Pentazocine and naloxone (Oral route)
nal-OX-one hye-droe-KLOR-ide, pen-TAZ-oh-seen hye-droe-KLOR-ide
- Talwin NX
Addiction, Abuse, and Misuse:Pentazocine and naloxone tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing pentazocine and naloxone tablets, and monitor all patients regularly for the development of these behaviors or conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant eduction programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory Depression:Serious, life-threatening, or fatal respiratory depression may occur with use of pentazocine and naloxone tablets. Monitor for respiratory depression, especially during initiation of pentazocine and naloxone tablets or following a dose increase.Accidental Ingestion:Accidental ingestion of even one dose of pentazocine and naloxone tablets, especially by children, can result in a fatal overdose of pentazocine.Neonatal Opioid Withdrawal Syndrome:Prolonged use of pentazocine and naloxone tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants:Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of pentazocine and naloxone tablets or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation .
Uses of This Medicine:
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.
Before Using This Medicine:
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:
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.
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.
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.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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.
- Chloral Hydrate
- Eslicarbazepine Acetate
- Methylene Blue
- Morphine Sulfate Liposome
- Nitrous Oxide
- Opium Alkaloids
- Sodium Oxybate
- St John's Wort
- Tolonium Chloride
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.
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.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison's disease (adrenal gland problem) or
- Alcohol abuse, or history of or
- Brain tumor, history of or
- Breathing problems, severe (eg, chronic obstructive pulmonary disease [COPD], hypoxia, hypercapnia) or
- Cholecystitis (inflammation of the gallbladder) or
- Chronic obstructive pulmonary disease (COPD) or
- Cor pulmonale (serious 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 (severe curvature of the spine with breathing problems) or
- Mental illness, history of or
- Pancreatitis (inflammation of the pancreas) or
- Problems with passing urine or
- Stomach or digestive problems (eg, slow or inflamed bowels)—Use with caution. May increase risk for more serious side effects.
- Heart attack, recent or
- Heart or blood vessel disease or
- Hypertension (high blood pressure) or
- Porphyria (an enzyme problem) 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 because of slower removal of the medicine from the body.
- Lung or breathing problems, severe (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.
Proper Use of This Medicine:
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.
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.
- For moderate to severe pain:
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.
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.
Precautions While Using This Medicine:
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.
Side Effects of This Medicine:
- Black, tarry stools
- chest pain
- difficult or troubled breathing
- general feeling of tiredness or weakness
- 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
- blistering, peeling, or loosening of the skin
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- constricted, pinpoint, or small pupils (black part of the eye)
- darkening of the skin
- decrease in the frequency of urination
- difficulty in passing urine (dribbling)
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- false or unusual sense of well-being
- fast, slow, pounding, or irregular heartbeat or pulse
- feeling of warmth
- hives or welts, itching, skin rash
- joint or muscle pain
- loss of bladder control
- loss of consciousness
- 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
- swelling of the face, arms, or lower legs
- tightness in the chest
- total body jerking
- upper abdominal or stomach pain
- weight gain
- Symptoms of overdose
- Chest pain
- 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
- 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
- dry mouth
- hearing loss
- loss of appetite
- mood or mental changes
- relaxed and calm feeling
- trouble with sleeping
- weight loss
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:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
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.
Last Updated: 12/6/2019