INFUMORPH Dosage & Rx Info | Uses, Side Effects

Infumorph Generic Name & Formulations

Legal Class

CII

General Description

Morphine sulfate 10mg/mL, 25mg/mL; soln for continuous microinfusion devices for intrathecal or epidural infusion; preservative-free.

Pharmacological Class

Opioid agonist.

How Supplied

Single-use ampuls (20mL)—1

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.

Infumorph Indications

Indications

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. 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.

Infumorph 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. 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.

Children

<18yrs: not recommended.

Infumorph 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.

Infumorph Boxed Warnings

Boxed Warning

Serious and life-threatening risks from use of Infumorph: 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.

Infumorph 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 esp. during initiation or following dose increases. 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. Indwelling intrathecal catheter: monitor for inflammatory masses that may result in neurologic impairment. 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.

Infumorph Pharmacokinetics

Absorption

Peak plasma concentration: 33–40 ng/mL achieved within 10–15 minutes (epidural administration); <1–7.8 ng/mL after 5–10 minutes (intrathecal administration).

Distribution

Volume of distribution: 22 ± 8 mL (intrathecal administration).

Metabolism

Hepatic glucuronidation.

Elimination

Fecal (10%), renal (2–12%). Half-life: 39–249 minutes (epidural administration).

Infumorph 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.

Infumorph Adverse Reactions

Adverse Reactions

Sedation, lightheadedness, dizziness, nausea, vomiting, constipation; orthostatic hypotension, syncope, myoclonic activity, urinary retention, respiratory depression/arrest, apnea, circulatory depression, shock, cardiac arrest, OIH and allodynia.

Infumorph Clinical Trials

See Literature

Infumorph Note

Not Applicable

Infumorph Patient Counseling