"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
- Advise patients that OPANA (oxymorphone hydrochloride) contains oxymorphone, which is a morphine-like pain reliever, and should be taken only as directed.
- Advise patients that OPANA (oxymorphone hydrochloride) 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.
- Advise patients to keep OPANA (oxymorphone hydrochloride) 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 (oxymorphone hydrochloride) is no longer needed, the unused tablets should be destroyed by flushing down the toilet.
- Advise patients 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.
- Advise patients not to adjust the dose of OPANA (oxymorphone hydrochloride) without consulting the prescriber.
- Advise patients that OPANA (oxymorphone hydrochloride) 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.
- Advise patients that OPANA (oxymorphone hydrochloride) 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).
- Advise patients not to combine OPANA (oxymorphone hydrochloride) 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.
- Advise patients 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 (oxymorphone hydrochloride) therapy.
- Advise women of childbearing potential who become or are planning to become pregnant to consult their physician regarding the effects of opioid analgesics and other drug use during pregnancy on themselves and their unborn child.
- Advise women of childbearing potential who become or are planning to become pregnant that 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.
- Advise patients that if they have been receiving treatment with OPANA (oxymorphone hydrochloride) for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the OPANA (oxymorphone hydrochloride) 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.
Last reviewed on RxList: 3/28/2011
This monograph has been modified to include the generic and brand name in many instances.
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