Opioid + opioid antagonist for treating pain


PHARMACOLOGIC CLASS: Opioid + opioid antagonist, CII

ACTIVE INGREDIENTS: Morphine sulfate/naltrexone HCl ext-rel caps.

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STRENGTHS: 20mg/0.8mg; 30mg/1.2mg; 50mg/2mg; 60mg/2.4mg; 80mg/3.2mg; 100mg/4mg, CII

INDICATION: Moderate-to-severe pain management when continuous, around-the-clock opioid is needed for an extended time period. Not for as-needed use.

PHARMACOLOGY: Embeda contains pellets of an extended-release formulation of the opioid analgesic, morphine, surrounding a sequestered core of naltrexone, a mu-opioid antagonist. The naltrexone is intended to have no effect when this product is taken as directed; however, if it is crushed or chewed, the naltrexone will be released. Naltrexone reverses the subjective and analgesic effects of morphine by competitively binding at mu-opioid receptors.

CLINICAL TRIALS: The efficacy of Embeda was evaluated in a 12-week trial in osteoarthritis patients with moderate-to-severe pain. The patients were initially titrated to pain control in an open-label phase using Embeda, then randomized to either continuation with Embeda or placebo. The mean change in the weekly pain assessment score from randomization to the end of the study was statistically significantly superior for patients using Embeda compared to those given placebo.

ADULTS: Swallow whole, or sprinkle pellets on applesauce; do not chew pellets. See literature. Do not give via NG or gastric tubes. ≥18 years: individualize; give on 24-hour or 12-hour schedule.

OPIOID-NAIVE: start at lowest dose. Adjust at intervals of at least 2 days. Withdraw gradually.

CHILDREN: <18 years: not recommended.

CONTRAINDICATIONS: Concomitant alcohol (increases morphine absorption; may be fatal). Significant respiratory depression, acute or severe asthma or hypercapnia (in unmonitored settings or in absence of resuscitative equipment). Paralytic ileus. During or within 14 days of MAOIs.

PRECAUTIONS: Ingestion of tampered product may precipitate withdrawal symptoms in opioid-tolerant; overdose in opioid-naive. 100/4 strength for opioid- tolerant only. Head injury. Increased intracranial pressure. COPD. Cor pulmonale. Kyphoscoliosis. Seizure disorders. Shock. CNS depression. Toxic psychosis. Impaired pulmonary, renal, hepatic, thyroid, or adrenocortical function. GI or GU obstruction. Biliary tract disease. Acute pancreatitis. Acute abdomen. Volume-depleted. Acute alcoholism. Delirium tremens. Discontinue 24 hours before cordotomy. Elderly. Debilitated. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended.

INTERACTIONS: See Contraindications. CNS depression with CNS depressants (eg, antiemetics, phenothiazines, sedatives, hypnotics, muscle relaxants; reduce dose of either by 1/2). Paralytic ileus with anticholinergics. May be potentiated by PGP-inhibitors (eg, quinidine). Antagonizes diuretics. Possible withdrawal symptoms with mixed agonist/antagonist opioids.

ADVERSE REACTIONS: Constipation, GI upset, somnolence; respiratory depression/ arrest, apnea, circulatory depression, cardiac arrest, hypotension, shock.


For more information call (800) 776-3637 or visit www.Embeda.com.