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MorphaBond
Overview
What is MorphaBond?
MORPHABOND 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: hypromellose, xanthan gum, microcrystalline cellulose, sodium alginate, alginic acid, mannitol, colloidal silicon dioxide, magnesium stearate, ethyl acrylate and methyl methacrylate copolymer dispersion, lactose monohydrate, polysorbate 80, titanium dioxide, polyethylene glycol, shellac in ethanol, isopropyl alcohol, iron oxide black, n-butyl alcohol, propylene glycol, and ammonium hydroxide.
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. 1, FD&C Red No. 40 and FD&C Yellow No. 6
The 30 mg tablets also contain: FD&C Blue No. 2 and FD&C Red No. 40
The 60 mg tablets also contain: FD&C Yellow No. 6 and FD&C Red No. 40
The 100 mg tablets also contain: FD&C Blue No. 2, FD&C Yellow No. 6 and FD&C Red No. 40
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 pK is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:
What does MorphaBond look like?
What are the available doses of MorphaBond?
Extended-release tablets: 15 mg, 30 mg, 60 mg, 100 mg ()
What should I talk to my health care provider before I take MorphaBond?
How should I use MorphaBond?
MORPHABOND 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
MORPHABOND ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
MORPHABOND ER 100mg tablets, a single dose 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 swallow MORPHABOND ER tablets whole
Crushing, chewing, or dissolving MORPHABOND ER tablets will result in uncontrolled delivery of morphine and can lead to overdose or death
.
MORPHABOND ER is administered orally every 12 hours.
What interacts with MorphaBond?
Sorry No Records found
What are the warnings of MorphaBond?
Sorry No Records found
What are the precautions of MorphaBond?
Sorry No Records found
What are the side effects of MorphaBond?
Sorry No records found
What should I look out for while using MorphaBond?
MORPHABOND ER is contraindicated in patients with:
Addiction, Abuse, and Misuse
MORPHABOND™ 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 MORPHABOND ER, and monitor all patients regularly for the development of these behaviors and conditions
[see Warnings and Precautions (
)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of MORPHABOND ER. Monitor for respiratory depression, especially during initiation of MORPHABOND ER or following a dose increase. Instruct patients to swallow MORPHABOND ER tablets whole; crushing, chewing, or dissolving MORPHABOND 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 MORPHABOND ER, especially by children, can result in a fatal overdose of morphine
[see Warnings and Precautions (
)].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of MORPHABOND 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 (
)].
What might happen if I take too much MorphaBond?
Clinical Presentation
Acute overdosage with MORPHABOND ER 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 with 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 MORPHABOND ER, carefully monitor the patient until spontaneous respiration is reliably reestablished. MORPHABOND 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 usual 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 MorphaBond?
Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [].MORPHABOND™ ER (morphine sulfate) extended-release tablets 15 mg are round, blue-colored, coated tablets ink-printed with IDT/M15 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-301-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 30 mg are round, purple-colored, coated tablets ink-printed with IDT/M30 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-302-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 60 mg are round, orange-colored, coated tablets ink-printed with IDT/M60 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-303-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 100 mg are round, gray-colored, coated tablets ink-printed with IDT/M100 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-304-10).Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F .Dispense in a tight, light-resistant container.MORPHABOND™ ER (morphine sulfate) extended-release tablets 15 mg are round, blue-colored, coated tablets ink-printed with IDT/M15 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-301-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 30 mg are round, purple-colored, coated tablets ink-printed with IDT/M30 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-302-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 60 mg are round, orange-colored, coated tablets ink-printed with IDT/M60 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-303-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 100 mg are round, gray-colored, coated tablets ink-printed with IDT/M100 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-304-10).Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F .Dispense in a tight, light-resistant container.MORPHABOND™ ER (morphine sulfate) extended-release tablets 15 mg are round, blue-colored, coated tablets ink-printed with IDT/M15 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-301-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 30 mg are round, purple-colored, coated tablets ink-printed with IDT/M30 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-302-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 60 mg are round, orange-colored, coated tablets ink-printed with IDT/M60 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-303-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 100 mg are round, gray-colored, coated tablets ink-printed with IDT/M100 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-304-10).Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F .Dispense in a tight, light-resistant container.MORPHABOND™ ER (morphine sulfate) extended-release tablets 15 mg are round, blue-colored, coated tablets ink-printed with IDT/M15 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-301-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 30 mg are round, purple-colored, coated tablets ink-printed with IDT/M30 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-302-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 60 mg are round, orange-colored, coated tablets ink-printed with IDT/M60 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-303-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 100 mg are round, gray-colored, coated tablets ink-printed with IDT/M100 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-304-10).Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F .Dispense in a tight, light-resistant container.MORPHABOND™ ER (morphine sulfate) extended-release tablets 15 mg are round, blue-colored, coated tablets ink-printed with IDT/M15 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-301-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 30 mg are round, purple-colored, coated tablets ink-printed with IDT/M30 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-302-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 60 mg are round, orange-colored, coated tablets ink-printed with IDT/M60 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-303-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 100 mg are round, gray-colored, coated tablets ink-printed with IDT/M100 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-304-10).Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F .Dispense in a tight, light-resistant container.MORPHABOND™ ER (morphine sulfate) extended-release tablets 15 mg are round, blue-colored, coated tablets ink-printed with IDT/M15 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-301-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 30 mg are round, purple-colored, coated tablets ink-printed with IDT/M30 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-302-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 60 mg are round, orange-colored, coated tablets ink-printed with IDT/M60 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-303-10).MORPHABOND™ ER (morphine sulfate) extended-release tablets 100 mg are round, gray-colored, coated tablets ink-printed with IDT/M100 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (65597-304-10).Store 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
MORPHABOND ER is contraindicated in patients with:Addiction, Abuse, and Misuse
MORPHABOND™ 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 MORPHABOND ER, and monitor all patients regularly for the development of these behaviors and conditions
[see Warnings and Precautions (
)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of MORPHABOND ER. Monitor for respiratory depression, especially during initiation of MORPHABOND ER or following a dose increase. Instruct patients to swallow MORPHABOND ER tablets whole; crushing, chewing, or dissolving MORPHABOND 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 MORPHABOND ER, especially by children, can result in a fatal overdose of morphine
[see Warnings and Precautions (
)].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of MORPHABOND 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 (
)].
Drug Interactions
Studies to evaluate possible interactions between naltrexone hydrochloride and drugs other than opiates have not been performed. Consequently, caution is advised if the concomitant administration of naltrexone hydrochloride and other drugs is required.
The safety and efficacy of concomitant use of naltrexone hydrochloride and disulfiram is unknown, and the concomitant use of two potentially hepatotoxic medications is not ordinarily recommended unless the probable benefits outweigh the known risks.
Lethargy and somnolence have been reported following doses of naltrexone hydrochloride and thioridazine.
Patients taking naltrexone hydrochloride may not benefit from opioid containing medicines, such as cough and cold preparations, antidiarrheal preparations, and opioid analgesics. In an emergency situation when opioid analgesia must be administered to a patient receiving naltrexone hydrochloride, the amount of opioid required may be greater than usual, and the resulting respiratory depression may be deeper and more prolonged (see )
MORPHABOND ER contains morphine, a Schedule II controlled substance. As an opioid, MORPHABOND ER exposes its users to the risks of addiction, abuse, and misuse. Because extended-release products such as MORPHABOND 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 MORPHABOND ER. 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 MORPHABOND ER, and monitor all patients receiving MORPHABOND ER for development of these behaviors and 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 MORPHABOND ER, but use in such patients necessitates intensive counseling about the risks of proper use of MORPHABOND ER along with intensive monitoring for signs of addiction, abuse, and misuse.
Abuse or misuse of MORPHABOND ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of morphine and can result in 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 MORPHABOND 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 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, or described in greater detail, in other sections:
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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