DRUG ABUSE AND DEPENDENCE
Controlled Substance
TALWIN Nx is a Schedule IV controlled substance.
There have been some reports of dependence and of withdrawal symptoms with orally administered pentazocine. Patients with a history of drug dependence should be under close supervision while receiving pentazocine orally. There have been rare reports of possible abstinence syndromes in newborns after prolonged use of pentazocine during pregnancy.
There have been instances of psychological and physical dependence on parenteral pentazocine in patients with a history of drug abuse and rarely, in patients without such a history. Abrupt discontinuance following the extended use of parenteral pentazocine has resulted in withdrawal symptoms.
In prescribing pentazocine for chronic use, the physician should take precautions to avoid increases in dose by the patient.
The amount of naloxone present in TALWIN Nx (0.5 mg per tablet) has no action when taken orally and will not interfere with the pharmacologic action of pentazocine. However, this amount of naloxone given by injection has profound antagonistic action to narcotic analgesics.
Severe, even lethal, consequences may result from misuse of tablets by injection either alone or in combination with other substances, such as pulmonary emboli, vascular occlusion, ulceration and abscesses, and withdrawal symptoms in narcotic dependent individuals.
TALWIN Nx contains an opioid antagonist, naloxone (0.5 mg). Naloxone is inactive when administered orally at this dose, and its inclusion in TALWIN Nx is intended to curb a form of misuse of oral pentazocine. Parenterally, naloxone is an active narcotic antagonist. Thus, TALWIN Nx has a lower potential for parenteral misuse than the previous oral pentazocine formulation TALWIN® 50 (pentazocine hydrochloride tablets, USP). However, it is still subject to patient misuse and abuse by the oral route.
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