Drugs Details

Drugs Info of Talwin NX
Drugs Details
  • Drugs Type  : Multum
  • Date : 16th Jun 2015 08:27 am
  • Brand Name : Talwin NX
  • Generic Name :  naloxone and pentazocine (oral) (Pronunciation: nal OX one and pen TAZ oh seen)
Descriptions

TALWIN NX (pentazocine and naloxone hydrochlorides, USP) contains pentazocine hydrochloride, USP, equivalent to 50 mg base and is a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride, USP, equivalent to 0.5 mg base.

TALWIN NX (pentazocine and naloxone) is an analgesic for oral administration.

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

 

pentazocine hydrochloride Structural Formula Illustration

C19H27NO·HCl............M.W. 321.88

Chemically, naloxone hydrochloride is Morphinan-6-one,4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, hydrochloride, (5α)-. It is a slightly off-white powder, and is soluble in water and dilute acids, and has the following structural formula:

 

naloxone hydrochloride Structural Formula Illustration

C19H21NO4·HCl..............M.W.=363.84

Inactive Ingredients: Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, D&C Yellow #10, FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Starch.

What are the possible side effects of naloxone and pentazocine (Talwin NX)?

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

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

  • weak or shallow breathing, slow heartbeats;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe weakness or dizziness;
  • seizure (convulsions);
  • feeling like you might pass out; or
  • severe skin reaction -- fever, sore throat, swelling in your face or...

Read All Potential Side Effects and See Pictures of Talwin Nx »

What are the precautions when taking pentazocine and naloxone (Talwin Nx)?

Before taking this product, tell your doctor or pharmacist if you are allergic to pentazocine or naloxone; or if you have any other allergies. This product may contain inactive ingredients, 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), personal or family history of regular use/abuse of drugs/alcohol, brain disorders (such as seizures, head injury, tumor, increased intracranial...

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

Indications

TALWIN NX (pentazocine and naloxone hydrochlorides, USP) is indicated for the relief of moderate to severe pain.

TALWIN NX (pentazocine and naloxone) is indicated for oral use only.

Dosage Administration

Adults

The usual initial adult dose is 1 tablet every three or four hours. This may be increased to 2 tablets when needed. Total daily dosage should not exceed 12 tablets.

Discontinuation

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

How Supplied

TALWIN NX (pentazocine and naloxone hydrochlorides, USP) is available as yellow, scored, oblong tablets, debossed with a "W" surrounded by a box on one side and "T51" on the other. Each tablet contains pentazocine hydrochloride equivalent to 50 mg base and naloxone hydrochloride equivalent to 0.5 mg base.

Bottles of 100 (NDC 0024-1951-04).

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


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

Side Effects

Cardiovascular

Hypertension, hypotension, circulatory depression, tachycardia, syncope.

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 DependenceSections).

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.

Read the Talwin Nx (pentazocine and naloxone) 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

TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) may cause CNS excitation and hypertension through their respective effects on catecholamines. Caution should therefore be observed in administering TALWIN NX (pentazocine and naloxone) 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 Talwin Nx 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

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, pentazocine 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 TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) should be employed only under careful medical supervision at the lowest effective dose in such patients.

Acute CNS Manifestations

Patients receiving therapeutic doses of TALWIN NX (pentazocine and naloxone) 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 very 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

TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) . Patients with a history of drug dependence should be under close supervision while receiving TALWIN NX (pentazocine and naloxone) . There have been rare reports of possible abstinence syndromes in newborns after prolonged use of TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) , 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 TALWIN NX (pentazocine and naloxone) 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.

The amount of naloxone present in TALWIN NX (pentazocine and naloxone) (0.5 mg per tablet) has no action when taken orally and will not interfere with the pharmacologic action of pentazocine. However, this amount of naloxone given by injection has profound antagonistic action to narcotic analgesics.

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 TALWIN NX (pentazocine and naloxone) is administered to patients prone to seizures; seizures have occurred in a few such patients in association with the use of pentazocine though 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.

TALWIN NX (pentazocine and naloxone) should be used with caution in patients with myocardial infarction who have nausea or vomiting.

Impaired Renal or Hepatic Function

Decreased metabolism of pentazocine 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.

Other

Caution should also be observed when administering TALWIN NX (pentazocine and naloxone) 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

No long-term studies in animals to test for carcinogenesis have been performed with the components of TALWIN NX (pentazocine and naloxone) .

Studies to evaluate the mutagenic potential of the components of TALWIN NX (pentazocine and naloxone) 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. TALWIN NX (pentazocine and naloxone) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 (0.4-times the maximum daily human dose of pentazocine via 12 tablets on a mg/m2 basis).

Animal reproduction studies testing the combination of pentazocine and naloxone during organogenesis have been completed in rats and rabbits. In rats, a pentazocine:naloxone dose of 64 mg/kg:0.64 mg/kg via oral gavage increased the incidences of resorptions and extra ribs (0.2-times the maximum daily human dose of pentazocine via 12 tablets on a mg/m2 basis). There were no clear treatment related effects in rabbits treated with a pentazocine:naloxone dose of up to 64 mg/kg:0.64 mg/kg via oral gavage (0.3-times the maximum daily human dose of pentazocine via 12 tablets on a mg/m2 basis).

Nonteratogenic Effects

There has been no experience in this regard with TALWIN NX (pentazocine and naloxone) . 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. 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. TALWIN NX (pentazocine and naloxone) should be used with caution in women delivering premature infants. The effect of TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) on the later growth, development, and functional maturation of the child are unknown at the present time.

Nursing Mothers

Pentazocine is excreted in human milk. Caution should be exercised when TALWIN NX (pentazocine and naloxone) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Geriatric Use

Controlled clinical studies of TALWIN NX (pentazocine and naloxone) 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 or effectiveness in analgesic activity 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 hypertension 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.

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 pentazocine, 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.

ContrainDications

TALWIN NX (pentazocine and naloxone) is contraindicated in patients who are hypersensitive to either pentazocine or naloxone.


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

Clinical Pharamacology

Pentazocine is a Schedule IV opioid analgesic which when administered orally in a 50 mg dose appears equivalent in analgesic effect to 60 mg of codeine.

Pentazocine weakly antagonizes the analgesic effects of morphine and meperidine; 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 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. Concentrations in plasma coincide closely with 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).

Pentazocine is metabolized in the liver and excreted primarily 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 the fetal circulation.

Naloxone when administered orally at 0.5 mg has no pharmacologic activity. Naloxone hydrochloride administered parenterally at the same dose is an antagonist to pentazocine and a pure antagonist to narcotic analgesics.

TALWIN NX (pentazocine and naloxone) is a potent analgesic when administered orally. However, the presence of naloxone in TALWIN NX (pentazocine and naloxone) is intended to prevent the effect of pentazocine if the product is misused by injection.

Studies in animals indicate that the presence of naloxone does not affect pentazocine analgesia when the combination is given orally. If the combination is given by injection the action of pentazocine is neutralized.


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

Patient Information

Patients receiving TALWIN NX (pentazocine and naloxone) should be given the following instructions by the physician:

  • Patients should be advised that TALWIN NX (pentazocine and naloxone) is a narcotic pain reliever, and should be taken only as directed.
  • The dose of TALWIN NX (pentazocine and naloxone) should not be adjusted without consulting with a physician or other healthcare professional.
  • Patients should be advised that TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) or patients whose dose has been adjusted should refrain from any potentially dangerous activity until it is established that they are not adversely affected.
  • TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) .
  • 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 TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) in a secure place out of the reach of children. When TALWIN NX (pentazocine and naloxone) is no longer needed, please consult your pharmacist for proper disposal instructions.
  • As with other opioids, patients taking TALWIN NX (pentazocine and naloxone) 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 TALWIN NX (pentazocine and naloxone) : constipation, nausea, somnolence, lightheadedness, dizziness, sedation, vomiting, and sweating.


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

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/NALOXONE - ORAL

 

(pen-TAZZ-oh-seen/nal-OX-own)

 

COMMON BRAND NAME(S): Talwin NX

 

WARNING: This medication should only be taken by mouth. Do not try to dissolve and inject the tablets. Injecting this product, alone or with other substances, may cause serious, possibly fatal, side effects.

 

USES: This product is used to treat moderate to severe pain. It contains 2 medications, pentazocine and naloxone. Pentazocine is a narcotic pain reliever (opiate-type). It acts on certain centers in the brain to give you pain relief. Naloxone helps to prevent misuse of this product. It blocks the effect of pentazocine and may cause withdrawal reactions if this product is dissolved and injected. Naloxone does not have any effect when taken by mouth.

 

HOW TO USE: Take this medication by mouth with or without food, usually every 3 to 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 take more than 600 milligrams of pentazocine in a 24-hour period. 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.

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: 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, severe stomach/abdominal pain, change in the amount of urine, signs of infection (such as fever, persistent sore throat).

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

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 Talwin Nx (pentazocine and naloxone) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to pentazocine or naloxone; or if you have any other allergies. This product may contain inactive ingredients, 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), 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).

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. Limit 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 this product passes into breast milk. Disc

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also How to Use section.

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: fluoxetine, MAO inhibitors (for example, isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), naltrexone.

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 ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (including 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.

 

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 product 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.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Talwin NX

Generic Name: naloxone and pentazocine (oral) (Pronunciation: nal OX one and pen TAZ oh seen)

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

What is naloxone and pentazocine (Talwin Nx)?

Naloxone is an special narcotic drug that reverses the effects of other narcotic medicines.

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

The combination of naloxone and pentazocine is used to treat moderate-to-severe pain. Naloxone is included in this medication to prevent the misuse of the narcotic ingredient.

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

Naloxone-Pentazocine 50 mg-WAT

oblong, green, imprinted with 395 50 0 .5, WATSON

What are the possible side effects of naloxone and pentazocine (Talwin Nx)?

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

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

  • weak or shallow breathing, slow heartbeats;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe weakness or dizziness;
  • seizure (convulsions);
  • feeling like you might pass out; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • dizziness, drowsiness;
  • headache, weakness;
  • feeling restless or irritable;
  • diarrhea, constipation;
  • dry mouth, nausea, vomiting, loss of appetite;
  • tremor, chills, sweating;
  • flushing (warmth, redness, or tingly feeling);
  • sleep problems (insomnia), strange dreams;
  • blurred vision; or
  • ringing in your ears.

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 Talwin Nx (pentazocine and naloxone) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about naloxone and pentazocine (Talwin Nx)?

You should not use this medication if you are allergic to naloxone (Narcan, Suboxone) or pentazocine (Talacen).

Never crush a naloxone and pentazocine tablet to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of pentazocine and similar prescription drugs.

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

Never take naloxone and pentazocine in larger amounts, or for longer than recommended by your doctor. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not drink alcohol while you are using this medication. Dangerous side effects or death can occur when alcohol is combined with naloxone and pentazocine. Check your food and medicine labels to be sure these products do not contain alcohol.

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

Do not stop using naloxone 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 naloxone and pentazocine.

Side Effects Centers
  • Talwin Nx

Patient Detailed How Take

What should I discuss with my health care provider before taking naloxone and pentazocine (Talwin Nx)?

You should not use this medication if you are allergic to naloxone (Narcan, Suboxone) or pentazocine (Talacen).

To make sure you can safely take naloxone 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 or history of heart attack;
  • underactive thyroid;
  • a blockage in your digestive tract (stomach or intestines);
  • a history of head injury or brain tumor;
  • epilepsy or other seizure disorder;
  • Addison's disease or other adrenal gland disorder;
  • low blood pressure;
  • gallbladder or pancreas problems:
  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
  • enlarged prostate, urination problems;
  • mental illness;
  • a history of drug or alcohol addiction; or
  • if you have recently received other narcotic pain medicine or methadone.

Naloxone and pentazocine may be habit forming and should be used only by the person for whom it was prescribed. Never share naloxone and pentazocine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether naloxone and pentazocine will harm an unborn baby. Naloxone and pentazocine may cause addiction or 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 naloxone and pentazocine.

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

Naloxone and pentazocine should not be given to a child younger than 12 years old.

How should I take naloxone and pentazocine (Talwin Nx)?

Take exactly as prescribed. Never take naloxone and pentazocine in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Naloxone and pentazocine is usually taken as 1 or 2 tablets every 3 to 4 hours. Follow your doctor's instructions. Do not take more than 12 tablets in a 24-hour period.

Never crush a naloxone and pentazocine tablet to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of pentazocine and similar prescription drugs.

Do not stop using naloxone and pentazocine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Naloxone 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
  • Talwin Nx

Patient Detailed Avoid Taking

What happens if I miss a dose (Talwin Nx)?

Since naloxone 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.

Do not take more than 12 tablets in a 24-hour period.

What happens if I overdose (Talwin Nx)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme drowsiness, cold and clammy skin, pinpoint pupils, shallow breathing, slow heart rate, fainting, seizure (convulsions), or coma.

What should I avoid while taking naloxone and pentazocine (Talwin Nx)?

Do not drink alcohol while you are taking naloxone and pentazocine. Alcohol can increase some of the side effects of narcotic pain medicine.

Naloxone and pentazocine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid smoking, which can make this medication less effective in relieving your pain.

What other drugs will affect naloxone and pentazocine (Talwin Nx)?

You should not take naloxone and pentazocine with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. Tell your doctor if you regularly use any of these medications, or medicine for seizures, depression, or anxiety.

If you are using any other opioid pain medication, the pain-relieving effects of the narcotic will be reversed while you are also receiving naloxone and pentazocine. Opioid medicines include:

  • codeine (Tylenol #3);
  • fentanyl (Abstral, Actiq, Fentora, Duragesic, Lazanda, Onsolis);
  • hydrocodone (Lortab, Vicodin, Vicoprofen);
  • hydromorphone (Dilaudid, Palladone);
  • methadone (Methadose, Dolophine);
  • morphine (Kadian, MS Contin, Oramorph);
  • oxycodone (OxyContin, Combunox, Roxicodone, Percocet); or
  • and many others.

Tell your doctor about all other medicines you use, especially:

  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), nortriptyline (Pamelor), and others;
  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate); or
  • a phenothiazine such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine).

This list is not complete and other drugs may interact with naloxone 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 can provide more information about naloxone 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.

Copyright 1996-2013 Cerner Multum, Inc. Version: 4.01. Revision date: 7/12/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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