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Pentazocine HCl and Acetaminophen
Overview
What is Pentazocine HCl and Acetaminophen?
Pentazocine hydrochloride and acetaminophen tablets are a combination of pentazocine hydrochloride USP, equivalent to 25 mg base and acetaminophen USP, 650 mg.
Pentazocine is a member of the benzazocine series (also known as the benzomorphan series). Chemically, pentazocine hydrochloride is (2,6,11)-1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions. It has the following structural formula:
Chemically, acetaminophen is 4’-hydroxyacetanilide-. It has the following structural formula:
Pentazocine is an analgesic and acetaminophen is an analgesic and antipyretic.
Each tablet for oral administration contains 25 mg of pentazocine as the hydrochloride and 650 mg of acetaminophen. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, and stearic acid.
What does Pentazocine HCl and Acetaminophen look like?
What are the available doses of Pentazocine HCl and Acetaminophen?
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What should I talk to my health care provider before I take Pentazocine HCl and Acetaminophen?
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How should I use Pentazocine HCl and Acetaminophen?
Pentazocine hydrochloride and acetaminophen tablets are indicated for the relief of mild to moderate pain.
Adult.
The usual duration of therapy is dependent upon the condition being treated but in any case should be reviewed regularly by the physician. The effect of meals on the rate and extent of bioavailability of both pentazocine and acetaminophen has not been documented.
What interacts with Pentazocine HCl and Acetaminophen?
Pentazocine hydrochloride and acetaminophen tablets should not be administered to patients who are hypersensitive to either pentazocine or acetaminophen.
What are the warnings of Pentazocine HCl and Acetaminophen?
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Head Injury and Increased Intracranial Pressure.
Acute CNS Manifestations.
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. (See
)
Due to the potential for increased CNS depressant effects, alcohol should be used with caution in patients who are currently receiving pentazocine.
Pentazocine may precipitate opioid abstinence symptoms in patients receiving courses of opiates for pain relief.
What are the precautions of Pentazocine HCl and Acetaminophen?
In prescribing pentazocine hydrochloride and acetaminophen tablets for chronic use, the physician should take precautions to avoid increases in dose by the patient.
Myocardial Infarction
As with all drugs, pentazocine hydrochloride and acetaminophen tablets should be used with caution in patients with myocardial infarction who have nausea or vomiting.
Certain Respiratory Conditions
Although respiratory depression has rarely been reported after oral administration of pentazocine, the drug 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, the drug should be administered with caution to patients with such impairment.
Since acetaminophen is metabolized by the liver, the question of the safety of its use in the presence of liver disease should be considered.
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.
CNS Effect
Caution should be used when pentazocine hydrochloride and acetaminophen tablets are 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.
Information for 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. Pentazocine may cause physical and psychological dependence when taken alone and may have additive CNS depressant properties when taken in combination with alcohol or other CNS depressants.
Drug Interactions
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis, mutagenesis, and impairment of fertility studies have not been done with this combination product.
Pentazocine, when administered orally or parenterally, had no adverse effect on either the reproductive capabilities or the course of pregnancy in rabbits and rats. Embryotoxic effects on the fetuses were not shown.
The daily administration of 4 mg/kg to 20 mg/kg pentazocine subcutaneously to female rats during a 14 day pre-mating period and until the 13th day of pregnancy did not have any adverse effects on the fertility rate.
There is no evidence in long-term animal studies to demonstrate that pentazocine is carcinogenic.
Pregnancy Category C
Animal reproduction studies have not been conducted with pentazocine hydrochloride and acetaminophen tablets. It is also not known whether pentazocine hydrochloride and acetaminophen tablets can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Pentazocine hydrochloride and acetaminophen tablets should be given to pregnant women only if clearly needed. However, animal reproduction studies with pentazocine have not demonstrated teratogenic or embryotoxic effects.
There has been no experience in this regard with the combination pentazocine and acetaminophen. However, there have been rare reports of possible abstinence syndromes in newborns after prolonged use of pentazocine during pregnancy.
Labor and Delivery
Patients receiving pentazocine during labor have experienced no adverse effects other than those that occur with commonly used analgesics. Pentazocine hydrochloride and acetaminophen tablets should be used with caution in women delivering premature infants. The effect of pentazocine hydrochloride and acetaminophen tablets on the mother and fetus, the duration of labor or delivery, the possibility that forceps delivery or other intervention or resuscitation of the newborn may be necessary, or the effect of pentazocine hydrochloride and acetaminophen tablets on the later growth, development, and functional maturation of the child are unknown at the present time.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pentazocine hydrochloride and acetaminophen tablets are administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 12 have not been established.
Geriatric Use
Clinical studies of pentazocine hydrochloride and acetaminophen tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
What are the side effects of Pentazocine HCl and Acetaminophen?
Clinical experience with pentazocine hydrochloride and acetaminophen tablets has been insufficient to define all possible adverse reactions with this combination. However, reactions reported after oral administration of pentazocine hydrochloride in 50 mg dosage include nausea, vomiting, infrequently constipation; and rarely abdominal distress, anorexia, diarrhea. 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. sweating; infrequently flushing; and rarely chills. infrequently rash; and rarely urticaria, edema of the face. infrequently decrease in blood pressure, tachycardia. rarely depression of white blood cells (especially granulocytes), which is usually reversible, moderate transient eosinophilia. rarely respiratory depression, urinary retention, paresthesia, serious skin reactions, including erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, and in one instance, an apparent anaphylactic reaction has been reported.
Numerous clinical studies have shown that acetaminophen, when taken in recommended doses, is relatively free of adverse effects in most age groups, even in the presence of a variety of disease states.
A few cases of hypersensitivity to acetaminophen have been reported, as manifested by skin rashes, thrombocytopenic purpura, rarely hemolytic anemia and agranulocytosis. Occasional individuals respond to ordinary doses with nausea and vomiting and diarrhea.
What should I look out for while using Pentazocine HCl and Acetaminophen?
Pentazocine hydrochloride and acetaminophen tablets should not be administered to patients who are hypersensitive to either pentazocine or acetaminophen.
Head Injury and Increased Intracranial Pressure.
Acute CNS Manifestations.
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. (See
)
Due to the potential for increased CNS depressant effects, alcohol should be used with caution in patients who are currently receiving pentazocine.
Pentazocine may precipitate opioid abstinence symptoms in patients receiving courses of opiates for pain relief.
What might happen if I take too much Pentazocine HCl and Acetaminophen?
How should I store and handle Pentazocine HCl and Acetaminophen?
Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].See the FDA-approved Medication Guide.Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].See the FDA-approved Medication Guide.Pentazocine Hydrochloride and Acetaminophen Tablets, 25 mg base/650 mg are light aqua, capsule-shaped, scored tablets, debossed to the left of the score, over to the right of the score and on the reverse side supplied in bottles of 100.Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.30276-4Revised: February 2004Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320Pentazocine Hydrochloride and Acetaminophen Tablets, 25 mg base/650 mg are light aqua, capsule-shaped, scored tablets, debossed to the left of the score, over to the right of the score and on the reverse side supplied in bottles of 100.Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.30276-4Revised: February 2004Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320Pentazocine Hydrochloride and Acetaminophen Tablets, 25 mg base/650 mg are light aqua, capsule-shaped, scored tablets, debossed to the left of the score, over to the right of the score and on the reverse side supplied in bottles of 100.Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.30276-4Revised: February 2004Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320Pentazocine Hydrochloride and Acetaminophen Tablets, 25 mg base/650 mg are light aqua, capsule-shaped, scored tablets, debossed to the left of the score, over to the right of the score and on the reverse side supplied in bottles of 100.Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.30276-4Revised: February 2004Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320Pentazocine Hydrochloride and Acetaminophen Tablets, 25 mg base/650 mg are light aqua, capsule-shaped, scored tablets, debossed to the left of the score, over to the right of the score and on the reverse side supplied in bottles of 100.Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.30276-4Revised: February 2004Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320Pentazocine Hydrochloride and Acetaminophen Tablets, 25 mg base/650 mg are light aqua, capsule-shaped, scored tablets, debossed to the left of the score, over to the right of the score and on the reverse side supplied in bottles of 100.Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.30276-4Revised: February 2004Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320Pentazocine Hydrochloride and Acetaminophen Tablets, 25 mg base/650 mg are light aqua, capsule-shaped, scored tablets, debossed to the left of the score, over to the right of the score and on the reverse side supplied in bottles of 100.Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.30276-4Revised: February 2004Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320Pentazocine Hydrochloride and Acetaminophen Tablets, 25 mg base/650 mg are light aqua, capsule-shaped, scored tablets, debossed to the left of the score, over to the right of the score and on the reverse side supplied in bottles of 100.Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.]Dispense in a tight, light-resistant container as defined in the USP.Watson Laboratories, Inc.30276-4Revised: February 2004Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Pentazocine hydrochloride and acetaminophen tablets are an analgesic possessing antipyretic actions.
Pentazocine is an analgesic with agonist/antagonist action which when administered orally is approximately equivalent on a mg for mg basis in analgesic effect to codeine.
Acetaminophen is an analgesic and antipyretic.
Onset of significant analgesia with pentazocine usually occurs between 15 and 30 minutes after oral administration, and duration of action is usually three hours or longer. Onset and duration of action and the degree of pain relief are related both to dose and the severity of pretreatment pain. Pentazocine weakly antagonizes the analgesic effects of morphine, meperidine, and phenazocine; in addition, it produces incomplete reversal of cardiovascular, respiratory, and behavioral depression induced by morphine and meperidine. Pentazocine has about 1/50 the antagonistic activity of nalorphine. It also has a sedative activity.
Pentazocine is well absorbed from the gastrointestinal tract. Plasma levels closely correspond to the onset, duration, and intensity of analgesia. The time to mean peak concentration in 24 normal volunteers was 1.7 hours (range 0.5 to 4 hours) after oral administration and the mean plasma elimination half-life was 3.6 hours (range 1.5 to 10 hours).
The action of pentazocine is terminated for the most part by biotransformation in the liver with some free pentazocine excreted in the urine. The products of the oxidation of the terminal methyl groups and glucuronide conjugates are excreted by the kidney. Elimination of approximately 60% of the total dose occurs within 24 hours. Pentazocine passes the placental barrier.
Onset of significant analgesic and antipyretic activity of acetaminophen when administered orally occurs within 30 minutes and is maximal at approximately 2/ hours. The pharmacological mode of action of acetaminophen is unknown at this time.
Acetaminophen is rapidly and almost completely absorbed from the gastrointestinal tract. In 24 normal volunteers the mean time to peak plasma concentration was 1 hour (range 0.25 to 3 hours) after oral administration and the mean plasma elimination half-life was 2.8 hours (range 2 to 4 hours).
The effect of pentazocine on acetaminophen plasma protein binding or vice versa has not been established. For acetaminophen there is little or no plasma protein binding at normal therapeutic doses. When toxic doses of acetaminophen are ingested and drug plasma levels exceed 90 mcg/mL, plasma binding may vary from 8% to 43%.
Acetaminophen is conjugated in the liver with glucuronic acid and to a lesser extent with sulfuric acid. Approximately 80% of acetaminophen is excreted in the urine after conjugation and about 3% is excreted unchanged. The drug is also conjugated to a lesser extent with cysteine and additionally metabolized by hydroxylation.
If pentazocine hydrochloride and acetaminophen tablets are taken every 4 hours over an extended period of time, accumulation of pentazocine and to a lesser extent, acetaminophen, may occur.
Non-Clinical Toxicology
Pentazocine hydrochloride and acetaminophen tablets should not be administered to patients who are hypersensitive to either pentazocine or acetaminophen.Head Injury and Increased Intracranial Pressure.
Acute CNS Manifestations.
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. (See )
Due to the potential for increased CNS depressant effects, alcohol should be used with caution in patients who are currently receiving pentazocine.
Pentazocine may precipitate opioid abstinence symptoms in patients receiving courses of opiates for pain relief.
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.
In prescribing pentazocine hydrochloride and acetaminophen tablets for chronic use, the physician should take precautions to avoid increases in dose by the patient.
Clinical experience with pentazocine hydrochloride and acetaminophen tablets has been insufficient to define all possible adverse reactions with this combination. However, reactions reported after oral administration of pentazocine hydrochloride in 50 mg dosage include nausea, vomiting, infrequently constipation; and rarely abdominal distress, anorexia, diarrhea. 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. sweating; infrequently flushing; and rarely chills. infrequently rash; and rarely urticaria, edema of the face. infrequently decrease in blood pressure, tachycardia. rarely depression of white blood cells (especially granulocytes), which is usually reversible, moderate transient eosinophilia. rarely respiratory depression, urinary retention, paresthesia, serious skin reactions, including erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, and in one instance, an apparent anaphylactic reaction has been reported.
Numerous clinical studies have shown that acetaminophen, when taken in recommended doses, is relatively free of adverse effects in most age groups, even in the presence of a variety of disease states.
A few cases of hypersensitivity to acetaminophen have been reported, as manifested by skin rashes, thrombocytopenic purpura, rarely hemolytic anemia and agranulocytosis. Occasional individuals respond to ordinary doses with nausea and vomiting and diarrhea.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Interactions
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