"FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no"...
(Generic versions may still be available.)
Drug Dependence. 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. There have been a few 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 TALWIN Compound (pentazocine and aspirin) orally. There have been rare reports of possible abstinence syndromes in newborns after prolonged use of pentazocine during pregnancy.
In prescribing TALWIN Compound (pentazocine and aspirin) for chronic use, the physician should take precautions to avoid increases in dose by the patient and to prevent the use of the drug in anticipation of pain rather than for the relief of pain.
Head Injury and Increased Intracranial Pressure. The respiratory depressant effects of pentazocine and its potential for elevating cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure. Furthermore, pentazocine can produce effects which may obscure the clinical course of patients with head injuries. In such patients, TALWIN Compound (pentazocine and aspirin) must be used with extreme caution and only if its use is deemed essential.
Usage in Pregnancy. Safe use of pentazocine during pregnancy (other than labor) has not been established. Animal reproduction studies have not demonstrated teratogenic or embryotoxic effects. However, TALWIN Compound (pentazocine and aspirin) should be administered to pregnant patients (other than labor) only when, in the judgment of the physician, the potential benefits outweigh the possible hazards. Patients receiving pentazocine during labor have experienced no adverse effects other than those that occur with commonly used analgesics. TALWIN Compound (pentazocine and aspirin) , should be used with caution in women delivering premature infants.
Acute CNS Manifestations. Patients receiving therapeutic doses of pentazocine have experienced hallucinations (usually visual), disorientation, and confusion which have cleared spontaneously within a period of hours. The mechanism of this reaction is not known. Such patients should be closely observed and vital signs checked. If the drug is reinstituted it should be done with caution since these acute CNS manifestations may recur.
Due to the potential for increased CNS depressant effects, alcohol should be used with caution in patients who are currently receiving pentazocine.
Usage in pediatric patients. Because clinical experience in children under 12 years of age is limited, administration of TALWIN Compound (pentazocine and aspirin) in this age group is not recommended.
Ambulatory Patients. Since sedation, dizziness, and occasional euphoria have been noted, ambulatory patients should be warned not to operate machinery, drive cars, or unnecessarily expose themselves to hazards.
Other. Because of its aspirin content, TALWIN Compound (pentazocine and aspirin) should be used with caution in the presence of peptic ulcer, in conjunction with anticoagulant therapy, or in any situation where the effects of aspirin may be deleterious.
Certain Respiratory Conditions. Although respiratory depression has rarely been reported after oral administration of pentazocine, TALWIN Compound (pentazocine and aspirin) , should be administered with caution to patients with respiratory depression from any cause, severely limited respiratory reserve, severe bronchial asthma and other obstructive respiratory conditions, or cyanosis.
Impaired Renal or Hepatic Function. Decreased metabolism of the drug by the liver in extensive liver disease may predispose to accentuation of side effects. Although laboratory tests have not indicated that pentazocine causes or increases renal or hepatic impairment, TALWIN Compound (pentazocine and aspirin) should be administered with caution to patients with such impairment.
Biliary Surgery. Narcotic drug products are generally considered to elevate biliary tract pressure for varying periods following administration. Some evidence suggests that pentazocine may differ in this respect (i.e., it causes little or no elevation in biliary tract pressures). The clinical significance of these findings, however, is not yet known.
Patients Receiving Narcotics. Pentazocine is a mild narcotic antagonist. Some patients previously given narcotics, including methadone for the daily treatment of narcotic dependence, have experienced withdrawal symptoms after receiving pentazocine.
CNS Effect. Caution should be used when pentazocine is administered to patients prone to seizures. Seizures have occurred in a few such patients in association with the use of pentazocine although no cause and effect relationship has been established.
Pediatric Use. For usage in pediatric patients see
Last reviewed on RxList: 1/28/2005
This monograph has been modified to include the generic and brand name in many instances.
Additional Talwin Compound Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.