Description
Oxycodone and aspirin combination is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. Oxycodone belongs to the group of medicines called opioid analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.
Aspirin is used to relieve pain and reduce fever in patients. Aspirin belongs to the group of medicines known as salicylates and acts on the immune system to reduce inflammation. It is also known as an antiinflammatory analgesic.
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 under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.
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 oxycodone and aspirin combination in the pediatric population. Because of aspirin's toxicity, use in children is not recommended. Do not give aspirin to a child who has chickenpox or flu symptoms, unless approved by a doctor. Aspirin can cause a life-threatening reaction called Reye syndrome.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone and aspirin combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving oxycodone and aspirin combination.
Breastfeeding
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.
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.
- Abrocitinib
- Defibrotide
- Dichlorphenamide
- Influenza Virus Vaccine, Live
- Ketorolac
- Levoketoconazole
- Mavorixafor
- Naltrexone
- Safinamide
- Samidorphan
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
- Acarbose
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Acepromazine
- Acetazolamide
- Aclidinium
- Alclometasone
- Aldosterone
- Alfentanil
- Alipogene Tiparvovec
- Almotriptan
- Alosetron
- Alprazolam
- Alteplase, Recombinant
- Amantadine
- Amcinonide
- Amifampridine
- Amikacin
- Amiloride
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amphotericin B
- Amprenavir
- Amtolmetin Guacil
- Anagrelide
- Anileridine
- Anisindione
- Apalutamide
- Apixaban
- Aprepitant
- Ardeparin
- Argatroban
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.
- Acebutolol
- Atenolol
- Betaxolol
- Bisoprolol
- Carteolol
- Carvedilol
- Celiprolol
- Delapril
- Esmolol
- Imidapril
- Labetalol
- Levobunolol
- Metipranolol
- Metoprolol
- Nadolol
- Nebivolol
- Nitroglycerin
- Oxprenolol
- Penbutolol
- Pindolol
- Probenecid
- Propranolol
- Sotalol
- Streptokinase
- Tamarind
- Temocapril
- Tenecteplase
- Timolol
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
Using this medicine with any of the following may cause an increased risk of certain side effects 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 use disorder, or history of or
- Bleeding problems or
- Brain tumor, history of or
- Breathing or lung problems (eg, COPD, sleep apnea) or
- Cor pulmonale (serious heart condition) or
- Drug dependence, especially with opioids, or history of or
- Gallbladder disease or gallstones or
- Head injury, history of or
- Hypothyroidism (an underactive thyroid) or
- Hypovolemia (low blood volume) or
- Kyphoscoliosis (curvature of the spine with breathing problems) or
- Peptic ulcer disease, active or history of or
- Problems with passing urine or
- Prostatic hypertrophy (enlarged prostate, BPH) or
- Vitamin K deficiency—Use with caution. May increase risk for more serious side effects.
- Hemophilia (bleeding problem) or
- Kidney disease, severe or
- Liver disease, severe or
- Lung or breathing problems (eg, asthma, respiratory depression), severe or
- Reye's syndrome or
- Stomach or bowel blockage (eg, paralytic ileus) or
- Viral infection—Should not be used in patients with these conditions.
- Hypotension (low blood pressure) or
- Pancreatitis (swelling of the pancreas) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Kidney disease, mild to moderate or
- Liver disease, mild to moderate—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).
It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of oxycodone and aspirin combination. This medicine should come with a Medication Guide. Read and follow the instructions carefully. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.
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 (tablets):
- For moderate to moderately severe pain:
- Adults—At first, 1 tablet every 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 12 tablets per day.
- Children—Use and dose must be determined by your doctor.
- For moderate to moderately severe pain:
Missed Dose
If you miss a dose of this medicine, 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.
Store the medicine in a safe and secure place. 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
Precautions
It is very important that your doctor check your progress while you are using 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 and urine tests may be needed to check for unwanted effects.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) including isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
Using this medicine while you are pregnant, especially during the later part of pregnancy may cause serious unwanted effects, including neonatal 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.
This medicine may be present in your breast milk and passed to your baby. Breastfeeding is usually not recommended while taking this medicine. Talk to your doctor if you plan to breastfeed.
Check with your doctor before using Percodan® with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with Percodan® may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or opioids, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also 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. Signs 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 may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
Do not change your dose or suddenly stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This will decrease your chance of having withdrawal symptoms, including restlessness, chills, muscle pain, runny nose, sweating, tearing of the eyes, or yawning.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
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. If this problem continues or gets worse, check with your doctor right away.
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.
This medicine may cause bleeding in your stomach or bowels. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (eg, NSAIDs).
Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.
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.
This medicine may cause bleeding in your stomach or bowels. Check with your doctor right away if you have bloody or black, tarry stools, heartburn, nausea, vomiting, stomach pain, or vomiting of blood or material that looks like coffee grounds.
This medicine may cause a serious allergic reaction called anaphylaxis, which 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.
Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of serious skin reaction including drug reaction with eosinophilia and systemic symptoms (DRESS).
For nursing mothers:
- Talk to your doctor if you have any questions about taking oxycodone or about how this medicine may affect your baby.
- Call your doctor if you become extremely tired and have difficulty caring for your baby.
- Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
- Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan 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:
Incidence not known
- Agitation
- bleeding gums
- bloating
- blood in the urine or stools
- bloody, black, or tarry stools
- blue lips, fingernails, or skin
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in consciousness or confusion
- chest pain, tightness, or discomfort
- chills
- clay-colored stools
- confusion
- cough
- coughing or vomiting blood
- dark urine
- darkening of the skin
- decrease in urine volume or frequency
- decreased appetite
- depression
- difficult, fast, noisy breathing
- difficulty in passing urine (dribbling)
- difficulty having a bowel movement (stool)
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- dry mouth
- fainting
- fast, slow, irregular, pounding, or racing heartbeat or pulse
- feeling of hostility or irritability
- feeling of warmth
- feeling that something terrible will happen
- fever
- headache, sudden, severe
- heartburn
- hives, itching, or skin rash
- increased menstrual flow or vaginal bleeding
- increased sensitivity to pain
- increased sweating
- indigestion
- irregular, fast, slow, or shallow breathing
- large, flat, blue or purplish patches on the skin
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of consciousness
- muscle cramps, pain, stiffness, weakness, or tremors
- nausea
- nosebleeds
- numbness or tingling in the hands, feet, or lips
- overactive reflexes
- painful or difficult urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- pinpoint red or purple spots on the skin
- poor coordination
- prolonged bleeding from cuts
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red or black, tarry stools or dark urine
- restlessness
- seizures
- shivering
- sleepiness
- sunken eyes
- sweating
- swelling of the face, ankles, hands, feet, or lower legs
- stomach pain, cramping, or tenderness
- talking or acting with excitement you cannot control
- thirst
- trembling or shaking
- twitching
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- vomiting of material that looks like coffee grounds, severe and continuing
- weak or feeble pulse
- weakness or heaviness of the legs
- weight gain
- worsening of pain
- wrinkled skin
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blue lips and fingernails
- blurred vision
- change in consciousness
- chest pain
- cold, clammy skin
- confusion
- continuing ringing or buzzing or other unexplained noise in the ears
- coughing that sometimes produces a pink frothy sputum
- decreased awareness or responsiveness
- diarrhea
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- enlarged pupils
- extremely high fever or body temperature
- fast, weak heartbeat
- hearing loss
- increase in heart rate
- increased sweating
- loss of consciousness
- pale skin
- restlessness
- severe sleepiness
- swelling in legs and ankles
- unusual tiredness or weakness
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
- Relaxed and calm feeling
- sleepiness
Incidence not known
- Belching
- bloated, full feeling
- blurred or loss of vision
- change in color perception
- cold sweats
- constricted, pinpoint, or small pupils (black part of the eye)
- cool, pale skin
- double vision
- excess air or gas in the stomach
- false or unusual sense of well-being
- flushed, dry skin
- fruit-like breath odor
- halos around lights
- increased hunger or thirst
- increased urination
- lack or loss of strength
- night blindness
- nightmares
- overbright appearance of lights
- red eyes
- redness of the skin
- seeing, hearing, or feeling things that are not there
- shakiness
- slurred speech
- trouble sleeping
- tunnel vision
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- weight 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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