FDA Black-Box Warning
Addiction, Abuse, and Misuse
Pentazocine and naloxone tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing pentazocine and naloxone tablets, and monitor all patients regularly for the development of these behaviors or conditions.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of pentazocine and naloxone tablets. Monitor for respiratory depression, especially during initiation of pentazocine and naloxone tablets or following a dose increase.
Accidental ingestion of even one dose of pentazocine and naloxone tablets, especially by children, can result in a fatal overdose of pentazocine and naloxone tablets.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of pentazocine and naloxone tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Cytochrome P450 3A4 Interaction
The concomitant use of pentazocine and naloxone tablets with all cytochrome P450 3A4 inhibitors may result in an increase in pentazocine and naloxone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in pentazocine and naloxone plasma concentration. Monitor patients receiving pentazocine and naloxone tablets and any CYP3A4 inhibitor or inducer.
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Reserve concomitant prescribing of pentazocine and naloxone tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation.
Pentazocine and naloxone tablets are intended for oral use only. Severe, potentially lethal, reactions may result from misuse of pentazocine and naloxone tablets by injection either alone or in combination with other substances.
If you are currently taking zolpidem and develop complex sleep behaviors, discontinue the drug immediately and seek medical help.
Otherwise, if you have been taking zolpidem for awhile, do not stop taking this drug suddenly because it may cause drug-induced dependence. Instead, work with your doctor to create a schedule to stop it gradually to avoid withdrawal reactions (including stomach cramps, vomiting, nervousness and panic attacks).