Talwin
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For the relief of moderate to severe pain. TALWIN may also be used for preoperative or preanesthetic medication and as a supplement to surgical anesthesia.
History
There is currently no drug history available for this drug.
Other Information
TALWIN injection, Pentazocine Injection, USP, is a member of the benzazocine series (also known as the benzomorphan series). Chemically, pentazocine lactate is 1, 2, 3, 4, 5, 6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol lactate, a white, crystalline substance soluble in acidic aqueous solutions.
Sources
Talwin Manufacturers
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Hospira, Inc.
![Talwin (Pentazocine Lactate) Injection, Solution [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Talwin | Hospira, Inc.
Adults, Excluding Patients in Labor: The recommended single parenteral dose is 30 mg by intramuscular, subcutaneous, or intravenous route. This may be repeated every 3 to 4 hours. Doses in excess of 30 mg intravenously or 60 mg intramuscularly or subcutaneously are not recommended. Total daily dosage should not exceed 360 mg. Elderly patients may be more sensitive to the analgesic effects of TALWIN than younger patients. Elderly patients generally should be started on low doses of TALWIN and observed closely.
The subcutaneous route of administration should be used only when necessary because of possible severe tissue damage at injection sites (see WARNINGS). When frequent injections are needed, the drug should be administered intramuscularly. In addition, constant rotation of injection sites (e.g., the upper outer quadrants of the buttocks, mid-lateral aspects of the thighs, and the deltoid areas) is essential.
Patients in Labor: A single, intramuscular 30 mg dose has been most commonly administered. An intravenous 20 mg dose has given adequate pain relief to some patients in labor when contractions become regular, and this dose may be given two or three times at two- to three-hour intervals, as needed.
Pediatric Patients Excluding Patients Less Than One Year Old: The recommended single parenteral dose as premedication for sedation is 0.5 mg/kg by intramuscular route.
CAUTION: TALWIN should not be mixed in the same syringe with soluble barbiturates because precipitation will occur.
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General Injectables & Vaccines, Inc
Talwin | General Injectables & Vaccines, Inc
Adults, Excluding Patients in Labor: The recommended single parenteral dose is 30 mg by intramuscular, subcutaneous, or intravenous route. This may be repeated every 3 to 4 hours. Doses in excess of 30 mg intravenously or 60 mg intramuscularly or subcutaneously are not recommended. Total daily dosage should not exceed 360 mg. Elderly patients may be more sensitive to the analgesic effects of TALWIN than younger patients. Elderly patients generally should be started on low doses of TALWIN and observed closely. The subcutaneous route of administration should be used only when necessary because of possible severe tissue damage at injection sites (see WARNINGS). When frequent injections are needed, the drug should be administered intramuscularly. In addition, constant rotation of injection sites (e.g., the upper outer quadrants of the buttocks, mid-lateral aspects of the thighs, and the deltoid areas) is
essential.
Patients in Labor: A single, intramuscular 30 mg dose has been most commonly administered. An intravenous 20 mg dose has given adequate pain relief to some patients in labor when contractions become regular, and this dose may be given two or three times at two to three-hour intervals, as needed.
Pediatric Patients Excluding Patients Less Than One Year Old: The recommended single parenteral dose as premedication for sedation is 0.5 mg/kg by intramuscular route.
CAUTION: TALWIN should not be mixed in the same syringe with soluble barbiturates because precipitation will occur.
![Talwin (Pentazocine Lactate) Injection, Solution [General Injectables & Vaccines, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1d225639-c326-4d9e-bc8d-e380e7958b8f&name=Label1.jpg)
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