"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
Patients receiving TALACEN (pentazocine and acetaminophen) should be given the following instructions by the physician:
- Patients should be advised that TALACEN (pentazocine and acetaminophen) is a narcotic pain reliever, and should be taken only as directed.
- The dose of TALACEN (pentazocine and acetaminophen) should not be adjusted without consulting with a physician or other healthcare professional.
- Patients should be advised that TALACEN (pentazocine and acetaminophen) may cause drowsiness, dizziness, or lightheadedness and may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery). Patients started on
- TALACEN (pentazocine and acetaminophen) or patients whose dose has been adjusted should refrain from any potentially dangerous activity until it is established that they are not adversely affected.
- TALACEN (pentazocine and acetaminophen) 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).
- Patients should not combine TALACEN (pentazocine and acetaminophen) 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 consult a physician prior to initiating or continuing therapy with TALACEN (pentazocine and acetaminophen) .
- Safe use in pregnancy has not been established. Prolonged use of opioid analgesics during pregnancy may cause neonatal physical dependence, and neonatal withdrawal may occur.
- If patients have been receiving treatment with TALACEN (pentazocine and acetaminophen) 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.
- Patients should be advised that TALACEN (pentazocine and acetaminophen) 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.
- Patients should be instructed to keep TALACEN (pentazocine and acetaminophen) in a secure place out of the reach of children. When TALACEN (pentazocine and acetaminophen) is no longer needed, please consult your pharmacist for proper disposal instructions.
- As with other opioids, patients taking TALACEN (pentazocine and acetaminophen) 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.
- Patients should be advised of the most common adverse events that may occur while taking TALACEN (pentazocine and acetaminophen) : constipation, nausea, somnolence, lightheadedness, dizziness, sedation, vomiting, and sweating.
Last reviewed on RxList: 5/2/2011
This monograph has been modified to include the generic and brand name in many instances.
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