, urinary retention, OIH and allodynia, possible infertility (long-term use).

Duramorph Clinical Trials

See Literature

Duramorph Note

Not Applicable

Duramorph Patient Counseling