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EMBEDA (Morphine Sulfate and Naltrexone Hydrochloride)
Embeda is an analgesic (medication for pain) indicated for moderate to severe pain when “round-the-clock” pain management is needed for an extended period of time. This potent analgesic is NOT to be used on an “as needed” basis. The drug is dosed twice daily, is available as a capsule and may be opened and the medication which is manufactured as pellets may be sprinkled in a (small amount) tablespoon of applesauce and the entire spoonful consumed, the pellets should NOT be chewed.
The Embeda pellets consist of the opioid analgesic morphine sulfate and a core of Naltrexone hydrochloride, an opioid receptor antagonist. The drug is available in pellet contained capsules of the combination of morphine/Naltrexone as: 20mg.0.8mg, 30mg./1.2mg, 50mg/2.4mg, 80m/3.2mg, 100mg/4mg with the latter ONLY being used in opioid-tolerant patients, those patients with a prolonged history of opioid medications.
CONTRAINDICATIONS
Embeda should not be used in patients with a history of sensitivity or allergy to either morphine or Naltrexone or in situations where opioids are contraindicated, such as respiratory depression, acute or severe bronchospasm patients, patients with elevated blood carbon dioxide or elevated increased cerebrospinal fluid pressure, and patients with significant bowel /intestinal motility diseases. In the elderly and those patients with severe renal (kidney) or hepatic (liver) reduced function, it should be monitored cautiously with reduced doses. Caution should also be used in administration of the drug to debilitated patients (those with other serious illnesses with are in a weakened state), prostate hypertrophy (enlargement), thyroid diseases, and urinary diseases due to anatomy problems. It is contraindication in pregnancy or in nursing mothers. Members of the Chinese race have demonstrated a higher faster clearance, and thus reduced levels of opioids when given intravenously, compared to other races. It is not recommended in patients under the age of 18.
DRUG INTERACTIONS
Interactions with anti-emetics (medications for vomiting), phenothiazine antidepressants/antianxiety drugs), and anticholinergics (drugs for gastrointestinal disorders or those various medications that produce pharmacologic effects by the cholinergic peripheral receptors)may occur and should be used with extreme caution when taking Embeda preferably in a controlled medical environment with resuscitative equipment and trained personnel. Diuretics, “water pills” may have reduced efficacy and lead to a patient’s urinary retention (reduced urine output) when taken with Embeda.
SIDE EFFECTS
The adverse side effects include constipation or diarrhea, nausea and somnolence(sleep),fatigue, dry mouth, vomiting, dizziness, headaches, anxiety, pruritis (itching) and hyperhidrosis (abnormal perspiration). Embeda interacts with skeletal muscle relaxants which will have an enhanced effect, and certain antidepressants of the MAOI, monoamine oxidase inhibitor classification. It can produce a hypotensive effect (severe lowering of blood pressure) and should be avoided in patients with already established lowered blood volume due to surgery or loss of blood from injury.
Generally, Embeda is not chosen as the initial opioid medication, and specific medical conversions are necessary for its change from previous non successful medications such as Duragesic (Fentanyl transferal), hydrocodone, hydromorphone, and methadone, various extended release morphine products, oxycodone, and oxymorphone. When used as the initial analgesic, Embeda should be administered as the lowest possible dose, and then titrated to once or twice daily as necessary for pain relief., but no more than once every –other-day to allow patients to stabilize. Doses of the medication can be increased but the frequency never greater than twice daily, and if breakthrough pain (pain experienced till appropriated dosing levels for adequate blood level concentration is achieved) then the patient may be supplemented with a short-acting analgesic in a small dose. When the drug is to be discontinued, it should be tapered gradually, not an abrupt stop. Both physical dependence (the manifestation of symptoms following the withdrawal abruptly) and tolerance (the need for increasing doses to maintain the same effect) occurs with this any other opioids. Withdrawal symptoms include restlessness, rhinorrhea (runny nose), yawning, perspiration, chills, muscle aches (myalgia).
REFERENCES
MPR, Monthly Prescribing Reference, 2011 Edition, Pain Management
EMBEDA, Medication Guide, King Pharmaceuticals/Alpharma Pharmaceuticals, LLC. June 2009.
As a podiatrist, I have no direct prescribing experiences with Embeda, however in my practice I have had consults on those patients taking the medication, and find when used by pain management experts, patients do acknowledge significant relief with the medication that previous had the breakthrough pain when other medications were previously used. The combination of the two medications allows for better patient management than the morphine alone.
ADDITIONAL REFERENCES
See our other pain medication discussions.
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