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Morphine Sulfate Ext-rel Caps Generic Name & Formulations
Legal Class
CII
General Description
Morphine sulfate 10mg, 20mg, 30mg, 50mg, 60mg, 80mg, 100mg.
Pharmacological Class
Opioid agonist.
How Supplied
Contact supplier
Manufacturer
Morphine Sulfate Ext-rel Caps Indications
Indications
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate.
Limitations of Use
Not for use as an as-needed (prn) analgesic. Use only if alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate to provide sufficient management of pain.
Morphine Sulfate Ext-rel Caps Dosage and Administration
Adult
Use lowest effective dose for shortest duration. Swallow whole or may sprinkle contents on applesauce. May be given through 16 French gastrostomy tube. Do not give via NG tube. Individualize. May be given on 24hr or 12hr schedule. Usually not for initial therapy; begin with an immediate-release product and convert to an ext-rel product. Opioid non-tolerant: initially 30mg every 24hrs. Adjust dose at 1–2 day intervals. Use 100mg or 200mg caps, a single dose >60mg, or a total daily dose >120mg in opioid-tolerant patients only. Renal failure, cirrhosis: initiate at lower dose; titrate slowly and monitor. Conversion 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 Ext-rel Caps 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 Ext-rel Caps Boxed Warnings
Boxed Warning
Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Interaction with alcohol. Risks from concomitant use with benzodiazepines or other CNS depressants.
Morphine Sulfate Ext-rel Caps 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 and alcohol abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.
REMS
Morphine Sulfate Ext-rel Caps Pharmacokinetics
See Literature
Morphine Sulfate Ext-rel Caps Interactions
Interactions
See Contraindications. Avoid alcohol or alcohol-containing products. 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 increase serum amylase.
Morphine Sulfate Ext-rel Caps Adverse Reactions
Adverse Reactions
Drowsiness, constipation, nausea, dizziness, anxiety; respiratory depression, severe hypotension, syncope.
Morphine Sulfate Ext-rel Caps Clinical Trials
See Literature
Morphine Sulfate Ext-rel Caps Note
Notes
Formerly known under the brand name Kadian.
Morphine Sulfate Ext-rel Caps Patient Counseling
See Literature
