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EMBEDA is to be swallowed whole or the contents
of the capsules sprinkled on apple sauce. The pellets in the capsules are not to
be crushed, dissolved, or chewed. The resulting morphine dose may be fatal,
particularly in opioid-naive individuals. In opioid-tolerant individuals, the
absorption of naltrexone may increase the risk of precipitating
withdrawal.
EMBEDA 100 mg/4 mg is for use in opioid-tolerant patients
only. Ingestion of these capsules or of the pellets within the capsules may
cause fatal respiratory depression when administered to patients not already
tolerant to high doses of opioids.
[see DRUG ABUSE
AND DEPENDENCE (9) ].
Concerns about abuse and addiction should not prevent the proper management
of pain. Healthcare professionals should contact their State Professional
Licensing Board or State Controlled Substances Authority for information on how
to prevent and detect abuse of this product.
[see CLINICAL
PHARMACOLOGY ].
[see DRUG INTERACTIONS ]. EMBEDA may produce orthostatic hypotension and syncope in
ambulatory patients.
EMBEDA should be administered with caution to patients in circulatory shock,
as vasodilation produced by the drug may further reduce cardiac output and blood
pressure.
[see
DRUG INTERACTIONS
(7.1)
].
[see DOSAGE AND
ADMINISTRATION ].
[see DRUG INTERACTIONS ].
5.13 Anaphylaxis
Although extremely rare, cases of anaphylaxis have been reported
with the use of a similar extended release morphine formulation.
5.14 Accidentally Precipitated Withdrawal
Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine,
butorphanol) should be administered with caution to a patient who has received
or is receiving a course of therapy with EMBEDA. In this situation, mixed
agonist/antagonist analgesics may reduce the analgesic effect of EMBEDA and/or
may precipitate withdrawal symptoms in these patients.
Consuming EMBEDA that have been tampered by crushing, chewing, or dissolving
the extended-release formulation can release sufficient naltrexone to
precipitate withdrawal in opioid-dependent individuals. Symptoms of withdrawal
usually appear within five minutes of ingestion of naltrexone and can last for
up to 48 hours. Mental status changes can include confusion, somnolence, and
visual hallucinations. Significant fluid losses from vomiting and diarrhea can
require intravenous fluid administration. Patients should be closely monitored
and therapy with non-opioid medications tailored to meet individual
requirements.
5.15 Laboratory Tests
Naltrexone does not interfere with thin-layer, gas-liquid, and
high pressure liquid chromatographic methods which may be used for the
separation and detection of morphine, methadone, or quinine in the urine.
Naltrexone may or may not interfere with enzymatic methods for the detection of
opioids depending on the specificity of the test. Please consult the test
manufacturer for specific details.
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