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Morphine Sulfate Oral Solution Generic Name & Formulations
Legal Class
CII
General Description
Morphine sulfate 10mg/5mL (2mg/mL), 20mg/5mL (4mg/mL), 100mg/5mL (20mg/mL).
Pharmacological Class
Opioid agonist.
See Also
How Supplied
Contact supplier.
Manufacturer
Morphine Sulfate Oral Solution Indications
Indications
Oral soln (2mg/mL and 4mg/mL strengths) for management of: adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate; or pediatrics (≥2yrs) with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. For 20mg/mL strength: the relief of acute and chronic pain in opioid-tolerant adults only.
Limitations of Use
Reserve for use if alternative treatment options (eg, non-opioid analgesics, opioid combination products) are ineffective, not tolerated, or otherwise inadequate to provide sufficient analgesia.
Morphine Sulfate Oral Solution Dosage and Administration
Adult
Measure dose with graduated oral syringe. Use lowest effective dose for shortest duration. Individualize. 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
<2yrs: not established. Measure dose with graduated oral syringe. Use lowest effective dose for shortest duration. Individualize. ≥2yrs: initially 0.15mg–0.3mg/kg every 4hrs as needed; max 20mg. 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.
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
Risk of medication errors. Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Risks from concomitant use with benzodiazepines or other CNS depressants.
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; monitor within first 24–72hrs of initiating therapy and 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. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. 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
Morphine Sulfate Oral Solution Pharmacokinetics
See Literature
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, severe hypotension, syncope.
Morphine Sulfate Oral Solution Clinical Trials
See Literature
Morphine Sulfate Oral Solution Note
Not Applicable
Morphine Sulfate Oral Solution Patient Counseling
See Literature
