Generic name: MORPHINE SULFATE 10mg
Dosage form: capsule, extended release
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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 2 to 4 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.