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Health Guide

Oxycodone and naltrexone (Oral route)

Pronunciation:

ox-i-KOE-done hye-droe-KLOR-ide, nal-TREX-one hye-droe-KLOR-ide

Brand Names:

  • Troxyca ER

Dosage Forms:

  • Capsule, Extended Release

Warnings:

Oral route(Capsule, Extended Release)

Misuse and abuse may lead to overdose and death. Assess risk before prescribing and regularly monitor for signs of these behaviors and conditions. Serious and potentially fatal respiratory depression may occur. Monitor for respiratory depression, particularly when initiating or increasing dosage. Instruct patients to swallow capsules whole. Do not crush, chew, or dissolve capsules. Accidental ingestion of one dose or more can lead to fatal overdose, especially in children. Prolonged use during pregnancy can lead to potentially life-threatening neonatal opioid withdrawal syndrome. Initiation of CYP3A4 inhibitors or discontinuation of CYP3A4 inducers may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression .

Classifications:

Therapeutic

Analgesic Combination, Opioid

Pharmacologic

Naltrexone

Chemical

Oxycodone

Uses of This Medicine:

Oxycodone and naltrexone combination is used to relieve severe pain. It belongs to the group of medicines called narcotic 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-narcotic 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, 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 with your doctor's prescription.

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:

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.

Children

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.

Older adults

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 Troxyca® ER in order to avoid potentially serious side effects.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

Breast-feeding

Naltrexone

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.

Oxycodone

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.

Other 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.

  • Alfentanil
  • Alphaprodine
  • Amifampridine
  • Anileridine
  • Buprenorphine
  • Butorphanol
  • Codeine
  • Diacetylmorphine
  • Difenoxin
  • Dihydrocodeine
  • Diphenoxylate
  • Ethylmorphine
  • Fentanyl
  • Hydrocodone
  • Hydromorphone
  • Ketobemidone
  • Levorphanol
  • Meperidine
  • Methadone
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Naltrexone
  • Nicomorphine
  • Opium
  • Opium Alkaloids
  • Oxycodone
  • Oxymorphone
  • Papaveretum
  • Paregoric
  • Piritramide
  • Propoxyphene
  • Remifentanil
  • Sufentanil
  • Tapentadol
  • Tilidine
  • Tramadol

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
  • Acepromazine
  • Alfentanil
  • Alprazolam
  • Alvimopan
  • Amiodarone
  • Amisulpride
  • Amprenavir
  • Anileridine
  • Aprepitant
  • Aripiprazole
  • Asenapine
  • Atazanavir
  • Baclofen
  • Benperidol
  • Boceprevir
  • Brofaromine
  • Bromazepam
  • Bromopride
  • Buprenorphine
  • Buspirone
  • Butorphanol
  • Carisoprodol
  • Carphenazine
  • Ceritinib
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpromazine
  • Chlorzoxazone
  • Clarithromycin
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Clorgyline
  • Clozapine
  • Cobicistat
  • Codeine
  • Conivaptan
  • Cyclobenzaprine
  • Darunavir
  • Delavirdine
  • Dexmedetomidine
  • Dezocine
  • Diacetylmorphine
  • Diazepam
  • Dichloralphenazone
  • Difenoxin
  • Dihydrocodeine
  • Diphenhydramine
  • Diphenoxylate
  • Donepezil
  • Doxylamine
  • Droperidol
  • Enflurane
  • Erythromycin
  • Escitalopram
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Etomidate
  • Fentanyl
  • Flibanserin
  • Flunitrazepam
  • Fluphenazine
  • Flurazepam
  • Fluspirilene
  • Fluvoxamine
  • Fosaprepitant
  • Fospropofol
  • Furazolidone
  • Halazepam
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Hydrocodone
  • Hydromorphone
  • Hydroxyzine
  • Idelalisib
  • Imatinib
  • Indinavir
  • Iproniazid
  • Isocarboxazid
  • Isoflurane
  • Ketamine
  • Ketazolam
  • Ketobemidone
  • Ketoconazole
  • Lazabemide
  • Levorphanol
  • Linezolid
  • Loprazolam
  • Lorazepam
  • Lormetazepam
  • Meclizine
  • Medazepam
  • Melperone
  • Meperidine
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methadone
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Methylnaltrexone
  • Midazolam
  • Mifepristone
  • Moclobemide
  • Molindone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nalmefene
  • Nalorphine
  • Naloxegol
  • Naloxone
  • Nefazodone
  • Nelfinavir
  • Nialamide
  • Nicomorphine
  • Nitrazepam
  • Nitrous Oxide
  • Olanzapine
  • Opium
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Papaveretum
  • Paregoric
  • Pargyline
  • Pentazocine
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenelzine
  • Pimozide
  • Piperacetazine
  • Pipotiazine
  • Piritramide
  • Posaconazole
  • Prazepam
  • Procarbazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propofol
  • Propoxyphene
  • Quazepam
  • Quetiapine
  • Ramelteon
  • Rasagiline
  • Regorafenib
  • Remifentanil
  • Remoxipride
  • Ritonavir
  • Samidorphan
  • Saquinavir
  • Selegiline
  • Sertindole
  • Sertraline
  • Sodium Oxybate
  • Sufentanil
  • Sulpiride
  • Tapentadol
  • Telaprevir
  • Telithromycin
  • Temazepam
  • Thiopropazate
  • Thioridazine
  • Ticagrelor
  • Tilidine
  • Tizanidine
  • Tolonium Chloride
  • Toloxatone
  • Topiramate
  • Tramadol
  • Tranylcypromine
  • Triazolam
  • Trifluoperazine
  • Trifluperidol
  • Triflupromazine
  • Trimeprazine
  • Zaleplon
  • Zolpidem
  • Zopiclone
  • Zotepine

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.

  • Miconazole
  • Rifampin
  • St John's Wort
  • Voriconazole
  • 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

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 abuse, or history of or
  • Brain tumor, history of or
  • Breathing problems (eg, hypoxia) or
  • Central nervous system (CNS) depression or
  • Chronic obstructive pulmonary disease (COPD) or
  • Drug dependence, especially with narcotics, or history of or
  • Gallbladder disease or gallstones or
  • Head injuries, history of or
  • Psychosis (a mental disease) Use with caution. May increase risk for more serious side effects.
  • 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 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).

This medicine comes with a Medication Guide. 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 it and pour the medicine into a small amount of applesauce. This mixture must be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the pellets. Do not give this medicine in a nasogastric tube.

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 narcotic 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 narcotic 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 narcotic 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.

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.

Flush any unused capsules down the toilet.

This medicine can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires 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 use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. 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.

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 narcotics, 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.

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. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics 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.

If you 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 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 chills, runny nose, muscle pain, sweating, restlessness, or yawning.

Using this medicine while you are pregnant may cause serious unwanted effects 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.

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).

Make sure your doctor knows about all the other medicines you are using. This medicine may cause a serious condition called serotonin syndrome when taken with certain medicines such as linezolid, mirtazapine, trazodone, MAO inhibitors, some pain medicines (eg, tramadol (Ultram®), sumatriptan (Imitrex®), zolmitriptan (Zomig®), or rizatriptan (Maxalt®). Check with your doctor first before taking any other medicines.

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:

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.


Last Updated: 9/15/2016
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