Drugs Details

Drugs Info of Talacen
Drugs Details
  • Drugs Type  : Multum
  • Date : 16th Jun 2015 07:33 am
  • Brand Name : Talacen
  • Generic Name : acetaminophen and pentazocine (Pronunciation: a SEET a MIN oh fen and pen TAZ oh seen)
Descriptions

TALACEN (pentazocine and acetaminophen) is 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 is (2R*,6R*,11R*)1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2butenyl)-2,6-methano-3-benzazocin-8-ol, a white, crystalline substance soluble in acidic aqueous solutions, and has the following structural formula:

 

Pentazocine Structural Formula Illustration

C19H27NO HCl      M.W. 321.88

Chemically, acetaminophen is Acetamide, N-(4-hydroxyphenyl)-, and has the following structural formula:

 

Acetaminophen Structural Formula Illustration

C8H9NO2      M.W. 151.16

Pentazocine is an analgesic and acetaminophen is an analgesic and antipyretic. Inactive Ingredients: Colloidal Silicon Dioxide, FD&C Blue #1, Gelatin, Microcrystalline Cellulose, Potassium Sorbate, Pregelatinized Starch, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Starch Glycolate, Stearic Acid.

What are the possible side effects of acetaminophen and pentazocine (Talacen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using acetaminophen and pentazocine and call your doctor at once if you have a serious side effect such as:

  • fast heart rate;
  • weak or shallow breathing, slow heartbeat;
  • feeling like you might pass out;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe headache, ringing in your ears, anxiety, chest pain;
  • seizure...

Read All Potential Side Effects and See Pictures of Talacen »

What are the precautions when taking pentazocine and acetaminophen (Talacen)?

See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to pentazocine or acetaminophen; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung disease (such as asthma, chronic obstructive pulmonary disease-COPD), a certain spinal problem (kyphoscoliosis), breathing problems (such as slow/shallow breathing, sleep apnea), certain heart problems (irregular heartbeat, recent heart attack), personal or family history of regular use/abuse of drugs/alcohol,...

This monograph has been modified to include the generic and brand name in many instances.

Indications

TALACEN (pentazocine and acetaminophen) is indicated for the relief of mild to moderate pain.

Dosage Administration

Adult

The usual adult dose is 1 caplet every 4 hours as needed for pain relief, up to a maximum of 6 caplets per day.

Discontinuation

Due to the potential for withdrawal symptoms associated with abrupt discontinuation, consideration should be given to tapering patients off TALACEN (pentazocine and acetaminophen) after prolonged periods of treatment with TALACEN (See PRECAUTIONS, Drug Abuse and Dependence).

How Supplied

TALACEN (pentazocine and acetaminophen) is available for oral administration as a pale blue, scored caplet embossed with “Winthrop” on one side and “T37” on the other side.

Bottles of 100 (NDC 0024-1937-04).

Store at 25° C (77° F); excursions permitted between 15° - 30°C (59° - 86° F).

Revised February 2011. Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical experience with TALACEN 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 the following:

Cardiovascular: hypertension, hypotension, circulatory depression, tachycardia.

Respiratory: rarely respiratory depression,

Acute CNS Manifestations: Hallucinations (usually visual), disorientation, and confusion

Other CNS effects: grand mal convulsions, increase in intracranial pressure, dizziness, lightheadedness, hallucinations, sedation, euphoria, headache, confusion, disorientation; infrequently weakness, disturbed dreams, insomnia, syncope, and depression; and rarely tremor, irritability, excitement, tinnitus.

Autonomic: sweating; infrequently flushing; and rarely chills.

Gastrointestinal: nausea, vomiting, constipation; diarrhea, anorexia, dry mouth, Biliary tract spasm, and rarely abdominal distress.

Allergic: edema of the face, anaphylactic shock, dermatitis including pruritus, flushed skin including plethora, infrequently rash; and rarely urticaria.

Ophthalmic: visual blurring and focusing difficulty, miosis.

Hematologic: depression of white blood cells (especially granulocytes) with rare cases of agranulocytosis, which is usually reversible, moderate transient eosinophilia.

Dependence and Withdrawal Symptoms: (See WARNINGS, PRECAUTIONS, and Drug Abuse And Dependence Sections).

Other: urinary retention, paresthesia, serious skin reactions, including erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, and alterations in rate or strength of uterine contractions during labor.

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.

Read the Talacen (pentazocine and acetaminophen) Side Effects Center for a complete guide to possible side effects

Interactions

CNS Depressants

Other central nervous system (CNS) depressants including sedatives, hypnotics, general anesthetics, antiemetics, phenothiazines, or other tranquilizers or alcohol increases the risk of respiratory depression, hypotension, profound sedation, or coma. Use morphine sulfate with caution and in reduced dosages in patients taking these agents.

Opioid Agonist Analgesics

TALACEN can antagonize the effects of a pure opioid agonist analgesic and/or may precipitate withdrawal symptoms.

Monoamine Oxidase Inhibitors (MAOIs)

Concomitant use of monoamine oxidase inhibitors (MAOIs) with TALACEN may cause CNS excitation and hypertension through their respective effects on catecholamines. Caution should therefore be observed in administering TALACEN to patients who are currently receiving MAOIs or who have received them within the preceding 14 days.

Anticholinergics

Anticholinergics or other medications with anticholinergic activity when used concurrently with opioid analgesics may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

Tobacco

Smoking tobacco could enhance the metabolic clearance rate of pentazocine reducing the clinical effectiveness of a standard dose of pentazocine.

Read the Talacen Drug Interactions Center for a complete guide to possible interactions


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Hypersensitivity/anaphylaxis

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. 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.

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergent medical attention. Instruct patients to discontinue TALACEN (pentazocine and acetaminophen) immediately and seek medical care if they experience these symptoms. Do not prescribe TALACEN (pentazocine and acetaminophen) for patients with acetaminophen allergy.

Drug Dependence

Pentazocine can cause a physical and psychological dependence. (See Drug Abuse And Dependence.)

Use In Head Injury and Increased Intracranial Pressure

In the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure, the possible respiratory depressant effects of pentazocine and its potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly increased. Furthermore, pentazocine can produce effects on pupillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries. In such patients, TALACEN (pentazocine and acetaminophen) must be used with extreme caution and only if its use is deemed essential.

Interactions with Alcohol and Drugs of Abuse

Pentazocine may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression because respiratory depression, hypotension, profound sedation, coma or death may result.

Patients Receiving Narcotics

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.

Respiratory Depression

Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation. Use TALACEN (pentazocine and acetaminophen) with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale and in patients having a substantially decreased respiratory reserve (e.g., severe kyphoscoliosis), hypoxia, hypercapnia, or pre-existing respiratory depression. Alternative non-opioid analgesics should be considered, and TALACEN (pentazocine and acetaminophen) should be employed only under careful medical supervision at the lowest effective dose in such patients.

Acute CNS Manifestations

Patients receiving therapeutic doses of TALACEN (pentazocine and acetaminophen) 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.

Precautions

Drug Abuse And Dependence

TALACEN (pentazocine and acetaminophen) is a Schedule IV controlled substance.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of a drug for non-medical purposes, often in combination with other psychoactive substances. Addiction is a disease of repeated drug abuse. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. Addiction is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of addiction and is characterized by misuse of the drug for non-medical purposes, and often in combination with other psychoactive substances.

There have been some reports of dependence and of withdrawal symptoms with TALACEN (pentazocine and acetaminophen) . Patients with a history of drug dependence should be under close supervision while receiving pentazocine orally. There have been rare reports of possible abstinence syndromes in newborns after prolonged use of pentazocine during pregnancy.

There have been reports of development of addiction and physical dependence in patients receiving parenteral pentazocine. People with a history of drug abuse or alcohol abuse may have a higher chance of becoming addicted to opioid medicines.

Abrupt dose cessation or rapid dose reduction following the extended use of parenteral pentazocine has resulted in withdrawal symptoms such as abdominal cramps, nausea, vomiting, elevated temperature, chills, rhinorrhea, restlessness, anxiety, or lacrimation. In general opioid therapy should not be abruptly discontinued. When the patient no longer requires treatment with TALACEN (pentazocine and acetaminophen) , the drug should be tapered gradually to prevent signs and symptoms of withdrawal in patients who have been receiving opioids for an extended period of time and might have become physically dependent.

In prescribing TALACEN (pentazocine and acetaminophen) for chronic use, the physician should take under consideration that proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to identify and decrease misuse and abuse of opioid drugs.

Severe, even lethal, consequences may result from misuse of tablets by injection either alone or in combination with other substances, such as pulmonary emboli, vascular occlusion, ulceration and abscesses, and withdrawal symptoms in narcotic dependent individuals.

CNS Effect

Caution should be used when TALACEN (pentazocine and acetaminophen) is 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.

Porphyria

Particular caution should be exercised in administering pentazocine to patients with porphyria since it may provoke an acute attack in susceptible individuals.

Cardiovascular Disease

Pentazocine can elevate blood pressure, possibly through the release of endogenous catecholamines. Particular caution should be exercised in conditions where alterations in vascular resistance and blood pressure might be particularly undesirable, such as in the acute phase of myocardial infarction.

TALACEN (pentazocine and acetaminophen) should be used with caution in patients with myocardial infarction who have nausea or vomiting.

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.

Other

Caution should also be observed when administering TALACEN (pentazocine and acetaminophen) in patients with hypothyroidism, adrenocortical insufficiency, prostate hypertrophy, inflammatory or obstructive bowel disease, acute abdominal syndromes of unknown etiology, cholecystitis, pancreatitis, or acute alcohol intoxication and delirium tremens.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis, mutagenesis, and impairment of fertility studies have not been done with this combination product.

Studies to evaluate the mutagenic potential of the components of TALACEN (pentazocine and acetaminophen) have not been conducted.

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.

Pregnancy

Teratogenic Effects

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. TALACEN (pentazocine and acetaminophen) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Animal studies with the combination of pentazocine and acetaminophen have not been completed.

In a published report, a single dose of pentazocine administered to pregnant hamsters on gestation day 8 increased the incidence of exencephaly and cranioschisis at a dose of 196 mg/kg, SC (0.2-times the maximum daily human dose of pentazocine via 6 caplets on a mg/m² basis).

Nonteratogenic 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. Frequent use of acetaminophen (defined as most days or daily use) in late pregnancy may be associated with an increased risk of persistent wheezing in the infant which may persist into childhood.

Labor and Delivery

Patients receiving pentazocine during labor have experienced no adverse effects other than those that occur with commonly used analgesics. However, pentazocine can cross the placental barrier and cause central nervous system depression in the newborn and, if used regularly throughout pregnancy, may lead to symptoms of withdrawal in the newborn. TALACEN (pentazocine and acetaminophen) should be used with caution in women delivering premature infants. The effect of TALACEN (pentazocine and acetaminophen) 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 TALACEN (pentazocine and acetaminophen) , on the later growth, development, and functional maturation of the child are unknown at the present time.

Nursing Mothers

Pentazocine and acetaminophen are excreted in human milk. Caution should be exercised when TALACEN (pentazocine and acetaminophen) is 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 TALACEN (pentazocine and acetaminophen) 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.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

Manifestations

For pentazocine alone in single doses above 60 mg there have been reports of the occurrence of nalorphine-like psychotomimetic effects such as anxiety, nightmares, strange thoughts, and hallucinations. Somnolence, marked respiratory depression associated with increased blood pressure and tachycardia have also resulted as have seizures, hypotension, dizziness, nausea, vomiting, lethargy, and paresthesias. The respiratory depression is antagonized by naloxone (see Treatment). Circulatory failure and deepening coma may occur in more severe cases, particularly in patients who have also ingested other CNS depressants such as alcohol, sedative/hypnotics, or antihistamines.

In acute acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur.

In adults, a single dose of 10 g to 15 g (200 mg/kg to 250 mg/kg) of acetaminophen may cause hepatotoxicity. A dose of 25 g or more is potentially fatal. The potential seriousness of the intoxication may not be evident during the first two days of acute acetaminophen poisoning. During the first 24 hours, nausea, vomiting, anorexia, and abdominal pain occur. These may persist for a week or more. Liver injury may become evident the second day, initial signs being elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration, and prolongation of prothrombin time. Serum albumin concentration and alkaline phosphatase activity may remain normal. The hepatotoxicity may lead to encephalopathy, coma, and death. Transient azotemia is evident in a majority of patients and acute renal failure occurs in some.

There have been reports of glycosuria and impaired glucose tolerance, but hypoglycemia may also occur. Metabolic acidosis and metabolic alkalosis have been reported. Cerebral edema and non-specific myocardial depression have also been noted. Biopsy reveals centrolobular necrosis with sparing of the periportal area. The hepatic lesions are reversible over a period of weeks or months in nonfatal cases.

The severity of the liver injury can be determined by measurement of the plasma halftime of acetaminophen during the first day of acute poisoning. If the halftime exceeds 4 hours, hepatic necrosis is likely and if the halftime is greater than 12 hours, hepatic coma will probably occur. Only minimal liver damage has developed when the serum concentration was below 120 mcg/mL at 12 hours after ingestion of the drug. If serum bilirubin concentration is greater than 4 mg/100 mL during the first 5 days, encephalopathy may occur.

Treatment

Adequate measures to maintain ventilation and general circulatory support should be employed. Assisted or controlled ventilation, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Consideration should be given to gastric lavage and gastric aspiration. For respiratory depression due to overdosage or unusual sensitivity to TALACEN (pentazocine and acetaminophen) , parenteral naloxone is a specific and effective antagonist. Initial doses of 0.4 to 2.0 mg of naloxone are recommended, repeated at 2-3 minute intervals, if needed, up to a total of 10 mg. Anti-convulsant therapy may be necessary.

The toxic effects of acetaminophen may be prevented or minimized by antidotal therapy with N-acetylcysteine. In order to obtain the best possible results, N-acetylcysteine should be administered as soon as possible.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication. Induction of vomiting or gastric lavage, followed by oral administration of activated charcoal should be done in all cases.

If hemodialysis can be initiated within the first 12 hours, it is advocated for patients with a plasma acetaminophen concentration exceeding 120 mcg/mL at 4 hours after ingestion of the drug.

ContrainDications

TALACEN (pentazocine and acetaminophen) is contraindicated in patients who are hypersensitive to either pentazocine or acetaminophen.

TALACEN (pentazocine and acetaminophen) is contraindicated in patients with sulfite allergy.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Pentazocine is a Schedule IV opioid 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.

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 sedative activity.

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.

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 into fetal circulation.

Onset of significant analgesic and antipyretic activity of acetaminophen when administered orally occurs within 30 minutes and is maximal at approximately 2 ½ 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 time to mean 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 TALACEN (pentazocine and acetaminophen) is taken every 4 hours over an extended period of time, accumulation of pentazocine and to a lesser extent, acetaminophen, may occur.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients receiving TALACEN (pentazocine and acetaminophen) should be given the following instructions by the physician:

  • Patients should be advised that TALACEN (pentazocine and acetaminophen) is a narcotic pain reliever, and should be taken only as directed.
  • The dose of TALACEN (pentazocine and acetaminophen) should not be adjusted without consulting with a physician or other healthcare professional.
  • Patients should be advised that TALACEN (pentazocine and acetaminophen) may cause drowsiness, dizziness, or lightheadedness and may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery). Patients started on
  • TALACEN (pentazocine and acetaminophen) or patients whose dose has been adjusted should refrain from any potentially dangerous activity until it is established that they are not adversely affected.
  • TALACEN (pentazocine and acetaminophen) will add to the effect of alcohol and other CNS depressants (such as antihistamines, sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and monoamine oxidase [MAO]inhibitors).
  • Patients should not combine TALACEN (pentazocine and acetaminophen) with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because dangerous additive effects may occur, resulting in serious injury or death.
  • Women of childbearing potential who become or are planning to become pregnant should consult a physician prior to initiating or continuing therapy with TALACEN (pentazocine and acetaminophen) .
  • Safe use in pregnancy has not been established. Prolonged use of opioid analgesics during pregnancy may cause neonatal physical dependence, and neonatal withdrawal may occur.
  • If patients have been receiving treatment with TALACEN (pentazocine and acetaminophen) for more than a few weeks and cessation of therapy is indicated, they should be counseled on the importance of safely tapering the dose and that abruptly discontinuing the medication could precipitate withdrawal symptoms. The physician should provide a dose schedule to accomplish a gradual discontinuation of the medication.
  • Patients should be advised that TALACEN (pentazocine and acetaminophen) is a potential drug of abuse. They should protect it from theft. It should never be given to anyone other than the individual for whom it was prescribed.
  • Patients should be instructed to keep TALACEN (pentazocine and acetaminophen) in a secure place out of the reach of children. When TALACEN (pentazocine and acetaminophen) is no longer needed, please consult your pharmacist for proper disposal instructions.
  • As with other opioids, patients taking TALACEN (pentazocine and acetaminophen) should be advised of the potential for severe constipation; appropriate laxatives and/or stool softeners as well as other appropriate treatments should be initiated from the onset of opioid therapy.
  • Patients should be advised of the most common adverse events that may occur while taking TALACEN (pentazocine and acetaminophen) : constipation, nausea, somnolence, lightheadedness, dizziness, sedation, vomiting, and sweating.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

PENTAZOCINE/ACETAMINOPHEN - ORAL

 

(pen-TAZ-oh-seen/a-SEET-a-MIN-oh-fen)

 

COMMON BRAND NAME(S): Talacen

 

WARNING: One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, stomach/abdominal pain, extreme tiredness, or yellowing eyes/skin.

Acetaminophen is an ingredient found in many nonprescription products and in some combination prescription medications (such as pain/fever drugs or cough-and-cold products). Carefully check the labels on all your medicines because they may also contain acetaminophen. Ask your pharmacist about using those products safely. Get medical help right away if you have taken more than 4000 milligrams of acetaminophen a day, even if you feel well.

 

USES: This product is used to treat mild to moderate pain. It contains 2 medications, pentazocine and acetaminophen. Pentazocine is a narcotic pain reliever (opiate-type). It acts on certain centers in the brain to give you pain relief. Acetaminophen is a non-narcotic pain reliever.

 

HOW TO USE: Take this medication by mouth with or without food, usually every 4 hours or as directed by your doctor. If you have nausea, it may help to take this drug with food. Consult your doctor or pharmacist about other ways to decrease nausea (such as taking antihistamines, lying down for 1 to 2 hours with as little head movement as possible).

The dosage is based on your medical condition and response to treatment. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed. Do not take more acetaminophen than recommended. (See also Warning sections.)

Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

If you have been regularly using other narcotic pain medications (for example, morphine, methadone), withdrawal reactions (such as restlessness, watery eyes, widened pupils, sweating, runny nose) may occur when you start this product. Consult with your doctor or pharmacist for more details.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watery eyes, widened pupils, sweating, runny nose) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your pain persists or worsens.

 

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, increased sweating, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as agitation, hallucinations, confusion), difficulty urinating, vision changes, fast heartbeat, change in the amount of urine, signs of infection (such as fever, persistent sore throat), easy bruising/bleeding.

Get medical help right away if you have any very serious side effects, including: fainting, slow/shallow breathing, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Talacen (pentazocine and acetaminophen) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to pentazocine or acetaminophen; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung disease (such as asthma, chronic obstructive pulmonary disease-COPD), a certain spinal problem (kyphoscoliosis), breathing problems (such as slow/shallow breathing, sleep apnea), certain heart problems (irregular heartbeat, recent heart attack), personal or family history of regular use/abuse of drugs/alcohol, brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as toxic psychosis), gallbladder disease, adrenal gland problem (such as Addison's disease), intestinal disorders (such as colitis, blockage, paralytic ileus, infectious diarrhea), certain blood disorders (porphyrias).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.

It is unknown if pentazocine passes into breast milk. Acetaminophen passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also How to Use and Warning sections.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: "blood thinners" (such as warfarin), fluoxetine, isoniazid, ketoconazole, MAO inhibitors ( isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), naltrexone, phenothiazines (such as chlorpromazine, prochlorperazine, promethazine).

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or their doses may need to be changed.

Check the labels on all your medicines (such as cough-and-cold products) because they may contain acetaminophen or ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain medical/laboratory tests (including urine 5-HIAA, amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, severe drowsiness, severe dizziness, pinpoint pupils, severe nausea/vomiting, unusual sweating, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, extreme tiredness.

 

NOTES: Do not share this medication with others. It is against the law.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

 

MISSED DOSE: If you take this medication regularly and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

 

Patient Detailed Side Effect

Brand Names: Talacen

Generic Name: acetaminophen and pentazocine (Pronunciation: a SEET a MIN oh fen and pen TAZ oh seen)

  • What is acetaminophen and pentazocine (Talacen)?
  • What are the possible side effects of acetaminophen and pentazocine (Talacen)?
  • What is the most important information I should know about acetaminophen and pentazocine (Talacen)?
  • What should I discuss with my health care provider before taking acetaminophen and pentazocine (Talacen)?
  • How should I take acetaminophen and pentazocine (Talacen)?
  • What happens if I miss a dose (Talacen)?
  • What happens if I overdose (Talacen)?
  • What should I avoid while taking acetaminophen and pentazocine (Talacen)?
  • What other drugs will affect acetaminophen and pentazocine (Talacen)?
  • Where can I get more information?

What is acetaminophen and pentazocine (Talacen)?

Acetaminophen is a pain reliever and a fever reducer.

Pentazocine is an opioid pain medication. An opioid is sometimes called a narcotic.

The combination of acetaminophen and pentazocine is used to treat mild to moderate pain.

Acetaminophen and pentazocine may also be used for purposes not listed in this medication guide.

Acetaminophen-Pentazocine 650 mg-25 mg-WAT

oblong, turquoise, imprinted with 396 25 650, WATSON

What are the possible side effects of acetaminophen and pentazocine (Talacen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using acetaminophen and pentazocine and call your doctor at once if you have a serious side effect such as:

  • fast heart rate;
  • weak or shallow breathing, slow heartbeat;
  • feeling like you might pass out;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe headache, ringing in your ears, anxiety, chest pain;
  • seizure (convulsions);
  • easy bruising or bleeding; or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • feeling dizzy or drowsy;
  • mild nausea, vomiting, upset stomach, constipation, diarrhea;
  • dry mouth; or
  • blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Talacen (pentazocine and acetaminophen) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about acetaminophen and pentazocine (Talacen)?

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

This medication may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how acetaminophen and pentazocine will affect you.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Side Effects Centers
  • Talacen

Patient Detailed How Take

What should I discuss with my health care provider before taking acetaminophen and pentazocine (Talacen)?

You should not use this medication if you are allergic to acetaminophen (Tylenol) or pentazocine (Talwin).

Pentazocine may be habit-forming and should be used only by the person it was prescribed for. Acetaminophen and pentazocine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

To make sure you can safely take acetaminophen and pentazocine, tell your doctor if you have any of these other conditions:

  • asthma, COPD, sleep apnea, or other breathing disorders;
  • liver or kidney disease;
  • heart disease, high or low blood pressure;
  • a history of head injury or brain tumor;
  • epilepsy or other seizure disorder;
  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
  • a thyroid or adrenal gland disorder;
  • problems with your pancreas or gallbladder;
  • an enlarged prostate;
  • a stomach or intestinal disorder;
  • curvature of the spine;
  • mental illness; or
  • a history of drug or alcohol addiction.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

FDA pregnancy category C. It is not known whether acetaminophen and pentazocine will harm an unborn baby. Acetaminophen and pentazocine may cause breathing problems or addiction and withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using acetaminophen and pentazocine.

Acetaminophen and pentazocine may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of this medicine.

How should I take acetaminophen and pentazocine (Talacen)?

Take exactly as prescribed. Never take acetaminophen and pentazocine in larger amounts, or for longer than recommended by your doctor. An overdose of acetaminophen can damage your liver or cause death. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take this medicine with food or milk if it upsets your stomach.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and pentazocine. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor.

Do not stop using acetaminophen and pentazocine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and pentazocine.

This medication can cause unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and pentazocine.

If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and pentazocine. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Acetaminophen and pentazocine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Side Effects Centers
  • Talacen

Patient Detailed Avoid Taking

What happens if I miss a dose (Talacen)?

Since acetaminophen and pentazocine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Talacen)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and pentazocine can be fatal.

Overdose symptoms may include extreme drowsiness, anxiety, nightmares, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, fainting, weak pulse, coma, blue lips, shallow breathing, or no breathing.

What should I avoid while taking acetaminophen and pentazocine (Talacen)?

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how acetaminophen and pentazocine will affect you.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol while taking acetaminophen and pentazocine. Alcohol may increase your risk of liver damage while taking acetaminophen.

Smoking tobacco can make acetaminophen and pentazocine less effective.

What other drugs will affect acetaminophen and pentazocine (Talacen)?

Cold or allergy medicine, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by pentazocine. Tell your doctor if you regularly use any of these medicines, or any other narcotic medicine.

Tell your doctor about all other medications you are using, especially:

  • glycopyrrolate (Robinul);
  • mepenzolate (Cantil);
  • naloxone (Narcan);
  • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
  • a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva);
  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine);
  • a phenothiazine such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine); or
  • if you have taken an MAO inhibitor in the past 14 days, such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate).

This list is not complete and other drugs may interact with acetaminophen and pentazocine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has information about acetaminophen and pentazocine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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