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Talwin (Pentazocine Lactate) - Warnings and Precautions

 
 



Warnings

Drug Dependence:Special care should be exercised in prescribing pentazocine for emotionally unstable patients and for those with a history of drug misuse. Such patients should be closely supervised when greater than 4 or 5 days of therapy is contemplated. There have been instances of psychological and physical dependence on TALWIN in patients with such a history and, rarely, in patients without such a history. Extended use of parenteral TALWIN may lead to physical or psychological dependence in some patients. When TALWIN is abruptly discontinued, withdrawal symptoms such as abdominal cramps, elevated temperature, rhinorrhea, restlessness, anxiety, and lacrimation may occur. However, even when these have occurred, discontinuance has been accomplished with minimal difficulty. In the rare patient in whom more than minor difficulty has been encountered, reinstitution of parenteral TALWIN with
gradual withdrawal has ameliorated the patient’s symptoms. Substituting methadone or other narcotics for TALWIN in the treatment of the pentazocine abstinence syndrome should be avoided. There have been rare reports of possible abstinence syndromes in newborns after prolonged use of TALWIN during pregnancy. In prescribing parenteral TALWIN for chronic use, particularly if the drug is to be self-administered, the physician should take precautions to avoid increases in dose and frequency of injection by the patient. Just as with all medication, the oral form of TALWIN is preferable for chronic administration.

Tissue Damage at Injection Sites: Severe sclerosis of the skin, subcutaneous tissues, and underlying muscle have occurred at the injection sites of patients who have received multiple doses of pentazocine lactate. Constant rotation of injection sites is, therefore, essential. In addition, animal studies have demonstrated that TALWIN is tolerated less well subcutaneously than intramuscularly. (See DOSAGE AND ADMINISTRATION.)
Head Injury and Increased Intracranial Pressure: As in the case of other potent analgesics, the potential of TALWIN injection for elevating cerebrospinal fluid pressure may be attributed to CO2 retention due to the respiratory depressant effects of the drug. These effects may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure. Furthermore, TALWIN can produce effects which may obscure the clinical course of patients with head injuries. In such patients, TALWIN must be used with extreme caution and only if its use is deemed essential.
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.
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.
Myocardial Infarction: Caution should be exercised in the intravenous use of pentazocine for patients with acute myocardial infarction accompanied by hypertension or left ventricular failure. Data suggest that intravenous administration of pentazocine increases systemic and pulmonary arterial pressure and systemic vascular resistance in patients with acute myocardial infarction.
NOTE: Acetone sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people, is contained in multiple-dose vials. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. The ampuls in the Uni-Amp® Pak do not contain acetone sodium bisulfite.

Precautions

Certain Respiratory Conditions: The possibility that TALWIN may cause respiratory depression should be considered in treatment of patients with bronchial asthma. TALWIN should be administered only with caution and in low dosage to patients with respiratory depression (e.g., from other medication, uremia, or severe infection), severely limited respiratory reserve, obstructive respiratory conditions, or cyanosis.
Impaired Renal or Hepatic Function: Although laboratory tests have not indicated that TALWIN causes or increases renal or hepatic impairment, the drug should be administered with caution to patients with such impairment. Extensive liver disease appears to predispose to greater side effects (e.g., marked apprehension, anxiety, dizziness, sleepiness) from the usual clinical dose, and may be the result of decreased metabolism of the drug by the liver.
Biliary Surgery: Narcotic drug products are generally considered to elevate biliary tract pressure for varying periods following their administration. Some evidence suggests that pentazocine may differ from other marketed narcotics 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: TALWIN 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 TALWIN.
CNS Effect: Caution should be used when TALWIN is administered to patients prone to seizures; seizures have occurred in a few such patients in association with the use of TALWIN although no cause and effect relationship has been established.
Use in Anesthesia: Concomitant use of CNS depressants with parenteral TALWIN may produce additive CNS depression. Adequate equipment and facilities should be available to identify and treat systemic emergencies should they occur.

Usage in Pregnancy:
Safe use of TALWIN during pregnancy (other than labor) has not been established. Animal reproduction studies have not demonstrated teratogenic or embryotoxic effects. However, TALWIN 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 TALWIN during labor have experienced no adverse effects other than those that occur with commonly used analgesics. TALWIN should be used with caution in women delivering premature infants.

Pediatric Use:
The safety and efficacy of TALWIN as preoperative or preanesthetic medication have been established in pediatric patients 1 to 16 years of age. Use of TALWIN in these age groups is supported by evidence from adequate and controlled studies in adults with additional data from published controlled trials in pediatric patients. The safety and efficacy of TALWIN as a premedication for sedation have not been established in pediatric patients less than one year old. Information on the safety profile of TALWIN as a postoperative analgesic in children less than 16 years is limited.

Geriatric Use:
Elderly patients may be more sensitive to the analgesic effects of TALWIN than younger patients. (See DOSAGE AND ADMINISTRATION.) Clinical data indicate that differences in various pharmacokinetic parameters of TALWIN may exist between elderly and younger patients. (See CLINICAL PHARMACOLOGY.) Sedating drugs may cause confusion and oversedation in the elderly; elderly patients generally should be started on low doses of TALWIN and observed closely. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose
selection, and it may be useful to monitor renal function.

Page last updated: 2012-02-17

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