Oxycodone/Aspirin, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to relieve moderate to severe pain. Take it exactly as directed. Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death.
• This medicine may make you constipated. Talk with your provider about this.
• This medicine may cause serious or life-threatening breathing problems, ulcers and bleeding in the stomach and intestines or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Taking this medicine with alcohol or other medicines that make you sleepy or slow your breathing can cause coma or death. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: narcotic (opioid) pain reliever/analgesic

Generic and brand names: oxycodone/aspirin, oral; Endodan; Percodan

What is this medicine used for?

This medicine is a combination of 2 medicines taken by mouth to treat moderate to severe pain. Aspirin helps decrease pain and inflammation, and oxycodone (a narcotic) decreases pain.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, ulcerative colitis, or severe constipation
• A stroke, head injury, or brain tumor
• Addison's disease
• Blood disorders or bleeding problems
• Diabetes
• Gout
• Heart problems
• Liver or kidney disease
• Low blood pressure
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Mental health problems such as depression or bipolar disorder
• Nasal polyps
• Pancreas or gallbladder problems
• Porphyria (nerve pain or sensitivity to sunlight)
• Problems with alcohol or drug abuse
• Seizures
• Thyroid problems
• Trouble urinating or an enlarged prostate gland
• Ulcers

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. This medicine is not usually given to pregnant women because it can harm the baby, especially during the last 3 months of pregnancy. Do not become pregnant during treatment with this medicine. Long-term use of this medicine during pregnancy can cause withdrawal symptoms in your newborn baby. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or take it longer than prescribed.

Check with your healthcare provider before you give any medicine that contains aspirin or salicylates to a child or teen under age 18. Do not give medicines that contain aspirin to children and teenagers with flu symptoms or chickenpox without your healthcare provider's approval. It may lead to a rare but serious illness known as Reye's syndrome.

Do not take additional aspirin or products that contain aspirin unless directed to do so by your healthcare provider. This medicine also contains aspirin and it may increase your risk of bleeding. Taking an overdose can cause serious problems. If you are not sure about which products contain aspirin, ask your pharmacist.

You may take this medicine with or without food. Taking it with meals or milk may lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: extreme drowsiness, pinpoint pupils, vision problems, confusion, trouble breathing or breathing that stops, muscle weakness, seizures, headache, nausea, vomiting, diarrhea, sweating, dizziness, ringing in the ears, cold and clammy skin, slow heartbeat, sweating, coma.

What should I watch out for?

Do not take other medicines unless you check with your healthcare provider first. Taking this medicine with alcohol or medicines that make you sleepy or slow your breathing can cause life-threatening side effects. Tell your healthcare if you take any kind of sleeping pill, pain medicine, muscle relaxant, nausea medicine, or medicine to treat anxiety, depression, or seizures. This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as migraine medicines, some cough medicines, St. John’s wort, and others. Make sure that your healthcare providers know ALL of the medicines that you take.

This medicine may cause life-threatening or fatal breathing problems. Taking this medicine for a long time may also cause a rare but very serious adrenal gland problem or decreased sex hormone levels. Talk with your healthcare provider about this.

Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death. Take it exactly as directed by your healthcare provider. Do not take more of it or take it more often than directed. Taking too much of this medicine increases your chance of side effects. If you use this medicine regularly for a long time or in high doses, ask your healthcare provider how to reduce your dose gradually. Follow your healthcare provider’s instructions about how to stop taking the medicine.

This medicine is a controlled substance. It is illegal for you to give it to anyone else. Keep this medicine away from children. Accidental use by a child can cause death.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert. This medicine may make you feel dizzy or faint, especially when you get up from sitting or lying down. Getting up slowly may help.

This medicine may make you constipated. You may need to take a laxative or stool softener while taking this medicine. Talk with healthcare provider or pharmacist about this.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Trouble breathing; slow or shallow breathing; extreme sleepiness; confusion; hallucinations (seeing or hearing things that are not there); fast, slow, or irregular heartbeat; bloody or dark urine; black or tarry bowel movements; unusual bruising or bleeding; unusual tiredness or weakness; decreased or trouble urinating; yellowing of your skin or eyes; severe nausea or vomiting; severe or continued stomach pain; severe constipation; severe diarrhea; mood changes; trembling; severe headache; severe dizziness or fainting; ringing or buzzing in the ears; pinpoint pupils.

Other: Diarrhea, dizziness, drowsiness, confusion, blurred vision, decreased appetite, constipation, change in sexual desire or ability, minor itching, nausea, dry mouth.

What products might interact with this medicine?

This medicine may interact with MANY other medicines and cause life-threatening side effects. This list does not include all possible medicines that may interact. Do not start or stop ANY medicine unless you check with your healthcare provider or pharmacist first. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Tell your healthcare provider all the products you take, for example:

• Abiraterone (Zytiga)
• ACE inhibitors such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), and others
• Acetazolamide (Diamox)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, diazepam (Valium), lorazepam (Ativan), and others
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), telithromycin (Ketek), and others
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), and others
• Antidepressants such as duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), venlafaxine (Effexor), and others
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), voriconazole (Vfend), and others
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), meclizine (Dramamine), and others
• Antipsychotic medicines such as clozapine (Clozaril, FazaClo), haloperidol (Haldol), olanzapine (Zyprexa), ziprasidone (Geodon), and others
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenytoin (Dilantin, Phenytek), topiramate (Qudexy, Topamax, Trokendi), valproic acid (Depacon, Depakene, Depakote), and others
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, secobarbital (Seconal), and others
• Beta blockers such as bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), and others
• Bladder control medicines such as darifenacin (Enablex), oxybutynin (Ditropan XL, Oxytrol), solifenacin (VESIcare), and tolterodine (Detrol)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cidofovir (Vistide)
• Corticosteroids such as dexamethasone, methylprednisolone (Medrol, Solu-Medrol), prednisone (Prednisone Intensol), and others
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), repaglinide (Prandin), rosiglitazone (Avandia), and others
• Diuretics (water pills) such as bumetanide, furosemide (Lasix), hydrochlorothiazide (Microzide), torsemide (Demadex), and others
• Doxepin (Silenor)
• Gemfibrozil (Lopid)
• Heart medicines such as amiodarone (Cordarone, Pacerone), dronedarone (Multaq), quinidine, and others
• HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and others
• Imatinib (Gleevec)
• Isoniazid
• Live flu vaccine (FluMist nasal spray)
• Lorcaserin (Belviq)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines that block or may partially block the effect of narcotic pain medicines such as buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv), bupropion/naltrexone (Contrave), naltrexone (ReVia, Vivitrol), and others
• Medicines to treat breathing or lung problems such as aclidinium (Tudorza), ipratropium (Atrovent), tiotropium (Spiriva), and umeclidinium (Incruse Ellipta), and others
• Medicines to treat or prevent blood clots such as clopidogrel (Plavix), dabigatran (Pradaxa), rivaroxaban (Xarelto), warfarin (Coumadin), and others
• Methazolamide (Neptazane)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), tizanidine (Zanaflex), and others
• Narcotic allergy, cold, or cough medicines such as guaifenesin/codeine (Robitussin AC, Tussi-Organidin), hydrocodone/chlorpheniramine (Tussionex), promethazine/codeine (Phenergan with codeine), and others
• Natural remedies such as garlic, ginger, ginkgo, glucosamine, St. John's wort, tryptophan, and others
• Nilotinib (Tasigna)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), ibuprofen (Advil, Motrin), meloxicam (Mobic), naproxen (Aleve, Anaprox, Naprelan), and others
• Other medicines that contain salicylates such as Alka Seltzer and Pepto Bismol
• Other pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), morphine (Kadian, MS Contin), and others
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pralatrexate (Folotyn)
• Probenecid
• Prochlorperazine (Compro)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• Rifampin (Rifadin)
• Sleeping pills such as eszopiclone (Lunesta), triazolam (Halcion), zaleplon (Sonata), zolpidem (Ambien, Edluar, Intermezzo), and others
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Tedizolid (Sivextro)
• Varicella (chickenpox) vaccine or varicella zoster (shingles) vaccine

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.