How does this medication work? What will it do for me?
This combination medication contains two active ingredients: oxycodone and naloxone. Oxycodone belongs to the group of medications known as opioid analgesics (narcotic pain relievers). Naloxone belongs to a group of medications known as opiate antagonists and is used to lessen the constipation caused by oxycodone. This combination is used to treat severe pain for adults who require 24-hour pain relief for several days or more. It should only be used by people for whom other treatment options are ineffective or not tolerated.
Oxycodone decreases pain by working on the central nervous system. Naloxone works by blocking receptors in the gut that slow the elimination of the stool. This medication relieves pain for up to 12 hours.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
5 mg/2.5 mg tablet
Each blue, oblong, controlled-release tablet with a film coating, marked "OXN" on one side and "5" on the other, contains 5 mg of oxycodone hydrochloride and 2.5 mg of naloxone hydrochloride. Nonmedicinal ingredients: tablet core: ethylcellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, stearyl alcohol, and talc; tablet coating: Opadry II blue, FD&C Blue No. 1 Aluminum Lake (E133), polyethylene glycol (Macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide (E171).
10 mg/5 mg tablet
Each white, oblong, controlled-release tablet with a film coating, marked "OXN" on one side and "10" on the other contains 10 mg of oxycodone hydrochloride and 5 mg of naloxone hydrochloride. Nonmedicinal ingredients: tablet core: ethylcellulose, lactose monohydrate, magnesium stearate, povidone K30, stearyl alcohol, and talc; tablet coating: Opadry II white, polyethylene glycol (Macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide (E171).
20 mg/10 mg tablet
Each pink, oblong, controlled-release tablet with a film coating, marked "OXN" on one side and "20" on the other contains 20 mg of oxycodone hydrochloride and 10 mg of naloxone hydrochloride. Nonmedicinal ingredients: tablet core: ethylcellulose, lactose monohydrate, magnesium stearate, povidone K30, stearyl alcohol, and talc; tablet coating: Opadry II pink, iron oxide red (E172), polyethylene glycol (Macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide (E171).
40 mg/20 mg tablet
Each yellow, oblong, controlled-release tablet with a film coating, marked "OXN" on one side and "40" on the other contains 40 mg of oxycodone hydrochloride and 20 mg of naloxone hydrochloride. Nonmedicinal ingredients: tablet core: ethylcellulose, lactose monohydrate, magnesium stearate, povidone K30, stearyl alcohol, and talc; tablet coating: Opadry II yellow, iron oxide yellow (E172), polyethylene glycol (Macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide (E171).
How should I use this medication?
The usual recommended dose of oxycodone - naloxone is one tablet taken by mouth every 12 hours. This medication should be started at a low dose and gradually increased as needed for further relief. The maximum daily dose is 80 mg of oxycodone and 40 mg of naloxone per day or 40 mg of oxycodone and 20 mg of naloxone every 12 hours.
Swallow the tablet whole and do not chew, break, crush, or dissolve it. Doing so may cause too much medication to be absorbed into the body at one time and may be fatal.
This medication can be taken with or without food and should be taken with enough fluid (e.g., a glass of water). Do not take this medication by the rectal route.
Due to the formulation of the tablets, you may see the remains of the tablet in your stool. This empty matrix no longer contains any medication.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice. If you miss more than 2 or 3 doses in a row, talk to your doctor about how you should restart the medication.
Store this medication at room temperature, protect it from light, heat, and moisture, and keep it out of the reach of children. Accidental ingestion of this medication by a child can result in severe harm or even death.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to oxycodone, naloxone, or any ingredients of the medication
- are breast-feeding, pregnant, or during labour and delivery
- are dependent upon opioids or are being treated for narcotic withdrawal
- are taking monoamine oxidase (MAO) inhibitors (or have taken MAO inhibitors within the past 14 days)
- have a recent head injury
- have acute alcoholism, delirium tremens, or a convulsive disorder (seizures)
- have acute asthma or other obstructive airway condition, or status asthmaticus
- have acute pain (pain that has lasted a short period of time)
- have acute respiratory depression, increased carbon dioxide levels in the blood, and cor pulmonale
- have immediate post-operative pain (i.e., surgery less than 24 hours ago)
- have known or suspected mechanical gastrointestinal obstruction (e.g., bowel obstruction, strictures) or any diseases or conditions that affect the movement of the bowel
- have mild, intermittent, or short duration pain that can be managed with other pain medications
- has moderately to severely reduced liver function
- have severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury
- have suspected surgical abdomen (e.g., acute appendicitis or pancreatitis)
- have severely reduced kidney function
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- decreased interest in sexual activity
- decreased sexual ability
- dizziness or light-headedness
Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- fast, slow, or irregular, pounding heartbeat
- low blood pressure (e.g., dizziness, fainting, light-headedness)
- severe diarrhea (or diarrhea that lasts more than 3 days)
- withdrawal symptoms (e.g., nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating)
- worsening pain
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- slow, shallow, weak breathing
- symptoms of a blockage in the bowel (e.g., abdominal pain, severe constipation, nausea)
- symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)
- symptoms of too much medication (overdose; e.g., cold, clammy skin; feeling faint, dizzy, confused, or unable to think, walk, or talk normally; hallucinations; cold and clammy skin; severe drowsiness; slow, shallow breathing or difficulty breathing; slow heartbeat)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Abdominal (stomach) conditions: Oxycodone-naloxone, like other narcotic medications, may make diagnosing abdominal conditions more difficult or it may worsen these conditions. If you have abdominal problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Accidental use: When this medication is used by anyone other than the person for whom it was prescribed, the effects of even one dose may be fatal. Keep this medication out of sight and reach of children. If a child accidentally ingests this medication, get immediate medical attention.
Adrenal gland problems: Adrenal glands produce chemical messengers that are responsible for the normal function of the body's organs, including maintaining blood pressure and response to injury or stress. When used for prolonged periods of time, opioid medications, such as oxycodone, may cause your adrenal glands to stop functioning properly. If you experience symptoms such as nausea, vomiting, dizziness, loss of appetite, or fatigue, talk to your doctor.
Alcohol and other medications that cause drowsiness: Do not combine this medication with alcohol or other medications (e.g., antidepressants, sleeping pills, anxiety medications) that cause drowsiness. Doing so can cause additional drowsiness and reduced breathing which can be dangerous and life threatening.
Breathing: Oxycodone can suppress breathing. If you have asthma, sleep apnea, or another lung disease that increases your risk for breathing difficulties, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Dependence: As with other opioid medications (narcotics), this medication may become habit-forming if taken for long periods of time. Misuse of oxycodone - naloxone usually is not a problem when it is used appropriately for pain relief. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication.
Withdrawal symptoms (e.g., body aches, diarrhea, nausea, nervousness, restlessness, runny nose, sneezing, goose bumps, shaking, shivering, nausea, stomach cramps, fast heart rate, fever, sweating) may occur if oxycodone - naloxone is stopped suddenly. People who are taking this medication for a long time and no longer require it for pain control should stop the medication gradually as directed by their doctor.
Drowsiness/reduced alertness: People taking oxycodone - naloxone should not drive a car or perform hazardous tasks until they determine that this medication does not impair their ability to perform these tasks safely.
Head injury: If you have a head injury or increased pressure in the head, you may have a higher risk of experiencing side effects (breathing problems) or worsening of your condition while taking this medication. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of your medication, and whether any special monitoring is needed.
Heart problems: This medication may worsen symptoms of heart disease. If you have heart disease such as angina, congestive heart failure, or another condition that can be affected by reduced blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
Low blood pressure: Some people taking oxycodone - naloxone may experience sudden blood pressure drops when getting up from a sitting or lying position. These blood pressure drops could lead to dizziness, lightheadedness, and falls. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor. If you have or have had heart disease, a stroke, a "mini-stroke," or are at risk of experiencing low blood pressure (e.g., dehydration, taking medications for high blood pressure), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Proper use of medication: Oxycodone - naloxone must be swallowed whole and is meant to work over a 12-hour period. Do not chew, break, crush, or dissolve the tablet because the entire 12-hour dose will be absorbed quickly into your body. This can cause serious problems such as overdose, which can be fatal.
Accidental use of this medication by people other than the person for whom it is prescribed can be fatal.
Seizures: There have been reports of seizures occurring with this medication. Seizures are more likely to occur when higher doses of this medication are taken. If you have a history of epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Serotonin syndrome: Severe reactions are possible when this medication is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, medications used to treat depression. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, or changes in mental state including delirium and agitation. Coma and death are possible.
If you are taking antidepressants, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Surgical pain: This medication should not be used to control pain for 24 hours before or after surgery.
Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Babies born to mothers who have used this medication during pregnancy may experience withdrawal symptoms that may be life-threatening.
Breast-feeding: Oxycodone and naloxone pass into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Oxycodone-naloxone is not recommended for breast-feeding mothers.
Children: The safety and effectiveness of using this medication have not been established for children. Accidental ingestion of this medication by children may have severe and even fatal consequences. Keep this medication out of the reach of children.
Seniors: Seniors may be more sensitive to the side effects of this medication as a result of reduced kidney, liver, and heart function.
What other drugs could interact with this medication?
There may be an interaction between oxycodone - naloxone and any of the following:
- amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
- antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
- benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
- chloral hydrate
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- ergot alkaloids (e.g., ergotamine, dihydroergotamine)
- general anesthetics (medications used to put people to sleep before surgery)
- grapefruit juice
- HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- kava kava
- lumacaftor and ivacaftor
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
- muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
- narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
- certain protein kinase inhibitors (e.g., crizotinib, dabrafenib, dasatinib, imatinib, nilotinib)
- St. John's wort
- seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
- "triptan" migraine medications (e.g., eletriptan, rizatriptan, sumatriptan)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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