MS Contin (Page 2 of 9)

2.3 Titration and Maintenance of Therapy

Individually titrate MS CONTIN to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving MS CONTIN 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 MS CONTIN, 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 MS CONTIN dosage. Because steady-state plasma concentrations are approximated in 1 day, MS CONTIN 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.

2.4 Dosage Modifications with Concomitant Use of Central Nervous System Depressants

If the patient is currently taking a central nervous system (CNS) depressant and the decision is made to begin MS CONTIN, start with the lowest possible dose, 15 mg every 12 hours, monitor patients for signs of respiratory depression, sedation, and hypotension, and consider using a lower dosage of the concomitant CNS depressant [see Warnings and Precautions (5.4), Drug Interactions (7)].

2.5 Discontinuation of MS CONTIN

When a patient no longer requires therapy with MS CONTIN tablets, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the 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 MS CONTIN [see Warnings and Precautions (5.12), Drug Abuse and Dependence (9.3)].

3 DOSAGE FORMS AND STRENGTHS


  • MS CONTIN® (morphine sulfate extended-release tablets) 15 mg
    Round, blue-colored, film-coated tablets bearing the symbol PF on one side and M 15 on the other
  • MS CONTIN® (morphine sulfate extended-release tablets) 30 mg
    Round, lavender-colored, film-coated tablets bearing the symbol PF on one side and M 30 on the other
  • MS CONTIN® (morphine sulfate extended-release tablets) 60 mg
    Round, orange-colored, film-coated tablets bearing the symbol PF on one side and M 60 on the other
  • MS CONTIN® (morphine sulfate extended-release tablets) 100 mg
    Round, gray-colored, film-coated tablets bearing the symbol PF on one side and 100 on the other
  • MS CONTIN® (morphine sulfate extended-release tablets) 200 mgCapsule-shaped, green-colored, film-coated tablets bearing the symbol PF on one side and M 200 on the other

4 CONTRAINDICATIONS

MS CONTIN is contraindicated in patients with:

  • Significant respiratory depression [see Warnings and Precautions (5.2)]
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.5)]
  • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.6), Drug Interactions (7)]
  • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.10)]
  • Hypersensitivity (e.g., anaphylaxis) to morphine [see Adverse Reactions (6.2)]

5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

MS CONTIN contains morphine, a Schedule II controlled substance. As an opioid, MS CONTIN exposes its users to the risks of addiction, abuse, and misuse. Because extended-release products such as MS CONTIN deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of morphine present [see Drug Abuse and Dependence (9)].

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed MS CONTIN. Addiction can occur at recommended doses and if the drug is misused or abused.

Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing MS CONTIN, and monitor all patients receiving MS CONTIN for development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as MS CONTIN, but use in such patients necessitates intensive counseling about the risks of proper use of MS CONTIN along with intensive monitoring for signs of addiction, abuse, and misuse.

Abuse or misuse of MS CONTIN by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of morphine and can result in overdose and death [see Overdosage (10)].

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing MS CONTIN. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information (17)]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

5.2 Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see Overdosage (10)]. Carbon dioxide (CO2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of MS CONTIN, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression especially within the first 24-72 hours of initiating therapy and following dosage increases of with MS CONTIN.

To reduce the risk of respiratory depression, proper dosing and titration of MS CONTIN are essential [see Dosage and Administration (2)]. Overestimating the MS CONTIN dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.

Accidental ingestion of even one dose of MS CONTIN, especially by children, can result in respiratory depression and death due to an overdose of morphine.

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