1. Patients should be advised that OPANA contains oxymorphone, which is a morphine-like pain reliever, and should be taken only as directed.

2. Patients should be advised to report episodes of breakthrough pain and adverse experiences occurring during therapy to their doctor. Individualization of dosage is essential to make optimal use of this medication.

3. Patients should be advised not to adjust the dose of OPANA without consulting the prescribing professional.

4. Patients should be cautioned that OPANA may cause drowsiness, dizziness, or lightheadedness and may impair mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car, operating machinery, etc.

5. OPANA will add to the effect of alcohol and other CNS depressants (such as antihistamines, sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and monoamine oxidase [MAO] inhibitors).

6. Patients should not combine OPANA 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. Patients taking OPANA should be advised of the potential for severe constipation. Appropriate laxatives and/or stool softeners and other therapeutic approaches should be considered for use with the initiation of OPANA therapy.

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

9. Safe use in pregnancy has not been established. Prolonged use of opioid analgesics during pregnancy may cause fetal-neonatal physical dependence, and neonatal withdrawal may occur.

10. Patients should be advised that if they have been receiving treatment with OPANA for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the OPANA 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 advised that OPANA 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.

12. Patients should be instructed to keep OPANA in a secure place out of the reach of children and pets. Accidental consumption especially in children may result in overdose or death. When OPANA is no longer needed, the unused tablets should be destroyed by flushing down the toilet.

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