Oxycontin

[oxycodone hydrochloride]

Information for Patients/ Caregivers

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

1. Patients should be aware that OxyContin Tablets contain oxycodone, which is a morphine-like substance.

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2. Patients should be advised that OxyContin Tablets were designed to work properly only if swallowed whole. OxyContin Tablets will release all their contents at once if broken, chewed, or crushed, resulting in a risk of fatal overdose.

3. 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.

4. Patients should be advised not to adjust the dose of OxyContin ® without consulting the prescribing professional.

5. Patients should be advised that OxyContin may impair mental and/ or physical ability required for the performance of potentially hazardous tasks (e. g., driving, operating heavy machinery).

6. Patients should not combine OxyContin with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because dangerous additive effects may occur, resulting in serious injury or death.

7. Women of childbearing potential who become, or are planning to become, pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.

8. Patients should be advised that OxyContin 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.

9. Patients should be advised that they may pass empty matrix "ghosts" (tablets) via colostomy or in the stool, and that this is of no concern since the active medication has already been absorbed.

10. Patients should be advised that if they have been receiving treatment with OxyContin for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the OxyContin dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.

11. Patients should be instructed to keep OxyContin in a secure place out of the reach of children. When OxyContin is no longer needed, the unused tablets should be destroyed by flushing down the toilet. Use in Drug and Alcohol Addiction OxyContin is an opioid with no approved use in the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia.

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