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DESCRIPTION

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 sulfat

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

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

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

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:

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home drugs a-z list side effects drug center morphine tablets (morphine sulfate extended-release tablets) drugPrivacy & Trust InfoDrug Description

MORPHINE
(morphine sulfate) Extended-release Tablets

WARNING

ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; and NEONATAL OPIOID WITHDRAWAL SYNDROME

Addiction, Abuse, and Misuse

Morphine sulfate extended-release tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing morphine sulfate extended-release tablets, and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS AND PRECAUTIONS].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of morphine sulfate extended-release tablets. Monitor for respiratory depression, especially during initiation of morphine sulfate extended-release tablets or following a dose increase. Instruct patients to swallow morphine sulfate extended-release tablets whole; crushing, chewing, or dis solving morphine sulfate extended-release tablets can cause rapid release and absorption of a potentially fatal dose of morphine [see WARNINGS AND PRECAUTIONS].

Accidental Ingestion

Accidental ingestion of even one dose of morphine sulfate extended-release tablets, especially by children, can result in a fatal overdose of morphine [see WARNINGS AND PRECAUTIONS].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of morphine sulfate extended-release tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS AND PRECAUTIONS].

DESCRIPTION

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 monohydrate, polysorbate 80

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

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

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:

INDICATIONS

Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations Of Use

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