Pentazocine and naloxone

Generic name: Pentazocine And Naloxone
Drug class: Narcotic analgesic combinations

Usage of Pentazocine and naloxone

Pentazocine and naloxone combination is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated.

Pentazocine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain. Naloxone is an opioid antagonist. It acts on the CNS to block the effects of narcotics, especially the "high'' feeling that makes you want to use them. It will not produce any narcotic-like effects or cause mental or physical dependence.

When pentazocine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

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

Pentazocine and naloxone side effects

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

Before taking Pentazocine and naloxone

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also 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 problems that would limit the usefulness of pentazocine and naloxone combination in the elderly. However, 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 risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines 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 taking this medicine, 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 medicines is not recommended. Your doctor 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 medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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

Dezocine

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 risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Clonidine

Yohimbine

Interactions with Food/Tobacco/Alcohol

Certain medicines 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 medicines 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 medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Relate drugs

How to use Pentazocine and 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.

Warnings

It is very important that your doctor check your or your child's progress while using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

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

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

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures 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 you are using this medicine.

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

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin using this medicine, or when the dose is increased. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. 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 cause severe constipation. To prevent this, your doctor may direct you or your child to take laxatives, drink lots of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

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 checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

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

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect the serotonin levels in your body.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal opioid withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

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

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com'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. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com 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.