Morphine Sulfate Controlled-Release

MS CONTIN (morphine sulfate extended-release tablets) are for oral use and contain morphine sulfate, an agonist at the mu-opioid receptor.

Each tablet contains the following inactive ingredients common to all strengths: cetostearyl alcohol, hydroxyethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, talc and titanium dioxide.

The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate).

The 15 mg tablets also contain: FD&C Blue No. 2, lactose, polysorbate 80

The 30 mg tablets also contain: D&C Red No. 7, FD&C Blue No. 1, lactose, polysorbate 80

The 60 mg tablets also contain: D&C Red No. 30, D&C Yellow No. 10, hydroxypropyl cellulose, lactose

The 100 mg tablets also contain: black iron oxide

The 200 mg tablets also contain: D&C Yellow No. 10, FD&C Blue No. 1, hydroxypropyl cellulose

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:

Dosage Forms And Strengths

• MS CONTIN® (morphine sulfate extended-release tablets) 15 mg Round, blue-colored, film-coated tablets bearing the symbol PF on one side and M 15 on the other
• MS CONTIN® (morphine sulfate extended-release tablets) 30 mg Round, lavender-colored, film-coated tablets bearing the symbol PF on one side and M 30 recommendations are not available because of a lack of systematic evidence for these types on the other
• MS CONTIN® (morphine sulfate extended-release tablets) 60 mg Round, orange-colored, film-coated tablets bearing the symbol PF on one side and M 60 on the other
• MS CONTIN® (morphine sulfate extended-release tablets) 100 mg* Round, gray-colored, film-coated tablets bearing the symbol PF on one side and 100 on the other
• MS CONTIN® (morphine sulfate extended-release tablets) 200 mg* Capsule-shaped, green-colored, film-coated tablets bearing the symbol PF on one side and M 200 on the other

*100 mg and 200 mg tablets are for use in opioid-tolerant patients only

Storage And Handling

MS CONTIN® (morphine sulfate extended-release tablets) 15 mg are round, blue-colored, filmcoated tablets bearing the symbol PF on one side and M 15 on the other. They are supplied as follows:

NDC 59011-260-10: opaque plastic bottles containing 100 tablets

MS CONTIN® (morphine sulfate extended-release tablets) 30 mg are round, lavender-colored, film-coated tablets bearing the symbol PF on one side and M 30 on the other. They are supplied as follows:

NDC 59011-261-25: opaque plastic bottles containing 100 tablets
NDC 59011-261-05: opaque plastic bottles containing 500 tablets

MS CONTIN® (morphine sulfate extended-release tablets) 60 mg are round, orange-colored, filmcoated tablets bearing the symbol PF on one side and M 60 on the other. They are supplied as follows:

NDC 59011-262-10: opaque plastic bottles containing 100 tablets
NDC 59011-262-05: opaque plastic bottles containing 500 tablets

MS CONTIN® (morphine sulfate extended-release tablets) 100 mg are round, gray-colored, filmcoated tablets bearing the symbol PF on one side and 100 on the other. They are supplied as follows:

NDC 59011-263-10: opaque plastic bottles containing 100 tablets
NDC 59011-263-05: opaque plastic bottles containing 500 tablets

MS CONTIN® (morphine sulfate extended-release tablets) 200 mg are capsule-shaped, greencolored, film-coated tablets bearing the symbol PF on one side and M 200 on the other. They are supplied as follows:

NDC 59011-264-10: opaque plastic bottles containing 100 tablets

Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container.

CAUTION: DEA FORM REQUIRED

Manufactured by: Purdue Pharma L.P., Stamford, CT 06901-3431. www.purduepharma.com or call 1-888-726-7535. Revised: April 2014

Included as part of the PRECAUTIONS section.

Morphine is an opioid pain medication. An opioid is sometimes called a narcotic.

Morphine is used to treat moderate to severe pain. Short-acting morphine is taken as needed for pain. Extended-release morphine is for use when around-the-clock pain relief is needed.

Morphine is not for treating pain just after surgery unless you were already taking morphine before the surgery.

Morphine may also be used for purposes not listed in this medication guide.

Your pharmacist can provide more information about morphine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 9.02. Revision date: 9/13/2012.

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