Morphine Sulfate Extended-release
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Questions & Answers
Side Effects & Adverse Reactions
(see CLINICAL PHARMACOLOGY)
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED, OR CRUSHED. TAKING BROKEN, CHEWED, DISSOLVED, OR CRUSHED MORPHINE SULFATE EXTENDED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.
Morphine sulfate extended-release 100 mg AND 200 mg tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids.
Morphine sulfate extended-release 100 mg AND 200 mg tablets are for use only in opioid-tolerant patients requiring daily morphine equivalent dosages of 200 mg or more for the 100 mg tablet and 400 mg or more for the 200 mg tablet. Care should be taken in the prescribing of these tablet strengths. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Morphine sulfate extended-release tablets are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic.
The morphine sulfate extended-release tablets 100 mg and 200 mg strengths are high dose, extended-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only.
Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established.
Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time.
Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)
History
There is currently no drug history available for this drug.
Other Information
Morphine Sulfate Extended-Release Tablets are supplied in tablet form for oral administration.
Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula:
Morphine sulfate extended-release tablets are opiate analgesics supplied in 15, 30, 60, 100 and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate USP).
All strengths contain the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, silicone dioxide, titanium dioxide, and triacetine.
The 15 mg tablets also contain: polyethylene glycol, polydextrose, and FD&C Blue No. 2.
The 30 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Blue No. 2, and D&C Red No. 7.
The 60 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Yellow No. 6, and iron oxide red.
The 100 mg* tablets also contain: iron oxide black.
The 200 mg* tablets also contain: polyethylene glycol, FD&C Blue No. 1, and D&C Yellow No. 10 Lake.
*100 mg and 200 mg ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY.
Sources
Morphine Sulfate Extended-release Manufacturers
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Lake Erie Medical Surgical & Supply Dba Quality Care Products Llc
![Morphine Sulfate Extended-release (Morphine Sulfate) Tablet [Lake Erie Medical Surgical & Supply Dba Quality Care Products Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Morphine Sulfate Extended-release | Lake Erie Medical Surgical & Supply Dba Quality Care Products Llc
(see CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections)
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE OPIOID AGONISTS AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO OTHER OPIOID AGONISTS. MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA CAN BE ABUSED AND ARE SUBJECT TO CRIMINAL DIVERSION.
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE, AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED, OR CRUSHED. TAKING BROKEN, CHEWED, DISSOLVED, OR CRUSHED MORPHINE SULFATE EXTENDED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.
Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as those outlined by the World Health Organization, the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).
Morphine sulfate extended-release tablets are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The extended-release nature of the formulation allows it to be administered on a more convenient schedule than conventional immediate-release oral morphine products (see CLINICAL PHARMACOLOGY and PHARMACOKINETICS AND METABOLISM). However, morphine sulfate extended-release tablets do not release morphine continuously over the course of a dosing interval. The administration of single doses of morphine sulfate extended-release tablets on a q12h dosing schedule will result in higher peak and lower trough plasma levels than those that occur when an identical daily dose of morphine is administered using conventional oral formulations on a q4h regimen. The clinical significance of greater fluctuations in morphine plasma level has not been systematically evaluated.
As with any potent opioid drug product, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient’s prior opioid and non-opioid analgesic treatment experience. Although it is clearly impossible to enumerate every consideration that is important to the selection of initial dose and dosing interval of morphine sulfate extended-release tablets, attention should be given to 1) the daily dose, potency, and precise characteristics of the opioid the patient has been taking previously (e.g., whether it is a pure agonist or mixed agonist/antagonist), 2) the reliability of the relative potency estimate used to calculate the dose of morphine needed [N.B. potency estimates may vary with the route of administration], 3) the degree of opioid tolerance, if any, and 4) the general condition and medical status of the patient.
The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions in the management of the pain of an individual patient.
During periods of changing analgesic requirements including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family.
-
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Morphine Sulfate Extended-release | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
(see CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections)
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE OPIOID AGONISTS AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO OTHER OPIOID AGONISTS. MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA CAN BE ABUSED AND ARE SUBJECT TO CRIMINAL DIVERSION.
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE, AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED, OR CRUSHED. TAKING BROKEN, CHEWED, DISSOLVED, OR CRUSHED MORPHINE SULFATE EXTENDED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.
Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as those outlined by the World Health Organization, the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).
Morphine sulfate extended-release tablets are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The extended-release nature of the formulation allows it to be administered on a more convenient schedule than conventional immediate-release oral morphine products (see CLINICAL PHARMACOLOGY and PHARMACOKINETICS AND METABOLISM). However, morphine sulfate extended-release tablets do not release morphine continuously over the course of a dosing interval. The administration of single doses of morphine sulfate extended-release tablets on a q12h dosing schedule will result in higher peak and lower trough plasma levels than those that occur when an identical daily dose of morphine is administered using conventional oral formulations on a q4h regimen. The clinical significance of greater fluctuations in morphine plasma level has not been systematically evaluated.
As with any potent opioid drug product, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient’s prior opioid and non-opioid analgesic treatment experience. Although it is clearly impossible to enumerate every consideration that is important to the selection of initial dose and dosing interval of morphine sulfate extended-release tablets, attention should be given to 1) the daily dose, potency, and precise characteristics of the opioid the patient has been taking previously (e.g., whether it is a pure agonist or mixed agonist/antagonist), 2) the reliability of the relative potency estimate used to calculate the dose of morphine needed [N.B. potency estimates may vary with the route of administration], 3) the degree of opioid tolerance, if any, and 4) the general condition and medical status of the patient.
The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions in the management of the pain of an individual patient.
During periods of changing analgesic requirements including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family.
-
Stat Rx Usa Llc
Morphine Sulfate Extended-release | Stat Rx Usa Llc
(see CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections)
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE OPIOID AGONISTS AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO OTHER OPIOID AGONISTS. MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA CAN BE ABUSED AND ARE SUBJECT TO CRIMINAL DIVERSION.
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE, AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED, OR CRUSHED. TAKING BROKEN, CHEWED, DISSOLVED, OR CRUSHED MORPHINE SULFATE EXTENDED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.
Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as those outlined by the World Health Organization, the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).
Morphine sulfate extended-release tablets are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The extended-release nature of the formulation allows it to be administered on a more convenient schedule than conventional immediate-release oral morphine products (see CLINICAL PHARMACOLOGY and PHARMACOKINETICS AND METABOLISM). However, morphine sulfate extended-release tablets do not release morphine continuously over the course of a dosing interval. The administration of single doses of morphine sulfate extended-release tablets on a q12h dosing schedule will result in higher peak and lower trough plasma levels than those that occur when an identical daily dose of morphine is administered using conventional oral formulations on a q4h regimen. The clinical significance of greater fluctuations in morphine plasma level has not been systematically evaluated.
As with any potent opioid drug product, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient’s prior opioid and non-opioid analgesic treatment experience. Although it is clearly impossible to enumerate every consideration that is important to the selection of initial dose and dosing interval of morphine sulfate extended-release tablets, attention should be given to 1) the daily dose, potency, and precise characteristics of the opioid the patient has been taking previously (e.g., whether it is a pure agonist or mixed agonist/antagonist), 2) the reliability of the relative potency estimate used to calculate the dose of morphine needed [N.B. potency estimates may vary with the route of administration], 3) the degree of opioid tolerance, if any, and 4) the general condition and medical status of the patient.
The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions in the management of the pain of an individual patient.
During periods of changing analgesic requirements including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family.
-
Bryant Ranch Prepack
Morphine Sulfate Extended-release | Bryant Ranch Prepack
(see CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections)
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE OPIOID AGONISTS AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO OTHER OPIOID AGONISTS. MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA CAN BE ABUSED AND ARE SUBJECT TO CRIMINAL DIVERSION.
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE, AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED, OR CRUSHED. TAKING BROKEN, CHEWED, DISSOLVED, OR CRUSHED MORPHINE SULFATE EXTENDED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.
Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as those outlined by the World Health Organization, the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).
Morphine sulfate extended-release tablets are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The extended-release nature of the formulation allows it to be administered on a more convenient schedule than conventional immediate-release oral morphine products (see CLINICAL PHARMACOLOGY and PHARMACOKINETICS AND METABOLISM). However, morphine sulfate extended-release tablets do not release morphine continuously over the course of a dosing interval. The administration of single doses of morphine sulfate extended-release tablets on a q12h dosing schedule will result in higher peak and lower trough plasma levels than those that occur when an identical daily dose of morphine is administered using conventional oral formulations on a q4h regimen. The clinical significance of greater fluctuations in morphine plasma level has not been systematically evaluated.
As with any potent opioid drug product, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient’s prior opioid and non-opioid analgesic treatment experience. Although it is clearly impossible to enumerate every consideration that is important to the selection of initial dose and dosing interval of morphine sulfate extended-release tablets, attention should be given to 1) the daily dose, potency, and precise characteristics of the opioid the patient has been taking previously (e.g., whether it is a pure agonist or mixed agonist/antagonist), 2) the reliability of the relative potency estimate used to calculate the dose of morphine needed [N.B. potency estimates may vary with the route of administration], 3) the degree of opioid tolerance, if any, and 4) the general condition and medical status of the patient.
The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions in the management of the pain of an individual patient.
During periods of changing analgesic requirements including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family.
![Morphine Sulfate Extended-release (Morphine Sulfate) Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=67df468c-ce7e-4e8f-8a26-016eee1051f6&name=MorphineSulfate200mgMallinckrodt.jpg)
![Morphine Sulfate Extended-release (Morphine Sulfate) Tablet, Extended Release [Stat Rx Usa Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e3ec6c6-7c9d-41ab-ad62-da8d4556f391&name=MorphineSulfERC-II15mg42549.jpg)
![Morphine Sulfate Extended-release (Morphine Sulfate) Tablet [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2e8ec435-acce-0c3e-26d9-0a069eb5a000&name=label1datamaxfda577.jpg)
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