APO-OXYCODONE

How does this medication work? What will it do for me?

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.

How should I use this medication?

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.

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.

What form(s) does this medication come in?

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.

Who should NOT take this medication?

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

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.

• 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.