Pentazocine and naloxone (Oral)

Pentazocine and naloxone combination is used to relieve pain that is severe enough to need opioid treatment, especially when other pain medicines have not worked well or cannot be tolerated.

Pentazocine is part of a group of medicines called narcotic analgesics (pain medicines). It works on the central nervous system (CNS) to relieve pain. Naloxone is an opioid antagonist. It works on the CNS to block the effects of narcotics, especially the "high" feeling that makes people want to use them. It does not create any narcotic-like effects or cause mental or physical dependence.

When pentazocine is used for a long time, it may become habit-forming, leading to mental or physical dependence. However, people with ongoing pain should not let the fear of dependence prevent them from using narcotics to manage their pain. Mental dependence (addiction) is not likely to happen when narcotics are used for this reason. Physical dependence may cause withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be avoided by gradually reducing the dose over time before stopping treatment completely.

This medicine is available only through a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

It is very important for your doctor to monitor your or your child's progress while using this medicine, especially during the first 24 to 72 hours of treatment. This will help your doctor determine if the medicine is effective and if you or your child should continue using it. Blood and urine tests may be necessary to check for side effects.

Symptoms of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor immediately if you notice these symptoms.

Do not use this medicine if you are currently using or have used an MAO inhibitor (MAOI) such as isocarboxazid (Marplan®), linezolid (Zyvox®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within the past 14 days.

This medicine will increase the effects of alcohol and other central nervous system (CNS) depressants (medicines that can cause drowsiness or less alertness). Some examples of CNS depressants include antihistamines or allergy or cold medicines, sedatives, tranquilizers, sleeping medicines, other prescription pain medicines or narcotics, seizure medications or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before you or your child take any of the medicines listed above while using this medicine.

This medicine may be habit-forming. If you or your child feel that the medicine is not as effective, do not take more than the prescribed dose. Call your doctor for guidance.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from lying or sitting down. These symptoms are more likely when you first start using this medicine or when your dose is increased. Getting up slowly may help reduce this issue. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may cause dizziness, drowsiness, or lightheadedness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Using narcotics for a long time can lead to severe constipation. To avoid this, your doctor may recommend that you or your child take laxatives, drink plenty of fluids, or increase fiber intake in your diet. Be sure to follow these instructions closely, as ongoing constipation can cause more serious issues.

If you or your child have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without consulting your doctor. Your doctor may want you or your child to gradually decrease the amount used before stopping completely. This may help prevent worsening of your condition and reduce the risk of withdrawal symptoms, such as abdominal cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and needs immediate medical help. Call your doctor immediately if you experience a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Contact your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or experience hallucinations. These may be signs of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using this medicine during pregnancy may lead to serious unwanted effects, including neonatal opioid withdrawal syndrome in your newborn baby. Inform your doctor immediately if you think you are pregnant or plan to become pregnant while using this medicine.

Taking too much of this medicine may lead to infertility (the inability to have children). Discuss with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the chances of taking the drug must be weighed against the beneficial it will do. This is a decision you and your clinician will make. For this drug, the following should be considered:

Allergies

Tell your clinician if you have ever had any unusual or allergic reaction to this medicine or any other medications. Additionally tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pentazocine and naloxone combination in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of pentazocine and naloxone combination in the elderly. Nevertheless, elderly patients are more likely to have age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving pentazocine and naloxone combination.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this drug during breastfeeding. Weigh the potential benefits against the potential risks prior to taking this medication while breastfeeding.

Interactions with Medicines

Although certain drugs should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using this drug, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medications is not recommended. Your physician may decide not to treat you with this medication or change some of the other medicines you take.

• Nalmefene

Using this medicine with any of the following medications is typically not advised, but may be required in some cases. If both medicines are prescribed together, your clinician may change the dose or how frequently you use one or both of the medications.

• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Aprepitant
• Armodafinil
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carisoprodol
• Carphenazine
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clorazepate
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclosporine
• Daridorexant
• Darunavir
• Delavirdine
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Eletriptan
• Enflurane
• Enzalutamide
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fenfluramine
• Fentanyl
• Flibanserin
• Fluconazole
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Iproniazid
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lasmiditan
• Lemborexant
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Lorazepam
• Lorcaserin
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirtazapine
• Mitotane
• Moclobemide
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naldemedine
• Naloxegol
• Naratriptan
• Nefazodone
• Nelfinavir
• Nevirapine
• Nialamide
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxycodone
• Oxymorphone
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Using this medicine with any of the following medicines may cause an increased chance of certain side effects, but using both drugs may be the best therapy for you. If both medications are prescribed together, your physician may change the dose or how frequently you use one or both of the drugs.

• Clonidine
• Yohimbine

Interactions with Food/Tobacco/Alcohol

Certain medications should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain drugs may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following may cause an increased chance of certain adverse effects but may be unavoidable in some cases. If used together, your physician may change the dose or how often you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medication. Make sure you inform your doctor if you have any other medical issues, especially:

• Addison's disease (adrenal gland problem) or
• Alcohol abuse, or history of or
• Brain tumor, history of or
• Breathing problems, serious (eg, chronic obstructive pulmonary disease [COPD], hypoxia, hypercapnia) or
• Cholecystitis (inflammation of the gallbladder) or
• Chronic obstructive pulmonary disease (COPD) or
• Cor pulmonale (severe heart condition) or
• Drug dependence, especially with narcotics, or history of or
• Enlarged prostate (BPH, prostatic hypertrophy) or
• Gallbladder disease or gallstones or
• Head injuries, history of or
• Hypothyroidism (an underactive thyroid) or
• Kyphoscoliosis (serious curvature of the spine with breathing issues) or
• Mental illness, history of or
• Pancreatitis (inflammation of the pancreas) or
• Issues with passing urine or
• Stomach or digestive issues (eg, slow or inflamed bowels)—Use with caution. May increase chance for more severe adverse effects.

• Heart attack, recent or
• Heart or blood vessel disease or
• Hypertension (high blood pressure) or
• Porphyria (an enzyme issue) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased since of slower removal of the medicine from the body.

• Lung or breathing problems, serious (eg, bronchial asthma, respiratory depression) or
• Stomach or bowel blockage (including paralytic ileus), known or suspected—Should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do happen, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Black, tarry stools
• chest pain
• chills
• cough
• difficult or troubled breathing
• fever
• general feeling of tiredness or weakness
• hoarseness
• irregular, fast or slow, or shallow breathing
• lower back or side pain
• painful or difficult urination
• pale or blue lips, fingernails, or skin
• shakiness in the legs, arms, hands, or feet
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• trembling or shaking of the hands or feet
• unusual bleeding or bruising
• unusual tiredness or weakness

Incidence not known

• Agitation
• blistering, peeling, or loosening of the skin
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• confusion
• constipation
• constricted, pinpoint, or small pupils (black part of the eye)
• darkening of the skin
• decrease in the frequency of urination
• depression
• diarrhea
• difficulty in passing urine (dribbling)
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• excitement
• fainting
• false or unusual sense of well-being
• fast, slow, pounding, or irregular heartbeat or pulse
• feeling of warmth
• headache
• hives or welts, itching, skin rash
• joint or muscle pain
• loss of bladder control
• loss of consciousness
• nervousness
• overactive reflexes
• poor coordination
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid breathing
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the face, neck, arms, and occasionally, upper chest
• restlessness
• sweating
• swelling of the face, arms, or lower legs
• tightness in the chest
• total body jerking
• upper abdominal or stomach pain
• weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Chest pain
• choking
• cold and clammy skin
• constricted, pinpoint, or small pupils (black part of the eye)
• coughing that sometimes produces a pink frothy sputum
• decreased awareness or responsiveness
• difficult, fast, or noisy breathing
• extremely shallow or slow breathing
• increased sweating
• loss of consciousness
• no muscle tone or movement
• pale skin
• seeing, hearing, or feeling things that are not there
• severe sleepiness or unusual drowsiness
• seizures (convulsions)
• slow heartbeat
• swelling in the legs and ankles

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

• Stomach distress

Incidence not known

• Continuing ringing or buzzing or other unexplained noise in the ears
• cracked, dry, or scaly skin
• difficulty in focusing the eyes
• disturbed dreams
• drowsiness
• dry mouth
• hearing loss
• irritability
• lightheadedness
• loss of appetite
• mood or mental changes
• nausea
• relaxed and calm feeling
• trouble with sleeping
• vomiting
• weakness
• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Talwin NX

Available Dosage Forms:

• Tablet

Therapeutic Class: Analgesic

Pharmacologic Class: Naloxone

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of pentazocine and naloxone combination. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Tell your doctor if you smoke tobacco. Smoking may change how well this medicine works.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For moderate to severe pain: Adults and children 12 years of age and older—At first, one tablet every 3 or 4 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 12 tablets per day. Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Mixed unused tablets with used coffee grounds or kitty litter, then place it in a sealable bag, empty can, or other container before throwing into the trash. Ask your pharmacist about the best way to dispose of medicine you do not use.