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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 moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

MS CONTIN is not for use:

  • As an as-needed (prn) analgesic.
  • For pain that is mild or not expected to persist for an extended period of time
  • For acute pain
  • In the immediate postoperative period (the first 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established.
  • For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.

MS CONTIN 100 mg and 200 mg tablets are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid-tolerant are those taking 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 for a week or longer.

DOSAGE AND ADMINISTRATION

Initial Dosing

Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with MS CONTIN [see WARNINGS AND PRECAUTIONS].

Consider the following factors when selecting an initial dose of MS CONTIN:

  • Total daily dose, potency, and any prior opioid the patient has been taking previously;
  • 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);
  • Patient's degree of opioid experience and opioid tolerance;
  • General condition and medical status of the patient;
  • Concurrent medication;
  • Type and severity of the patient's pain.

MS Contin is administered at a frequency of twice daily (every 12 hours) or three times daily (every 8 hours).

Use of MS Contin as the First Opioid Analgesic

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

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 24hour 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 Parenteral Morphine or Other Opioids (Parenteral or Oral) to MS CONTIN

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

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

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. 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.

If the level of pain increases, attempt to identify the source of increased pain, while adjusting the MS CONTIN dose to decrease the level of pain. Because steady-state plasma concentrations are approximated in 1 day, MS CONTIN dosage adjustments may be done every 1 to 2 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication with an appropriate dose of an immediate-release opioid and non-opioid medication.

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

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.

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

Instruct patients to swallow MS CONTIN tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of morphine [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

  • MS CONTIN®(morphine sulfate controlled-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 controlled-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 controlled-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 controlled-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 controlled-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 controlled-release) Tablets 15 mg are round, blue-colored, film-coated 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 controlled-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 controlled-release) Tablets 60 mg are round, orange-colored, film-coated 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 controlled-release) Tablets 100 mg are round, gray-colored, film-coated 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 controlled-release) Tablets 200 mg are capsule-shaped, green-colored, 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

Purdue Pharma L.P. Stamford, CT 06901-3431

Last reviewed on RxList: 7/23/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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