Patients receiving AVINZA (morphine sulfate extended-release capsules) should be given the following instructions by the physician:

1. Patients should be advised that AVINZA capsules contain morphine and should be taken once daily.
2. AVINZA must be swallowed whole (not chewed, crushed, or dissolved) or AVINZA may be opened and the entire bead contents sprinkled on a small amount of applesauce immediately prior to ingestion. The beads must NOT be chewed, crushed, or dissolved due to the risk of exposure to a potentially toxic dose of morphine.
3. Patients should be informed that they must not consume alcoholic beverages while on AVINZA therapy. Additionally, patients should be informed that they must not use prescription or non-prescription medication containing alcohol while on AVINZA therapy. Consumption of alcohol while taking AVINZA may result in the rapid release and absorption of a potentially fatal dose of morphine.
4. The dose of AVINZA should not be adjusted without consulting with a physician or other healthcare professional.
5. Patients should be advised that AVINZA may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery). Patients started on AVINZA or patients whose dose has been adjusted should refrain from any potentially dangerous activity until it is established that they are not adversely affected.
6. Patients should be advised that AVINZA should not be combined with alcohol or other CNS depressants (e.g., sleep medications, tranquilizers). A physician should be consulted if other medications are currently being used or are added in the future.
7. Women of childbearing potential who become or are planning to become pregnant should consult a physician prior to initiating or continuing therapy with AVINZA.
8. If patients have been receiving treatment with AVINZA for more than a few weeks and cessation of therapy is indicated, they should be counseled on the importance of safely tapering the dose and that abruptly discontinuing the medication could precipitate withdrawal symptoms. The physician should provide a dose schedule to accomplish a gradual discontinuation of the medication.
9. Patients should be advised that AVINZA is a potential drug of abuse. They should protect it from theft. It should never be given to anyone other than the individual for whom it was prescribed.
10. Patients should be instructed to keep AVINZA in a secure place out of the reach of children. When AVINZA is no longer needed, the unused capsules should be destroyed by flushing down the toilet.

As with other opioids, patients taking AVINZA should be advised of the potential for severe constipation; appropriate laxatives, and/or stool softeners as well as other appropriate treatments should be initiated from the onset of opioid therapy.

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