Morphine Sulfate Ext-rel Tabs

— THERAPEUTIC CATEGORIES —
  • Narcotic analgesics

Morphine Sulfate Ext-rel Tabs Generic Name & Formulations

General Description

Morphine sulfate 15mg, 30mg, 60mg, 100mg.

Pharmacological Class

Opioid agonist.

How Supplied

Contact supplier

Morphine Sulfate Ext-rel Tabs Indications

Indications

Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options 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 Tabs Dosage and Administration

Adult

Use lowest effective dose for shortest duration. Swallow whole; do not crush, chew, or dissolve. Individualize. Opioid-naive or opioid non-tolerant: initially 15mg every 8hrs or 12hrs. May adjust dose every 1–2 days. Use 100mg tabs, 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. Concomitant CNS depressants: initially 15mg every 12hrs (see Interactions). 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 Tabs 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 Tabs Boxed Warnings

Boxed Warning

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 Ext-rel Tabs Warnings/Precautions

Warnings/Precautions

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. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

REMS

YES

Morphine Sulfate Ext-rel Tabs Pharmacokinetics

See Literature

Morphine Sulfate Ext-rel Tabs 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. 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 (eg quinidine); monitor. May increase serum amylase.

Morphine Sulfate Ext-rel Tabs Adverse Reactions

Adverse Reactions

Constipation, dizziness, sedation, nausea, vomiting, sweating, dysphoria, euphoria; respiratory depression, severe hypotension, syncope.

Morphine Sulfate Ext-rel Tabs Clinical Trials

See Literature

Morphine Sulfate Ext-rel Tabs Note

Notes

Formerly known under the brand name MorphaBond ER.

Morphine Sulfate Ext-rel Tabs Patient Counseling

See Literature