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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

Do Not Use [what does this mean?]
Generic drug name: pentazocine and naloxone (pen TAZ oh seen and nal OX one)
Brand name(s): TALWIN-NX
GENERIC: not available FAMILY: Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Alternative Treatment [top]

See Narcotics.

Safety Warnings For This Drug [top]

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

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.

Warning:

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).

Facts About This Drug [top]

Pentazocine relieves moderate to severe pain. Older adults should not use this drug, either alone or in combination with naloxone, because of the high risk of adverse effects, especially confusion. The risk is so high that the World Health Organization recommends that this drug not be used if possible.[1]

This drug remains on a well-recognized list of drugs that are inappropriate for use in older adults. Pentazocine causes more central nervous system adverse effects, including confusion...

Pentazocine relieves moderate to severe pain. Older adults should not use this drug, either alone or in combination with naloxone, because of the high risk of adverse effects, especially confusion. The risk is so high that the World Health Organization recommends that this drug not be used if possible.[1]

This drug remains on a well-recognized list of drugs that are inappropriate for use in older adults. Pentazocine causes more central nervous system adverse effects, including confusion and hallucination, more often than other narcotic drugs.[2]

In 2012, Public Citizen filed a petition with the Food and Drug Administration (FDA) requesting changes in the drug labeling for opioid pain medications in an effort to prevent overprescribing of these medications. The petition states that opioid labels are especially broad because they fail to limit opioid use to severe pain, to include a time frame for use and to specify a maximum dose. Currently, the labels on opioid analgesics simply state that they are approved for moderate-to-severe pain. The petition calls for striking the term “moderate,” inserting a suggested duration of use and adding a suggested maximum dose equivalent of 100 milligrams of morphine. The requested changes relate only to opioids used for non-cancer pain.

If the requested changes are adopted, drug companies no longer would be able to promote these pain medications as safe and effective for long-term use by non-cancer patients.[3]

Patients who frequently use medication to relieve headache pain may develop a condition known as medication overuse headache (MOH). According to a 2004 review published in the medical journal Lancet Neurology,[4] there is substantial evidence that all headache drugs can cause MOH in patients who use these drugs excessively. Narcotic or opioid painkillers that are derivatives of morphine and codeine can cause MOH.[4]

Patients experiencing MOHs should discuss with their doctors the important details of their headaches and, depending on their individual case, the type of withdrawal from the MOH-causing drugs that is best.[5]

2016: The FDA issued a safety warning for the entire opioid class of drugs concerning potential harmful interactions with other medications, problems with the adrenal glands and decreased sex hormone levels.[6]

The FDA required the addition of a black-box warning, the agency’s strongest warning, to opioid and benzodiazepine drugs stating that profound sedation, depressed breathing, coma and death can occur when these medications are used together.

last reviewed February 28, 2021