Pentazocine

Pentazocine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Overview

Pentazocine is an analgesic opioid that is FDA approved for the {{{indicationType}}} of anesthesia; adjunct, labor pain, pain (moderate to severe). Common adverse reactions include gastrointestinal: nausea, vomiting, neurologic: dizziness, lightheadedness, psychiatric: euphoria.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Anesthesia; Adjunct: 30 mg IV, IM or SC every 3 to 4 hr as needed, MAX 360 mg/day; doses above 30 mg IV or 60 mg IM, SC are not recommended [1] Labor pain: a single 30 mg/dose IM (most common); OR 20 mg/dose IV for 2-3 doses at 2-3-hr intervals, as needed, after contractions have become regular [1] Pain (Moderate to Severe): 30 mg IV, IM or SC every 3-4 hr as needed, MAX 360 mg/day; doses above 30 mg IV or 60 mg IM, SC are not recommended [1]

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Pentazocine in adult patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Pentazocine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in children less than 12 yr of age not established Anesthesia; Adjunct: single 0.5 mg/kg IM dose [1]

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Pentazocine in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Pentazocine in pediatric patients.

Contraindications

TALWIN should not be administered to patients who are hypersensitive to it.

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.

Adverse Reactions

Clinical Trials Experience

The most commonly occurring reactions are: nausea, dizziness or lightheadedness, vomiting, euphoria.

Dermatologic Reactions: Soft tissue induration, nodules, and cutaneous depression can occur at injection sites. Ulceration (sloughing) and severe sclerosis of the skin and subcutaneous tissues (and, rarely, underlying muscle) have been reported after multiple doses. Other reported dermatologic reactions include diaphoresis, sting on injection, flushed skin including plethora, dermatitis including pruritus.

Infrequently occurring reactions are—respiratory: respiratory depression, dyspnea, transient apnea in a small number of newborn infants whose mothers received TALWIN during labor; cardiovascular: circulatory depression, shock, hypertension; CNS effects: dizziness, lightheadedness, hallucinations, sedation, euphoria, headache, confusion, disorientation; infrequently weakness, disturbed dreams, insomnia, syncope, visual blurring and focusing difficulty, depression; and rarely tremor, irritability, excitement, tinnitus; gastrointestinal: constipation, dry mouth; other: urinary retention, headache, paresthesia, alterations in rate or strength of uterine contractions during labor.

Rarely reported reactions include—neuromuscular and psychiatric: muscle tremor, insomnia, disorientation, hallucinations; gastrointestinal: taste alteration, diarrhea and cramps; ophthalmic: blurred vision, nystagmus, diplopia, miosis; hematologic: depression of white blood cells (especially granulocytes), which is usually reversible, moderate transient eosinophilia; other: tachycardia, weakness or faintness, chills; allergic reactions including edema of the face, toxic epidermal necrolysis. (See Acute CNS Manifestations and Drug Dependence under WARNINGS.)

Postmarketing Experience

There is limited information regarding Pentazocine Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Pentazocine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Pentazocine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pentazocine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Pentazocine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Pentazocine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Pentazocine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Pentazocine in geriatric settings.

Gender

There is no FDA guidance on the use of Pentazocine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Pentazocine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Pentazocine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Pentazocine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Pentazocine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Pentazocine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Pentazocine Administration in the drug label.

Monitoring

There is limited information regarding Pentazocine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Pentazocine and IV administrations.

Overdosage

There is limited information regarding Pentazocine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Pentazocine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Pentazocine Mechanism of Action in the drug label.

Structure

There is limited information regarding Pentazocine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pentazocine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Pentazocine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Pentazocine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Pentazocine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Pentazocine How Supplied in the drug label.

Storage

There is limited information regarding Pentazocine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Pentazocine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Pentazocine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Pentazocine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Pentazocine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.