July 29, 2015
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MS-Contin

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MS-Contin




Indications
Dosage
How Supplied

INDICATIONS

MS CONTIN is indicated for the management of pain severe enough to require daily, around-theclock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve MS CONTIN for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • MS CONTIN is not indicated as an as-needed (prn) analgesic.

DOSAGE AND ADMINISTRATION

Initial Dosing

MS CONTIN 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]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with MS CONTIN [see WARNINGS AND PRECAUTIONS].

MS CONTIN tablets must be taken whole. Crushing, chewing, or dissolving MS CONTIN tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see WARNINGS AND PRECAUTIONS].

Use of MS CONTIN as the First Opioid Analgesic

Initiate treatment with MS CONTIN with 15 mg tablets orally every 8 or 12 hours.

Use of MS CONTIN in Patients who are not Opioid Tolerant

The starting dose for patients who are not opioid tolerant is MS CONTIN 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 MS CONTIN

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

Conversion from Other Opioids to MS CONTIN

There are no established conversion ratios for conversion from other opioids to MS CONTIN defined by clinical trials. Discontinue all other around-the-clock opioid drugs when MS CONTIN therapy is initiated and initiate dosing using MS CONTIN 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 MS CONTIN

When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to MS CONTIN, 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 MS CONTIN

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

Discontinuation Of MS CONTIN

When the patient no longer requires therapy with MS CONTIN 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 MS CONTIN.

Administration Of MS CONTIN

MS CONTIN tablets must be taken whole. Crushing, chewing, or dissolving MS CONTIN tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

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 recommendations are not available because of a lack of systematic evidence for these types 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 mg* Capsule-shaped, green-colored, film-coated tablets bearing the symbol PF on one side and M 200 on the other

*100 mg and 200 mg tablets are for use in opioid-tolerant patients only

Storage And Handling

MS CONTIN® (morphine sulfate extended-release tablets) 15 mg are round, blue-colored, filmcoated tablets bearing the symbol PF on one side and M 15 on the other. They are supplied as follows:

NDC 59011-260-10: opaque plastic bottles containing 100 tablets

MS CONTIN® (morphine sulfate extended-release tablets) 30 mg are round, lavender-colored, film-coated tablets bearing the symbol PF on one side and M 30 on the other. They are supplied as follows:

NDC 59011-261-25: opaque plastic bottles containing 100 tablets
NDC 59011-261-05: opaque plastic bottles containing 500 tablets

MS CONTIN® (morphine sulfate extended-release tablets) 60 mg are round, orange-colored, filmcoated tablets bearing the symbol PF on one side and M 60 on the other. They are supplied as follows:

NDC 59011-262-10: opaque plastic bottles containing 100 tablets
NDC 59011-262-05: opaque plastic bottles containing 500 tablets

MS CONTIN® (morphine sulfate extended-release tablets) 100 mg are round, gray-colored, filmcoated tablets bearing the symbol PF on one side and 100 on the other. They are supplied as follows:

NDC 59011-263-10: opaque plastic bottles containing 100 tablets
NDC 59011-263-05: opaque plastic bottles containing 500 tablets

MS CONTIN® (morphine sulfate extended-release tablets) 200 mg are capsule-shaped, greencolored, film-coated tablets bearing the symbol PF on one side and M 200 on the other. They are supplied as follows:

NDC 59011-264-10: opaque plastic bottles containing 100 tablets

Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container.

CAUTION: DEA FORM REQUIRED

Manufactured by: Purdue Pharma L.P., Stamford, CT 06901-3431. www.purduepharma.com or call 1-888-726-7535. Revised: April 2014

Last reviewed on RxList: 7/21/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

MS-Contin - User Reviews

MS-Contin User Reviews

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