Kadian

Kadian Manufacturers

• Physicians Total Care, Inc.
  

  ×

  Kadian | Physicians Total Care, Inc.

  

  ---

  KADIAN® may be administered once or twice daily.

  KADIAN® capsules should be swallowed whole.  The pellets in KADIAN® 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, KADIAN® 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 and 200 mg capsules are for use only in opioid-tolerant patients. 

  KADIAN® is 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.

  KADIAN® is 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 KADIAN® 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 KADIAN® 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 KADIAN®, 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 KADIAN® 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 KADIAN®

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

  Conversion from Parenteral Morphine or Other Parenteral or Oral Opioids to KADIAN®

  KADIAN® 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 2-6 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 KADIAN® 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 KADIAN®.

  Use of KADIAN® as the First Opioid Analgesic

  There has been no evaluation of KADIAN® 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.  KADIAN® is 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.

  KADIAN® 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 KADIAN® 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, KADIAN® pellets sprinkled over apple sauce were found to be bioequivalent to KADIAN® 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 KADIAN® 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 KADIAN® 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 KADIAN® is 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 KADIAN® should not be reduced below 12 hours.

  Cessation of Therapy

  When the patient no longer requires therapy with KADIAN® capsules, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from KADIAN® to Other Extended-Release Oral Morphine Formulations

  KADIAN® is not bioequivalent to other extended-release morphine preparations.  Although for a given dose the same total amount of morphine is available from KADIAN® as from morphine solution or extended-release morphine tablets, the slower release of morphine from KADIAN® results in reduced maximum and increased minimum plasma morphine concentrations than with shorter acting morphine products.  Conversion from KADIAN® to the same total daily dose of 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 KADIAN® to Parenteral Opioids

  When converting a patient from KADIAN® 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 KADIAN®, one would take the 24 hour KADIAN® 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 KADIAN® 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

  KADIAN® 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 KADIAN® capsules that are no longer needed.

  KADIAN® 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.

  KADIAN® consists of closed hard gelatin capsules containing polymer coated morphine sulfate pellets that pose no known handling risk to health care workers. KADIAN® 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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  No Recall

  More Info
• Stat Rx Usa Llc
  

  ×

  Kadian | Stat Rx Usa Llc

  

  ---

  KADIAN® may be administered once or twice daily.

  KADIAN® capsules should be swallowed whole.  The pellets in KADIAN® 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, KADIAN® 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 and 200 mg capsules are for use only in opioid-tolerant patients. 

  KADIAN® is 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.

  KADIAN® is 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 KADIAN® 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 KADIAN® 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 KADIAN®, 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 KADIAN® 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 KADIAN®

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

  Conversion from Parenteral Morphine or Other Parenteral or Oral Opioids to KADIAN®

  KADIAN® 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 2-6 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 KADIAN® 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 KADIAN®.

  Use of KADIAN® as the First Opioid Analgesic

  There has been no evaluation of KADIAN® 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. KADIAN® is 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.

  KADIAN® 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 KADIAN® 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, KADIAN® pellets sprinkled over apple sauce were found to be bioequivalent to KADIAN® 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 KADIAN® 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 KADIAN® 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 KADIAN® is 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 KADIAN® should not be reduced below 12 hours.

  Cessation of Therapy

  When the patient no longer requires therapy with KADIAN® capsules, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  
  Conversion from KADIAN® to Other Extended-Release Oral Morphine Formulations

  KADIAN® is not bioequivalent to other extended-release morphine preparations.  Although for a given dose the same total amount of morphine is available from KADIAN® as from morphine solution or extended-release morphine tablets, the slower release of morphine from KADIAN® results in reduced maximum and increased minimum plasma morphine concentrations than with shorter acting morphine products.  Conversion from KADIAN® to the same total daily dose of 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 KADIAN® to Parenteral Opioids

  When converting a patient from KADIAN® 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 KADIAN®, one would take the 24 hour KADIAN® 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 KADIAN® 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

  KADIAN® 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 KADIAN® capsules that are no longer needed.

  KADIAN® 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.

  KADIAN® consists of closed hard gelatin capsules containing polymer coated morphine sulfate pellets that pose no known handling risk to health care workers. KADIAN® 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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  More Info
• Bryant Ranch Prepack
  

  ×

  Kadian | Bryant Ranch Prepack

  

  ---

  KADIAN® may be administered once or twice daily.

  KADIAN® capsules should be swallowed whole.  The pellets in KADIAN® 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, KADIAN® 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 and 200 mg capsules are for use only in opioid-tolerant patients. 

  KADIAN® is 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.

  KADIAN® is 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 KADIAN® 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 KADIAN® 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 KADIAN®, 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 KADIAN® 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 KADIAN®

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

  Conversion from Parenteral Morphine or Other Parenteral or Oral Opioids to KADIAN®

  KADIAN® 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 2-6 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 KADIAN® 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 KADIAN®.

  Use of KADIAN® as the First Opioid Analgesic

  There has been no evaluation of KADIAN® 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. KADIAN® is 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.

  KADIAN® 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 KADIAN® 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, KADIAN® pellets sprinkled over apple sauce were found to be bioequivalent to KADIAN® 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 KADIAN® 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 KADIAN® 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 KADIAN® is 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 KADIAN® should not be reduced below 12 hours.

  Cessation of Therapy

  When the patient no longer requires therapy with KADIAN® capsules, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from KADIAN® to Other Extended-Release Oral Morphine Formulations

  KADIAN® is not bioequivalent to other extended-release morphine preparations.  Although for a given dose the same total amount of morphine is available from KADIAN® as from morphine solution or extended-release morphine tablets, the slower release of morphine from KADIAN® results in reduced maximum and increased minimum plasma morphine concentrations than with shorter acting morphine products.  Conversion from KADIAN® to the same total daily dose of 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 KADIAN® to Parenteral Opioids

  When converting a patient from KADIAN® 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 KADIAN®, one would take the 24 hour KADIAN® 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 KADIAN® 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

  KADIAN® 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 KADIAN® capsules that are no longer needed.

  KADIAN® 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.

  KADIAN® consists of closed hard gelatin capsules containing polymer coated morphine sulfate pellets that pose no known handling risk to health care workers. KADIAN® 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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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Kadian | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  KADIAN® may be administered once or twice daily.

  KADIAN® capsules should be swallowed whole.  The pellets in KADIAN® 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, KADIAN® 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 and 200 mg capsules are for use only in opioid-tolerant patients. 

  KADIAN® is 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.

  KADIAN® is 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 KADIAN® 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 KADIAN® 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 KADIAN®, 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 KADIAN® 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 KADIAN®

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

  Conversion from Parenteral Morphine or Other Parenteral or Oral Opioids to KADIAN®

  KADIAN® 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 2-6 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 KADIAN® 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 KADIAN®.

  Use of KADIAN® as the First Opioid Analgesic

  There has been no evaluation of KADIAN® 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. KADIAN® is 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.

  KADIAN® 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 KADIAN® 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, KADIAN® pellets sprinkled over apple sauce were found to be bioequivalent to KADIAN® 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 KADIAN® 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 KADIAN® 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 KADIAN® is 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 KADIAN® should not be reduced below 12 hours.

  Cessation of Therapy

  When the patient no longer requires therapy with KADIAN® capsules, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  
  Conversion from KADIAN® to Other Extended-Release Oral Morphine Formulations

  KADIAN® is not bioequivalent to other extended-release morphine preparations.  Although for a given dose the same total amount of morphine is available from KADIAN® as from morphine solution or extended-release morphine tablets, the slower release of morphine from KADIAN® results in reduced maximum and increased minimum plasma morphine concentrations than with shorter acting morphine products.  Conversion from KADIAN® to the same total daily dose of 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 KADIAN® to Parenteral Opioids

  When converting a patient from KADIAN® 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 KADIAN®, one would take the 24 hour KADIAN® 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 KADIAN® 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

  KADIAN® 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 KADIAN® capsules that are no longer needed.

  KADIAN® 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.

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

  Close
  No Recall

  More Info
• Lake Erie Medical Dba Quality Care Products Llc
  

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  Kadian | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  KADIAN® may be administered once or twice daily.

  KADIAN® capsules should be swallowed whole.  The pellets in KADIAN® 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, KADIAN® 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 and 200 mg capsules are for use only in opioid-tolerant patients. 

  KADIAN® is 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.

  KADIAN® is 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 KADIAN® 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 KADIAN® 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 KADIAN®, 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 KADIAN® 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 KADIAN®

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

  Conversion from Parenteral Morphine or Other Parenteral or Oral Opioids to KADIAN®

  KADIAN® 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 2-6 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 KADIAN® 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 KADIAN®.

  Use of KADIAN® as the First Opioid Analgesic

  There has been no evaluation of KADIAN® 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. KADIAN® is 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.

  KADIAN® 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 KADIAN® 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, KADIAN® pellets sprinkled over apple sauce were found to be bioequivalent to KADIAN® 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 KADIAN® 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 KADIAN® 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 KADIAN® is 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 KADIAN® should not be reduced below 12 hours.

  Cessation of Therapy

  When the patient no longer requires therapy with KADIAN® capsules, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from KADIAN® to Other Extended-Release Oral Morphine Formulations

  KADIAN® is not bioequivalent to other extended-release morphine preparations.  Although for a given dose the same total amount of morphine is available from KADIAN® as from morphine solution or extended-release morphine tablets, the slower release of morphine from KADIAN® results in reduced maximum and increased minimum plasma morphine concentrations than with shorter acting morphine products.  Conversion from KADIAN® to the same total daily dose of 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 KADIAN® to Parenteral Opioids

  When converting a patient from KADIAN® 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 KADIAN®, one would take the 24 hour KADIAN® 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 KADIAN® 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

  KADIAN® 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 KADIAN® capsules that are no longer needed.

  KADIAN® 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.

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

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Kadian | Bryant Ranch Prepack

  

  ---

  2.1 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 to 72 hours of initiating therapy with KADIAN [see Warnings and Precautions (5.2)].

  Consider the following factors when selecting an initial dose of KADIAN:

  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.

  KADIAN is administered at a frequency of either once daily (every 24 hours) or twice daily (every 12 hours).

  Use of KADIAN as the First Opioid Analgesic

  There has been no evaluation of KADIAN 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 KADIAN as described below.

  Conversion from Other Oral Morphine Formulations to KADIAN

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

  KADIAN is not bioequivalent to other extended-release morphine preparations.  Conversion from KADIAN 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 KADIAN therapy and adjust the dosage of KADIAN as needed.

  Conversion from  Parenteral Morphine, or Other Opioids to KADIAN

  While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variation in the relative potency of different opioid drugs and formulations. As such, it is safer to underestimate a patient's 24-hour oral morphine requirement and provide rescue medication (e.g. immediate-release morphine) than to overestimate and manage an adverse reaction.  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: 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 KADIAN may be taken with the last dose of any immediate-release opioid medication due to the extended-release characteristics of the KADIAN formulation.

  2.2 Titration and Maintenance of Therapy

  Individually titrate KADIAN to a dose that provides adequate analgesia and minimizes adverse reactions at a frequency of either once or twice daily.  Continually reevaluate patients receiving KADIAN 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 KADIAN dose to decrease the level of pain.  Because steady-state plasma concentrations are approximated within 24 to 36 hours, KADIAN dosage adjustments may be done every 1 to 2 days.   Patients who experience breakthrough pain may require dosage adjustment or rescue medication with a small dose of an immediate-release medication.  In patients experiencing inadequate analgesia with once daily dosing of KADIAN, consider a twice daily regimen.

  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.

  2.3 Discontinuation of KADIAN

  When a patient no longer requires therapy with KADIAN, 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 KADIAN.

  2.4 Administration of KADIAN

  Instruct patients to swallow KADIAN capsules intact. The pellets in the capsules 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 (5.2)].

  Alternatively, the contents of the KADIAN 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 KADIAN capsules after the contents have been sprinkled on applesauce.

  The contents of the KADIAN 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 KADIAN 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 KADIAN pellets through a nasogastric tube.

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Kadian | Bryant Ranch Prepack

  

  ---

  2.1 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 to 72 hours of initiating therapy with KADIAN [see Warnings and Precautions (5.2)].

  Consider the following factors when selecting an initial dose of KADIAN:

  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.

  KADIAN is administered at a frequency of either once daily (every 24 hours) or twice daily (every 12 hours).

  Use of KADIAN as the First Opioid Analgesic

  There has been no evaluation of KADIAN 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 KADIAN as described below.

  Conversion from Other Oral Morphine Formulations to KADIAN

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

  KADIAN is not bioequivalent to other extended-release morphine preparations.  Conversion from KADIAN 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 KADIAN therapy and adjust the dosage of KADIAN as needed.

  Conversion from  Parenteral Morphine, or Other Opioids to KADIAN

  While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variation in the relative potency of different opioid drugs and formulations. As such, it is safer to underestimate a patient's 24-hour oral morphine requirement and provide rescue medication (e.g. immediate-release morphine) than to overestimate and manage an adverse reaction.  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: 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 KADIAN may be taken with the last dose of any immediate-release opioid medication due to the extended-release characteristics of the KADIAN formulation.

  2.2 Titration and Maintenance of Therapy

  Individually titrate KADIAN to a dose that provides adequate analgesia and minimizes adverse reactions at a frequency of either once or twice daily.  Continually reevaluate patients receiving KADIAN 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 KADIAN dose to decrease the level of pain.  Because steady-state plasma concentrations are approximated within 24 to 36 hours, KADIAN dosage adjustments may be done every 1 to 2 days.   Patients who experience breakthrough pain may require dosage adjustment or rescue medication with a small dose of an immediate-release medication.  In patients experiencing inadequate analgesia with once daily dosing of KADIAN, consider a twice daily regimen.

  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.

  2.3 Discontinuation of KADIAN

  When a patient no longer requires therapy with KADIAN, 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 KADIAN.

  2.4 Administration of KADIAN

  Instruct patients to swallow KADIAN capsules intact. The pellets in the capsules 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 (5.2)].

  Alternatively, the contents of the KADIAN 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 KADIAN capsules after the contents have been sprinkled on applesauce.

  The contents of the KADIAN 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 KADIAN 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 KADIAN pellets through a nasogastric tube.

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• Actavis Kadian Llc
  

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  Kadian | Actavis Kadian Llc

  

  ---

  2.1 Initial Dosing

  KADIAN should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  KADIAN 100 mg, 130 mg, 150 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 KADIAN [see Warnings and Precautions (5.2)].

  KADIAN capsules must be taken whole. Crushing, chewing, or dissolving the pellets in KADIAN 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 KADIAN should be instructed to sprinkle the capsule contents on applesauce and immediately swallow without chewing [see Administration of KADIAN (2.4)].

  KADIAN is administered at a frequency of either once daily (every 24 hours) or twice daily (every 12 hours). 

  Use of KADIAN as the First Opioid Analgesic

  There has been no evaluation of KADIAN 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 KADIAN as described below.

  Use of KADIAN in Patients who are not Opioid Tolerant

  The starting dose for patients who are not opioid tolerant is KADIAN 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 KADIAN

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

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

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

  Conversion from Parenteral Morphine, or Other Opioids to KADIAN

  When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to KADIAN, 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: 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 KADIAN

  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 KADIAN to a dose that provides adequate analgesia and minimizes adverse reactions at a frequency of either once or twice daily.  Continually reevaluate patients receiving KADIAN 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 KADIAN dose to decrease the level of pain.  Because steady-state plasma concentrations are approximated within 24 to 36 hours, KADIAN dosage adjustments may be done every 1 to 2 days. 

  Patients who experience breakthrough pain may require a dose increase of KADIAN, 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 KADIAN dose.  In patients experiencing inadequate analgesia with once daily dosing of KADIAN, 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 KADIAN

  When a patient no longer requires therapy with KADIAN, 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 KADIAN.

  2.4 Administration of KADIAN

  KADIAN capsules must be taken whole. Crushing, chewing, or dissolving the pellets in KADIAN 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 KADIAN 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 KADIAN capsules after the contents have been sprinkled on applesauce.

  The contents of the KADIAN 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 KADIAN 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 KADIAN pellets through a nasogastric tube.

  Close
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• Actavis Pharma, Inc.
  

  ×

  Kadian | Actavis Pharma, Inc.

  

  ---

  2.1 Initial Dosing

  KADIAN should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  KADIAN 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 KADIAN [see Warnings and Precautions (5.2)].

  KADIAN capsules must be taken whole. Crushing, chewing, or dissolving the pellets in KADIAN 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 KADIAN should be instructed to sprinkle the capsule contents on applesauce and immediately swallow without chewing [see Administration of KADIAN (2.4)].

  KADIAN is administered at a frequency of either once daily (every 24 hours) or twice daily (every 12 hours). 

  Use of KADIAN as the First Opioid Analgesic

  There has been no evaluation of KADIAN 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 KADIAN as described below.

  Use of KADIAN in Patients who are not Opioid Tolerant

  The starting dose for patients who are not opioid tolerant is KADIAN 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 KADIAN

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

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

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

  Conversion from Parenteral Morphine, or Other Opioids to KADIAN

  When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to KADIAN, 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: 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 KADIAN

  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 KADIAN to a dose that provides adequate analgesia and minimizes adverse reactions at a frequency of either once or twice daily.  Continually reevaluate patients receiving KADIAN 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 KADIAN dose to decrease the level of pain.  Because steady-state plasma concentrations are approximated within 24 to 36 hours, KADIAN dosage adjustments may be done every 1 to 2 days. 

  Patients who experience breakthrough pain may require a dose increase of KADIAN, 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 KADIAN dose.  In patients experiencing inadequate analgesia with once daily dosing of KADIAN, 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 KADIAN

  When a patient no longer requires therapy with KADIAN, 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 KADIAN.

  2.4 Administration of KADIAN

  KADIAN capsules must be taken whole. Crushing, chewing, or dissolving the pellets in KADIAN 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 KADIAN 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 KADIAN capsules after the contents have been sprinkled on applesauce.

  The contents of the KADIAN 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 KADIAN 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 KADIAN pellets through a nasogastric tube.

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  No Recall

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