This combination product contains two medications: oxycodone and acetaminophen. Acetaminophen belongs to the group of medications called analgesics (pain relievers) and antipyretics (fever reducers). Oxycodone belongs to the group of medications called narcotic analgesics. Oxycodone - acetaminophen is used to relieve moderate to moderately severe pain, including conditions associated with fever. This medication should only be used when other non-narcotic pain medications are not effective or tolerated.

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.

The dosage varies according to each individual and can be affected by the severity of the pain as well as each person's response to the medication.

The usual recommended adult dose of oxycodone - acetaminophen (each tablet contains 5 mg oxycodone and 325 mg acetaminophen) is one tablet every 6 hours as needed for pain. This medication should be used at the lowest dose that provides pain relief for a maximum of 7 days.

Swallow the tablets whole with fluid. Do not cut, break, crush, chew, or dissolve the tablets. Doing so can result in dangerous adverse events, including death.

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.

This medication may be habit-forming if taken for long periods of time. Do not stop taking this medication without talking with your doctor. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shakiness, nausea, tremors, diarrhea, or hallucinations. If you plan on stopping the medication, your doctor may want you to reduce the dose gradually to reduce the severity of withdrawal effects.

It is important to take this medication exactly as prescribed by your doctor. If your doctor has told you to take this medication on a regular basis and you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next 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.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Each white-to-off-white, round, biconvex tablet, engraved "APO" on one side, "5" over score "325" on the other side, contains 5 mg of oxycodone HCl and 325 mg of acetaminophen. Nonmedicinal ingredients:microcrystalline cellulose, povidone, starch, sodium starch glycolate, and stearic acid.

Do not take this medication if you:

• are allergic to oxycodone, acetaminophen, or to any of the ingredients of the medication
• have severely decreased liver function or active liver disease
• have a seizure disorder
• have pre-existing respiratory depression
• have status asthmaticus (unresponsive asthma)
• are pregnant, breast-feeding, or in labour
• are taking or have taken (within the last 14 days) MAO inhibitors (e.g., phenelzine, tranylcypromine)
• have a head injury
• have a brain tumour
• have acute alcoholism
• have mild pain that can be controlled by occasional use of pain medications
• have acute asthma or other obstructive airway diseases (e.g., chronic bronchitis, emphysema)
• have cor pulmonale (heart failure caused by chronic high blood pressure in the arteries of the lungs)
• have delirium tremens (e.g., confusion, diarrhea, shaking, fever, hallucinations, disorientation) associated with alcohol withdrawal
• have increased cerebral spinal fluid pressure
• have increased levels of carbon dioxide in the blood
• have an abdominal condition that may require immediate surgery (e.g., appendicitis, pancreatitis)
• have or may have bowel or digestive system problems (e.g., paralytic ileus), or may have a blockage in the digestive system

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.

• constipation
• decreased ability or interest in sexual activity
• decreased coordination
• dizziness
• drowsiness
• headache
• itching
• lightheadedness or feeling faint
• nausea
• sweating
• vomiting
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blurred or double vision or other changes in vision
• difficulty sleeping
• dizziness when rising from a lying down or sitting position
• dry mouth
• fast, slow, or pounding heartbeat
• loss of appetite
• symptoms of withdrawal (e.g., nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• convulsions (seizures)
• signs of a bowel blockage (abdominal pain, nausea, severe constipation)signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of breathing problems (e.g., shallow, irregular breathing, or slow or troubled breathing)
• signs of severe skin reactions (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)
• symptoms of overdose (e.g., cold, clammy skin, abnormally slow or weak breathing, severe dizziness, confusion, slow heartbeat, or extreme drowsiness)
• symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)

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.

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 conditions: Oxycodone may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. People with abdominal conditions such as inflammatory or obstructive bowel disease, acute cholecystitis, or pancreatitis should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Accidental use: When oxycodone - acetaminophen is used by anyone other than the person for whom it was prescribed, the effects of the medication may be fatal. Children are especially at risk. Keep this medication out of sight and reach of children.

Alcohol and other medications that cause drowsiness: People taking this medication should not combine it with alcohol, and should avoid combining it with other medications that cause drowsiness or slow down your breathing (e.g., antidepressants, sleeping pills, anxiety medications). Doing so can cause additive drowsiness and reduced breathing, as well as other side effects, which can be dangerous and possibly fatal.

Breathing: Oxycodone can suppress breathing. People at risk for breathing difficulties, such as asthma, should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dependence and withdrawal: This medication contains oxycodone. Physical dependence, psychological dependence, and abuse have occurred with the use of oxycodone. 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. Abuse is not a problem with people who require this medication for pain relief. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.

Drowsiness/reduced alertness: This medication may cause drowsiness. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.

Head injury: People with head injuries or increased pressure in the head may have a higher risk of experiencing side effects (breathing problems) or worsening of their condition while taking this medication. These people should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: Decreased kidney function can 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: Acetaminophen can cause severe and potentially fatal liver damage. Acetaminophen is a common ingredient in many non-prescription medications for colds and flu, pain, arthritis, and fever. Check the product label on all the medications you are taking to make sure that you are not exceeding the recommended dose of acetaminophen. An overdose of acetaminophen can lead to potentially fatal liver damage.

Contact your doctor immediately if you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin.

Low blood pressure: This medication can make low blood pressure worse or cause low blood pressure, which may be severe. If you experience severe dizziness, especially when standing from a lying or sitting position, contact your doctor.

Other medical conditions: People about to undergo surgery of the biliary tract should use caution while taking oxycodone as it may worsen their condition. Oxycodone will worsen the effects of acute alcohol intoxication and delirium tremens.

As well, people with an irregular heart rhythm, low blood pressure, low thyroid (hypothyroidism), Addison's disease, benign prostatic hypertrophy (enlarged prostate), urethral stricture, decreased function of the adrenal glands, or porphyria should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Seizures: This medication may cause seizures, especially when higher doses are used or when taken with other medications that may increase the risk of seizures. The risk of seizures is also higher for people with epilepsy, a history of seizures, or who are at risk of seizures (e.g., people with head trauma).

Serotonin Syndrome: Although rare, severe reactions are possible when oxycodone is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, medications used to treat depression. These combinations should be avoided if possible. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, 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.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Infants born to mothers who have taken oxycodone during pregnancy have been born with signs of narcotic withdrawal. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking oxycodone and acetaminophen, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using full-strength oxycodone - acetaminophen have not been established for children under 18 years of age.

Seniors: Seniors who take this medication may be more likely to experience side effects or worsening of preexisting medical conditions.

There may be an interaction between oxycodone - acetaminophen and any of the following:

• acetazolamide
• aclidinium
• alcohol
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• anesthetics
• antihistamines (e.g., bilastine, cetirizine, dimenhydrinate, diphenhydramine, hydroxyzine, rupatadine)
• antipsychotics (e.g., haloperidol, quetiapine, olanzapine, perphenazine, risperidone, thioridazine)
• aprepitant
• atropine
• azelastine
• "azole" antifungal medications (e.g., fluconazole, itraconazole, ketoconazole)
• barbiturates (e.g., butalbital, phenobarbital)
• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
• benztropine
• bosentan
• brimonidine
• buprenorphine
• bupropion
• buspirone
• butorphanol
• cannabis
• chloral hydrate
• clidinium
• cobicistat
• conivaptan
• diuretics (e.g., amiloride, bumetanide, furosemide, hydrochlorothiazide)
• desmopressin
• diltiazem
• diphenoxylate
• disopyramide
• domperidone
• dronedarone
• efavirenz
• etravirine
• eluxadoline
• entacapone
• enzalutamide
• eplerenone
• esketamine
• fesoterodine
• flibanserin
• flunarizine
• glycopyrrolate
• grapefruit juice
• HIV protease inhibitors (e.g., darunavir, indinavir, lopinavir, ritonavir saquinavir)
• ipratropium
• isoniazid
• kava kava
• lemborexant
• letermovir
• lidocaine
• linezolid
• lithium
• macrolide antibiotics (e.g., clarithromycin, erythromycin,)
• methylene blue
• metoclopramide
• mifepristone
• mirabegron
• mirtazapine
• modafinil
• monoamine oxidase inhibitors (MAOIs; e.g., tranylcypromine, phenelzine, moclobemide, rasagiline, selegiline)
• muscle relaxants (e.g., baclofen, methocarbamol, orphenadrine)
• naltrexone
• other narcotic analgesics (e.g., fentanyl, codeine, morphine)
• oxybutynin
• pegvisomant
• phenylephrine
• pomalidomide
• pregabalin
• protein kinase inhibitors (e.g., ceritinib, crizotinib, dabrafenib, dasatinib, imatinib, nilotinib)
• quinidine
• rifabutin
• rifampin
• ropinirole
• rotigotine
• St. John's wort
• scopolamine
• seizure medications (e.g., carbamazepine, felbamate, lamotrigine, levetiracetam, phenytoin, primidone, topiramate, vigabatrin)
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, sertraline)
• serotonin/norepinephrine reuptake inhibitors (e.g., desvenlafaxine, duloxetine, venlafaxine)
• sodium oxybate
• somatostatin analogues (e.g., lanreotide, octreotide, pasireotide)
• tetrabenazine
• tiotropium
• tizanidine
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine)
• tryptophan
• valerian
• verapamil
• warfarin
• zolpidem
• zopiclone

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.