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Generic name: MORPHINE SULFATE 15mg
Dosage form: tablet, extended release
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Important Dosage and Administration Instructions
MORPHABOND ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
MORPHABOND ER 100 mg tablets, a single dose greater than 60 mg, or a total daily dose greater than 120 mg, are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
- Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
- Initiate the dosing regimen for each patient individually; taking into account the patient's severity of pain, patient response, 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 24-72 hours of initiating therapy and following dosage increases with MORPHABOND ER and adjust the dosage accordingly [see Warnings and Precautions (5.2)].
Instruct patients to swallow MORPHABOND ER tablets whole [see Patient Counseling Information (17)]. Crushing, chewing, or dissolving MORPHABOND ER tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].
MORPHABOND ER is administered orally every 12 hours.
Use of MORPHABOND ER as the First Opioid Analgesic (opioid-naïve patients)
Initiate treatment with MORPHABOND ER with 15 mg tablets orally every 12 hours.
Use of MORPHABOND ER in Patients who are not Opioid Tolerant (opioid non-tolerant patients)
The starting dosage for patients who are not opioid tolerant is MORPHABOND ER 15 mg orally every 12 hours.
Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression [see Warnings and Precautions (5.2)].
Conversion from Other Oral Morphine to MORPHABOND ER
Patients receiving other oral morphine formulations may be converted to MORPHABOND ER by administering one-half of the patient's 24-hour requirement as MORPHABOND ER on an every-12-hour schedule.
Conversion from Other Opioids to MORPHABOND ER
Discontinue all other around-the-clock opioid drugs when MORPHABOND ER therapy is initiated.
There are no established conversion ratios for conversion from other opioids to MORPHABOND ER defined by clinical trials. Initiate dosing using MORPHABOND ER 15 mg orally every 12 hours.
It is safer to underestimate a patient’s 24-hour oral morphine dosage and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine dosage and manage an adverse reaction due to an overdose. While useful tables of opioid equivalents are readily available, there is inter-patient variability in the relative potency of opioid drugs and formulations.
Close observation and frequent titration are warranted until pain management is stable on the new opioid. Monitor patients for signs and symptoms of opioid withdrawal and for signs of oversedation/toxicity after converting patients to MORPHABOND ER.
Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to MORPHABOND ER
When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to MORPHABOND ER, 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 Ratios: 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 MORPHABOND ER
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.
Titration and Maintenance of Therapy
Individually titrate MORPHABOND ER to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving MORPHABOND ER 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 [see Warnings and Precautions (5.1)]. 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 dosage adjustment of MORPHABOND ER, 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 MORPHABOND ER dosage. Because steady-state plasma concentrations are approximated in 1 day, MORPHABOND ER dosage adjustments may be done every 1 to 2 days.
If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Discontinuation of MORPHABOND ER
When the patient no longer requires therapy with MORPHABOND ER tablets, taper the dosage gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If a patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue MORPHABOND ER [see Warnings and Precautions (5.12), Drug Abuse and Dependence (9.3)].