EMBEDA CII

Indications for EMBEDA:

Moderate to severe pain management when continuous, around-the-clock opioid is needed for an extended time period. Not for use: as an as-needed (prn) analgesic, for pain that is mild or not expected to persist for an extended period of time, for acute pain, or for postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.

Adult Dose for EMBEDA:

Swallow whole, or sprinkle pellets on applesauce; do not chew pellets. Do not give via NG or gastric tubes. ≥18yrs: individualize; give on 24 hour or 12 hour schedule. Opioid-naive: start at lowest dose. Adjust at intervals of 1–2 days. Withdraw gradually. Converting from other morphine formulations, other opioids: see full labeling.

Children's Dose for EMBEDA:

<18yrs: not established.

Pharmacological Class:

Opioid + opioid antagonist.

Contraindications:

Concomitant alcohol (increases morphine absorption; may be fatal). Significant respiratory depression, acute or severe bronchial asthma (in unmonitored settings or in absence of resuscitative equipment). Paralytic ileus.

Warnings/Precautions:

Abuse potential. Life-threatening respiratory depression possible; monitor first 24–72hrs after initiating therapy and during dose increases. Accidental ingestion may cause fatal overdose (esp. in children). Ingestion of tampered product may precipitate withdrawal symptoms in opioid-tolerant; overdose in opioid-naive. 100mg/4mg strength for opioid-tolerant only. Head injury. Increased intracranial pressure. COPD. Cor pulmonale. Seizure disorders. Shock. CNS depression. Impaired pulmonary, renal, or hepatic function. GI or GU obstruction. Biliary tract disease. Acute pancreatitis. Volume-depleted. Acute alcoholism. Elderly. Cachectic. Debilitated. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended.

Interactions:

Do not use during or within 14 days of MAOIs. Co-ingestion of alcohol may cause potential fatal overdose. CNS depression with other CNS depressants (eg, antiemetics, phenothiazines, sedatives, hypnotics, general anesthetics, tranquilizers; reduce initial dose of either). Avoid muscle relaxants. Paralytic ileus with anticholinergics. May be potentiated by PGP inhibitors (eg, quinidine). Antagonizes diuretics. Possible withdrawal symptoms, antagonism of analgesia with mixed agonist/antagonist opioids; avoid. Potentiated by cimetidine; monitor.

Adverse Reactions:

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

Metabolism:

Hepatic.

Elimination:

Renal.

Generic Availability:

NO

How Supplied:

Caps 20mg/0.8mg, 30mg/1.2mg—75; 50mg/2mg—150; 60mg/2.4mg, 80mg/3.2mg—200; 100mg/4mg—300