See Supplemental Patient Information
- Morphine/naltrexone ECAP should be swallowed whole or the contents sprinkled on applesauce. If crushed, dissolved, or chewed, it may result into fatal dose of morphine particularly in opioid-naive individuals and the absorption of naltrexone may increase the risk of precipitating withdrawal in opioid-tolerant individuals [US Black Box Warning]
- Morphine sulfate is an opioid agonist and a schedule II controlled substance having liability for abuse. Morphine and other opioids used for analgesia can be abused and are subject to criminal diversion [US Black Box Warning]
- Consumption of alcohol, other opioids, or illicit drugs that cause CNS depression in conjuction with morphine/naltrexone will have additive effects, resulting into respiratory depression, hypotension, and profound sedation or coma [US Black Box Warning]
- Fatal respiratory depression can occur with all morphine preparation including morphine/naltrexone. Elderly and debilitated patients and those suffering pulmonary diseases or having substantially decreased respiratory reserve are at higher risk. Use with extreme caution in these patients or consider using alternative non-opioid analgesics
- Presence of head injury, other intracranial lesions, or pre-existing increase in intracranial pressure exaggerates respiratory depressant effects of morphine with carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure
- Morphine/naltrexone can produce effects on pupillary response and consciousness which may obscure neurologic signs of further increases in pressure in patients with head injuries. Hence should only be used when considered essential and then with extreme care
- Patients with depleted blood volume, or using concurrent administration of drugs such as phenothiazines or general anesthetics are prone to severe hypotension. Orthostatic hypotension and syncope can occur in ambulatory patients
- Obscures the diagnosis or clinical course in patients with acute abdominal conditions
- Do not use in patients with GI obstruction particularly paralytic ileus, as there is a risk of the product remaining in the stomach for an extended period and resulting into release of a bolus of morphine when normal gut motility is restored
- Ceased morphine/naltrexone therapy 24 hrs prior to cordotomy. The post-procedure titration of analgesics should be individualized to avoid either oversedation or withdrawal syndromes
- Use cautiously in patients with biliary tract disease, including acute pancreatitis, as it may cause spasm of the sphincter of Oddi
- Physical dependence and tolerance are common during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia and physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist
- Opioid abstinence or withdrawal syndrome is characterized by restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, piloerection, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate
- Morphine/naltrexone should not be discontinued abruptly, discontinue by slowly tapering the daily dose
- Administration of agonist/antagonist analgesics to a patient who has received or is receiving morphine/naltrexone therapy, may reduce the analgesic effect of morphine/naltrexone and/or may precipitate withdrawal symptoms in these patients, hence use cautiously
Cautions: Use cautiously in:
- Renal impairment
- Hepatic impairment
- Pulmonary impairment
- COPD
- Cor pulmonale
- Decreased respiratory reserve
- Hypoxia
- Pre-existing respiratory depression
- Circulatory shock
- Coma
- CNS depression
- Head injury
- Intracranial lesion
- ICP increased
- Seizure disorder
- Abuse
- Delirium tremens
- Toxic psychosis
- Addison's Disease
- Myxedema
- Hypothyroidism
- Prostatic hypertrophy
- Urethral stricture
- Convulsive disorders
- Acute abdomen
- Biliary tract diseases
- Acute pancreatitis
- Geriatrics
- Debilitated patients
- Concomitant use of agonist/antagonist analgesics
- Concomitant CNS depressants
Supplemental Patient Information
- Caution patients that the therapy could impair the mental and/or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery
- Caution patients about the potential effects of morphine sulfate on concomitant use with other CNS depressants, including other opioids, phenothiazines, sedative/hypnotics and alcohol
- REMS Medication Guide Required:
Pregnancy Category:C
Breastfeeding: Oral doses of maternal morphine in the immediate postpartum period result in higher milk levels than with epidural morphine; however, these levels are quite low. It is best to limit maternal parenteral morphine dosage and to supplement analgesia with a nonnarcotic analgesic if mother's milk comes in. If the baby shows signs of increased sleepiness (more than usual), difficulty in breastfeeding, breathing difficulties, or limpness, immediately contact a physician. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 27 May 2011). Limited data indicates that naltrexone is minimally excreted in breastmilk. It is not a reason to discontinue breastfeeding, if naltrexone is required by the mother. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 27 May 2011). As per manufacturer data moephin is excreted in the maternal milk in milk to plasma ratio of 2.5:1. Withdrawal symptoms can occur in breast-feeding infants when maternal administration of morphine sulfate is stopped. Because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
Embeda (morphine/naltrexone)
- ECAPS
- 20 mg/0.8 mg
- 30 mg/1.2 mg
- 50 mg/2 mg
- 60 mg/2.4 mg
- 80 mg/3.2 mg
- 100 mg/4 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Embeda 20-0.8 MG CPCR [Bottle] (KING PHARMA)
20 mg = $96.99
30 mg = $144.98 - Embeda 50-2 MG CPCR [Bottle] (KING PHARMA)
30 mg = $239.98
90 mg = $699.99
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
