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Arymo
Overview
What is Arymo?
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 pK is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:
What does Arymo look like?
What are the available doses of Arymo?
Extended-release: 15 mg, 30 mg, 60 mg ()
What should I talk to my health care provider before I take Arymo?
How should I use Arymo?
ARYMO ER is 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
ARYMO ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
A single dose of ARYMO ER greater than 60 mg, or a total daily dose greater than 120 mg, are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
Instruct patients to take ARYMO ER tablets whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth . Instruct patients not to pre-soak, lick, or otherwise wet the tablet prior to placing in the mouth . Cutting, breaking, crushing, chewing, or dissolving ARYMO ER tablets will result in uncontrolled delivery of morphine that could lead to overdose and death .
ARYMO ER is administered orally every 8 or 12 hours.
What interacts with Arymo?
Sorry No Records found
What are the warnings of Arymo?
Sorry No Records found
What are the precautions of Arymo?
Sorry No Records found
What are the side effects of Arymo?
Sorry No records found
What should I look out for while using Arymo?
ARYMO ER is contraindicated in patients with:
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
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
Accidental Ingestion
Accidental ingestion of even one dose of ARYMO ER, especially by children, can result in a fatal overdose of morphine
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 .
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
What might happen if I take too much Arymo?
Clinical Presentation
Acute overdosage with morphine can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations .
Treatment of Overdose
In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to morphine overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to morphine overdose.
Because the duration of reversal would be expected to be less than the duration of action of morphine in ARYMO ER, carefully monitor the patient until spontaneous respiration is reliably re-established. ARYMO ER will continue to release morphine and add to the morphine load for 24 to 48 hours or longer following ingestion, necessitating prolonged monitoring. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
How should I store and handle Arymo?
Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. ARYMO ER (morphine sulfate) extended-release tablets 15 mg are blue film coated, capsule shaped tablets debossed with “EGLT 15”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 30 mg are light purple film coated, capsule shaped tablets debossed with “EGLT 30”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 60 mg are light orange film coated, capsule shaped tablets debossed with “EGLT 60”. They are supplied as:NDCStore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.ARYMO ER (morphine sulfate) extended-release tablets 15 mg are blue film coated, capsule shaped tablets debossed with “EGLT 15”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 30 mg are light purple film coated, capsule shaped tablets debossed with “EGLT 30”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 60 mg are light orange film coated, capsule shaped tablets debossed with “EGLT 60”. They are supplied as:NDCStore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.ARYMO ER (morphine sulfate) extended-release tablets 15 mg are blue film coated, capsule shaped tablets debossed with “EGLT 15”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 30 mg are light purple film coated, capsule shaped tablets debossed with “EGLT 30”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 60 mg are light orange film coated, capsule shaped tablets debossed with “EGLT 60”. They are supplied as:NDCStore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.ARYMO ER (morphine sulfate) extended-release tablets 15 mg are blue film coated, capsule shaped tablets debossed with “EGLT 15”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 30 mg are light purple film coated, capsule shaped tablets debossed with “EGLT 30”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 60 mg are light orange film coated, capsule shaped tablets debossed with “EGLT 60”. They are supplied as:NDCStore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.ARYMO ER (morphine sulfate) extended-release tablets 15 mg are blue film coated, capsule shaped tablets debossed with “EGLT 15”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 30 mg are light purple film coated, capsule shaped tablets debossed with “EGLT 30”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 60 mg are light orange film coated, capsule shaped tablets debossed with “EGLT 60”. They are supplied as:NDCStore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.ARYMO ER (morphine sulfate) extended-release tablets 15 mg are blue film coated, capsule shaped tablets debossed with “EGLT 15”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 30 mg are light purple film coated, capsule shaped tablets debossed with “EGLT 30”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 60 mg are light orange film coated, capsule shaped tablets debossed with “EGLT 60”. They are supplied as:NDCStore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.ARYMO ER (morphine sulfate) extended-release tablets 15 mg are blue film coated, capsule shaped tablets debossed with “EGLT 15”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 30 mg are light purple film coated, capsule shaped tablets debossed with “EGLT 30”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 60 mg are light orange film coated, capsule shaped tablets debossed with “EGLT 60”. They are supplied as:NDCStore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.ARYMO ER (morphine sulfate) extended-release tablets 15 mg are blue film coated, capsule shaped tablets debossed with “EGLT 15”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 30 mg are light purple film coated, capsule shaped tablets debossed with “EGLT 30”. They are supplied as:NDCARYMO ER (morphine sulfate) extended-release tablets 60 mg are light orange film coated, capsule shaped tablets debossed with “EGLT 60”. They are supplied as:NDCStore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Morphine is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of morphine is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.
The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
Non-Clinical Toxicology
ARYMO ER is contraindicated in patients with: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
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
Accidental Ingestion
Accidental ingestion of even one dose of ARYMO ER, especially by children, can result in a fatal overdose of morphine
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 .
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
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore it should be used with caution in patients receiving such agents.
ARYMO ER contains morphine, a Schedule II controlled substance. As an opioid, ARYMO ER exposes its users to the risks of addiction, abuse, and misuse. As extended-release products such as ARYMO ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of morphine present .
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed ARYMO ER and in those who obtain the drug illicitly. Addiction can occur at recommended doses and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing ARYMO ER, and monitor all patients receiving ARYMO ER for development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as ARYMO ER, but use in such patients necessitates intensive counseling about the risks of proper use of ARYMO ER along with intensive monitoring for signs of addiction, abuse, and misuse.
Attempts at misuse or abuse of ARYMO ER by crushing, snorting, or injecting the dissolved product may compromise some of the extended-release properties resulting in delivery of morphine that could lead to overdose and death .
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing ARYMO ER. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper storage and disposal of unused drug . Contact the local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
The following serious adverse reactions are described elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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