Embeda (Morphine Sulfate and Naltrexone Hydrochloride) Patient Information: Side Effects and Drug Images at RxList

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May 27, 2012

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EMBEDA™
(morphine sulfate and naltrexone hydrochloride) Extended Release Capsules

WARNING

EMBEDA™ (morphine sulfate and naltrexone hydrochloride) capsules contain morphine, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid agonists. EMBEDA (morphine sulfate and naltrexone hydrochloride) can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing EMBEDA (morphine sulfate and naltrexone hydrochloride) in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

EMBEDA (morphine sulfate and naltrexone hydrochloride) contains pellets of an extended-release oral formulation of morphine sulfate, an opioid receptor agonist, surrounding an inner core of naltrexone hydrochloride, an opioid receptor antagonist indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

EMBEDA (morphine sulfate and naltrexone hydrochloride) is NOT intended for use as a prn analgesic.

EMBEDA (morphine sulfate and naltrexone hydrochloride) 100 mg/4 mg IS FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. Ingestion of these capsules or the pellets within the capsules may cause fatal respiratory depression when administered to patients not already tolerant to high doses of opioids.

Patients should not consume alcoholic beverages while on EMBEDA (morphine sulfate and naltrexone hydrochloride) therapy. Additionally, patients must not use prescription or non-prescription medications containing alcohol while on EMBEDA (morphine sulfate and naltrexone hydrochloride) therapy. The co-ingestion of alcohol with EMBEDA (morphine sulfate and naltrexone hydrochloride) may result in an increase of plasma levels and potentially fatal overdose of morphine. EMBEDA (morphine sulfate and naltrexone hydrochloride) 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 due to the risk of rapid release and absorption of a potentially fatal dose of morphine.

Crushing, chewing, or dissolving EMBEDA (morphine sulfate and naltrexone hydrochloride) will also result in the release of naltrexone which may precipitate withdrawal in opioid-tolerant individuals.

DRUG DESCRIPTION

EMBEDA (morphine sulfate and naltrexone hydrochloride) Capsules contain pellets of morphine sulfate and naltrexone hydrochloride at a ratio of 100:4. Morphine sulfate is an agonist and naltrexone hydrochloride is an antagonist at the mu-opioid receptor.

The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C₁₇H₁₉NO₃)₂• H₂SO₄•5H₂O and its molecular weight is 758.85.

Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:

Morphine sulfate Structural Formula Illustration

The chemical name of naltrexone hydrochloride is (5α)-17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. The empirical formula is C₂₀H₂₃NO₄•HCl and its molecular weight is 377.46.

Naltrexone hydrochloride is a white to slightly off-white powder that is soluble in water. Its structural formula is:

Naltrexone hydrochloride Structural Formula Illustration

Each capsule contains the following inactive ingredients common to all strengths: talc, ammonio methacrylate copolymer, sugar spheres, ethylcellulose, sodium chloride, polyethylene glycol, hydroxypropyl cellulose, dibutyl sebacate, methacrylic acid copolymer, diethyl phthalate, magnesium stearate, sodium lauryl sulfate, and ascorbic acid. The capsule shells contain gelatin, titanium dioxide, and grey ink, D&C yellow #10 (EMBEDA (morphine sulfate and naltrexone hydrochloride) 20 mg/0.8 mg), FD&C red #3, FD&C blue #1 (EMBEDA (morphine sulfate and naltrexone hydrochloride) 30 mg/1.2 mg), D&C red #28, FD&C red #40, FD&C blue #1 (EMBEDA (morphine sulfate and naltrexone hydrochloride) 50 mg/2 mg), D&C red #28, FD&C red #40, FD&C blue #1 (EMBEDA (morphine sulfate and naltrexone hydrochloride) 60 mg/2.4 mg), FD&C blue #1, FD&C red #40, FD&C yellow #6 (EMBEDA (morphine sulfate and naltrexone hydrochloride) 80 mg/3.2 mg), D&C yellow #10, FD&C blue #1 (EMBEDA (morphine sulfate and naltrexone hydrochloride) 100 mg/4 mg).

EMBEDA (morphine sulfate and naltrexone hydrochloride) contains no gluten.

Last reviewed on RxList: 8/27/2009
This monograph has been modified to include the generic and brand name in many instances.