"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
Patients receiving DILAUDID (hydromorphone hydrochloride) ORAL LIQUID or DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS or their caregivers should be given the following information by the physician, nurse, or pharmacist:
- Patients should be aware that DILAUDID (hydromorphone hydrochloride) tablets contain hydromorphone, which is a morphinelike substance and which could cause severe adverse effects including respiratory depression and even death if not taken according to the prescriber's directions.
- Patients should be advised to report pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.
- Patients should be advised not to adjust the dose of DILAUDID (hydromorphone hydrochloride) without consulting the prescribing professional.
- Patients should be advised that DILAUDID (hydromorphone hydrochloride) may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
- Patients should not combine DILAUDID (hydromorphone 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.
- 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.
- Patients should be advised that DILAUDID (hydromorphone 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.
- Patients should be advised that if they have been receiving treatment with DILAUDID (hydromorphone hydrochloride) for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the DILAUDID (hydromorphone 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.
- Patients should be instructed to keep DILAUDID (hydromorphone hydrochloride) in a secure place out of the reach of children. When DILAUDID (hydromorphone hydrochloride) is no longer needed, the unused tablets should be destroyed by flushing down the toilet.
Last reviewed on RxList: 8/12/2011
This monograph has been modified to include the generic and brand name in many instances.
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