Morphine Sulfate Oral Solution Dosage & Rx Info

Morphine Sulfate Oral Solution Generic Name & Formulations

Legal Class

CII

General Description

Morphine sulfate 100mg/5mL (20mg/mL).

Pharmacological Class

Opioid agonist.

How Supplied

Contact supplier

Manufacturer

Various generic manufacturers

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. The precise mechanism of action is not known but the effects are thought to be mediated through opioid-specific receptors located in the CNS.

Morphine Sulfate Oral Solution Indications

Indications

Management of acute and chronic pain in opioid-tolerant patients severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

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.

Morphine Sulfate Oral Solution Dosage and Administration

Adult

Measure dose with graduated oral syringe. Use lowest effective dose for shortest duration. Individualize. ≥18yrs: Initially 10–20mg every 4hrs as needed. Conversion to and from other morphine formulations or other opioids: see full labeling. Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.

Children

<18yrs: not established.

Morphine Sulfate Oral Solution 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.

Morphine Sulfate Oral Solution Boxed Warnings

Boxed Warning

Serious and life-threatening risks from use of Morphine Sulfate Oral Solution: Risk of medication errors; Addiction, abuse, and misuse; Life-threatening respiratory depression; Accidental ingestion; Risks from concomitant use with benzodiazepines or other CNS depressants; Neonatal opioid withdrawal syndrome; Opioid analgesic risk evaluation and mitigation strategy (REMS).

Morphine Sulfate Oral Solution Warnings/Precautions

Warnings/Precautions

Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Abuse potential (monitor). Life-threatening respiratory depression esp. during initiation or following dose increases. Accidental exposure may cause fatal overdose (esp. in children). 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. Adrenal insufficiency. Monitor for signs of hypotension when initiating or titrating dose. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Drug abusers. Renal or hepatic impairment; initiate lower doses and titrate slowly. 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.

REMS

YES

Morphine Sulfate Oral Solution Pharmacokinetics

Absorption

Oral bioavailability: <40%. Maximum analgesic effect occurs 60 minutes post-administration.

Distribution

Volume of distribution: ~1–6 L/kg. Plasma protein bound: 20–35%.

Metabolism

Hepatic (conjugation).

Elimination

Renal (primary), fecal (7–10%). Half-life: ~2 hours (after IV admin). Plasma clearance: ~20–30 mL/min/kg (adult).

Morphine Sulfate Oral Solution Interactions

Interactions

See Contraindications. 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 closely; consider prescribing naloxone if concomitant use is warranted. 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 be potentiated by cimetidine, P-gp inhibitors; monitor. May delay the effects of oral P2Y₁₂ inhibitors (eg, clopidogrel, prasugrel, ticagrelor); consider IV form instead. May increase serum amylase.

Morphine Sulfate Oral Solution Adverse Reactions

Adverse Reactions

Constipation, nausea, somnolence, lightheadedness, dizziness, sedation, vomiting, sweating; respiratory depression, orthostatic hypotension, syncope, OIH and allodynia.

Morphine Sulfate Oral Solution Clinical Trials

See Literature

Morphine Sulfate Oral Solution Note

Not Applicable

Morphine Sulfate Oral Solution Patient Counseling