Morphine Sulfate

Morphine Sulfate Manufacturers

• Mallinckrodt, Inc.
  

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  Morphine Sulfate | Mallinckrodt, Inc.

  

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  2.1    Initial Dosing

  Morphine sulfate extended-release tablets should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with morphine sulfate extended-release tablets [see Warnings and Precautions (5.2)].

  Morphine sulfate extended-release tablets must be taken whole. Crushing, chewing, or dissolving morphine sulfate extended-release tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  Initiate treatment with morphine sulfate extended-release tablets with 15 mg tablets orally every 8 or 12 hours.

  Use of Morphine Sulfate Extended-Release Tablets in Patients who are not Opioid Tolerant

  The starting dose for patients who are not opioid tolerant is morphine sulfate extended-release tablets 15 mg orally every 12 hours. 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, or an equianalgesic dose of another opioid.

  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

  Conversion from Other Oral Morphine to Morphine Sulfate Extended-Release Tablets

  Patients receiving other oral morphine formulations may be converted to morphine sulfate extended-release tablets by administering one-half of the patient's 24-hour requirement as morphine sulfate extended-release tablets on an every-12-hour schedule or by administering one-third of the patient's daily requirement as morphine sulfate extended-release tablets on an every-8-hour schedule.

  Conversion from Other Opioids to Morphine Sulfate Extended-Release Tablets

  There are no established conversion ratios for conversion from other opioids to morphine sulfate extended-release tablets defined by clinical trials. Discontinue all other around-the-clock opioid drugs when morphine sulfate extended-release tablets therapy is initiated and initiate dosing using morphine sulfate extended-release tablets 15 mg orally every 8 to 12 hours.

  It is safer to underestimate a patient’s 24-hour oral morphine requirements and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine requirements and manage an adverse reaction. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to morphine sulfate extended-release tablets, consider the following general points:

  Parenteral to oral morphine ratio: Between 2 to 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of morphine that is approximately three times the previous daily parenteral morphine requirement is sufficient.

  Other parenteral or oral non-morphine opioids to oral morphine sulfate: Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.

  Conversion from Methadone to Morphine Sulfate Extended-Release Tablets

  Close monitoring is of particular importance when converting methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

  2.2    Titration and Maintenance of Therapy

  Individually titrate morphine sulfate extended-release tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving morphine sulfate extended-release tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy periodically reassess the continued need for the use of opioid analgesics.

  Patients who experience breakthrough pain may require a dose increase of morphine sulfate extended-release tablets, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the morphine sulfate extended-release tablets dose. Because steady-state plasma concentrations are approximated in 1 day, morphine sulfate extended-release tablets dosage adjustments may be done every 1 to 2 days.

  If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  2.3    Discontinuation of Morphine Sulfate Extended-Release Tablets

  When the patient no longer requires therapy with morphine sulfate extended-release tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue morphine sulfate extended-release tablets.

  2.4    Administration of Morphine Sulfate Extended-Release Tablets

  Morphine sulfate extended-release tablets must be taken whole. Crushing, chewing, or dissolving morphine sulfate extended-release tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].

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• Zydus Pharmaceuticals (Usa) Inc.
  

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  Morphine Sulfate | Topco Associates Llc

  

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  • do not take more than directed (see overdose warning) • do not take more than 10 caplets in any 24-hour period • adults and children 12 years and older: take 2 caplets every 4 hours • children under 12 years of age: do not use

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• American Health Packaging
  

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  Morphine Sulfate | American Health Packaging

  

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  2.1 Initial Dosing

  Morphine sulfate extended-release tablets should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with morphine sulfate extended-release tablets [see Warnings and Precautions (5.2)].

  Morphine sulfate extended-release tablets must be taken whole. Crushing, chewing, or dissolving morphine sulfate extended-release tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  Initiate treatment with morphine sulfate extended-release tablets with 15 mg tablets orally every 8 or 12 hours.

  Use of Morphine Sulfate Extended-Release Tablets in Patients who are not Opioid Tolerant

  The starting dose for patients who are not opioid tolerant is morphine sulfate extended-release tablets 15 mg orally every 12 hours. 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, or an equianalgesic dose of another opioid.

  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

  Conversion from Other Oral Morphine to Morphine Sulfate Extended-Release Tablets

  Patients receiving other oral morphine formulations may be converted to morphine sulfate extended-release tablets by administering one-half of the patient's 24-hour requirement as morphine sulfate extended-release tablets on an every-12-hour schedule or by administering one-third of the patient's daily requirement as morphine sulfate extended-release tablets on an every-8-hour schedule.

  Conversion from Other Opioids to Morphine Sulfate Extended-Release Tablets

  There are no established conversion ratios for conversion from other opioids to morphine sulfate extended-release tablets defined by clinical trials. Discontinue all other around-the-clock opioid drugs when morphine sulfate extended-release tablets therapy is initiated and initiate dosing using morphine sulfate extended-release tablets 15 mg orally every 8 to 12 hours.

  It is safer to underestimate a patient’s 24-hour oral morphine requirements and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine requirements and manage an adverse reaction. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to morphine sulfate extended-release tablets, consider the following general points:

  Parenteral to oral morphine ratio: Between 2 to 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of morphine that is approximately three times the previous daily parenteral morphine requirement is sufficient.

  Other parenteral or oral non-morphine opioids to oral morphine sulfate: Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.

  Conversion from Methadone to Morphine Sulfate Extended-Release Tablets

  Close monitoring is of particular importance when converting methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

  2.2 Titration and Maintenance of Therapy

  Individually titrate morphine sulfate extended-release tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving morphine sulfate extended-release tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy periodically reassess the continued need for the use of opioid analgesics.

  Patients who experience breakthrough pain may require a dose increase of morphine sulfate extended-release tablets, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the morphine sulfate extended-release tablets dose. Because steady-state plasma concentrations are approximated in 1 day, morphine sulfate extended-release tablets dosage adjustments may be done every 1 to 2 days.

  If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  2.3 Discontinuation of Morphine Sulfate Extended-Release Tablets

  When the patient no longer requires therapy with morphine sulfate extended-release tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient.  Do not abruptly discontinue morphine sulfate extended-release tablets.

  2.4 Administration of Morphine Sulfate Extended-Release Tablets

  Morphine sulfate extended-release tablets must be taken whole. Crushing, chewing, or dissolving morphine sulfate extended-release tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].

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• Direct Rx
  

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  Morphine Sulfate | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

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  Dosage must be individualized, depending on the type and severity of the condition to be treated.

  Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur.

  The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour.

  If necessary, the effects of the drug can be abolished promptly by atropine (see OVERDOSAGE).

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• Ethex Corporation
  

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  Morphine Sulfate | Ethex Corporation

  

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  (See also CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections)

  MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE AN OPIOID AGONIST 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 a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-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;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.

  Conversion from Immediate-Release Oral Morphine to Morphine Sulfate Extended-Release Tablets

  A patient’s daily morphine requirement is established using immediate-release oral morphine (dosing every 4 to 6 hours). The patient is then converted to morphine sulfate extended-release tablets in either of two ways: 1) by administering one-half of the patient’s 24-hour requirement as morphine sulfate extended-release tablets on an every 12-hour schedule; or, 2) by administering one-third of the patient’s daily requirement as morphine sulfate extended-release tablets on an every eight hour schedule. With either method, dose and dosing interval is then adjusted as needed (see discussion below). The 15 mg tablet should be used for initial conversion for patients whose total daily requirement is expected to be less than 60 mg. The 30 mg tablet strength is recommended for patients with a daily morphine requirement of 60 mg to 120 mg. When the total daily dose is expected to be greater than 120 mg, the appropriate combination of tablet strengths should be employed.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  Morphine sulfate extended-release tablets can be administered as the initial oral morphine drug product; in this case, however, particular care must be exercised in the conversion process. Because of uncertainty about, and intersubject variation in, relative estimates of opioid potency and cross tolerance, initial dosing regimens should be conservative. It is better to underestimate the 24-hour oral morphine requirement than to overestimate. To this end, initial individual doses of morphine sulfate extended-release tablets should be estimated conservatively. In patients whose daily morphine requirements are expected to be less than or equal to 120 mg per day, the 30 mg tablet strength is recommended for the initial titration period. Once a stable dose regimen is reached, the patient can be converted to the 60 mg or 100 mg tablet strength, or an appropriate combination of tablet strengths, if desired.

  Estimates of the relative potency of opioids are only approximate and are influenced by route of administration, individual patient differences, and possibly, by an individual’s medical condition. Consequently, it is difficult to recommend any fixed rule for converting a patient to morphine sulfate extended-release tablets directly. The following general points should be considered, however.

  Parenteral to Oral Morphine Ratio: Estimates of the oral to parenteral potency of morphine vary. Some authorities suggest that a dose of oral morphine only three times the daily parenteral morphine requirement may be sufficient in chronic use settings. Other Parenteral or Oral Opioids to Oral Morphine: Because there is lack of systematic evidence bearing on these types of analgesic substitutions, specific recommendations are not possible.

  Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safer to underestimate the daily dose of morphine sulfate extended-release tablets required and rely upon ad hoc supplementation to deal with inadequate analgesia (see discussion which follows).

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  There has been no systematic evaluation of morphine sulfate extended-release tablets as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using a controlled-release morphine, it is ordinarily advisable to begin treatment using an immediate-release formulation (see Special Instructions for Morphine Sulfate Extended-Release 100 mg and 200 mg Tablets).

  Considerations in the Adjustment of Dosing Regimens

  Whatever the approach, if signs of excessive opioid effects are observed early in a dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, “breakthrough” pain occurs late in the dosing interval, the dosing interval may be shortened. Alternatively, a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments can be made to obtain an appropriate balance between pain relief, opioid side effects, and the convenience of the dosing schedule.

  In adjusting dosing requirements, it is recommended that the dosing interval never be extended beyond 12 hours because the administration of very large single doses may lead to acute overdose. (N.B. Morphine sulfate extended-release tablets are a controlled-release formulation; it does not release morphine continuously over the dosing interval.)

  For patients with low daily morphine requirements, the 15 mg tablet should be used.

  Special Instructions for Morphine Sulfate Extended-Release 100 mg and 200 mg Tablets

  (For use in opioid-tolerant patients only.)

  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. It is recommended that these strengths be reserved for patients that have already been titrated to a stable analgesic regimen using lower strengths of morphine sulfate extended-release tablets or other opioids.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (including incident pain).

  Continuation of Therapy

  The intent of the titration period is to establish a patient-specific daily dose that will provide adequate analgesia with acceptable side effects and minimal rescue doses (2 or less) for as long as pain relief is necessary. Should pain recur, the dose can be increased to re-establish pain control as outlined above. During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with morphine sulfate extended-release tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from Morphine Sulfate Extended-Release Tablets to Parenteral Opioids

  When converting a patient from morphine sulfate extended-release tablets to parenteral opioids, it is best to assume that the parenteral to oral potency is high. NOTE THAT THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE CONSERVATIVELY. For example, to estimate the required 24-hour dose of morphine for IM use, one could employ a conversion of 1 mg of morphine IM for every 6 mg of morphine as morphine sulfate extended-release tablets. The IM 24-hour dose would have to be divided by six and administered on a q4h regimen. This approach is recommended because it is least likely to cause overdose.

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• Baxter Healthcare Corporation
  

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  Morphine Sulfate | Baxter Healthcare Corporation

  

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  Morphine Sulfate Injection should be given via the subcutaneous, intramuscular or slow intravenous routes. NOT FOR EPIDURAL OR INTRATHECAL USE.

  In patients with severe, chronic pain, dosage should be adjusted according to the severity of the pain and the response and tolerance of the patient. In patients with exceptionally severe, chronic pain or in those who have become tolerant to the analgesic effect of opiate agonists, it may be necessary to exceed the usual dosage.

  Reduced dosage is indicated in poor-risk patients, in very young or very old patients and in patients receiving other CNS depressants.

  Morphine Sulfate Injection is usually administered subcutaneously; the drug may also be administered by intramuscular or slow intravenous injection. Intramuscular administration is preferred to subcutaneous injection when repeated parenteral doses are necessary, since repeated subcutaneous administration causes local tissue irritation, pain and induration.

  Adults

  The usual adult subcutaneous or intramuscular dosage of Morphine Sulfate Injection is 10 mg every 4 hours as necessary; dosage may range from 5-20 mg every 4 hours as necessary depending on patient requirements and response.

  For intravenous administration, the usual dosage is 4-10 mg administered very slowly over 4-5 minutes. A strength of 2.5-15 mg of morphine sulfate may be diluted in 4-5 mL of sterile water for injection.

  Infants and Children

  Do not use in premature infants (see CONTRAINDICATIONS). Safety and effectiveness in newborn infants have not been established. Infants and children may receive a subcutaneous dose of 0.1-0.2 mg/kg as necessary; a single pediatric dose should not exceed 15 mg.

  PAIN OF MYOCARDIAL INFARCTION-8-15 mg of Morphine Sulfate Injection may be administered parenterally. For very severe pain, additional smaller doses may be given every 3-4 hours.

  ANALGESIA DURING LABOR-10 mg of morphine sulfate is usually administered subcutaneously or intramuscularly.

  When morphine sulfate is administered intravenously, an opiate antagonist and facilities for administration of oxygen and control of respiration should be available.

  Morphine sulfate has been reported to be physically or chemically incompatible with various drug products. Specialized references should be consulted for specific compatibility information.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Amphastar Pharmaceuticals, Inc.
  

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  Morphine Sulfate | Amphastar Pharmaceuticals, Inc.

  

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  PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE LIFECARE PCA INFUSER BEFORE PRESCRIBING MORPHINE SULFATE INJECTION USP.

  When administered intravenously, morphine sulfate should be given very slowly. Rapid intravenous injection increases the incidence of adverse reactions as described above. This drug should be administered intravenously only if a narcotic antagonist (i.e., naloxone) is available. When morphine sulfate is given parenterally, especially intravenously, the patient should be nonambulatory.

  For use in a LifeCare PCA Infuser, dosage should be adjusted according to the severity of the pain and the response of the patient. There can be considerable variability in both the dosage requirement and patient response.

  Morphine 1 mg/mL Adults

  The usual dose for adults is 1 mg, with a range of 0.1 mg – 5 mg per incremental dose.

  Occasionally, it may be necessary to exceed the usual dosage recommended in cases of exceptionally severe pain or in those patients who become tolerant.

  Incompatibility

  Morphine Sulfate Injection USP, is incompatible with admixtures of soluble barbiturates, chlorothiazide, aminophylline, heparin, meperidine, methicillin, phenytoin, sodium bicarbonate, iodide, sulfadiazine and sulfisoxazole.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use unless solution is clear and package is undamaged. Morphine products may discolor over a period of time. No loss of analgesic potency and no increase in toxicity has ever been demonstrated for such discolored solutions. Do not use the injection if it is darker than pale yellow or discolored in any other way, or if it contains a precipitate.

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• Watson Laboratories, Inc.
  

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  Morphine Sulfate | Watson Laboratories, Inc.

  

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  (See also: CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections)

  MORPHINE SULFATE EXTENDED-RELEASE TABLETS IS AN OPIOID AGONIST 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 is an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock 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; 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.

  Conversion from Immediate-Release Oral Morphine to Morphine Sulfate Extended-Release Tablets

  A patient's daily morphine requirement is established using immediate-release oral morphine (dosing every 4 to 6 hours). The patient is then converted to Morphine Sulfate Extended-Release Tablets in either of two ways: 1) by administering one-half of the patient's 24-hour requirement as Morphine Sulfate Extended-Release Tablets on an every 12-hour schedule; or, 2) by administering one-third of the patient's daily requirement as Morphine Sulfate Extended-Release Tablets on an every eight hour schedule. With either method, dose and dosing interval is then adjusted as needed (see discussion below). The 15 mg tablet should be used for initial conversion for patients whose total daily requirement is expected to be less than 60 mg. The 30 mg tablet strength is recommended for patients with a daily morphine requirement of 60 to 120 mg. When the total daily dose is expected to be greater than 120 mg, the appropriate combination of tablet strengths should be employed.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  Morphine Sulfate Extended-Release Tablets can be administered as the initial oral morphine drug product; in this case, however, particular care must be exercised in the conversion process. Because of uncertainty about, and intersubject variation in, relative estimates of opioid potency and cross tolerance, initial dosing regimens should be conservative. It is better to underestimate the 24-hour oral morphine requirement than to overestimate. To this end, initial individual doses of Morphine Sulfate Extended-Release Tablets should be estimated conservatively. In patients whose daily morphine requirements are expected to be less than or equal to 120 mg per day, the 30 mg tablet strength is recommended for the initial titration period. Once a stable dose regimen is reached, the patient can be converted to the 60 mg or 100 mg tablet strength, or an appropriate combination of tablet strengths, if desired.

  Estimates of the relative potency of opioids are only approximate and are influenced by route of administration, individual patient differences, and possibly, by an individual's medical condition. Consequently, it is difficult to recommend any fixed rule for converting a patient to Morphine Sulfate Extended-Release Tablets directly. The following general points should be considered, however.

  Parenteral to oral morphine ratio: Estimates of the oral to parenteral potency of morphine vary. Some authorities suggest that a dose of oral morphine only three times the daily parenteral morphine requirement may be sufficient in chronic use settings.
  Other parenteral or oral opioids to oral morphine: Because there is lack of systematic evidence bearing on these types of analgesic substitutions, specific recommendations are not possible.

  Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safer to underestimate the daily dose of Morphine Sulfate Extended-Release Tablets required and rely upon ad hoc supplementation to deal with inadequate analgesia. (See discussion which follows.)

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  There has been no systematic evaluation of Morphine Sulfate Extended-Release Tablets as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using an extended-release morphine, it is ordinarily advisable to begin treatment using an immediate-release formulation. (See Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets)

  Considerations in the Adjustment of Dosing Regimens

  Whatever the approach, if signs of excessive opioid effects are observed early in a dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, "breakthrough" pain occurs late in the dosing interval, the dosing interval may be shortened. Alternatively, a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments can be made to obtain an appropriate balance between pain relief, opioid side effects, and the convenience of the dosing schedule.

  In adjusting dosing requirements, it is recommended that the dosing interval never be extended beyond 12 hours because the administration of very large single doses may lead to acute overdose. (N.B. Morphine Sulfate Extended-Release Tablets is an extended-release formulation; it does not release morphine continuously over the dosing interval.)

  For patients with low daily morphine requirements, the 15 mg tablet should be used.

  Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets

  (For use in opioid-tolerant patients only.)

  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. It is recommended that these strengths be reserved for patients that have already been titrated to a stable analgesic regimen using lower strengths of Morphine Sulfate Extended-Release Tablets or other opioids.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (including incident pain).

  Continuation of Therapy

  The intent of the titration period is to establish a patient-specific daily dose that will provide adequate analgesia with acceptable side effects and minimal rescue doses (2 or less) for as long as pain relief is necessary. Should pain recur, the dose can be increased to re-establish pain control as outlined above. During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g. every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with Morphine Sulfate Extended-Release Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from Morphine Sulfate Extended-Release Tablets to Parenteral Opioids

  When converting a patient from Morphine Sulfate Extended-Release Tablets to parenteral opioids, it is best to assume that the parenteral to oral potency is high. NOTE THAT THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE CONSERVATIVELY. For example, to estimate the required 24-hour dose of morphine for IM use, one could employ a conversion of 1 mg of morphine IM for every 6 mg of morphine as Morphine Sulfate Extended-Release Tablets. The IM 24-hour dose would have to be divided by six and administered on a q4h regimen. This approach is recommended because it is least likely to cause overdose.

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  (SEE ALSO: CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS SECTIONS)
  MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE AN OPIOID AGONIST 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 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: PHARMACOKENTICS 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 ql2h 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.

  Conversion from Immediate-Release Oral Morphine to Morphine Sulfate Extended-Release Tablets

  A patient’s daily morphine requirement is established using immediate-release oral morphine (dosing every 4 to 6 hours). The patient is then converted to morphine sulfate extended-release tablets in either of two ways: 1) by administering one-half of the patient’s 24-hour requirement as morphine sulfate extended-release tablets on an every 12-hour schedule; or, 2) by administering one-third of the patient's daily requirement as morphine sulfate extended-release tablets on an every eight hour schedule. With either method, dose and dosing interval is then adjusted as needed (see discussion below). The 15 mg should be used for initial conversion for patients whose total daily requirement is expected to be less than 60 mg. The 30 mg tablet strength is recommended for patients with a daily morphine requirement of 60 to 120 mg. When the total daily dose is expected to be greater than 120 mg, the appropriate combination of tablet strengths should be employed.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  Morphine sulfate extended-release tablets can be administered as the initial oral morphine drug product; in this case, however, particular care must be exercised in the conversion process. Because of uncertainty about, and intersubject variation in, relative estimates of opioid potency and cross tolerance, initial dosing regimens should be conservative. It is better to underestimate the 24-hour oral morphine requirement than to overestimate. To this end, initial individual doses of morphine sulfate extended-release tablets should be estimated conservatively. In patients whose daily morphine requirements are expected to be less than or equal to 120 mg per day, the 30 mg tablet strength is recommended for the initial titration period. Once a stable dose regimen is reached, the patient can be converted to the 60 mg or 100 mg tablet strength, or appropriate combination of tablet strengths, if desired.

  Estimates of the relative potency of opioids are only approximate and are influenced by route of administration, individual patient differences, and possibly, by an individual’s medical condition. Consequently, it is difficult to recommend any fixed rule for converting a patient to morphine sulfate extended-release tablets directly. The following general points should be considered, however.
  

  Parenteral to oral morphine ratio: Estimates of the oral to parenteral potency of morphine vary. Some authorities suggest that a dose of oral morphine only three times the daily parenteral morphine requirement may be sufficient in chronic use settings. Other parenteral or oral opioids to oral morphine: Because there is lack of systematic evidence bearing on these types of analgesic substitutions, specific recommendations are not possible.

  Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safer to underestimate the daily dose of morphine sulfate extended-release tablets required and rely upon ad hoc supplementation to deal with inadequate analgesia. (See discussion which follows.)

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  There has been no systematic evaluation of morphine sulfate extended-release tablets as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using an extended-release morphine, it is ordinarily advisable to begin treatment using an immediate-release formulation. (See Special Instructions for morphine sulfate extended-release tablets 100 and 200 mg)

  Considerations in the Adjustment of Dosing Regimens

  Whatever the approach, if signs of excessive opioid effects are observed early in a dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, "breakthrough" pain occurs late in the dosing interval, the dosing interval may be shortened. Alternatively, a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments can be made to obtain an appropriate balance between pain relief, opioid side effects, and the convenience of the dosing schedule.

  In adjusting dosing requirements, it is recommended that the dosing interval never be extended beyond 12 hours because the administration of very large single doses may lead to acute overdose. (N.B. morphine sulfate extended-release tablets are an extended-release formulation; it does not release morphine continuously over the dosing interval.)

  For patients with low daily morphine requirements, the 15 mg tablet should be used.

  Special Instructions for Morphine Sulfate Extended-Release Tablets, 100 and 200 mg

  (For use in opioid tolerant patients only.)

  Morphine Sulfate Extended-Release tablets, 100 and 200 mg 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. It is recommended that these strengths be reserved for patients that have already been titrated to a stable analgesic regimen using lower strengths of morphine extended-release tablets or other opioids.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with extended-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (including incident pain).

  Continuation of Therapy

  The intent of the titration period is to establish a patient-specific daily dose that will provide adequate analgesia with acceptable side effects and minimal rescue doses (2 or less) for as long as pain relief is necessary. Should pain recur, the dose can be increased to reestablish pain control as outlined above. During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g. every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with morphine sulfate extended-release tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from Morphine Sulfate Extended-Release Tablets to Parenteral Opioids:

  When converting a patient from morphine sulfate extended-release tablets to parenteral opioids, it is best to assume that the parenteral to oral potency is high. NOTE THAT THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE CONSERVATIVELY. For example, to estimate the required 24-hour dose of morphine for IM use, one could employ a conversion of 1 mg of morphine IM for every 6 mg of morphine as morphine sulfate extended-release tablets. The IM 24-hour dose would have to be divided by six and administered on a q4h regimen. This approach is recommended because it is least likely to cause overdose.

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  MORPHINE SULFATE EXTENDED-RELEASE TABLETS IS AN OPIOID AGONIST 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.

  Morphine Sulfate Extended-Release Tablets is an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock 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; 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.

  Conversion from Immediate-Release Oral Morphine to Morphine Sulfate Extended -Release Tablets

  A patient's daily morphine requirement is established using immediate-release oral morphine (dosing every 4 to 6 hours). The patient is then converted to Morphine Sulfate Extended-Release Tablets in either of two ways: 1) by administering one-half of the patient's 24-hour requirement as Morphine Sulfate Extended-Release Tablets on an every 12-hour schedule; or, 2) by administering one-third of the patient's daily requirement as Morphine Sulfate Extended-Release Tablets on an every eight hour schedule. With either method, dose and dosing interval is then adjusted as needed (see discussion below). The 15 mg tablet should be used for initial conversion for patients whose total daily requirement is expected to be less than 60 mg. The 30 mg tablet strength is recommended for patients with a daily morphine requirement of 60 to 120 mg. When the total daily dose is expected to be greater than 120 mg, the appropriate combination of tablet strengths should be employed.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended -Release Tablets

  Morphine Sulfate Extended-Release Tablets can be administered as the initial oral morphine drug product; in this case, however, particular care must be exercised in the conversion process. Because of uncertainty about, and intersubject variation in, relative estimates of opioid potency and cross tolerance, initial dosing regimens should be conservative. It is better to underestimate the 24-hour oral morphine requirement than to overestimate. To this end, initial individual doses of Morphine Sulfate Extended-Release Tablets should be estimated conservatively. In patients whose daily morphine requirements are expected to be less than or equal to 120 mg per day, the 30 mg tablet strength is recommended for the initial titration period. Once a stable dose regimen is reached, the patient can be converted to the 60 mg or 100 mg tablet strength, or an appropriate combination of tablet strengths, if desired.

  Estimates of the relative potency of opioids are only approximate and are influenced by route of administration, individual patient differences, and possibly, by an individual's medical condition. Consequently, it is difficult to recommend any fixed rule for converting a patient to Morphine Sulfate Extended-Release Tablets directly. The following general points should be considered, however.

  Parenteral to oral morphine ratio: Estimates of the oral to parenteral potency of morphine vary. Some authorities suggest that a dose of oral morphine only three times the daily parenteral morphine requirement may be sufficient in chronic use settings.
  Other parenteral or oral opioids to oral morphine: Because there is lack of systematic evidence bearing on these types of analgesic substitutions, specific recommendations are not possible.

  Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safer to underestimate the daily dose of Morphine Sulfate Extended-Release Tablets required and rely upon ad hoc supplementation to deal with inadequate analgesia. (See discussion which follows.)

  Use of Morphine Sulfate Extended -Release Tablets as the First Opioid Analgesic

  There has been no systematic evaluation of Morphine Sulfate Extended-Release Tablets as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using an extended-release morphine, it is ordinarily advisable to begin treatment using an immediate-release formulation.

  Considerations in the Adjustment of Dosing Regimens

  Whatever the approach, if signs of excessive opioid effects are observed early in a dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, "breakthrough" pain occurs late in the dosing interval, the dosing interval may be shortened. Alternatively, a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments can be made to obtain an appropriate balance between pain relief, opioid side effects, and the convenience of the dosing schedule.

  In adjusting dosing requirements, it is recommended that the dosing interval never be extended beyond 12 hours because the administration of very large single doses may lead to acute overdose. (N.B. Morphine Sulfate Extended-Release Tablets is an extended-release formulation; it does not release morphine continuously over the dosing interval.)

  For patients with low daily morphine requirements, the 15 mg tablet should be used.

  Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets

  (For use in opioid-tolerant patients only.)

  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. It is recommended that these strengths be reserved for patients that have already been titrated to a stable analgesic regimen using lower strengths of Morphine Sulfate Extended-Release Tablets or other opioids.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (including incident pain).

  Continuation of Therapy

  The intent of the titration period is to establish a patient-specific daily dose that will provide adequate analgesia with acceptable side effects and minimal rescue doses (2 or less) for as long as pain relief is necessary. Should pain recur, the dose can be increased to re-establish pain control as outlined above. During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g. every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with Morphine Sulfate Extended-Release Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from Morphine Sulfate Extended -Release Tablets to Parenteral Opioids

  When converting a patient from Morphine Sulfate Extended-Release Tablets to parenteral opioids, it is best to assume that the parenteral to oral potency is high. NOTE THAT THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE CONSERVATIVELY. For example, to estimate the required 24-hour dose of morphine for IM use, one could employ a conversion of 1 mg of morphine IM for every 6 mg of morphine as Morphine Sulfate Extended-Release Tablets. The IM 24-hour dose would have to be divided by six and administered on a q4h regimen. This approach is recommended because it is least likely to cause overdose.

  SAFETY AND HANDLING

  Morphine Sulfate Extended-Release Tablets contain morphine sulfate which is a controlled substance under Schedule II of the Controlled Substances Act. Morphine, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to flush any unneeded Morphine Sulfate Extended-Release Tablets down the toilet.

  Morphine Sulfate Extended-Release Tablets may be targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

  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 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. This strength is potentially fatal if accidentally ingested and patients and their families should be instructed to take special care to avoid accidental or intentional ingestion by individuals other than those for whom the medication was originally prescribed.

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  (See also: CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections)

  MORPHINE SULFATE EXTENDED-RELEASE TABLETS IS AN OPIOID AGONIST 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 is an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock 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; 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.

  Conversion from Immediate-Release Oral Morphine to Morphine Sulfate Extended-Release Tablets

  A patient's daily morphine requirement is established using immediate-release oral morphine (dosing every 4 to 6 hours). The patient is then converted to Morphine Sulfate Extended-Release Tablets in either of two ways: 1) by administering one-half of the patient's 24-hour requirement as Morphine Sulfate Extended-Release Tablets on an every 12-hour schedule; or, 2) by administering one-third of the patient's daily requirement as Morphine Sulfate Extended-Release Tablets on an every eight hour schedule. With either method, dose and dosing interval is then adjusted as needed (see discussion below). The 15 mg tablet should be used for initial conversion for patients whose total daily requirement is expected to be less than 60 mg. The 30 mg tablet strength is recommended for patients with a daily morphine requirement of 60 to 120 mg. When the total daily dose is expected to be greater than 120 mg, the appropriate combination of tablet strengths should be employed.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  Morphine Sulfate Extended-Release Tablets can be administered as the initial oral morphine drug product; in this case, however, particular care must be exercised in the conversion process. Because of uncertainty about, and intersubject variation in, relative estimates of opioid potency and cross tolerance, initial dosing regimens should be conservative. It is better to underestimate the 24-hour oral morphine requirement than to overestimate. To this end, initial individual doses of Morphine Sulfate Extended-Release Tablets should be estimated conservatively. In patients whose daily morphine requirements are expected to be less than or equal to 120 mg per day, the 30 mg tablet strength is recommended for the initial titration period. Once a stable dose regimen is reached, the patient can be converted to the 60 mg or 100 mg tablet strength, or an appropriate combination of tablet strengths, if desired.

  Estimates of the relative potency of opioids are only approximate and are influenced by route of administration, individual patient differences, and possibly, by an individual's medical condition. Consequently, it is difficult to recommend any fixed rule for converting a patient to Morphine Sulfate Extended-Release Tablets directly. The following general points should be considered, however.

  Parenteral to oral morphine ratio: Estimates of the oral to parenteral potency of morphine vary. Some authorities suggest that a dose of oral morphine only three times the daily parenteral morphine requirement may be sufficient in chronic use settings.
  Other parenteral or oral opioids to oral morphine: Because there is lack of systematic evidence bearing on these types of analgesic substitutions, specific recommendations are not possible.

  Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safer to underestimate the daily dose of Morphine Sulfate Extended-Release Tablets required and rely upon ad hoc supplementation to deal with inadequate analgesia. (See discussion which follows.)

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  There has been no systematic evaluation of Morphine Sulfate Extended-Release Tablets as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using an extended-release morphine, it is ordinarily advisable to begin treatment using an immediate-release formulation. (See Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets)

  Considerations in the Adjustment of Dosing Regimens

  Whatever the approach, if signs of excessive opioid effects are observed early in a dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, "breakthrough" pain occurs late in the dosing interval, the dosing interval may be shortened. Alternatively, a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments can be made to obtain an appropriate balance between pain relief, opioid side effects, and the convenience of the dosing schedule.

  In adjusting dosing requirements, it is recommended that the dosing interval never be extended beyond 12 hours because the administration of very large single doses may lead to acute overdose. (N.B. Morphine Sulfate Extended-Release Tablets is an extended-release formulation; it does not release morphine continuously over the dosing interval.)

  For patients with low daily morphine requirements, the 15 mg tablet should be used.

  Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets

  (For use in opioid-tolerant patients only.)

  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. It is recommended that these strengths be reserved for patients that have already been titrated to a stable analgesic regimen using lower strengths of Morphine Sulfate Extended-Release Tablets or other opioids.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (including incident pain).

  Continuation of Therapy

  The intent of the titration period is to establish a patient-specific daily dose that will provide adequate analgesia with acceptable side effects and minimal rescue doses (2 or less) for as long as pain relief is necessary. Should pain recur, the dose can be increased to re-establish pain control as outlined above. During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g. every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with Morphine Sulfate Extended-Release Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from Morphine Sulfate Extended-Release Tablets to Parenteral Opioids

  When converting a patient from Morphine Sulfate Extended-Release Tablets to parenteral opioids, it is best to assume that the parenteral to oral potency is high. NOTE THAT THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE CONSERVATIVELY. For example, to estimate the required 24-hour dose of morphine for IM use, one could employ a conversion of 1 mg of morphine IM for every 6 mg of morphine as Morphine Sulfate Extended-Release Tablets. The IM 24-hour dose would have to be divided by six and administered on a q4h regimen. This approach is recommended because it is least likely to cause overdose.

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• Pd-rx Pharmaceuticals, Inc.
  

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  Morphine Sulfate | Pd-rx Pharmaceuticals, Inc.

  

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  (See also: CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections)

  MORPHINE SULFATE EXTENDED-RELEASE TABLETS IS AN OPIOID AGONIST 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 is an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock 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; 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.

  Conversion from Immediate-Release Oral Morphine to Morphine Sulfate Extended-Release Tablets

  A patient's daily morphine requirement is established using immediate-release oral morphine (dosing every 4 to 6 hours). The patient is then converted to Morphine Sulfate Extended-Release Tablets in either of two ways: 1) by administering one-half of the patient's 24-hour requirement as Morphine Sulfate Extended-Release Tablets on an every 12-hour schedule; or, 2) by administering one-third of the patient's daily requirement as Morphine Sulfate Extended-Release Tablets on an every eight hour schedule. With either method, dose and dosing interval is then adjusted as needed (see discussion below). The 15 mg tablet should be used for initial conversion for patients whose total daily requirement is expected to be less than 60 mg. The 30 mg tablet strength is recommended for patients with a daily morphine requirement of 60 to 120 mg. When the total daily dose is expected to be greater than 120 mg, the appropriate combination of tablet strengths should be employed.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  Morphine Sulfate Extended-Release Tablets can be administered as the initial oral morphine drug product; in this case, however, particular care must be exercised in the conversion process. Because of uncertainty about, and intersubject variation in, relative estimates of opioid potency and cross tolerance, initial dosing regimens should be conservative. It is better to underestimate the 24-hour oral morphine requirement than to overestimate. To this end, initial individual doses of Morphine Sulfate Extended-Release Tablets should be estimated conservatively. In patients whose daily morphine requirements are expected to be less than or equal to 120 mg per day, the 30 mg tablet strength is recommended for the initial titration period. Once a stable dose regimen is reached, the patient can be converted to the 60 mg or 100 mg tablet strength, or an appropriate combination of tablet strengths, if desired.

  Estimates of the relative potency of opioids are only approximate and are influenced by route of administration, individual patient differences, and possibly, by an individual's medical condition. Consequently, it is difficult to recommend any fixed rule for converting a patient to Morphine Sulfate Extended-Release Tablets directly. The following general points should be considered, however.

  Parenteral to oral morphine ratio: Estimates of the oral to parenteral potency of morphine vary. Some authorities suggest that a dose of oral morphine only three times the daily parenteral morphine requirement may be sufficient in chronic use settings.
  Other parenteral or oral opioids to oral morphine: Because there is lack of systematic evidence bearing on these types of analgesic substitutions, specific recommendations are not possible.

  Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safer to underestimate the daily dose of Morphine Sulfate Extended-Release Tablets required and rely upon ad hoc supplementation to deal with inadequate analgesia. (See discussion which follows.)

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  There has been no systematic evaluation of Morphine Sulfate Extended-Release Tablets as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using an extended-release morphine, it is ordinarily advisable to begin treatment using an immediate-release formulation. (See Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets)

  Considerations in the Adjustment of Dosing Regimens

  Whatever the approach, if signs of excessive opioid effects are observed early in a dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, "breakthrough" pain occurs late in the dosing interval, the dosing interval may be shortened. Alternatively, a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments can be made to obtain an appropriate balance between pain relief, opioid side effects, and the convenience of the dosing schedule.

  In adjusting dosing requirements, it is recommended that the dosing interval never be extended beyond 12 hours because the administration of very large single doses may lead to acute overdose. (N.B. Morphine Sulfate Extended-Release Tablets is an extended-release formulation; it does not release morphine continuously over the dosing interval.)

  For patients with low daily morphine requirements, the 15 mg tablet should be used.

  Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets

  (For use in opioid-tolerant patients only.)

  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. It is recommended that these strengths be reserved for patients that have already been titrated to a stable analgesic regimen using lower strengths of Morphine Sulfate Extended-Release Tablets or other opioids.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (including incident pain).

  Continuation of Therapy

  The intent of the titration period is to establish a patient-specific daily dose that will provide adequate analgesia with acceptable side effects and minimal rescue doses (2 or less) for as long as pain relief is necessary. Should pain recur, the dose can be increased to re-establish pain control as outlined above. During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g. every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with Morphine Sulfate Extended-Release Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from Morphine Sulfate Extended-Release Tablets to Parenteral Opioids

  When converting a patient from Morphine Sulfate Extended-Release Tablets to parenteral opioids, it is best to assume that the parenteral to oral potency is high. NOTE THAT THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE CONSERVATIVELY. For example, to estimate the required 24-hour dose of morphine for IM use, one could employ a conversion of 1 mg of morphine IM for every 6 mg of morphine as Morphine Sulfate Extended-Release Tablets. The IM 24-hour dose would have to be divided by six and administered on a q4h regimen. This approach is recommended because it is least likely to cause overdose.

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  Morphine Sulfate | West-ward Pharmaceutical Corp.

  

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  Morphine Sulfate Injection should be given via the subcutaneous, intramuscular or slow intravenous routes. NOT FOR EPIDURAL OR INTRATHECAL USE.

  In patients with severe, chronic pain, dosage should be adjusted according to the severity of the pain and the response and tolerance of the patient. In patients with exceptionally severe, chronic pain or in those who have become tolerant to the analgesic effect of opiate agonists, it may be necessary to exceed the usual dosage.

  Reduced dosage is indicated in poor-risk patients, in very young or very old patients and in patients receiving other CNS depressants.

  Morphine Sulfate Injection is usually administered subcutaneously; the drug may also be administered by intramuscular or slow intravenous injection. Intramuscular administration is preferred to subcutaneous injection when repeated parenteral doses are necessary, since repeated subcutaneous administration causes local tissue irritation, pain and induration.

  Adults

  The usual adult subcutaneous or intramuscular dosage of Morphine Sulfate Injection is 10 mg every 4 hours as necessary; dosage may range from 5-20 mg every 4 hours as necessary depending on patient requirements and response.

  For intravenous administration, the usual dosage is 4-10 mg administered very slowly over 4-5 minutes. A strength of 2.5-15 mg of morphine sulfate may be diluted in 4-5 mL of sterile water for injection.

  Infants and Children

  Do not use in premature infants (see CONTRAINDICATIONS). Safety and effectiveness in newborn infants have not been established. Infants and children may receive a subcutaneous dose of 0.1-0.2 mg/kg as necessary; a single pediatric dose should not exceed 15 mg.

  PAIN OF MYOCARDIAL INFARCTION-8-15 mg of Morphine Sulfate Injection may be administered parenterally. For very severe pain, additional smaller doses may be given every 3-4 hours.

  ANALGESIA DURING LABOR-10 mg of morphine sulfate is usually administered subcutaneously or intramuscularly.

  When morphine sulfate is administered intravenously, an opiate antagonist and facilities for administration of oxygen and control of respiration should be available.

  Morphine sulfate has been reported to be physically or chemically incompatible with various drug products. Specialized references should be consulted for specific compatibility information.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Watson Laboratories, Inc.
  

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  Morphine Sulfate | Watson Laboratories, Inc.

  

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  Morphine sulfate extended-release capsules may be administered once or twice daily.

  Morphine sulfate extended-release capsules should be swallowed whole. The pellets in morphine sulfate extended-release capsules should not be chewed, crushed, or dissolved due to the risk of rapid release and absorption of a potentially fatal dose of morphine.

  Alternatively, morphine sulfate extended-release capsules may be administered as a sprinkle on apple sauce or through a 16 French gastrostomy tube (see ALTERNATIVE METHODS OF ADMINISTRATION section).

  The 100 mg capsules are for use only in opioid-tolerant patients.

  Morphine sulfate extended-release capsules are not indicated for pre-emptive analgesia (administration pre-operatively for the management of post-operative pain), or for pain in the immediate post-operative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in these settings have not been established.

  Morphine sulfate extended-release capsules are only indicated for post-operative 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.

  Patients who are already receiving morphine sulfate extended-release capsules as part of ongoing analgesic therapy may be safely continued on the drug if appropriate dosage adjustments are made considering the procedure, other drugs given, and the temporary changes in physiology caused by the surgical intervention.

  Initiating Therapy with Morphine sulfate extended-release Capsules

  Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Health care professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring.

  It is critical to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of morphine sulfate extended-release capsules, USP, attention should be given to:

  the total daily dose, potency and kind of opioid the patient has been taking previously;
  the reliability of the relative potency estimate used to calculate the equivalent dose of morphine needed (Note: potency estimates may vary with the route of administration);
  the patient's degree of opioid experience and opioid tolerance;
  the general condition and medical status of the patient;
  concurrent medication;
  the type and severity of the patient's pain.

  Care should be taken to use low initial doses of morphine sulfate extended-release capsules in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS).

  During periods of changing analgesic requirements including initial titration, frequent communication is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family.

  The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of an individual patient.

  Conversion from Other Oral Morphine Formulations to Morphine sulfate extended-release capsules

  Patients on other oral morphine formulations may be converted to morphine sulfate extended-release capsules by administering one-half of the patient's total daily oral morphine dose as morphine sulfate extended-release capsules every 12 hours (twice-a-day) or by administering the total daily oral morphine dose as morphine sulfate extended-release capsules every 24 hours (once-a-day). Morphine sulfate extended-release capsules should not be given more frequently than every 12 hours.

  Conversion from Parenteral Morphine or Other Parenteral or Oral Opioids to Morphine sulfate extended-release capsules

  Morphine sulfate extended-release capsules can be administered to patients previously receiving treatment with parenteral morphine or other opioids. While there are useful tables of oral and parenteral equivalents in cancer analgesia, there is substantial interpatient variation in the relative potency of different opioid drugs and formulations. For these reasons, it is better to underestimate the patient's 24-hour oral morphine requirement and provide rescue medication, than to overestimate and manage an adverse event. The following general points should be considered:

  Parenteral to Oral Morphine Ratio: It may take anywhere from 2 to 6 mg of oral morphine to provide analgesia equivalent to 1 mg of parenteral morphine. A dose of oral morphine three times the daily parenteral morphine requirement may be sufficient in chronic use settings.
  Other Parenteral or Oral Opioids to Oral Morphine Sulfate: There is lack of systematic evidence bearing on these types of analgesic substitutions. Therefore, specific recommendations are not possible. Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safest to give half of the estimated daily morphine demand as the initial dose, and to manage inadequate analgesia by supplementation with immediate-release morphine. (See discussion which follows.)

  The first dose of morphine sulfate extended-release capsules may be taken with the last dose of any immediate-release (short-acting) opioid medication due to the long delay until the peak effect after administration of morphine sulfate extended-release capsules.

  Use of morphine sulfate extended-release capsules as the First Opioid Analgesic

  There has been no evaluation of morphine sulfate extended-release capsules as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient to adequate analgesia using an extended-release morphine, it is ordinarily advisable to begin treatment using an immediate-release morphine formulation.

  Individualization of Dosage

  The best use of opioid analgesics in the management of chronic malignant and non-malignant pain is challenging, and is well described in materials published by the World Health Organization and the Agency for Health Care Policy and Research which are available from Alpharma Pharmaceuticals LLC upon request. Morphine sulfate extended-release capsules, USP are a third step drug which is most useful when the patient requires a constant level of opioid analgesia as a "floor" or "platform" from which to manage breakthrough pain. When a patient has reached the point where comfort cannot be provided with a combination of non-opioid medications (NSAIDs and acetaminophen) and intermittent use of moderate or strong opioids, the patient's total opioid therapy should be converted into a 24 hour oral morphine equivalent.

  Morphine sulfate extended-release capsules should be started by administering one-half of the estimated total daily oral morphine dose every 12 hours (twice-a-day) or by administering the total daily oral morphine dose every 24 hours (once-a-day). The dose should be titrated no more frequently than every-other-day to allow the patients to stabilize before escalating the dose. If breakthrough pain occurs, the dose may be supplemented with a small dose (less than 20% of the total daily dose) of a short-acting analgesic. Patients who are excessively sedated after a once-a-day dose or who regularly experience inadequate analgesia before the next dose should be switched to twice-a-day dosing.

  Patients who do not have a proven tolerance to opioids should be started only on the 10 mg or 20 mg strength, and usually should be increased at a rate not greater than 20 mg every-other-day. Most patients will rapidly develop some degree of tolerance, requiring dosage adjustment until they have achieved their individual best balance between baseline analgesia and opioid side effects such as confusion, sedation and constipation. No guidance can be given as to the recommended maximal dose, especially in patients with chronic pain of malignancy. In such cases the total dose of morphine sulfate extended-release capsules should be advanced until the desired therapeutic endpoint is reached or clinically significant opioid-related adverse reactions intervene.

  Alternative Methods of Administration

  In a study of healthy volunteers, morphine sulfate extended-release pellets sprinkled over apple sauce were found to be bioequivalent to morphine sulfate extended-release capsules swallowed whole with apple sauce under fasting conditions. Other foods have not been tested. Patients who have difficulty swallowing whole capsules or tablets may benefit from this alternative method of administration.

  Sprinkle the pellets onto a small amount of apple sauce. Apple sauce should be room temperature or cooler.
  The patient must be cautioned not to chew the pellets which could result in the immediate release of a potentially dangerous, even fatal dose of morphine.
  Use immediately.
  Rinse mouth to ensure all pellets have been swallowed.
  Patients should consume entire portion and should not divide apple sauce into separate doses.

  The entire capsule contents may alternatively be administered through a 16 French gastrostomy tube.

  Flush the gastrostomy tube with water to ensure that it is wet.
  Sprinkle the morphine sulfate extended-release pellets into 10 mL of water.
  Use a swirling motion to pour the pellets and water into the gastrostomy tube through a funnel.
  Rinse the beaker with a further 10 mL of water and pour this into the funnel.
  Repeat rinsing until no pellets remain in the beaker.

  THE ADMINISTRATION OF MORPHINE SULFATE EXTENDED-RELEASE PELLETS THROUGH A NASOGASTRIC TUBE SHOULD NOT BE ATTEMPTED.

  Considerations in the Adjustment of Dosing Regimens

  If signs of excessive opioid effects are observed early in the dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, if breakthrough pain occurs when morphine sulfate extended-release capsules are administered on an every 24 hours dosing regimen, consideration should be given to dosing every 12 hours. If breakthrough pain occurs on a 12 hour dosing regimen a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments in both dose and dosing interval can be made to obtain an appropriate balance between pain relief and opioid side effects. To avoid accumulation the dosing interval of morphine sulfate extended-release capsules should not be reduced below 12 hours.

  Cessation of Therapy

  When the patient no longer requires therapy with morphine sulfate extended-release capsules, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from Morphine Sulfate Extended-Release Capsules to Other Extended-Release Oral Morphine Formulations

  Morphine sulfate extended-release capsules are not bioequivalent to other extended-release morphine preparations. Although for a given dose the same total amount of morphine is available from morphine sulfate extended-release capsules as from morphine solution or extended-release morphine tablets, the slower release of morphine from morphine sulfate extended-release capsules results in reduced maximum and increased minimum plasma morphine concentrations than with shorter acting morphine products. Conversion from morphine sulfate extended-release capsules to the same total daily dose of other extended-release morphine preparations may lead to either excessive sedation at peak or inadequate analgesia at trough and close observation and appropriate dosage adjustments are recommended.

  Conversion from Morphine Sulfate Extended-Release Capsules to Parenteral Opioids

  When converting a patient from morphine sulfate extended-release capsules to parenteral opioids, it is best to calculate an equivalent parenteral dose, and then initiate treatment at half of this calculated value. For example, to estimate the required 24 hour dose of parenteral morphine for a patient taking morphine sulfate extended-release capsules, one would take the 24 hour morphine sulfate extended-release capsules dose, divide by an oral to parenteral conversion ratio of 3, divide the estimated 24 hour parenteral dose into six divided doses (for a four hour dosing interval), then halve this dose as an initial trial.

  For example, to estimate the required parenteral morphine dose for a patient taking 360 mg of morphine sulfate extended-release capsules a day, divide the 360 mg daily oral morphine dose by a conversion ratio of 1 mg of parenteral morphine for every 3 mg of oral morphine. The estimated 120 mg daily parenteral requirement is then divided into six 20 mg doses, and half of this, or 10 mg, is then given every 4 hours as an initial trial dose.

  This approach is likely to require a dosage increase in the first 24 hours for many patients, but is recommended because it is less likely to cause overdose than trying to establish an equivalent dose without titration.

  Safety and Handling

  Morphine sulfate extended-release capsules contain morphine sulfate which is a controlled substance under Schedule II of the Controlled Substances Act. Morphine, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to flush any morphine sulfate extended-release capsules that are no longer needed.

  Morphine sulfate extended-release capsules may be targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

  Morphine sulfate extended-release capsules consists of closed hard gelatin capsules containing polymer coated morphine sulfate pellets that pose no known handling risk to health care workers. Morphine sulfate extended-release capsules are liable to diversion and misuse both by the general public and health care workers, and should be handled accordingly.

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  Morphine Sulfate | Hospira, Inc.

  

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  Morphine Sulfate Injection is intended for intravenous administration.

  2.1 General Dosing Considerations

  Morphine Sulfate Injection is available in five concentrations for direct injection.  Take care when prescribing and administering Morphine Sulfate Injection to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed.  When writing prescriptions, include both the total dose in mg and total dose in volume.

  Administration Morphine Sulfate Injection should be limited to use by those familiar with the management of respiratory depression. Morphine must be injected slowly; rapid intravenous administration may result in chest wall rigidity.

  Selection of patients for treatment with Morphine Sulfate Injection USP should be governed by the same principles that apply to the use of similar opioid analgesics.  Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  2.2 Individualization of Dosage

  Adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience.  In the selection of the initial dose of Morphine Sulfate Injection USP, give attention to the following:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent Morphine Sulfate Injection USP dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient’s pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion  

  The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  Continual re-evaluation of the patient receiving Morphine Sulfate Injection USP is important, with special attention to the management of pain and the relative incidence of side effects associated with therapy.

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between the physician, other members of the healthcare team, the patient, and the caregiver/family.

  2.3 Direct Intravenous Injection

  The usual starting dose in adults is 0.1 mg to 0.2 mg per kg every 4 hours as needed to manage pain. Administer the injection slowly.

  2.4 Dosing with Hepatic and Renal Impairment

  Morphine Sulfate pharmacokinetics have been reported to be significantly altered in patients with cirrhosis and renal failure. Start these patients cautiously with lower doses of Morphine Sulfate Injection USP and titrate slowly while carefully monitoring for side effects. [See Use in Specific Populations (8.7 and 8.8).]

  2.1 General Dosing Considerations

  Morphine Sulfate Injection is available in five concentrations for direct injection.  Take care when prescribing and administering Morphine Sulfate Injection to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed.  When writing prescriptions, include both the total dose in mg and total dose in volume.

  Administration Morphine Sulfate Injection should be limited to use by those familiar with the management of respiratory depression. Morphine must be injected slowly; rapid intravenous administration may result in chest wall rigidity.

  Selection of patients for treatment with Morphine Sulfate Injection USP should be governed by the same principles that apply to the use of similar opioid analgesics.  Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  2.2 Individualization of Dosage

  Adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience.  In the selection of the initial dose of Morphine Sulfate Injection USP, give attention to the following:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent Morphine Sulfate Injection USP dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient’s pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion  

  The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  Continual re-evaluation of the patient receiving Morphine Sulfate Injection USP is important, with special attention to the management of pain and the relative incidence of side effects associated with therapy.

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between the physician, other members of the healthcare team, the patient, and the caregiver/family.

  2.3 Direct Intravenous Injection

  The usual starting dose in adults is 0.1 mg to 0.2 mg per kg every 4 hours as needed to manage pain. Administer the injection slowly.

  2.4 Dosing with Hepatic and Renal Impairment

  Morphine Sulfate pharmacokinetics have been reported to be significantly altered in patients with cirrhosis and renal failure. Start these patients cautiously with lower doses of Morphine Sulfate Injection USP and titrate slowly while carefully monitoring for side effects. [See Use in Specific Populations (8.7 and 8.8).]

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• Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
  

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  Morphine Sulfate | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

  

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  Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  2.1 Individualization of Dosage

  As with any opioid drug product adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of morphine sulfate, give attention to the following:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient’s pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.

  The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

  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.

  2.2 Initiation of Therapy in Opioid-Naïve Patients

  Start patients who have not been receiving opioid analgesics on morphine sulfate in the following dosing range using tablets, 15 mg or 30 mg strengths:

    Morphine Sulfate Tablets: 15 to 30 mg every 4 hours as needed for pain.

  Titrate the dose based upon the individual patient’s response to their initial dose of morphine sulfate. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the morphine by the patient.

  2.3 Conversion to Oral Morphine Sulfate

  There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of morphine sulfate. It is better to underestimate a patient’s 24-hour oral morphine sulfate dose and make available rescue medication than to overestimate the 24-hour oral morphine sulfate dose and manage an adverse experience of overdose.

  Consider the following general points regarding opioid conversions.

  Conversion From Parenteral Morphine to Oral Morphine Sulfate

  For conversion from parenteral to oral morphine sulfate, anywhere from 3 to 6 mg of oral morphine sulfate may be required to provide pain relief equivalent to 1 mg of parenteral morphine.

  Conversion From Parenteral Oral Non-Morphine Opioids to Oral Morphine Sulfate  

  In converting patients from other opioids to morphine sulfate, close observation and adjustment of dosage based upon the patient’s response to morphine sulfate is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

  Conversion From Controlled-Release Oral Morphine to Oral Morphine Sulfate

  For a given dose, the same total amount of morphine sulfate is available from Morphine Sulfate Tablets, Morphine Sulfate Oral Solution, and controlled-release and extended-release morphine capsules. The extended duration of release of morphine sulfate from controlled-release tablets or extended-release tablets results in reduced maximum and increased minimum plasma morphine sulfate concentrations than with shorter acting morphine sulfate products. Conversion from oral solution or immediate-release tablets to the same total daily dose of controlled-release tablets or extended-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

  2.4 Maintenance of Therapy

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

  2.5 Cessation of Therapy

  When the patient no longer requires therapy with morphine sulfate, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

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  (SEE ALSO: CLINICAL PHARMACOLOGY, WARNINGS, AND PRECAUTIONS SECTIONS)

  MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE AN OPIOID AGONIST 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 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; 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 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.

  Conversion from Immediate-Release Oral Morphine to Morphine Sulfate Extended-Release Tablets

  A patient's daily morphine requirement is established using immediate-release oral morphine (dosing every 4 to 6 hours). The patient is then converted to Morphine Sulfate Extended-Release Tablets in either of two ways: 1) by administering one-half of the patient's 24-hour requirement as Morphine Sulfate Extended-Release Tablets on an every 12-hour schedule; or, 2) by administering one-third of the patient's daily requirement as Morphine Sulfate Extended-Release Tablets on an every eight hour schedule. With either method, dose and dosing interval is then adjusted as needed (see discussion below). The 15 mg tablet should be used for initial conversion for patients whose total daily requirement is expected to be less than 60 mg. The 30 mg tablet strength is recommended for patients with a daily morphine requirement of 60 to 120 mg. When the total daily dose is expected to be greater than 120 mg, the appropriate combination of tablet strengths should be employed.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  Morphine Sulfate Extended-Release Tablets can be administered as the initial oral morphine drug product; in this case, however, particular care must be exercised in the conversion process. Because of uncertainty about, and intersubject variation in, relative estimates of opioid potency and cross tolerance, initial dosing regimens should be conservative. It is better to underestimate the 24-hour oral morphine requirement than to overestimate. To this end, initial individual doses of Morphine Sulfate Extended-Release Tablets should be estimated conservatively. In patients whose daily morphine requirements are expected to be less than or equal to 120 mg per day, the 30 mg tablet strength is recommended for the initial titration period. Once a stable dose regimen is reached, the patient can be converted to the 60 mg or 100 mg tablet strength, or an appropriate combination of tablet strengths, if desired.

  Estimates of the relative potency of opioids are only approximate and are influenced by route of administration, individual patient differences, and possibly, by an individual's medical condition. Consequently, it is difficult to recommend any fixed rule for converting a patient to Morphine Sulfate Extended-Release Tablets directly. The following general points should be considered, however.

  Parenteral to oral morphine ratio: Estimates of the oral to parenteral potency of morphine vary. Some authorities suggest that a dose of oral morphine only three times the daily parenteral morphine requirement may be sufficient in chronic use settings. Other parenteral or oral opioids to oral morphine: Because there is lack of systematic evidence bearing on these types of analgesic substitutions, specific recommendations are not possible.

  Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safer to underestimate the daily dose of Morphine Sulfate Extended-Release Tablets required and rely upon ad hoc supplementation to deal with inadequate analgesia. (See discussion which follows.)

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  There has been no systematic evaluation of Morphine Sulfate Extended-Release Tablets as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using an extended-release morphine, it is ordinarily advisable to begin treatment using an immediate-release formulation. (see Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets)

  Considerations in the Adjustment of Dosing Regimens

  Whatever the approach, if signs of excessive opioid effects are observed early in a dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, "breakthrough" pain occurs late in the dosing interval, the dosing interval may be shortened. Alternatively, a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments can be made to obtain an appropriate balance between pain relief, opioid side effects, and the convenience of the dosing schedule.

  In adjusting dosing requirements, it is recommended that the dosing interval never be extended beyond 12 hours because the administration of very large single doses may lead to acute overdose. (N.B. Morphine Sulfate Extended-Release Tablets is an extended-release formulation; it does not release morphine continuously over the dosing interval.)

  For patients with low daily morphine requirements, the 15 mg tablet should be used.

  Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets

  (For use in opioid-tolerant patients only.)

  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. It is recommended that these strengths be reserved for patients that have already been titrated to a stable analgesic regimen using lower strengths of Morphine Sulfate Extended-Release Tablets or other opioids.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (including incident pain).

  Continuation of Therapy

  The intent of the titration period is to establish a patient-specific daily dose that will provide adequate analgesia with acceptable side effects and minimal rescue doses (2 or less) for as long as pain relief is necessary. Should pain recur, the dose can be increased to re-establish pain control as outlined above. During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with Morphine Sulfate Extended-Release Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from Morphine Sulfate Extended-Release Tablets to Parenteral Opioids

  When converting a patient from Morphine Sulfate Extended-Release Tablets to parenteral opioids, it is best to assume that the parenteral to oral potency is high. NOTE THAT THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE CONSERVATIVELY. For example, to estimate the required 24-hour dose of morphine for IM use, one could employ a conversion of 1 mg of morphine IM for every 6 mg of morphine as Morphine Sulfate Extended-Release Tablets. The IM 24-hour dose would have to be divided by six and administered on a q4h regimen. This approach is recommended because it is least likely to cause overdose.

  SAFETY AND HANDLING

  Morphine Sulfate Extended-Release Tablets contain morphine sulfate which is a controlled substance under Schedule II of the Controlled Substances Act. Morphine, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to flush any unneeded Morphine Sulfate Extended-Release Tablets down the toilet.

  Morphine Sulfate Extended-Release Tablets may be targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

  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 MORPHIN 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 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. This strength is potentially fatal if accidentally ingested and patients and their families should be instructed to take special care to avoid accidental or intentional ingestion by individuals other than those for whom the medication was originally prescribed.

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  Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  2.1 Individualization of Dosage

  As with any opioid drug product adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of morphine sulfate, give attention to the following:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient’s pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.

  The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

  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.

  2.2 Initiation of Therapy in Opioid-Naïve Patients

  Start patients who have not been receiving opioid analgesics on morphine sulfate in the following dosing range using tablets, 15 mg or 30 mg strengths:

    Morphine Sulfate Tablets: 15 to 30 mg every 4 hours as needed for pain.

  Titrate the dose based upon the individual patient’s response to their initial dose of morphine sulfate. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the morphine by the patient.

  2.3 Conversion to Oral Morphine Sulfate

  There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of morphine sulfate. It is better to underestimate a patient’s 24-hour oral morphine sulfate dose and make available rescue medication than to overestimate the 24-hour oral morphine sulfate dose and manage an adverse experience of overdose.

  Consider the following general points regarding opioid conversions.

  Conversion From Parenteral Morphine to Oral Morphine Sulfate

  For conversion from parenteral to oral morphine sulfate, anywhere from 3 to 6 mg of oral morphine sulfate may be required to provide pain relief equivalent to 1 mg of parenteral morphine.

  Conversion From Parenteral Oral Non-Morphine Opioids to Oral Morphine Sulfate  

  In converting patients from other opioids to morphine sulfate, close observation and adjustment of dosage based upon the patient’s response to morphine sulfate is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

  Conversion From Controlled-Release Oral Morphine to Oral Morphine Sulfate

  For a given dose, the same total amount of morphine sulfate is available from Morphine Sulfate Tablets, Morphine Sulfate Oral Solution, and controlled-release and extended-release morphine capsules. The extended duration of release of morphine sulfate from controlled-release tablets or extended-release tablets results in reduced maximum and increased minimum plasma morphine sulfate concentrations than with shorter acting morphine sulfate products. Conversion from oral solution or immediate-release tablets to the same total daily dose of controlled-release tablets or extended-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

  2.4 Maintenance of Therapy

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

  2.5 Cessation of Therapy

  When the patient no longer requires therapy with morphine sulfate, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

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  Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  2.1 Individualization of Dosage

  As with any opioid drug product adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of morphine sulfate, give attention to the following:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient’s pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.

  The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

  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.

  2.2 Initiation of Therapy in Opioid-Naïve Patients

  Start patients who have not been receiving opioid analgesics on morphine sulfate in the following dosing range using tablets, 15 mg or 30 mg strengths:

    Morphine Sulfate Tablets: 15 to 30 mg every 4 hours as needed for pain.

  Titrate the dose based upon the individual patient’s response to their initial dose of morphine sulfate. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the morphine by the patient.

  2.3 Conversion to Oral Morphine Sulfate

  There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of morphine sulfate. It is better to underestimate a patient’s 24-hour oral morphine sulfate dose and make available rescue medication than to overestimate the 24-hour oral morphine sulfate dose and manage an adverse experience of overdose.

  Consider the following general points regarding opioid conversions.

  Conversion From Parenteral Morphine to Oral Morphine Sulfate

  For conversion from parenteral to oral morphine sulfate, anywhere from 3 to 6 mg of oral morphine sulfate may be required to provide pain relief equivalent to 1 mg of parenteral morphine.

  Conversion From Parenteral Oral Non-Morphine Opioids to Oral Morphine Sulfate  

  In converting patients from other opioids to morphine sulfate, close observation and adjustment of dosage based upon the patient’s response to morphine sulfate is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

  Conversion From Controlled-Release Oral Morphine to Oral Morphine Sulfate

  For a given dose, the same total amount of morphine sulfate is available from Morphine Sulfate Tablets, Morphine Sulfate Oral Solution, and controlled-release and extended-release morphine capsules. The extended duration of release of morphine sulfate from controlled-release tablets or extended-release tablets results in reduced maximum and increased minimum plasma morphine sulfate concentrations than with shorter acting morphine sulfate products. Conversion from oral solution or immediate-release tablets to the same total daily dose of controlled-release tablets or extended-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

  2.4 Maintenance of Therapy

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

  2.5 Cessation of Therapy

  When the patient no longer requires therapy with morphine sulfate, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

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  Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  2.1 Individualization of Dosage

  As with any opioid drug product adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of morphine sulfate, give attention to the following:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient’s pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.

  The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

  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.

  2.2 Initiation of Therapy in Opioid-Naïve Patients

  Start patients who have not been receiving opioid analgesics on morphine sulfate in the following dosing range using tablets, 15 mg or 30 mg strengths:

    Morphine Sulfate Tablets: 15 to 30 mg every 4 hours as needed for pain.

  Titrate the dose based upon the individual patient’s response to their initial dose of morphine sulfate. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the morphine by the patient.

  2.3 Conversion to Oral Morphine Sulfate

  There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of morphine sulfate. It is better to underestimate a patient’s 24-hour oral morphine sulfate dose and make available rescue medication than to overestimate the 24-hour oral morphine sulfate dose and manage an adverse experience of overdose.

  Consider the following general points regarding opioid conversions.

  Conversion From Parenteral Morphine to Oral Morphine Sulfate

  For conversion from parenteral to oral morphine sulfate, anywhere from 3 to 6 mg of oral morphine sulfate may be required to provide pain relief equivalent to 1 mg of parenteral morphine.

  Conversion From Parenteral Oral Non-Morphine Opioids to Oral Morphine Sulfate  

  In converting patients from other opioids to morphine sulfate, close observation and adjustment of dosage based upon the patient’s response to morphine sulfate is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

  Conversion From Controlled-Release Oral Morphine to Oral Morphine Sulfate

  For a given dose, the same total amount of morphine sulfate is available from Morphine Sulfate Tablets, Morphine Sulfate Oral Solution, and controlled-release and extended-release morphine capsules. The extended duration of release of morphine sulfate from controlled-release tablets or extended-release tablets results in reduced maximum and increased minimum plasma morphine sulfate concentrations than with shorter acting morphine sulfate products. Conversion from oral solution or immediate-release tablets to the same total daily dose of controlled-release tablets or extended-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

  2.4 Maintenance of Therapy

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

  2.5 Cessation of Therapy

  When the patient no longer requires therapy with morphine sulfate, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

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  Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  2.1 Individualization of Dosage

  As with any opioid drug product adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of morphine sulfate, give attention to the following:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient’s pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.

  The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

  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.

  2.2 Initiation of Therapy in Opioid-Naïve Patients

  Start patients who have not been receiving opioid analgesics on morphine sulfate in the following dosing range using tablets, 15 mg or 30 mg strengths:

    Morphine Sulfate Tablets: 15 to 30 mg every 4 hours as needed for pain.

  Titrate the dose based upon the individual patient’s response to their initial dose of morphine sulfate. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the morphine by the patient.

  2.3 Conversion to Oral Morphine Sulfate

  There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of morphine sulfate. It is better to underestimate a patient’s 24-hour oral morphine sulfate dose and make available rescue medication than to overestimate the 24-hour oral morphine sulfate dose and manage an adverse experience of overdose.

  Consider the following general points regarding opioid conversions.

  Conversion From Parenteral Morphine to Oral Morphine Sulfate

  For conversion from parenteral to oral morphine sulfate, anywhere from 3 to 6 mg of oral morphine sulfate may be required to provide pain relief equivalent to 1 mg of parenteral morphine.

  Conversion From Parenteral Oral Non-Morphine Opioids to Oral Morphine Sulfate  

  In converting patients from other opioids to morphine sulfate, close observation and adjustment of dosage based upon the patient’s response to morphine sulfate is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

  Conversion From Controlled-Release Oral Morphine to Oral Morphine Sulfate

  For a given dose, the same total amount of morphine sulfate is available from Morphine Sulfate Tablets, Morphine Sulfate Oral Solution, and controlled-release and extended-release morphine capsules. The extended duration of release of morphine sulfate from controlled-release tablets or extended-release tablets results in reduced maximum and increased minimum plasma morphine sulfate concentrations than with shorter acting morphine sulfate products. Conversion from oral solution or immediate-release tablets to the same total daily dose of controlled-release tablets or extended-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

  2.4 Maintenance of Therapy

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

  2.5 Cessation of Therapy

  When the patient no longer requires therapy with morphine sulfate, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

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  (SEE ALSO: CLINICAL PHARMACOLOGY, WARNINGS, AND PRECAUTIONS SECTIONS)

  MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE AN OPIOID AGONIST 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 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; 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 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.

  Conversion from Immediate-Release Oral Morphine to Morphine Sulfate Extended-Release Tablets

  A patient's daily morphine requirement is established using immediate-release oral morphine (dosing every 4 to 6 hours). The patient is then converted to Morphine Sulfate Extended-Release Tablets in either of two ways: 1) by administering one-half of the patient's 24-hour requirement as Morphine Sulfate Extended-Release Tablets on an every 12-hour schedule; or, 2) by administering one-third of the patient's daily requirement as Morphine Sulfate Extended-Release Tablets on an every eight hour schedule. With either method, dose and dosing interval is then adjusted as needed (see discussion below). The 15 mg tablet should be used for initial conversion for patients whose total daily requirement is expected to be less than 60 mg. The 30 mg tablet strength is recommended for patients with a daily morphine requirement of 60 to 120 mg. When the total daily dose is expected to be greater than 120 mg, the appropriate combination of tablet strengths should be employed.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  Morphine Sulfate Extended-Release Tablets can be administered as the initial oral morphine drug product; in this case, however, particular care must be exercised in the conversion process. Because of uncertainty about, and intersubject variation in, relative estimates of opioid potency and cross tolerance, initial dosing regimens should be conservative. It is better to underestimate the 24-hour oral morphine requirement than to overestimate. To this end, initial individual doses of Morphine Sulfate Extended-Release Tablets should be estimated conservatively. In patients whose daily morphine requirements are expected to be less than or equal to 120 mg per day, the 30 mg tablet strength is recommended for the initial titration period. Once a stable dose regimen is reached, the patient can be converted to the 60 mg or 100 mg tablet strength, or an appropriate combination of tablet strengths, if desired.

  Estimates of the relative potency of opioids are only approximate and are influenced by route of administration, individual patient differences, and possibly, by an individual's medical condition. Consequently, it is difficult to recommend any fixed rule for converting a patient to Morphine Sulfate Extended-Release Tablets directly. The following general points should be considered, however.

  Parenteral to oral morphine ratio: Estimates of the oral to parenteral potency of morphine vary. Some authorities suggest that a dose of oral morphine only three times the daily parenteral morphine requirement may be sufficient in chronic use settings. Other parenteral or oral opioids to oral morphine: Because there is lack of systematic evidence bearing on these types of analgesic substitutions, specific recommendations are not possible.

  Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safer to underestimate the daily dose of Morphine Sulfate Extended-Release Tablets required and rely upon ad hoc supplementation to deal with inadequate analgesia. (See discussion which follows.)

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  There has been no systematic evaluation of Morphine Sulfate Extended-Release Tablets as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using an extended-release morphine, it is ordinarily advisable to begin treatment using an immediate-release formulation. (see Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets)

  Considerations in the Adjustment of Dosing Regimens

  Whatever the approach, if signs of excessive opioid effects are observed early in a dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, "breakthrough" pain occurs late in the dosing interval, the dosing interval may be shortened. Alternatively, a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments can be made to obtain an appropriate balance between pain relief, opioid side effects, and the convenience of the dosing schedule.

  In adjusting dosing requirements, it is recommended that the dosing interval never be extended beyond 12 hours because the administration of very large single doses may lead to acute overdose. (N.B. Morphine Sulfate Extended-Release Tablets is an extended-release formulation; it does not release morphine continuously over the dosing interval.)

  For patients with low daily morphine requirements, the 15 mg tablet should be used.

  Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets

  (For use in opioid-tolerant patients only.)

  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. It is recommended that these strengths be reserved for patients that have already been titrated to a stable analgesic regimen using lower strengths of Morphine Sulfate Extended-Release Tablets or other opioids.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (including incident pain).

  Continuation of Therapy

  The intent of the titration period is to establish a patient-specific daily dose that will provide adequate analgesia with acceptable side effects and minimal rescue doses (2 or less) for as long as pain relief is necessary. Should pain recur, the dose can be increased to re-establish pain control as outlined above. During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with Morphine Sulfate Extended-Release Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from Morphine Sulfate Extended-Release Tablets to Parenteral Opioids

  When converting a patient from Morphine Sulfate Extended-Release Tablets to parenteral opioids, it is best to assume that the parenteral to oral potency is high. NOTE THAT THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE CONSERVATIVELY. For example, to estimate the required 24-hour dose of morphine for IM use, one could employ a conversion of 1 mg of morphine IM for every 6 mg of morphine as Morphine Sulfate Extended-Release Tablets. The IM 24-hour dose would have to be divided by six and administered on a q4h regimen. This approach is recommended because it is least likely to cause overdose.

  SAFETY AND HANDLING

  Morphine Sulfate Extended-Release Tablets contain morphine sulfate which is a controlled substance under Schedule II of the Controlled Substances Act. Morphine, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to flush any unneeded Morphine Sulfate Extended-Release Tablets down the toilet.

  Morphine Sulfate Extended-Release Tablets may be targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

  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 MORPHIN 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 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. This strength is potentially fatal if accidentally ingested and patients and their families should be instructed to take special care to avoid accidental or intentional ingestion by individuals other than those for whom the medication was originally prescribed.

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• Hospira, Inc.
  

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  Morphine Sulfate | Hospira, Inc.

  

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  PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE HOSPIRA INFUSION DEVICE BEFORE PRESCRIBING PRESERVATIVE-FREE MORPHINE SULFATE INJECTION, USP.

  Preservative-free Morphine Sulfate Injection was developed for intravenous administration with a compatible Hospira infusion device.

  Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate.

  Intravenous Administration

  For use in a compatible Hospira infusion device, dosage should be adjusted according to the severity of the pain and the response of the patient. Patients must be closely monitored because of the considerable variability in both the dosage requirements and patient response. Following are recommendations that have to be individualized for each patient.

  Intravenous Adult Dosage: The usual dose for administration to adults, via a compatible Hospira infusion device, is a 1 mg bolus, with a range of 0.2 to 3 mg per incremental dose for the 0.5 mg/mL and 1 mg/mL concentrations and a range of 0.5 to 3 mg per incremental dose for the 5 mg/mL concentration. The recommended Lockout Interval is 6 minutes. The physician may adjust the dosage either upward or downward (see INDIVIDUALIZATION OF DOSAGE); depending on patient response. Occasionally, it may be necessary to exceed the usual dosage in cases of exceptionally severe pain or in those patients who become tolerant.

  SAFETY AND HANDLING INSTRUCTIONS

  Preservative-free Morphine Sulfate Injection is supplied in sealed PCA vials. Accidental dermal exposure should be treated by the removal of any contaminated clothing and rinsing the affected area with water. Each vial of Preservative-free Morphine Sulfate Injection contains a potent narcotic which has been associated with abuse and dependence among health care providers. Due to the limited indications for this product, the risk of overdosage and the risk of its diversion and abuse, it is recommended that special measures be taken to control this product within the hospital or clinic. Preservative-free Morphine Sulfate Injection should be subject to rigid accounting, rigorous control of wastage and restricted access.

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• Hospira, Inc.
  

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  Morphine Sulfate | Hospira, Inc.

  

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  Morphine Sulfate Injection, USP is administered by intravenous infusion only after dilution in an ADD-Vantage Flexible Diluent Container (See INSTRUCTIONS FOR USE). CAUTION: The 250 mg ADD-Vantage morphine vial must be diluted in a 250 mL ADD-Vantage Flexible Diluent Container only.

  Morphine sulfate should be given in the smallest effective dose and as infrequently as possible in order to minimize the development of tolerance and physical dependence. Reduced dosage is indicated in poor-risk patients, in very young or very old patients, and in patients receiving other CNS depressants.

  In patients with severe, chronic pain, dosage should be adjusted according to the severity of the pain and the response and tolerance of the patient. In patients with exceptionally severe, chronic pain or in those who have become tolerant to the analgesic effect of opiate agonists, it may be necessary to exceed the usual dosage.

  Morphine sulfate should be administered by slow IV infusion after dilution. The usual dose for adults is 1 mg with a range of 0.1 mg to 5 mg per incremental dose. The physician should adjust the dosage depending on the patient’s response. A controlled infusion device should be used to monitor the infusion rate.

  Severe, Chronic Pain: When morphine sulfate is administered by continuous IV infusion for relief of severe, chronic pain associated with cancer, the dosage of the drug must be individualized according to the response and tolerance of the patient. If specific dose related information is required, the clinician should consult an appropriate text.

  For IV administration, morphine sulfate should be injected slowly. Rapid IV injection of the drug may result in an increased frequency of opiate-induced adverse effects; severe respiratory depression, apnea, hypotension, peripheral circulatory collapse, chest wall rigidity, cardiac arrest and anaphylactoid reactions have occurred following rapid IV injection. The rate of continuous IV infusion of the drug must be individualized according to the response and tolerance of the patient.

  Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear and container is undamaged. Discard unused portion.

  INSTRUCTIONS FOR USE

  To Use Vial in ADD-Vantage

  Flexible Diluent Container

  To Open:

  Peel overwrap at corner and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

  To Assemble Vial and

  Flexible Diluent Container:

  (Use Aseptic Technique)

  1.   Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:

  a.   To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (see FIGURE 1.), then pull straight up to remove the cap. (See FIGURE 2.) NOTE: Once the breakaway cap has been removed, do not access vial with syringe.

   Fig. 1  Fig. 2

  b.   To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (See FIGURE 3.)

  2.   Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (See FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go.

  NOTE: Once vial is seated, do not attempt to remove. (See FIGURE 4.)

  3.   Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.

  4.   Label appropriately.

  Fig. 3 Fig. 4

  To Prepare Admixture:

  1.   Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.

  2.   With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (See FIGURE 5.)

  3.   Pull the inner cap from the drug vial. (See FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.

  4.   Mix container contents thoroughly and use within 24 hours.

  Fig. 5 Fig. 6

  Preparation for Administration

  (Use Aseptic Technique)

  Confirm the activation and admixture of vial contents. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. Close flow control clamp of administration set. Remove cover from outlet port at bottom of container. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger. Squeeze and release drip chamber to establish proper fluid level in chamber. Open flow control clamp and clear air from set. Close clamp. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. Regulate rate of administration with flow control clamp.

  WARNING: Do not use flexible containers in series connections.

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• Hospira, Inc.
  

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  Morphine Sulfate | Hospira, Inc.

  

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  THESE PRODUCTS ARE FOR SLOW IV USE, NOT FOR INTRATHECAL OR EPIDURAL USE.

  For Relief of Pain and as Pre-anesthetic: The usual adult dose of 10 mg every 4 hours, depending on the severity of the condition and the patient’s response. The usual individual dose range is 5 to 15 mg. The usual daily dose range is 12 to 120 mg.

  Usual Pediatric Dose: Analgesic - Intravenous, 50 to 100 µg (0.05 to 0.1 mg) per kg of body weight, administered very slowly. Not to exceed 10 mg per dose.

  For Open Heart Surgery: Large doses (0.5 to 3 mg/kg) of morphine are administered intravenously as the sole anesthetic or with a suitable anesthetic agent. The patients are given oxygen and cardiovascular function is not depressed by morphine, as long as adequate ventilation is maintained.

  For Severe Chronic Pain Associated with Terminal Cancer: Continuous Intravenous infusion– Prior to the initiation of the morphine infusion (in concentrations between 0.2 to 1 mg/mL), a loading dose of 15 mg or higher of morphine sulfate may be administered by IV push to alleviate pain.

  The infusion dosage range is 0.8 mg/hr to 80 mg/hr, though doses of up to 144 mg/hr have been used. Thus, for the 1 mg/mL solution, the infusion may be run from 0.8 mL /hr to 80 mL /hr, and for the 0.5 mg/mL solution, the infusion may be run from 1.6 mL /hr to 160 mL /hr.

  A constant infusion rate must be maintained with an infusion pump in order to assure proper dosage control. Care must be taken to avoid overdosage (respiratory depression) or abrupt cessation of therapy, which may give rise to withdrawal symptoms.

  NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  EXAMPLES OF INFUSION PREPARATION:

  Concentrate

  Diluent

  Final

  Concentration

  Morphine Sulfate Injection, USP

  Dextrose 5% in Water

  Morphine Sulfate

  25 mg/mL

   

   

  10 mL

  490 mL

  0.5 mg/mL

  20 mL

  480 mL

  1.0 mg/mL

  40 mL

  960 mL

  1.0 mg/mL

   

   

   

  Morphine Sulfate Injection, USP

   

  50 mg/mL

   

   

  10 mL

  990 mL

  0.5 mg/mL

  20 mL

  980 mL

  1.0 mg/mL

   

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• Roxane Laboratories, Inc
  

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  Morphine Sulfate | Roxane Laboratories, Inc

  

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  Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  2.1 Individualization of Dosage

  As with any opioid drug product, adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of morphine sulfate, give attention to the following:

  • the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; • the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate dose needed; • the patient’s degree of opioid tolerance; • the general condition and medical status of the patient; • concurrent medications; • the type and severity of the patient’s pain; • risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.

  The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

  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.

  2.2 Initiation of Therapy in Opioid-Naïve Patients

  Start patients who have not been receiving opioid analgesics on morphine sulfate in the following dosing range using tablets, 15 mg or 30 mg strengths:

  Morphine Sulfate Tablets: 15 to 30 mg every 4 hours as needed for pain.

  Titrate the dose based upon the individual patient’s response to their initial dose of morphine sulfate. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the morphine by the patient.

  2.3 Conversion to Oral Morphine Sulfate

  There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of morphine sulfate. It is better to underestimate a patient’s 24-hour oral morphine sulfate dose and make available rescue medication than to overestimate the 24-hour oral morphine sulfate dose and manage an adverse experience of overdose.

  Consider the following general points regarding opioid conversions.

  Conversion From Parenteral Morphine to Oral Morphine Sulfate

  For conversion from parenteral to oral morphine sulfate, anywhere from 3 to 6 mg of oral morphine sulfate may be required to provide pain relief equivalent to 1 mg of parenteral morphine.

  Conversion From Parenteral Oral Non-Morphine Opioids to Oral Morphine Sulfate  

  In converting patients from other opioids to morphine sulfate, close observation and adjustment of dosage based upon the patient’s response to morphine sulfate is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

  Conversion From Controlled-Release Oral Morphine to Oral Morphine Sulfate

  For a given dose, the same total amount of morphine sulfate is available from Morphine Sulfate Tablets, Morphine Sulfate Oral Solution, and controlled-release and extended-release morphine capsules. The extended duration of release of morphine sulfate from controlled-release tablets or extended-release tablets results in reduced maximum and increased minimum plasma morphine sulfate concentrations than with shorter acting morphine sulfate products. Conversion from oral solution or immediate-release tablets to the same total daily dose of controlled-release tablets or extended-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

  2.4 Maintenance of Therapy

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

  2.5 Cessation of Therapy

  When the patient no longer requires therapy with morphine sulfate, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

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  Morphine Sulfate | Cantrell Drug Company

  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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• Par Pharmaceutical Inc.
  

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  Morphine Sulfate | Deseret Biologicals

  

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  One tablet three times daily or as directed by a health professional.

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• Pd-rx Pharmaceuticals, Inc.
  

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  Morphine Sulfate | Pd-rx Pharmaceuticals, Inc.

  

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  (See also: CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections)

  MORPHINE SULFATE EXTENDED-RELEASE TABLETS IS AN OPIOID AGONIST 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 is an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock 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; 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.

  Conversion from Immediate-Release Oral Morphine to Morphine Sulfate Extended-Release Tablets

  A patient's daily morphine requirement is established using immediate-release oral morphine (dosing every 4 to 6 hours). The patient is then converted to Morphine Sulfate Extended-Release Tablets in either of two ways: 1) by administering one-half of the patient's 24-hour requirement as Morphine Sulfate Extended-Release Tablets on an every 12-hour schedule; or, 2) by administering one-third of the patient's daily requirement as Morphine Sulfate Extended-Release Tablets on an every eight hour schedule. With either method, dose and dosing interval is then adjusted as needed (see discussion below). The 15 mg tablet should be used for initial conversion for patients whose total daily requirement is expected to be less than 60 mg. The 30 mg tablet strength is recommended for patients with a daily morphine requirement of 60 to 120 mg. When the total daily dose is expected to be greater than 120 mg, the appropriate combination of tablet strengths should be employed.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  Morphine Sulfate Extended-Release Tablets can be administered as the initial oral morphine drug product; in this case, however, particular care must be exercised in the conversion process. Because of uncertainty about, and intersubject variation in, relative estimates of opioid potency and cross tolerance, initial dosing regimens should be conservative. It is better to underestimate the 24-hour oral morphine requirement than to overestimate. To this end, initial individual doses of Morphine Sulfate Extended-Release Tablets should be estimated conservatively. In patients whose daily morphine requirements are expected to be less than or equal to 120 mg per day, the 30 mg tablet strength is recommended for the initial titration period. Once a stable dose regimen is reached, the patient can be converted to the 60 mg or 100 mg tablet strength, or an appropriate combination of tablet strengths, if desired.

  Estimates of the relative potency of opioids are only approximate and are influenced by route of administration, individual patient differences, and possibly, by an individual's medical condition. Consequently, it is difficult to recommend any fixed rule for converting a patient to Morphine Sulfate Extended-Release Tablets directly. The following general points should be considered, however.

  Parenteral to oral morphine ratio: Estimates of the oral to parenteral potency of morphine vary. Some authorities suggest that a dose of oral morphine only three times the daily parenteral morphine requirement may be sufficient in chronic use settings.
  Other parenteral or oral opioids to oral morphine: Because there is lack of systematic evidence bearing on these types of analgesic substitutions, specific recommendations are not possible.

  Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safer to underestimate the daily dose of Morphine Sulfate Extended-Release Tablets required and rely upon ad hoc supplementation to deal with inadequate analgesia. (See discussion which follows.)

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  There has been no systematic evaluation of Morphine Sulfate Extended-Release Tablets as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using an extended-release morphine, it is ordinarily advisable to begin treatment using an immediate-release formulation. (See Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets)

  Considerations in the Adjustment of Dosing Regimens

  Whatever the approach, if signs of excessive opioid effects are observed early in a dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, "breakthrough" pain occurs late in the dosing interval, the dosing interval may be shortened. Alternatively, a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments can be made to obtain an appropriate balance between pain relief, opioid side effects, and the convenience of the dosing schedule.

  In adjusting dosing requirements, it is recommended that the dosing interval never be extended beyond 12 hours because the administration of very large single doses may lead to acute overdose. (N.B. Morphine Sulfate Extended-Release Tablets is an extended-release formulation; it does not release morphine continuously over the dosing interval.)

  For patients with low daily morphine requirements, the 15 mg tablet should be used.

  Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets

  (For use in opioid-tolerant patients only.)

  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. It is recommended that these strengths be reserved for patients that have already been titrated to a stable analgesic regimen using lower strengths of Morphine Sulfate Extended-Release Tablets or other opioids.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (including incident pain).

  Continuation of Therapy

  The intent of the titration period is to establish a patient-specific daily dose that will provide adequate analgesia with acceptable side effects and minimal rescue doses (2 or less) for as long as pain relief is necessary. Should pain recur, the dose can be increased to re-establish pain control as outlined above. During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g. every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with Morphine Sulfate Extended-Release Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from Morphine Sulfate Extended-Release Tablets to Parenteral Opioids

  When converting a patient from Morphine Sulfate Extended-Release Tablets to parenteral opioids, it is best to assume that the parenteral to oral potency is high. NOTE THAT THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE CONSERVATIVELY. For example, to estimate the required 24-hour dose of morphine for IM use, one could employ a conversion of 1 mg of morphine IM for every 6 mg of morphine as Morphine Sulfate Extended-Release Tablets. The IM 24-hour dose would have to be divided by six and administered on a q4h regimen. This approach is recommended because it is least likely to cause overdose.

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  Morphine Sulfate | 1st Class Pharmaceuticals, Inc.

  

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  Apply directly to affected area. Do not use more than four times per day. Children under two-years of age: consult a physician.

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  Morphine Sulfate | Dispensing Solutions, Inc.

  

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  Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  2.1 Individualization of Dosage

  As with any opioid drug product adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of morphine sulfate, give attention to the following:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient’s pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.

  The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

  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.

  2.2 Initiation of Therapy in Opioid-Naïve Patients

  Start patients who have not been receiving opioid analgesics on morphine sulfate in the following dosing range using tablets, 15 mg or 30 mg strengths:

  Morphine Sulfate Tablets: 15 to 30 mg every 4 hours as needed for pain.

  Titrate the dose based upon the individual patient’s response to their initial dose of morphine sulfate. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the morphine by the patient.

  2.3 Conversion to Oral Morphine Sulfate

  There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of morphine sulfate. It is better to underestimate a patient’s 24-hour oral morphine sulfate dose and make available rescue medication than to overestimate the 24-hour oral morphine sulfate dose and manage an adverse experience of overdose.

  Consider the following general points regarding opioid conversions.

  Conversion From Parenteral Morphine to Oral Morphine Sulfate

  For conversion from parenteral to oral morphine sulfate, anywhere from 3 to 6 mg of oral morphine sulfate may be required to provide pain relief equivalent to 1 mg of parenteral morphine.

  Conversion From Parenteral Oral Non-Morphine Opioids to Oral Morphine Sulfate  

  In converting patients from other opioids to morphine sulfate, close observation and adjustment of dosage based upon the patient’s response to morphine sulfate is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

  Conversion From Controlled-Release Oral Morphine to Oral Morphine Sulfate

  For a given dose, the same total amount of morphine sulfate is available from Morphine Sulfate Tablets, Morphine Sulfate Oral Solution, and controlled-release and extended-release morphine capsules. The extended duration of release of morphine sulfate from controlled-release tablets or extended-release tablets results in reduced maximum and increased minimum plasma morphine sulfate concentrations than with shorter acting morphine sulfate products. Conversion from oral solution or immediate-release tablets to the same total daily dose of controlled-release tablets or extended-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

  2.4 Maintenance of Therapy

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

  2.5 Cessation of Therapy

  When the patient no longer requires therapy with morphine sulfate, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

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  Morphine Sulfate | Cantrell Drug Company

  

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  Morphine Sulfate | Par Pharmaceutical Inc.

  

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  2.1 Initial Dosing

  Morphine sulfate extended-release capsules should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  Morphine sulfate extended-release capsules 100 mg capsules are only for patients in whom tolerance to an opioid of comparable potency has been established. Patients considered opioidtolerant are those taking, for one week or longer, at least 60 mg of morphine daily, at least 30-mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.

  Initiate the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with morphine sulfate extended-release capsules [see Warnings and Precautions (5.2)].

  Morphine sulfate extended-release capsules must be taken whole. Crushing, chewing, or dissolving the pellets in morphine sulfate extended-release capsules will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.2)]. Patients who are unable to swallow morphine sulfate extended-release capsules should be instructed to sprinkle the capsule contents on applesauce and immediately swallow without chewing [see Administration of morphine sulfate extended-release capsules (2.4)]..

  Morphine sulfate extended-release capsules are administered at a frequency of either once daily (every 24 hours) or twice daily (every 12 hours).

  Use of Morphine Sulfate Extended-release Capsules as the First Opioid Analgesic

  There has been no evaluation of morphine sulfate extended-release capsules as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient to adequate analgesia using an extended-release morphine, begin treatment using an immediate-release morphine formulation and then convert patients to morphine sulfate extended-release capsules as described below.

  Use of Morphine Sulfate Extended-Release Capsules in Patients who are not Opioid Tolerant
  The starting dose for patients who are not opioid tolerant is morphine sulfate extended-release capsules 30 mg orally every 24 hours. 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, or an equianalgesic dose of another opioid.

  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

  Conversion from Other Opioids to Morphine Sulfate Extended-Release Capsules
  There are no established conversion ratios from other opioids to morphine sulfate extended-release capsules defined by clinical trials. Discontinue all other around-the-clock opioid drugs when morphine sulfate extended-release capsules therapy is initiated and initiate dosing using morphine sulfate extended-release capsules 30 mg orally every 24 hours.

  While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products. As such, it is safer to underestimate a patient’s 24-hour oral morphine requirements and provide rescue medication (e.g. immediate-release morphine) than to overestimate the 24-hour oral morphine requirements which could result in an adverse reaction.

  Conversion from Other Oral Morphine Formulations to Morphine Sulfate Extended-release Capsules

  Patients receiving other oral morphine formulations may be converted to morphine sulfate extended-release capsules by administering one-half of the patient's total daily oral morphine dose as morphine sulfate extended-release capsules twice daily or by administering the total daily oral morphine dose as morphine sulfate extended-release capsules once daily. There are no data to support the efficacy or safety of prescribing morphine sulfate extended-release capsules more frequently than every 12 hours.

  Morphine sulfate extended-release capsules are not bioequivalent to other extended-release morphine preparations. Conversion from morphine sulfate extended-release capsules to the same total daily dose of another extended-release morphine product may lead to either excessive sedation at peak or inadequate analgesia at trough. Therefore, monitor patients closely when initiating morphine sulfate extended-release capsules therapy and adjust the dosage of morphine sulfate extended-release capsules as needed.

  Conversion from Parenteral Morphine, or Other Opioids to Morphine Sulfate Extended-release Capsules

  When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to morphine sulfate extended-release capsules, consider the following general points:

        Parenteral to Oral Morphine Ratio: Between 2 mg and 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of oral morphine that is three times the daily parenteral morphine requirement is sufficient.

        Other Oral or Parenteral Opioids to Oral morphine sulfate extended-release capsules: Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine. 

  Conversion from Methadone to Morphine Sulfate Extended-Release Capsules
  Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

  2.2 Titration and Maintenance of Therapy

  Individually titrate morphine sulfate extended-release capsules to a dose that provides adequate analgesia and minimizes adverse reactions at a frequency of either once or twice daily. Continually reevaluate patients receiving morphine sulfate extended-release capsules to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.

  If the level of pain increases, attempt to identify the source of increased pain, while adjusting the morphine sulfate extended-release capsules dose to decrease the level of pain. Because steadystate plasma concentrations are approximated within 24 to 36 hours, morphine sulfate extendedrelease capsules dosage adjustments may be done every 1 to 2 days.

  Patients who experience breakthrough pain may require a dose increase of morphine sulfate extended-release capsules, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the morphine sulfate extended-release capsules dose. In patients experiencing inadequate analgesia with once daily dosing of morphine sulfate extended-release capsules, consider a twice daily regimen.

  If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions. 

  2.3 Discontinuation of Morphine Sulfate Extended-release Capsules, USP 

  When a patient no longer requires therapy with morphine sulfate extended-release capsules, use a gradual downward titration, of the dose every two to four days, to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue morphine sulfate extended-release capsules.

  2.4 Administration of Morphine Sulfate Extended-release Capsules, USP

  Morphine sulfate extended-release capsules must be taken whole. Crushing, chewing, or dissolving the pellets in morphine sulfate extended-release capsules will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.2)]. 

  Alternatively, the contents of the morphine sulfate extended-release capsules (pellets) may be sprinkled over applesauce and then swallowed. This method is appropriate only for patients able to reliably swallow the applesauce without chewing. Other foods have not been tested and should not be substituted for applesauce. Instruct the patient to:

  Sprinkle the pellets onto a small amount of applesauce and consume immediately without chewing.
  Rinse the mouth to ensure all pellets have been swallowed.
  Discard any unused portion of the morphine sulfate extended-release capsules after the contents have been sprinkled on applesauce.

  The contents of the morphine sulfate extended-release capsules (pellets) may be administered through a 16 French gastrostomy tube.

  Flush the gastrostomy tube with water to ensure that it is wet.
  Sprinkle the morphine sulfate extended-release pellets into 10 mL of water.
  Use a swirling motion to pour the pellets and water into the gastrostomy tube through a funnel.
  Rinse the beaker with a further 10 mL of water and pour this into the funnel.
  Repeat rinsing until no pellets remain in the beaker.

  Do not administer morphine sulfate extended-release pellets through a nasogastric tube.

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  Morphine Sulfate | Hospira, Inc.

  

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  Preservative-free morphine sulfate injection is intended for intravenous, epidural or intrathecal administration.

  Intravenous Administration

  Dosage: The initial dose of morphine sulfate should be 2 mg to 10 mg/70 kg of body weight. Patients under the age of 18; no information available.

  Epidural Administration

  PRESERVATIVE-FREE MORPHINE SULFATE INJECTION SHOULD BE ADMINISTERED EPIDURALLY ONLY BY PHYSICIANS EXPERIENCED IN THE TECHNIQUES OF EPIDURAL ADMINISTRATION AND WHO ARE THOROUGHLY FAMILIAR WITH THE LABELING. IT SHOULD BE ADMINISTERED ONLY IN SETTINGS WHERE ADEQUATE PATIENT MONITORING IS POSSIBLE. RESUSCITATIVE EQUIPMENT AND A SPECIFIC ANTAGONIST (NALOXONE HYDROCHLORIDE INJECTION) SHOULD BE IMMEDIATELY AVAILABLE FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS WHICH MIGHT RESULT FROM INADVERTENT INTRATHECAL OR INTRAVASCULAR INJECTION. (NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL DOSAGE) PATIENT MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS AFTER EACH DOSE, SINCE DELAYED RESPIRATORY DEPRESSION MAY OCCUR.

  Proper placement of a needle or catheter in the epidural space should be verified before preservative-free morphine sulfate injection is injected. Acceptable techniques for verifying proper placement include: a) aspiration to check for absence of blood or cerebrospinal fluid, or b) administration of 5 mL (3 mL in obstetric patients) of UNPRESERVED 1.5% Lidocaine and Epinephrine (1:200,000) Injection and then observe the patient for lack of tachycardia (this indicates that vascular injection has not been made) and lack of sudden onset of segmental anesthesia (this indicates that intrathecal injection has not been made).

  Epidural Adult Dosage: Initial injection of 5 mg in the lumbar region may provide satisfactory pain relief for up to 24 hours. If adequate pain relief is not achieved within one hour, careful administration of incremental doses of 1 to 2 mg at intervals sufficient to assess effectiveness may be given. No more than 10 mg/24 hr should be administered.

  Thoracic administration has been shown to dramatically increase the incidence of early and late respiratory depression even at doses of 1 to 2 mg.

  For continuous infusion an initial dose of 2 to 4 mg/24 hours is recommended. Further doses of 1 to 2 mg may be given if pain relief is not achieved initially.

  Aged or debilitated patients—Administer with extreme caution (see PRECAUTIONS). Doses of less than 5 mg may provide satisfactory pain relief for up to 24 hours.

  Epidural Pediatric Use: No information on use in pediatric patients is available.

  Intrathecal Administration

  NOTE: INTRATHECAL DOSAGE IS USUALLY
  1/10 THAT OF EPIDURAL DOSAGE.

  PRESERVATIVE-FREE MORPHINE SULFATE INJECTION SHOULD BE ADMINISTERED INTRATHECALLY ONLY BY PHYSICIANS EXPERIENCED IN THE TECHNIQUES OF INTRATHECAL ADMINISTRATION AND WHO ARE THOROUGHLY FAMILIAR WITH THE LABELING. IT SHOULD BE ADMINISTERED ONLY IN SETTINGS WHERE ADEQUATE PATIENT MONITORING IS POSSIBLE. RESUSCITATIVE EQUIPMENT AND A SPECIFIC ANTAGONIST (NALOXONE HYDROCHLORIDE INJECTION) SHOULD BE IMMEDIATELY AVAILABLE FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS WHICH MIGHT RESULT FROM INADVERTENT INTRAVASCULAR INJECTION. PATIENT MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS AFTER EACH DOSE, SINCE DELAYED RESPIRATORY DEPRESSION MAY OCCUR. RESPIRATORY DEPRESSION (BOTH EARLY AND LATE ONSET) HAS OCCURRED MORE FREQUENTLY FOLLOWING INTRATHECAL ADMINISTRATION.

  Intrathecal Adult Dosage: A single injection of 0.2 to 1 mg may provide satisfactory pain relief for up to 24 hours. (CAUTION: THIS IS ONLY 0.4 TO 2 ML OF THE 5 MG/10 ML CONTAINER OR 0.2 TO 1 ML OF THE 10 MG/10 ML CONTAINER OF PRESERVATIVE-FREE MORPHINE SULFATE INJECTION.) DO NOT INJECT INTRATHECALLY MORE THAN 2 ML OF THE 5 MG/10 ML CONTAINER OR 1 ML OF THE 10 MG/10 ML CONTAINER. USE IN THE LUMBAR AREA ONLY IS RECOMMENDED. Repeated intrathecal injections of preservative-free morphine sulfate injection are not recommended. A constant intravenous infusion of naloxone hydrochloride, 0.6 mg/hr, for 24 hours after intrathecal injection may be used to reduce the incidence of potential side effects.

  Aged or debilitated patients—Administer with extreme caution (see PRECAUTIONS). A lower dosage is usually satisfactory.

  Repeat Dosage: If pain recurs, alternative routes of administration should be considered, since experience with repeated doses of morphine by the intrathecal route is limited.

  Intrathecal Pediatric Use: No information on the use in pediatric patients is available.

  Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear and container is undamaged. Discard unused portion.

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  Morphine Sulfate | Bd Rx Inc.

  

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  Morphine Sulfate Injection is intended for intravenous and intramuscular administration.

  2.1 General Dosing Considerations

  Avoid Medication Errors

  Morphine Sulfate Injection is available in five concentrations for direct injection. Take care when prescribing and administering Morphine Sulfate Injection to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and total dose in volume.

  Administration of Morphine Sulfate Injection should be limited to use by those familiar with the management of respiratory depression. Morphine must be injected slowly; rapid intravenous administration may result in chest wall rigidity.

  Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  2.2 Individualization of Dosage

  Adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of Morphine Sulfate Injection USP, give attention to the following:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent Morphine Sulfate Injection USP dose needed; the patient's degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient's pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction.

  The following dosing recommendation, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in management of the pain of each individual patient.

  Continual re-evaluation of the patient receiving Morphine Sulfate Injection USP is important, with special attention to the management of pain and the occurrence of side effects associated with therapy.

  2.3 Direct Intravenous Injection

  The usual starting dose in adults is 0.1 mg to 0.2 mg per kg every 4 hours as needed to manage pain.

  Inspect Morphine Sulfate Injection for particulate matter and discoloration prior to administration. Administer the injection slowly. Monitor the patient closely for signs of respiratory and central nervous system depression. 2.4 Intramuscular Injection

  The initial IM dose is 10 mg, every 4 hours as needed to manage pain (based on a 70 kg adult).

  Inspect Morphine Sulfate Injection for particulate matter and discoloration prior to administration. Monitor the patient closely for signs of respiratory and central nervous system depression. 2.5 Dosing with Hepatic and Renal Impairment

  Morphine Sulfate pharmacokinetics have been reported to be significantly altered in patients with cirrhosis and renal failure. Start these patients with lower doses of Morphine Sulfate Injection USP and titrate slowly while carefully monitoring for respiratory and central nervous system depression. [See Use in Specific Populations (8.7 and 8.8).]

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  Morphine Sulfate | Actavis Pharma, Inc.

  

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  2.1 Initial Dosing

  Morphine sulfate extended-release capsules should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  Morphine sulfate extended-release 90 mg and 120 mg capsules are for use only 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, or an equianalgesic dose of another opioid.

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with morphine sulfate extended-release capsules [see Warnings and Precautions (5.2)].

  Morphine sulfate extended-release capsules must be taken whole. Crushing, chewing, or dissolving the pellets in morphine sulfate extended-release capsules will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.2)]. Patients who are unable to swallow morphine sulfate extended-release capsules should be instructed to sprinkle the capsule contents on applesauce and immediately swallow without chewing [see Administration of Morphine Sulfate Extended-Release Capsules (2.4)].

  Morphine sulfate extended-release capsules are administered at a frequency of once daily (every 24 hours).

  Use of Morphine Sulfate Extended-Release Capsules as the First Opioid Analgesic
  Initiate treatment with morphine sulfate extended-release with 30 mg capsule orally every 24 hours. Adjust the dose of morphine sulfate extended-release capsules in increments not greater than 30 mg every 3 to 4 days.

  Use of Morphine Sulfate Extended-Release Capsules in Patients who are not Opioid Tolerant
  The starting dose for patients who are not opioid tolerant is morphine sulfate extended-release capsules 30 mg orally every 24 hours. 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, or an equianalgesic dose of another opioid.

  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

  Conversion from Other Opioids to Morphine Sulfate Extended-Release Capsules
  There are no established conversion ratios from other opioids to morphine sulfate extended-release capsules defined by clinical trials. Discontinue all other around-the-clock opioid drugs when morphine sulfate extended-release capsules therapy is initiated and initiate dosing using morphine sulfate extended-release capsules 30 mg orally every 24 hours.

  While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products. As such, it is safer to underestimate a patient’s 24-hour oral morphine requirements and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine requirements which could result in adverse reactions.

  Conversion from Other Oral Morphine Formulations to Morphine Sulfate Extended-Release Capsules
  Patients receiving other oral morphine formulations may be converted to morphine sulfate extended-release capsules by administering the patient's total daily oral morphine dose as morphine sulfate extended-release capsules once-daily. Morphine sulfate extended-release capsules should not be given more frequently than every 24 hours.

  Conversion from Parenteral Morphine or Other Non-Morphine Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Capsules
  When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to morphine sulfate extended-release capsules, consider the following general points:

  Parenteral to oral morphine ratio: Between 2 to 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of morphine that is approximately three times the previous daily parenteral morphine requirement is sufficient.

  Other parenteral or oral non-morphine opioids to oral morphine sulfate: Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.

  Conversion from Methadone to Morphine Sulfate Extended-Release Capsules
  Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

  The first dose of morphine sulfate extended-release capsules may be taken with the last dose of any immediate-release opioid medication due to the extended-release characteristics of the morphine sulfate extended-release capsules formulation.

  2.2 Titration and Maintenance of Therapy

  Individually titrate morphine sulfate extended-release capsules to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving morphine sulfate extended-release capsules to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other  members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for opioid analgesics.

  If the level of pain increases, attempt to identify the source of increased pain, while adjusting the morphine sulfate extended-release capsules dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 2 to 3 days, morphine sulfate extended-release capsules dosage adjustments may be done every 3 to 4 days.

  Patients who experience breakthrough pain may require a dose increase of morphine sulfate extended-release capsules, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the morphine sulfate extended-release capsules dose.

  The daily dose of morphine sulfate extended-release capsules must be limited to a maximum of 1600 mg/day. Morphine sulfate extended-release capsules doses of over 1600 mg/day contain a quantity of fumaric acid that has not been demonstrated to be safe, and which may result in serious renal toxicity.

  If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  2.3 Discontinuation of Morphine Sulfate Extended-Release Capsules

  When a patient no longer requires therapy with morphine sulfate extended-release capsules, use a gradual downward titration of the dose every 2 to 4 days, to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue morphine sulfate extended-release capsules.

  2.4 Administration of Morphine Sulfate Extended-Release Capsules

  Morphine sulfate extended-release capsules must be taken whole. Crushing, chewing, or dissolving the pellets in morphine sulfate extended-release capsules will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.2)].

  Alternatively, the contents of the morphine sulfate extended-release capsules (pellets) may be sprinkled over applesauce and then swallowed. This method is appropriate only for patients able to reliably swallow the applesauce without chewing. Other foods have not been tested and should not be substituted for applesauce. Instruct the patient to:

  Sprinkle the pellets onto a small amount of applesauce and consume immediately without chewing. Rinse the mouth to ensure all pellets have been swallowed. Discard any unused portion of the morphine sulfate extended-release capsules after the contents have been sprinkled on applesauce.

  Do not administer morphine sulfate extended-release capsules pellets through a nasogastric or gastric tubes.

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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  Morphine Sulfate | Cantrell Drug Company

  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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  Morphine Sulfate | Publix Super Markets Inc

  

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  use only with enclosed dosing cup adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

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  2.1 Initial Dosing

  Morphine sulfate extended-release tablets should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with morphine sulfate extended-release tablets [see Warnings and Precautions (5.2)].

  Morphine sulfate extended-release tablets must be taken whole. Crushing, chewing, or dissolving morphine sulfate extended-release tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  Initiate treatment with morphine sulfate extended-release tablets with 15 mg tablets orally every 8 or 12 hours.

  Use of Morphine Sulfate Extended-Release Tablets in Patients who are not Opioid Tolerant

  The starting dose for patients who are not opioid tolerant is morphine sulfate extended-release tablets 15 mg orally every 12 hours. Patients who are opioid are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mg mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.

  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

  Conversion from Other Oral Morphine to Morphine Sulfate Extended-Release Tablets

  Patients receiving other oral morphine formulations may be converted to morphine sulfate extended-release tablets by administering one-half of the patient's 24-hour requirement as morphine sulfate extended-release tablets on an every-12-hour schedule or by administering one-third of the patient's daily requirement as morphine sulfate extended-release tablets on an every-8-hour schedule. 

  Conversion from Other Opioids to Morphine Sulfate Extended-Release Tablets

  There are no established conversion ratios for conversion from other opioids to morphine sulfate extended-release tablets defined by clinical trials. Discontinue all other around-the-clock opioid drugs when morphine sulfate extended-release tablets therapy is initiated and initiate dosing using morphine sulfate extended-release tablets 15 mg orally every 8 to 12 hours.

  It is safer to underestimate a patient’s 24-hour oral morphine requirements and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine requirements and manage an adverse reaction. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to morphine sulfate extended-release tablets, consider the following general points:

  Parenteral to oral morphine ratio: Between 2 to 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of morphine that is approximately three times the previous daily parenteral morphine requirement is sufficient.

  Other parenteral or oral non-morphine opioids to oral morphine sulfate: Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.

  Conversion from Methadone to Morphine Sulfate Extended-Release Tablets

  Close monitoring is of particular importance when converting methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

  2.2 Titration and Maintenance of Therapy

  Individually titrate morphine sulfate extended-release tablets to a dose that provides adequate analgesia and minimizes adverse reactions.  Continually reevaluate patients receiving morphine sulfate extended-release tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy periodically reassess the continued need for the use of opioid analgesics.

  Patients who experience breakthrough pain may require a dose increase of morphine sulfate extended-release tablets, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the morphine sulfate dose.  Because steady-state plasma concentrations are approximated in 1 day, morphine sulfate extended-release tablets dosage adjustments may be done every 1 to 2 days. 

  If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced.  Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  2.3 Discontinuation of Morphine Sulfate Extended-Release Tablets

  When the patient no longer requires therapy with morphine sulfate extended-release tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue morphine sulfate extended-release tablets.

  2.4 Administration of Morphine Sulfate Extended-Release Tablets

  Morphine sulfate extended-release tablets must be taken whole. Crushing, chewing, or dissolving morphine sulfate extended-release tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].

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  Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  2.1 Individualization of Dosage

  As with any opioid drug product, adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of morphine sulfate, give attention to the following:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient’s pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.

  The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

  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.

  2.2 Initiation of Therapy in Opioid-Naïve Patients

  Start patients who have not been receiving opioid analgesics on morphine sulfate in the following dosing range using tablets, 15 mg or 30 mg strengths:

  Morphine Sulfate Tablets: 15 to 30 mg every 4 hours as needed for pain.

  Titrate the dose based upon the individual patient’s response to their initial dose of morphine sulfate. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the morphine by the patient.

  2.3 Conversion to Oral Morphine Sulfate

  There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of morphine sulfate. It is better to underestimate a patient’s 24-hour oral morphine sulfate dose and make available rescue medication than to overestimate the 24-hour oral morphine sulfate dose and manage an adverse experience of overdose.

  Consider the following general points regarding opioid conversions.

  Conversion From Parenteral Morphine to Oral Morphine Sulfate

  For conversion from parenteral to oral morphine sulfate, anywhere from 3 to 6 mg of oral morphine sulfate may be required to provide pain relief equivalent to 1 mg of parenteral morphine.

  Conversion From Parenteral Oral Non-Morphine Opioids to Oral Morphine Sulfate  

  In converting patients from other opioids to morphine sulfate, close observation and adjustment of dosage based upon the patient’s response to morphine sulfate is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

  Conversion From Controlled-Release Oral Morphine to Oral Morphine Sulfate

  For a given dose, the same total amount of morphine sulfate is available from Morphine Sulfate Tablets, Morphine Sulfate Oral Solution, and controlled-release and extended-release morphine capsules. The extended duration of release of morphine sulfate from controlled-release tablets or extended-release tablets results in reduced maximum and increased minimum plasma morphine sulfate concentrations than with shorter acting morphine sulfate products. Conversion from oral solution or immediate-release tablets to the same total daily dose of controlled-release tablets or extended-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

  2.4 Maintenance of Therapy

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

  2.5 Cessation of Therapy

  When the patient no longer requires therapy with morphine sulfate, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

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  Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  2.1 Individualization of Dosage

  As with any opioid drug product, adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of morphine sulfate, give attention to the following:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient’s pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.

  The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

  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.

  2.2 Initiation of Therapy in Opioid-Naïve Patients

  Start patients who have not been receiving opioid analgesics on morphine sulfate in the following dosing range using tablets, 15 mg or 30 mg strengths:

  Morphine Sulfate Tablets: 15 to 30 mg every 4 hours as needed for pain.

  Titrate the dose based upon the individual patient’s response to their initial dose of morphine sulfate. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the morphine by the patient.

  2.3 Conversion to Oral Morphine Sulfate

  There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of morphine sulfate. It is better to underestimate a patient’s 24-hour oral morphine sulfate dose and make available rescue medication than to overestimate the 24-hour oral morphine sulfate dose and manage an adverse experience of overdose.

  Consider the following general points regarding opioid conversions.

  Conversion From Parenteral Morphine to Oral Morphine Sulfate

  For conversion from parenteral to oral morphine sulfate, anywhere from 3 to 6 mg of oral morphine sulfate may be required to provide pain relief equivalent to 1 mg of parenteral morphine.

  Conversion From Parenteral Oral Non-Morphine Opioids to Oral Morphine Sulfate  

  In converting patients from other opioids to morphine sulfate, close observation and adjustment of dosage based upon the patient’s response to morphine sulfate is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

  Conversion From Controlled-Release Oral Morphine to Oral Morphine Sulfate

  For a given dose, the same total amount of morphine sulfate is available from Morphine Sulfate Tablets, Morphine Sulfate Oral Solution, and controlled-release and extended-release morphine capsules. The extended duration of release of morphine sulfate from controlled-release tablets or extended-release tablets results in reduced maximum and increased minimum plasma morphine sulfate concentrations than with shorter acting morphine sulfate products. Conversion from oral solution or immediate-release tablets to the same total daily dose of controlled-release tablets or extended-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

  2.4 Maintenance of Therapy

  Continual re-evaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

  2.5 Cessation of Therapy

  When the patient no longer requires therapy with morphine sulfate, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

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  (SEE ALSO: CLINICAL PHARMACOLOGY, WARNINGS, AND PRECAUTIONS SECTIONS)

  MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE AN OPIOID AGONIST 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 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; 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 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.

  Conversion from Immediate-Release Oral Morphine to Morphine Sulfate Extended-Release Tablets

  A patient's daily morphine requirement is established using immediate-release oral morphine (dosing every 4 to 6 hours). The patient is then converted to Morphine Sulfate Extended-Release Tablets in either of two ways: 1) by administering one-half of the patient's 24-hour requirement as Morphine Sulfate Extended-Release Tablets on an every 12-hour schedule; or, 2) by administering one-third of the patient's daily requirement as Morphine Sulfate Extended-Release Tablets on an every eight hour schedule. With either method, dose and dosing interval is then adjusted as needed (see discussion below). The 15 mg tablet should be used for initial conversion for patients whose total daily requirement is expected to be less than 60 mg. The 30 mg tablet strength is recommended for patients with a daily morphine requirement of 60 to 120 mg. When the total daily dose is expected to be greater than 120 mg, the appropriate combination of tablet strengths should be employed.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  Morphine Sulfate Extended-Release Tablets can be administered as the initial oral morphine drug product; in this case, however, particular care must be exercised in the conversion process. Because of uncertainty about, and intersubject variation in, relative estimates of opioid potency and cross tolerance, initial dosing regimens should be conservative. It is better to underestimate the 24-hour oral morphine requirement than to overestimate. To this end, initial individual doses of Morphine Sulfate Extended-Release Tablets should be estimated conservatively. In patients whose daily morphine requirements are expected to be less than or equal to 120 mg per day, the 30 mg tablet strength is recommended for the initial titration period. Once a stable dose regimen is reached, the patient can be converted to the 60 mg or 100 mg tablet strength, or an appropriate combination of tablet strengths, if desired.

  Estimates of the relative potency of opioids are only approximate and are influenced by route of administration, individual patient differences, and possibly, by an individual's medical condition. Consequently, it is difficult to recommend any fixed rule for converting a patient to Morphine Sulfate Extended-Release Tablets directly. The following general points should be considered, however.

  Parenteral to oral morphine ratio: Estimates of the oral to parenteral potency of morphine vary. Some authorities suggest that a dose of oral morphine only three times the daily parenteral morphine requirement may be sufficient in chronic use settings. Other parenteral or oral opioids to oral morphine: Because there is lack of systematic evidence bearing on these types of analgesic substitutions, specific recommendations are not possible.

  Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safer to underestimate the daily dose of Morphine Sulfate Extended-Release Tablets required and rely upon ad hoc supplementation to deal with inadequate analgesia. (See discussion which follows.)

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  There has been no systematic evaluation of Morphine Sulfate Extended-Release Tablets as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using an extended-release morphine, it is ordinarily advisable to begin treatment using an immediate-release formulation. (see Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets)

  Considerations in the Adjustment of Dosing Regimens

  Whatever the approach, if signs of excessive opioid effects are observed early in a dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, "breakthrough" pain occurs late in the dosing interval, the dosing interval may be shortened. Alternatively, a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments can be made to obtain an appropriate balance between pain relief, opioid side effects, and the convenience of the dosing schedule.

  In adjusting dosing requirements, it is recommended that the dosing interval never be extended beyond 12 hours because the administration of very large single doses may lead to acute overdose. (N.B. Morphine Sulfate Extended-Release Tablets is an extended-release formulation; it does not release morphine continuously over the dosing interval.)

  For patients with low daily morphine requirements, the 15 mg tablet should be used.

  Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets

  (For use in opioid-tolerant patients only.)

  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. It is recommended that these strengths be reserved for patients that have already been titrated to a stable analgesic regimen using lower strengths of Morphine Sulfate Extended-Release Tablets or other opioids.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (including incident pain).

  Continuation of Therapy

  The intent of the titration period is to establish a patient-specific daily dose that will provide adequate analgesia with acceptable side effects and minimal rescue doses (2 or less) for as long as pain relief is necessary. Should pain recur, the dose can be increased to re-establish pain control as outlined above. During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with Morphine Sulfate Extended-Release Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from Morphine Sulfate Extended-Release Tablets to Parenteral Opioids

  When converting a patient from Morphine Sulfate Extended-Release Tablets to parenteral opioids, it is best to assume that the parenteral to oral potency is high. NOTE THAT THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE CONSERVATIVELY. For example, to estimate the required 24-hour dose of morphine for IM use, one could employ a conversion of 1 mg of morphine IM for every 6 mg of morphine as Morphine Sulfate Extended-Release Tablets. The IM 24-hour dose would have to be divided by six and administered on a q4h regimen. This approach is recommended because it is least likely to cause overdose.

  SAFETY AND HANDLING

  Morphine Sulfate Extended-Release Tablets contain morphine sulfate which is a controlled substance under Schedule II of the Controlled Substances Act. Morphine, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to flush any unneeded Morphine Sulfate Extended-Release Tablets down the toilet.

  Morphine Sulfate Extended-Release Tablets may be targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

  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 MORPHIN 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 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. This strength is potentially fatal if accidentally ingested and patients and their families should be instructed to take special care to avoid accidental or intentional ingestion by individuals other than those for whom the medication was originally prescribed.

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  (SEE ALSO: CLINICAL PHARMACOLOGY, WARNINGS, AND PRECAUTIONS SECTIONS)

  MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE AN OPIOID AGONIST 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 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; 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 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.

  Conversion from Immediate-Release Oral Morphine to Morphine Sulfate Extended-Release Tablets

  A patient's daily morphine requirement is established using immediate-release oral morphine (dosing every 4 to 6 hours). The patient is then converted to Morphine Sulfate Extended-Release Tablets in either of two ways: 1) by administering one-half of the patient's 24-hour requirement as Morphine Sulfate Extended-Release Tablets on an every 12-hour schedule; or, 2) by administering one-third of the patient's daily requirement as Morphine Sulfate Extended-Release Tablets on an every eight hour schedule. With either method, dose and dosing interval is then adjusted as needed (see discussion below). The 15 mg tablet should be used for initial conversion for patients whose total daily requirement is expected to be less than 60 mg. The 30 mg tablet strength is recommended for patients with a daily morphine requirement of 60 to 120 mg. When the total daily dose is expected to be greater than 120 mg, the appropriate combination of tablet strengths should be employed.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  Morphine Sulfate Extended-Release Tablets can be administered as the initial oral morphine drug product; in this case, however, particular care must be exercised in the conversion process. Because of uncertainty about, and intersubject variation in, relative estimates of opioid potency and cross tolerance, initial dosing regimens should be conservative. It is better to underestimate the 24-hour oral morphine requirement than to overestimate. To this end, initial individual doses of Morphine Sulfate Extended-Release Tablets should be estimated conservatively. In patients whose daily morphine requirements are expected to be less than or equal to 120 mg per day, the 30 mg tablet strength is recommended for the initial titration period. Once a stable dose regimen is reached, the patient can be converted to the 60 mg or 100 mg tablet strength, or an appropriate combination of tablet strengths, if desired.

  Estimates of the relative potency of opioids are only approximate and are influenced by route of administration, individual patient differences, and possibly, by an individual's medical condition. Consequently, it is difficult to recommend any fixed rule for converting a patient to Morphine Sulfate Extended-Release Tablets directly. The following general points should be considered, however.

  Parenteral to oral morphine ratio: Estimates of the oral to parenteral potency of morphine vary. Some authorities suggest that a dose of oral morphine only three times the daily parenteral morphine requirement may be sufficient in chronic use settings. Other parenteral or oral opioids to oral morphine: Because there is lack of systematic evidence bearing on these types of analgesic substitutions, specific recommendations are not possible.

  Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safer to underestimate the daily dose of Morphine Sulfate Extended-Release Tablets required and rely upon ad hoc supplementation to deal with inadequate analgesia. (See discussion which follows.)

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  There has been no systematic evaluation of Morphine Sulfate Extended-Release Tablets as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using an extended-release morphine, it is ordinarily advisable to begin treatment using an immediate-release formulation. (see Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets)

  Considerations in the Adjustment of Dosing Regimens

  Whatever the approach, if signs of excessive opioid effects are observed early in a dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, "breakthrough" pain occurs late in the dosing interval, the dosing interval may be shortened. Alternatively, a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments can be made to obtain an appropriate balance between pain relief, opioid side effects, and the convenience of the dosing schedule.

  In adjusting dosing requirements, it is recommended that the dosing interval never be extended beyond 12 hours because the administration of very large single doses may lead to acute overdose. (N.B. Morphine Sulfate Extended-Release Tablets is an extended-release formulation; it does not release morphine continuously over the dosing interval.)

  For patients with low daily morphine requirements, the 15 mg tablet should be used.

  Special Instructions for Morphine Sulfate Extended-Release 100 and 200 mg Tablets

  (For use in opioid-tolerant patients only.)

  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. It is recommended that these strengths be reserved for patients that have already been titrated to a stable analgesic regimen using lower strengths of Morphine Sulfate Extended-Release Tablets or other opioids.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (including incident pain).

  Continuation of Therapy

  The intent of the titration period is to establish a patient-specific daily dose that will provide adequate analgesia with acceptable side effects and minimal rescue doses (2 or less) for as long as pain relief is necessary. Should pain recur, the dose can be increased to re-establish pain control as outlined above. During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with Morphine Sulfate Extended-Release Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from Morphine Sulfate Extended-Release Tablets to Parenteral Opioids

  When converting a patient from Morphine Sulfate Extended-Release Tablets to parenteral opioids, it is best to assume that the parenteral to oral potency is high. NOTE THAT THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE CONSERVATIVELY. For example, to estimate the required 24-hour dose of morphine for IM use, one could employ a conversion of 1 mg of morphine IM for every 6 mg of morphine as Morphine Sulfate Extended-Release Tablets. The IM 24-hour dose would have to be divided by six and administered on a q4h regimen. This approach is recommended because it is least likely to cause overdose.

  SAFETY AND HANDLING

  Morphine Sulfate Extended-Release Tablets contain morphine sulfate which is a controlled substance under Schedule II of the Controlled Substances Act. Morphine, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to flush any unneeded Morphine Sulfate Extended-Release Tablets down the toilet.

  Morphine Sulfate Extended-Release Tablets may be targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

  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 MORPHIN 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 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. This strength is potentially fatal if accidentally ingested and patients and their families should be instructed to take special care to avoid accidental or intentional ingestion by individuals other than those for whom the medication was originally prescribed.

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  Morphine Sulfate | Qualitest Pharmaceuticals

  

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  2.1 Initial Dosing

  Morphine sulfate extended-release tablets should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with morphine sulfate extended-release tablets [see Warnings and Precautions (5.2)].

  Morphine sulfate extended-release tablets must be taken whole. Crushing, chewing, or dissolving morphine sulfate extended-release tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].

  Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic

  Initiate treatment with morphine sulfate extended-release tablets with 15 mg tablets orally every 8 or 12 hours.

  Use of Morphine Sulfate Extended-Release Tablets in Patients who are not Opioid Tolerant

  The starting dose for patients who are not opioid tolerant is morphine sulfate extended-release tablets 15 mg orally every 12 hours. 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, or an equianalgesic dose of another opioid.

  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

  Conversion from Other Oral Morphine to Morphine Sulfate Extended-Release Tablets

  Patients receiving other oral morphine formulations may be converted to morphine sulfate extended-release tablets by administering one-half of the patient's 24-hour requirement as morphine sulfate extended-release tablets on an every-12-hour schedule or by administering one-third of the patient's daily requirement as morphine sulfate extended-release tablets on an every-8-hour schedule.

  Conversion from Other Opioids to Morphine Sulfate Extended-Release Tablets

  There are no established conversion ratios for conversion from other opioids to morphine sulfate extended-release tablets defined by clinical trials. Discontinue all other around-the-clock opioid drugs when morphine sulfate extended-release tablets therapy is initiated and initiate dosing using morphine sulfate extended-release tablets 15 mg orally every 8 to 12 hours.

  It is safer to underestimate a patient’s 24-hour oral morphine requirements and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine requirements and manage an adverse reaction. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets

  When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to morphine sulfate extended-release tablets, consider the following general points:

  Parenteral to oral morphine ratio: Between 2 to 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of morphine that is approximately three times the previous daily parenteral morphine requirement is sufficient.

  Other parenteral or oral non-morphine opioids to oral morphine sulfate: Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.

  Conversion from Methadone to Morphine Sulfate Extended-Release Tablets

  Close monitoring is of particular importance when converting methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

  2.2 Titration and Maintenance of Therapy

  Individually titrate morphine sulfate extended-release tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving morphine sulfate extended-release tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy periodically reassess the continued need for the use of opioid analgesics.

  Patients who experience breakthrough pain may require a dose increase of morphine sulfate extended-release tablets, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the morphine sulfate extended-release tablets dose. Because steady-state plasma concentrations are approximated in 1 day, morphine sulfate extended-release tablets dosage adjustments may be done every 1 to 2 days.

  If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  2.3 Discontinuation of Morphine Sulfate Extended-Release Tablets

  When the patient no longer requires therapy with morphine sulfate extended-release tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient.  Do not abruptly discontinue morphine sulfate extended-release tablets.

  2.4 Administration of Morphine Sulfate Extended-Release Tablets

  Morphine sulfate extended-release tablets must be taken whole. Crushing, chewing, or dissolving morphine sulfate extended-release tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].

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  Morphine Sulfate | Cantrell Drug Company

  

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• Actavis Elizabeth Llc
  

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  Morphine Sulfate | Actavis Elizabeth Llc

  

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  2.1 Initial Dosing

  Morphine sulfate extended-release capsules should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  Morphine sulfate extended-release capsules 100 mg, and 200 mg capsules are only for patients in whom tolerance to an opioid of comparable potency has been established. Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with morphine sulfate extended-release capsules  [see Warnings and Precautions (5.2)].

  Morphine sulfate extended-release capsules must be taken whole. Crushing, chewing, or dissolving the pellets in morphine sulfate extended-release capsules will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.2)]. Patients who are unable to swallow morphine sulfate extended-release capsules should be instructed to sprinkle the capsule contents on applesauce and immediately swallow without chewing [see Administration of Morphine Sulfate Extended-Release Capsules (2.4)].

  Morphine sulfate extended-release capsules is administered at a frequency of either once daily (every 24 hours) or twice daily (every 12 hours).

  Use of Morphine Sulfate Extended-Release Capsules as the First Opioid Analgesic

  There has been no evaluation of morphine sulfate extended-release capsules as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient to adequate analgesia using an extended-release morphine, begin treatment using an immediate-release morphine formulation and then convert patients to morphine sulfate extended-release capsules as described below.

  Use of Morphine Sulfate Extended-Release Capsules in Patients who are not Opioid Tolerant

  The starting dose for patients who are not opioid tolerant is morphine sulfate extended-release capsules 30 mg orally every 24 hours. 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, or an equianalgesic dose of another opioid.

  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

  Conversion from Other Opioids to Morphine Sulfate Extended-Release Capsules

  There are no established conversion ratios from other opioids to morphine sulfate extended-release capsules defined by clinical trials. Discontinue all other around-the-clock opioid drugs when morphine sulfate extended-release capsules therapy is initiated and initiate dosing using morphine sulfate extended-release capsules 30 mg orally every 24 hours.

  While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products. As such, it is safer to underestimate a patient's 24-hour oral morphine requirements and provide rescue medication (e.g. immediate-release morphine) than to overestimate the 24-hour oral morphine requirements which could result in an adverse reaction.

  Conversion from Other Oral Morphine Formulations to Morphine Sulfate Extended-Release Capsules

  Patients receiving other oral morphine formulations may be converted to morphine sulfate extended-release capsules by administering one-half of the patient's total daily oral morphine dose as morphine sulfate extended-release capsules twice daily or by administering the total daily oral morphine dose as morphine sulfate extended-release capsules once daily. There are no data to support the efficacy or safety of prescribing morphine sulfate extended-release capsules more frequently than every 12 hours.

  Morphine sulfate extended-release capsules is not bioequivalent to other extended-release morphine preparations. Conversion from the same total daily dose of another extended-release morphine product to morphine sulfate extended-release capsules may lead to either excessive sedation at peak or inadequate analgesia at trough. Therefore, monitor patients closely when initiating morphine sulfate extended-release capsules therapy and adjust the dosage of morphine sulfate extended-release capsules as needed.

  Conversion from Parenteral Morphine, or Other Opioids to Morphine Sulfate Extended-Release Capsules 

  When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to morphine sulfate extended-release capsules, consider the following general points:

  Parenteral to Oral Morphine Ratio: Between 2 mg and 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of oral morphine that is three times the daily parenteral morphine requirement is sufficient.

  Other Oral or Parenteral Opioids to Oral Morphine Sulfate Extended-Release Capsules: Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.

  Conversion from Methadone to Morphine Sulfate Extended-Release Capsules

  Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

  2.2 Titration and Maintenance of Therapy

  Individually titrate morphine sulfate extended-release capsules to a dose that provides adequate analgesia and minimizes adverse reactions at a frequency of either once or twice daily. Continually reevaluate patients receiving morphine sulfate extended-release capsules to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.

  If the level of pain increases, attempt to identify the source of increased pain, while adjusting the morphine sulfate extended-release capsules dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 24 to 36 hours, morphine sulfate extended-release capsules dosage adjustments may be done every 1 to 2 days.

  Patients who experience breakthrough pain may require a dose increase of morphine sulfate extended-release capsules, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the morphine sulfate extended-release capsules dose. In patients experiencing inadequate analgesia with once daily dosing of morphine sulfate extended-release capsules, consider a twice daily regimen.

  If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  2.3 Discontinuation of Morphine Sulfate Extended-Release Capsules 

  When a patient no longer requires therapy with morphine sulfate extended-release capsules, use a gradual downward titration, of the dose every two to four days, to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue morphine sulfate extended-release capsules.

  2.4 Administration of Morphine Sulfate Extended-Release Capsules 

  Morphine sulfate extended-release capsules must be taken whole. Crushing, chewing, or dissolving the pellets in morphine sulfate extended-release capsules will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.2)].

  Alternatively, the contents of the morphine sulfate extended-release capsules (pellets) may be sprinkled over applesauce and then swallowed.  This method is appropriate only for patients able to reliably swallow the applesauce without chewing.  Other foods have not been tested and should not be substituted for applesauce.  Instruct the patient to:

  Sprinkle the pellets onto a small amount of applesauce and consume immediately without chewing. Rinse the mouth to ensure all pellets have been swallowed. Discard any unused portion of the morphine sulfate extended-release capsules after the contents have been sprinkled on applesauce.

  The contents of the morphine sulfate extended-release capsules (pellets) may be administered through a 16 French gastrostomy tube.

  Flush the gastrostomy tube with water to ensure that it is wet. Sprinkle the morphine sulfate extended-release capsules Pellets into 10 mL of water. Use a swirling motion to pour the pellets and water into the gastrostomy tube through a funnel. Rinse the beaker with a further 10 mL of water and pour this into the funnel. Repeat rinsing until no pellets remain in the beaker.

  Do not administer morphine sulfate extended-release capsules pellets through a nasogastric tube.

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  Morphine Sulfate | Mylan Pharmaceuticals Inc.

  

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  2.1 Initial Dosing

  Morphine sulfate extended-release tablets should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with morphine sulfate extended-release tablets [see Warnings and Precautions (5.2)].

  Morphine sulfate extended-release tablets must be taken whole. Crushing, chewing, or dissolving morphine sulfate extended-release tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].

  Use of Morphine Sulfate Extended-release Tablets as the First Opioid Analgesic

  Initiate treatment with morphine sulfate extended-release tablets with 15 mg tablets orally every 8 or 12 hours.

  Use of Morphine Sulfate Extended-release Tablets in Patients who are not Opioid Tolerant

  The starting dose for patients who are not opioid tolerant is morphine sulfate extended-release tablets 15 mg orally every 12 hours. 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, or an equianalgesic dose of another opioid.

  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

  Conversion from Other Oral Morphine to Morphine Sulfate Extended-release Tablets

  Patients receiving other oral morphine formulations may be converted to morphine sulfate extended-release tablets by administering one-half of the patient's 24-hour requirement as morphine sulfate extended-release tablets on an every-12-hour schedule or by administering one-third of the patient's daily requirement as morphine sulfate extended-release tablets on an every-8-hour schedule.

  Conversion from Other Opioids to Morphine Sulfate Extended-release Tablets

  There are no established conversion ratios for conversion from other opioids to morphine sulfate extended-release tablets defined by clinical trials. Discontinue all other around-the-clock opioid drugs when morphine sulfate extended-release tablet therapy is initiated and initiate dosing using morphine sulfate extended-release tablets 15 mg orally every 8 to 12 hours.

  It is safer to underestimate a patient’s 24-hour oral morphine requirements and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine requirements and manage an adverse reaction. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.

  Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-release Tablets

  When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to morphine sulfate extended-release tablets, consider the following general points:

  Parenteral to Oral Morphine Ratio

  Between 2 mg to 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of morphine that is approximately 3 times the previous daily parenteral morphine requirement is sufficient.

  Other Parenteral or Oral Non-Morphine Opioids to Oral Morphine Sulfate

  Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.

  Conversion from Methadone to Morphine Sulfate Extended-release Tablets

  Close monitoring is of particular importance when converting methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

  2.2 Titration and Maintenance of Therapy

  Individually titrate morphine sulfate extended-release tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving morphine sulfate extended-release tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy periodically reassess the continued need for the use of opioid analgesics.

  Patients who experience breakthrough pain may require a dose increase of morphine sulfate extended-release tablets, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the morphine sulfate extended-release tablet dose. Because steady-state plasma concentrations are approximated in one day, morphine sulfate extended-release tablet dosage adjustments may be done every 1 to 2 days.

  If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  2.3 Discontinuation of Morphine Sulfate Extended-release Tablets

  When the patient no longer requires therapy with morphine sulfate extended-release tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue morphine sulfate extended-release tablets.

  2.4 Administration of Morphine Sulfate Extended-release Tablets

  Morphine sulfate extended-release tablets must be taken whole. Crushing, chewing, or dissolving morphine sulfate extended-release tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].

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  Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

  If an infection develops, the use of Cordran Tape and other occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

  Replacement of the tape every 12 hours produces the lowest incidence of adverse reactions, but it may be left in place for 24 hours if it is well tolerated and adheres satisfactorily. When necessary, the tape may be used at night only and removed during the day.

  If ends of the tape loosen prematurely, they may be trimmed off and replaced with fresh tape.

  The directions given below are included for the patient to follow unless otherwise instructed by the physician.

  ________________________________________________________________________

  APPLICATION OF CORDRAN TAPE

  IMPORTANT: Skin should be clean and dry before tape is applied. Tape should always be cut, never torn.

  DIRECTIONS FOR USE:

  Prepare skin as directed by your physician or as follows: Gently clean the area to be covered to remove scales, crusts, dried exudates, and any previously used ointments or creams. A germicidal soap or cleanser should be used to prevent the development of odor under the tape. Shave or clip the hair in the treatment area to allow both good contact with the skin and comfortable removal. If shower or tub bath is to be taken, it should be completed before the tape is applied. The skin should be dry before application of the tape.
  Remove tape from package and cut a piece slightly larger than area to be covered. Round off corners.
  Pull white paper from transparent tape. Be careful that tape does not stick to itself.
  Apply tape, keeping skin smooth; press tape into place.

  REPLACEMENT OF TAPE:

  Unless instructed otherwise by your physician, replace tape after 12 hours. Cleanse skin and allow it to dry for 1 hour before applying new tape.

  IF IRRITATION OR INFECTION DEVELOPS, REMOVE TAPE AND CONSULT PHYSICIAN.

  ________________________________________________________________________

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