See FDA-approved patient labeling (Medication Guide)

Abuse Potential

Inform patients that EMBEDA contains morphine, a Schedule II controlled substance that is subject to abuse. Instruct patients not to share EMBEDA with others and to take steps to protect EMBEDA from theft or misuse.

Life-threatening Respiratory Depression

Discuss the risk of respiratory depression with patients, explaining that the risk is greatest when starting EMBEDA or when the dose is increased. Advise patients how to recognize respiratory depression and to seek medical attention if they are experiencing breathing difficulties.

Accidental Exposure

Instruct patients to take steps to store EMBEDA securely. Accidental exposure, especially in children, may results in serious harm or death. Advise patients to dispose of unused EMBEDA by flushing the capsules down the toilet.

Risks from Concomitant Use of Alcohol and other CNS Depressants

Inform patients that the concomitant use of alcohol with EMBEDA can increase the risk of life-threatening respiratory depression. Instruct patients not to consume alcoholic beverages, as well as prescription and over-the-counter drug products that contain alcohol, during treatment with EMBEDA.

Inform patients that potentially serious additive effects may occur if EMBEDA is used with other CNS depressants, and not to use such drugs unless supervised by a health care provider.

Important Administration Instructions

Instruct patients how to properly take EMBEDA, including the following:

• Swallowing EMBEDA capsules whole or sprinkling the capsule contents on applesauce and then swallowing immediately without chewing
• Not crushing, chewing, or dissolving the pellets in the capsules due to a risk of fatal morphine overdose or naltrexone precipitated withdrawal symptoms in opioid-dependent individuals
• Using EMBEDA exactly as prescribed to reduce the risk of life-threatening adverse reactions (e.g., respiratory depression)
• Not discontinuing EMBEDA without first discussing the need for a tapering regimen with the prescriber

Hypotension

Inform patients that EMBEDA may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position).

Driving or Operating Heavy Machinery

Inform patients that EMBEDA may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication.

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention.

Anaphylaxis

Inform patients that anaphylaxis has been reported with ingredients contained in EMBEDA. Advise patients how to recognize such a reaction and when to seek medical attention.

Pregnancy

Advise female patients that EMBEDA can cause fetal harm and to inform the prescriber if they are pregnant or plan to become pregnant.

Last reviewed on RxList: 6/14/2013
This monograph has been modified to include the generic and brand name in many instances.