Embeda

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-4,5?-epoxy-17-methyl-morphinan-3,6 ?-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 (5?)-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:

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.

What are the precautions when taking morphine sulfate and naltrexone hydrochloride (Embeda)?

Before taking morphine, tell your doctor or pharmacist if you are allergic to morphine; or to naltrexone; or to other narcotic pain medications (such as codeine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems/lung disease (such as asthma, chronic obstructive pulmonary disease-COPD, sleep apnea), chronic constipation/slow movement of the gut (such as paralytic ileus, blockage), kidney disease, liver disease, a certain spinal problem (kyphoscoliosis), heart problems (such as heart failure, low blood pressure, irregular heartbeat),...

Read All Potential Precautions of Embeda »


Embeda Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, nausea, vomiting, constipation, lightheadedness, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, mental/mood changes (such as agitation, hallucinations, confusion), severe stomach/abdominal pain, difficulty urinating, change in the amount of urine.

Seek immediate medical attention if any of these rare but serious side effects occur: slow/shallow breathing, chest pain, slow/fast heartbeat, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking morphine, tell your doctor or pharmacist if you are allergic to morphine; or to naltrexone; or to other narcotic pain medications (such as codeine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems/lung disease (such as asthma, chronic obstructive pulmonary disease-COPD, sleep apnea), chronic constipation/slow movement of the gut (such as paralytic ileus, blockage), kidney disease, liver disease, a certain spinal problem (kyphoscoliosis), heart problems (such as heart failure, low blood pressure, irregular heartbeat), personal or family history of regular use/abuse of drugs/alcohol, brain disorders (such as seizures, head injury, tumor), mental/mood disorders (such as hallucinations, addiction problems), thyroid problems, difficulty urinating (for example, due to enlarged prostate or narrowed urethra), gallbladder disease, disease of the pancreas (such as pancreatitis), adrenal gland problems (such as Addison's disease), diarrhea due to infection (such as traveler's diarrhea).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Alcohol may worsen this effect. Avoid alcoholic beverages because they can lead to the sudden release of a very large (possibly fatal) amount of drug into your body.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially slow/shallow breathing and drowsiness.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for a long time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.



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