Class: Opiate Partial Agonists
Note: This monograph also contains information on Pentazocine Lactate
VA Class: CN101
CAS Number: 64024-15-3
Analgesic; synthetic opiate partial agonist.a
Uses for Pentazocine Hydrochloride
Oral dosage form reformulated to contain small amount of naloxone hydrochloride (opiate antagonist) to potentially eliminate misuse via parenteral injection by opiate addicts and drug abusers.a b Naloxone is inactive when administered orally in the amount (0.5 mg) present in the oral formulation and does not affect the efficacy of pentazocine when administered orally.a b
Pentazocine Hydrochloride Dosage and Administration
If pentazocine hydrochloride tablets containing small amount of naloxone hydrochloride are ground up and solubilized for parenteral administration, the naloxone will antagonize the effects of pentazocine and will precipitate withdrawal symptoms in drug abusers who are dependent on opiates.a b
Oral administration is preferable to parenteral administration for chronic therapy.a
For drug compatibility information, see Compatibility under Stability.
IM or Sub-Q Administration
Rotation of injection sites is essential.c
Administer sub-Q only when necessary, because of possible severe tissue damage at the injection site.c
Available as pentazocine lactate (injection); dosage expressed in terms of pentazocine.a c Also available as pentazocine and naloxone hydrochlorides (tablets); dosage expressed in terms of the bases.100 101
Adjust dosage according to severity of pain, physical status of the patient, and other drugs that the patient is receiving.a
Children 1–16 years of age: 0.5 mg/kg.c
IV, IM, or Sub-Q
Maximum 600 mg daily.b
Maximum 30 mg as a single dose; maximum 360 mg daily.c
Maximum 60 mg as a single dose; maximum 360 mg daily.c
Maximum 60 mg as a single dose; maximum 360 mg daily.c
Cautions for Pentazocine Hydrochloride
Prescribe cautiously for patients who are emotionally unstable or have a history of opiate abuse; closely supervise these patients when therapy for more than 4 or 5 days is contemplated.a Avoid unnecessary increases in dosage or frequency of administration; avoid use in anticipation of pain.a
If tablets are ground up and solubilized for parenteral administration, the naloxone will antagonize the effects of pentazocine and can precipitate withdrawal in individuals physically dependent on opiates.100 106 161 However, since naloxone is inactive when administered orally in the amount present in the tablets, the tablets are still subject to misuse and abuse by the oral route.100
Pentazocine has been abused in combination with tripelennamine (no longer commercially available in US) (T’s and blues) via parenteral injection by opiate addicts and drug abusers in an attempt to provide effects similar to those of IV heroin.106 109 110 111 112 113 114 115 116 117 118 119 130 186
Head Injury and Increased Intracranial Pressure
Potential for elevation of CSF pressure as a result of vasodilation following carbon dioxide retention.a c Opiate effects may obscure the existence, extent, or course of intracranial pathology.b c Use in patients with head injury, other intracranial lesions, or preexisting elevation in intracranial pressure only if the potential benefits justify the possible risks.a b c
Patients Dependent on Opiates
Partial opiate antagonist.b c Use with caution in patients who have been chronically receiving opiates (including methadone); pentazocine does not suppress the abstinence syndrome in these patients; high doses may precipitate withdrawal symptoms.b c
Use with caution and in low doses in patients with impaired respiration caused by other drugs, uremia, or severe infection and in patients with severely limited respiratory reserve, bronchial asthma or other obstructive respiratory conditions, or cyanosis.b c
Pentazocine-induced respiratory depression can be reversed by naloxone.b
Abrupt discontinuance after prolonged use may result in withdrawal symptoms (e.g., abdominal cramps, vomiting, increased temperature, sweating, chills, restlessness, anxiety, lethargy, rhinorrhea, sneezing, lacrimation).166 169 172 173 174 175 176 181 182 184 185 Reinstitution of parenteral pentazocine followed by gradual withdrawal of the drug may ameliorate withdrawal symptoms, if necessary.c
Manufacturer states that substitution of methadone or other opiates to treat pentazocine abstinence syndrome should be avoided;184 however, opiates occasionally have been used in the management of pentazocine withdrawal;169 172 174 182 183 benzodiazepines also have been used in a limited number of individuals.181
Acute CNS Manifestations
Possible increased systemic and pulmonary arterial pressure and systemic vascular resistance with IV administration in patients with acute MI.c Administer IV with caution in patients with acute MI accompanied by hypertension or left ventricular failure.c
Administer oral pentazocine with caution in patients with acute MI accompanied by nausea and vomiting.b
Some formulations contain sodium metabisulfite or acetone sodium bisulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.c
Biliary Tract Surgery
Safe use in pregnant women (except during labor) not established.b c Should not be administered to women who are pregnant unless potential benefits outweigh possible risks to fetus.b c Possible abstinence (withdrawal) syndrome in neonates after prolonged maternal use during pregnancy.100 150 151 152 153 154
Following parenteral administration during labor, alterations (usually increases) in rate and strength of uterine contractions may occur.a
Not known whether pentazocine is distributed into milk; use with caution in nursing women.b
Safety and efficacy of parenteral pentazocine for preoperative sedation not established in infants <1 year of age.c
Possible increased sensitivity to pentazocine in some geriatric individuals.c
Insufficient experience with pentazocine tablets in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.b
Use with caution due to the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly.b c May be useful to monitor renal function.c
Use with caution.b c Extensive liver disease may predispose to greater incidence or severity of adverse effects than would be expected from usual doses, probably as a result of decreased hepatic metabolism of the drug.b c
Common Adverse Effects
Dizziness, lightheadedness, euphoria, sedation, nausea.a
Interactions for Pentazocine Hydrochloride
Specific Drugs and Laboratory Tests
Drug or Test
CNS depressants (e.g., general anesthetics, phenothiazines or other tranquilizers, anxiolytics, sedatives, hypnotics, alcohol)
Possible transient symptoms (e.g., diaphoresis, ataxia, flushing, tremor) suggestive of serotonin syndromea
Tests for urinary 17-hydroxycorticosteroids
Possible decrease in urinary 17-hydroxycorticosteroid determinations (Porter-Silber reaction)a
Clinical importance not establisheda
Pentazocine Hydrochloride Pharmacokinetics
Undergoes first-pass metabolism following oral administration, with <20% of an oral dose reaching systemic circulation as unchanged drug.a
Following oral administration, duration of analgesia is ≥3 hours.b
Following IM or sub-Q injection, duration of analgesia is about 2 hours; following IV administration, duration is about 1 hour.a
Widely distributed in the body.a
Not known whether pentazocine is distributed into milk.b
Plasma Protein Binding
Metabolized in the liver.b
In geriatric patients, elimination half-life may be prolonged and systemic exposure to pentazocine increased.c
25°C (may be exposed to 15–30°C).b
For information on systemic interactions resulting from concomitant use, see Interactions.
Hydrocortisone sodium succinate
Vitamin B complex with C
Believed to be a competitive antagonist at μ opiate receptors and an agonist at κ and Σ opiate receptors.a
Analgesic and respiratory depressant activity apparently results mainly from the l-isomer.a
Produces respiratory depression, sedation, miosis, and antitussive effects.a
In low doses (15 mg IM), pentazocine inhibits GI motility and slows the rate of gastric emptying; higher doses (30–45 mg) reportedly increase intestinal transit time and produce less elevation of biliary pressure than equianalgesic doses of morphine.a
Advice to Patients
Potential for pentazocine to impair mental alertness or physical coordination; do not drive or operate machinery until effects on individual are known.b
Importance of taking exactly as prescribed; do not exceed the recommended dosage.b
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and alcohol consumption.b Importance of avoiding alcohol while receiving the drug.b
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.b
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Subject to control under the Federal Controlled Substances Act of 1970 as schedule IV (C-IV) drugs. May be subject to more stringent control in some states.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Pentazocine Hydrochloride 50 mg (of pentazocine) and Naloxone Hydrochloride 0.5 mg (of naloxone)*
Pentazocine and Naloxone Hydrochlorides Tablets (C-IV)
30 mg (of pentazocine) per mL
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2015. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Pentazocine-Naloxone HCl 50-0.5MG Tablets (WATSON LABS): 30/$42.99 or 90/$112.97
AHFS DI Essentials. © Copyright, 2004-2015, Selected Revisions February 13, 2015. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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a. AHFS Drug Information 2004. McEvoy GK, ed. Pentazocine Hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2004.
b. Sanofi-Synthelabous. Talwin Nx (pentazocine and naloxone hydrochlorides) prescribing information. New York, NY; 2003 May.
c. Abbott Laboratories. Talwin (pentazocine lactate) injection prescribing information. North Chicago, IL; 2001 Jan.
d. Sanofi-Synthelabous. Talacen (pentazocine hydrochloride and acetaminophen) prescribing information. New York, NY; 2003 May.
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More about pentazocine
- Pentazocine Lactate (AHFS Monograph)
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