Description
Oxycodone and naltrexone combination is used to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment, when other pain medicines did not work well enough or cannot be tolerated. It belongs to the group of medicines called opioid analgesics (pain medicines). Oxycodone acts on the central nervous system (CNS) to relieve pain.
Oxycodone and naltrexone combination should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain, or in situations when non-opioid medication is effective. This medicine should not be used to treat pain that you only have once in a while or "as needed".
When oxycodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, under the close supervision of healthcare providers, people who have continuing pain should not let the fear of dependence keep them from using opioids to relieve their pain. Mental dependence (addiction) is less likely to occur when opioids are used for this purpose. Physical dependence may lead to withdrawal symptoms if treatment is stopped suddenly. However, severe withdrawal symptoms can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
This medicine is available only with your doctor's prescription.
Before Using
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 Troxyca® ER in the pediatric population. 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 Troxyca® ER in the elderly. However, elderly patients are more likely to have age-related lung, liver, or kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
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.
- Alfentanil
- Alphaprodine
- Anileridine
- Benzhydrocodone
- Buprenorphine
- Butorphanol
- Codeine
- Diacetylmorphine
- Difenoxin
- Dihydrocodeine
- Diphenoxylate
- Ethylmorphine
- Fentanyl
- Hydrocodone
- Hydromorphone
- Ketobemidone
- Levoketoconazole
- Levorphanol
- Mavorixafor
- Meperidine
- Methadone
- Morphine
- Morphine Sulfate Liposome
- Nalbuphine
- Naltrexone
- Nicomorphine
- Opium
- Opium Alkaloids
- Oxycodone
- Oxymorphone
- Papaveretum
- Paregoric
- Piritramide
- Propoxyphene
- Remifentanil
- Safinamide
- Samidorphan
- Sufentanil
- Tapentadol
- Tilidine
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.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acepromazine
- Aclidinium
- Alfentanil
- Almotriptan
- Alosetron
- Alprazolam
- Amantadine
- Amifampridine
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anileridine
- Apalutamide
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Asciminib
- Asenapine
- Atazanavir
- Atropine
- Avacopan
- Baclofen
- Belladonna
- Belzutifan
- Benperidol
- Bentazepam
- Benzhydrocodone
- Benzphetamine
- Benztropine
- Berotralstat
- Biperiden
- Boceprevir
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.
- Lofexidine
- Yohimbine
Other Interactions
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 is usually not recommended, 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
- Grapefruit Juice
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 disease (adrenal gland problem) or
- Alcohol use disorder, or history of or
- Brain tumor, history of or
- Breathing problems (eg, hypoxia) or
- Chronic obstructive pulmonary disease (COPD) or
- Cor pulmonale (serious heart problem) or
- Depression or
- Drug use disorder or dependence, or history of or
- Gallbladder disease or gallstones or
- Head injuries, history of or
- Increased pressure in the head or
- Psychosis (a mental disease)—Use with caution. May increase risk for more serious side effects.
- Asthma, acute or severe or
- Lung disease or breathing problems (eg, asthma, respiratory depression), severe or
- Stomach or bowel blockage (eg, paralytic ileus), known or suspected—Should not be used in patients with these conditions.
- Hypotension (low blood pressure) or
- Pancreatitis (inflammation or swelling of the pancreas) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Kidney disease, severe or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
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).
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the extended-release capsule whole. Do not dissolve, crush, break, or chew it.
If you have trouble swallowing the capsule, you may open and sprinkle the medicine into one tablespoon of applesauce. Swallow the mixture right away. Do not save the mixture for later use. Rinse your mouth to make sure you have swallowed all of the mixture. Do not chew it. Do not give this medicine through a nasogastric or gastric tube (stomach tube).
Close follow-up with healthcare providers and creation of a pain management plan is an effective way to manage chronic pain. This plan may include limiting opioid medicines to the lowest effective dose for a limited period of time. The plan may also include non-medicine treatments such as relaxation techniques, massage therapy, or transcutaneous electrical stimulation (TENS).
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 (extended-release capsules):
- For severe pain:
- Patients who are not taking opioid medicines or are not opioid tolerant:
- Adults—At first, 1 capsule (10 milligrams (mg) of oxycodone and 1.2 mg of naltrexone) every 12 hours. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor.
- Patients switching from regular oxycodone forms:
- Adults—The capsule is given every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular oxycodone that is taken per day. The total amount per day will be divided and given as 2 doses during the day. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor.
- Patients switching from other opioid medicines:
- Adults—The capsule is given every 12 hours. The total amount of milligrams (mg) per day will be determined by your doctor and depends on which opioid you were using. The total amount per day will be divided and given as 2 doses during the day. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor.
- Patients who are not taking opioid medicines or are not opioid tolerant:
- For severe pain:
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.
Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm
This medicine can cause serious unwanted effects if taken by adults who are not used to strong opioid pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.
Precautions
It is very important that your doctor check your progress while you are taking 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 should continue to take it. Blood tests may be needed to check for unwanted effects.
Do not use this medicine if you are using or have used an MAO inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
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. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, sneezing, weight loss, vomiting, yawning, or failure to gain weight.
This medicine may be present in your breast milk and passed to your baby. Breastfeeding is not recommended while taking this medicine.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin. Your doctor may give naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary.
This medicine will add to the effects of alcohol and other 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 opioids, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the 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 opioids for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot 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.
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, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you 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, including chills, runny nose, muscle pain, sweating, restlessness, or yawning.
Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable 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
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:
Less common
- Fast, pounding, or irregular heartbeat or pulse
- fever
- hives, itching, or rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- pale skin
- redness of the skin
- swelling of the eyelids, face, lips, hands, or feet
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tightness in the chest
- troubled breathing or swallowing
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Abdominal or stomach pain
- agitation
- blurred vision
- confusion
- cough
- diarrhea
- dizziness or fainting
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- headache
- irregular, fast or slow, or shallow breathing
- loss of appetite
- nausea with or without vomiting
- overactive reflexes
- pale or blue lips, fingernails, or skin
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- restlessness
- seizures
- shivering
- sweating
- talking or acting with excitement you cannot control
- trembling or shaking
- twitching
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:
More common
- Back pain
- difficulty having a bowel movement (stool)
- sleepiness or unusual drowsiness
- trouble sleeping
Less common
- Acid or sour stomach
- belching
- bloating or swelling of the face, arms, hands, lower legs, or feet
- decreased appetite
- difficulty with moving
- dry mouth
- feeling of warmth
- heartburn
- indigestion
- muscle pain or stiffness
- muscle spasms
- pain in the joints
- rapid weight gain
- redness of the face, neck, arms, and occasionally, upper chest
- stomach discomfort or upset
- sudden sweating
- tingling of the hands or feet
- unusual weight gain or 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.
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