Oxycodone and aspirin

Oxycodone and aspirin combination is used to relieve moderate to moderately severe pain. Oxycodone belongs to the group of medicines called narcotic 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, 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.

oxycodone and aspirin is available only with your doctor's prescription.

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:

• Abdominal pain, cramping, or tenderness
• 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 or discomfort
• chills
• clay-colored stools
• constipation
• convulsions
• coughing or vomiting blood
• dark-colored urine
• decrease in urine volume or frequency
• decreased appetite
• depression
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty in passing urine (dribbling)
• 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 sweating
• indigestion
• irregular, fast, slow, or shallow breathing
• large, flat, blue or purplish patches in the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of consciousness
• muscle cramping, weakness, or tremors
• muscle pain or stiffness
• nausea or vomiting
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• 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
• 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
• shivering
• sleepiness
• sunken eyes
• sweating
• swelling of face, ankles, hands, feet, or lower legs
• thirst
• tightness in the chest
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of material that looks like coffee grounds, severe and continuing
• weak or feeble pulse
• weakness or heaviness of the legs
• weight gain
• wrinkled skin
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Continuing ringing or buzzing or other unexplained noise in the ears
• decreased awareness or responsiveness
• diarrhea
• drowsiness
• enlarged pupils
• extremely high fever or body temperature
• fast, weak heartbeat
• hearing loss
• increase in heart rate
• restlessness
• severe sleepiness

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:

• Relaxed and calm feeling
• sleepiness

• 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
• sleepiness or unusual drowsiness
• 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.

(oks i KOE done & AS pir in)

Hypersensitivity (eg, angioedema) to oxycodone, aspirin, or any component of the formulation; use in children and teenagers for viral infections, with or without fever; significant respiratory depression; gastrointestinal obstruction, including paralytic ileus (known or suspected); acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; hemophilia.

Documentation of allergenic cross-reactivity for opioids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Refer to adult dosing.

GFR ≥10 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

GFR <10 mL/minute: Avoid use.

Refer to individual agents.

Also see individual agents

Frequency not defined.

Cardiovascular: Circulatory depression, shock

Central nervous system: Dizziness, dysphoria, euphoria, sedation

Dermatologic: Pruritus

Gastrointestinal: Constipation

Respiratory: Apnea, respiratory depression

<1% (Limited to important or life-threatening): Abdominal pain, accidental injury, acidosis, agitation, alkalosis, anaphylactoid reaction, anaphylaxis, angioedema, anxiety, aspiration, asthma, bradycardia, bronchospasm, cerebral edema, coma, confusion, decreased mental acuity, dehydration, depression, diaphoresis, diarrhea, disseminated intravascular coagulation, drowsiness, drug dependence, duodenal ulcer, dyspepsia, dyspnea, ecchymoses, eructation, eye redness, fever, flushing, gastric ulcer, gastrointestinal hemorrhage, hallucination, headache, hearing loss, hemorrhage, hemorrhage (subdural), hepatitis, hyperglycemia, hyperkalemia, hypersensitivity reaction, hyperventilation, hypoglycemia, hypogonadism (Brennan 2013; Debono 2011), hypotension, hypothermia, hypoventilation, increased liver enzymes (transient), increased thirst, interstitial nephritis, intestinal obstruction, intestinal perforation, intracranial hemorrhage, laryngeal edema, lethargy, malaise, metabolic acidosis, miosis, nausea, nervousness, orthostatic hypotension, palpitations, pancreatitis, paresthesia, prolonged prothrombin time, proteinuria, pulmonary edema, purpura, renal failure, renal insufficiency, renal papillary necrosis, respiratory alkalosis, reticulocytosis, Reye syndrome, rhabdomyolysis, seizure, skin rash, stupor, tachycardia, tachypnea, thrombocytopenia, tinnitus, urinary retention, urticaria, visual disturbance, vomiting, weakness, xerostomia

Oxycodone/aspirin exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing oxycodone/aspirin and monitor all patients regularly for the development of these behaviors and conditions.

Serious, life-threatening, or fatal respiratory depression may occur with use of oxycodone/aspirin. Monitor for respiratory depression, especially during initiation of oxycodone/aspirin or following a dose increase.

Accidental ingestion of even one dose of oxycodone/aspirin, especially by children, can result in a fatal overdose of oxycodone.

Prolonged use of oxycodone/aspirin during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

The concomitant use of oxycodone/aspirin with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving oxycodone/aspirin and any CYP3A4 inhibitor or inducer.

Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of oxycodone/aspirin and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.