If clinically advisable, patients receiving KADIAN®, or their caregivers should be given the following information by the physician, nurse, or pharmacist:

1. Patients should be advised that KADIAN® contains morphine and should be taken only as directed.
2. Patients should be advised that KADIAN® capsules should be swallowed whole (not chewed, crushed, or dissolved). Alternately, KADIAN® capsules may be opened and the entire contents sprinkled on a small amount of apple sauce immediately prior to ingestion. KADIAN® capsules or the contents of the capsules must not be chewed or crushed due to a risk of fatal overdose.
3. Patients should be advised that KADIAN® 100 mg and 200 mg Capsules are for use only in opioid-tolerant patients. Special care must be taken to avoid accidental ingestion or use by individuals (including children) other than the patient for whom it was originally prescribed, as such unsupervised use may have severe, even fatal, consequences.
4. Patients should be advised that the dose of KADIAN® should not be adjusted without consulting the prescribing health care provider.
5. Patients should be advised to report episodes of breakthrough pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.
6. Patients should be advised that KADIAN® may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery). Patients started on KADIAN® or whose dose has been changed should refrain from dangerous activity until it is established that they are not adversely affected.
7. Patients should be advised that KADIAN® should not be taken with alcohol or other CNS depressants (sleeping medication, tranquilizers) except by the orders of the prescribing healthcare provider because dangerous additive effects may occur resulting in serious injury or death.
8. Women of childbearing potential who become or are planning to become pregnant, should consult their prescribing healthcare provider prior to initiating or continuing therapy with KADIAN®.
9. Patients should be advised that if they have been receiving treatment with KADIAN® for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the KADIAN® dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their prescribing healthcare provider should provide a dose schedule to accomplish a gradual discontinuation of the medication.
10. Patients should be advised that KADIAN® is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
11. Patients should be advised that severe constipation could occur as a result of taking KADIAN® and appropriate laxatives, stool softeners and other appropriate treatments should be initiated from the beginning of opioid therapy.
12. Patients should be instructed to keep KADIAN® in a secure place out of the reach of children. When KADIAN® is no longer needed, the unused capsules should be destroyed by flushing down the toilet.

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