April 29, 2017
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Arymo ER

"Medscape Medical News
Deborah Brauser
August 22, 2016

The US Food and Drug Administration (FDA) has approved an oral, abuse-deterrent, extended-release (ER) formulation of oxycodone hydrochloride and naltrexone hydrochloride"...

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Arymo ER

ARYMO™ ER
(morphine sulfate) Extended-release Tablets

WARNING

ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

ARYMO™ ER exposes 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 ARYMO ER, 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 ARYMO ER. Monitor for respiratory depression, especially during initiation of ARYMO ER or following a dose increase. Instruct patients to swallow ARYMO ER tablets whole; crushing, chewing, or dissolving ARYMO ER 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 ARYMO ER, especially by children, can result in a fatal overdose of morphine [see WARNINGS AND PRECAUTIONS].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of ARYMO ER 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].

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].

  • Reserve concomitant prescribing of ARYMO ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

DRUG DESCRIPTION

ARYMO™ ER (morphine sulfate) extended-release tablets are for oral use and contain morphine sulfate, an opioid agonist.

Each tablet contains the following inactive ingredients common to all strengths: polyethylene oxide 400,000, butylated hydroxytoluene, polyvinyl alcohol, polyethylene glycol 3350, 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 and ferric oxide yellow.

The 30 mg tablets also contain: ferric oxide red, FD&C Blue No. 2, and ferrosoferric oxide.

The 60 mg tablets also contain: ferric oxide yellow, and ferric oxide red.

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

Last reviewed on RxList: 1/19/2017
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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