"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
Patients receiving TALWIN NX (pentazocine and naloxone) should be given the following instructions by the physician:
- Patients should be advised that TALWIN NX (pentazocine and naloxone) is a narcotic pain reliever, and should be taken only as directed.
- The dose of TALWIN NX (pentazocine and naloxone) should not be adjusted without consulting with a physician or other healthcare professional.
- Patients should be advised that TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) or patients whose dose has been adjusted should refrain from any potentially dangerous activity until it is established that they are not adversely affected.
- TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) .
- 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 TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) in a secure place out of the reach of children. When TALWIN NX (pentazocine and naloxone) is no longer needed, please consult your pharmacist for proper disposal instructions.
- As with other opioids, patients taking TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) : constipation, nausea, somnolence, lightheadedness, dizziness, sedation, vomiting, and sweating.
Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.
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