Xolox (Oral)

Oxycodone and acetaminophen mix is used to eliminate pain severe enough to need opioid therapy and when other discomfort medicines did not function well adequate or can not be tolerated.

Acetaminophen is utilized to alleviate pain and minimize fever in people. It does not come to be habit-forming when taken for a long time. However acetaminophen might cause other unwanted impacts when taken in huge doses, including liver damages.

Oxycodone comes from the group of medicines called numbing anesthetics (discomfort medicines). It acts on the central nervous system (CNS) to alleviate pain.

When oxycodone is made use of for a very long time, it might end up being habit-forming, triggering psychological or physical dependancy. Nevertheless, individuals that have proceeding pain ought to not allow the worry of dependancy keep them from utilizing narcotics to soothe their pain. Mental dependancy (dependency) is not most likely to happen when narcotics are utilized for this purpose. Physical dependancy may result in withdrawal side effects if treatment is quit all of a sudden. Nonetheless, extreme withdrawal negative effects can generally be avoided by gradually decreasing the dose over a time period prior to therapy is stopped totally.

This medication is readily available only with your physician's prescription. Percocet ® and Xartemis ™ are offered just under a restricted circulation program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

It is very important that your physician check your development while you are taking this medication, especially within the first 24 to 72 hours of treatment. This will permit your doctor to see if the medicine is functioning correctly and to make a decision if you should remain to take it. Blood and urine examinations may be needed to look for undesirable results.

It is against the legislation and unsafe for anyone else to utilize your medicine. Maintain your unused medicine in a risk-free and secure area. Individuals that are addicted to medications may wish to take it.

Get in touch with your physician prior to utilizing this medication with alcohol or various other medicines that affect the central nerve system (CNS). This medicine will contribute to the results of alcohol and other CNS depressants (medications that can make you sluggish or less sharp). Some examples of CNS downers are antihistamines or medication for allergic reactions or colds, sedatives, depressants, or sleeping medicine, various other prescription discomfort medication or narcotics, medication for seizures or barbiturates, muscle mass depressants, or anesthetics, consisting of some oral anesthetics. Additionally, there might be a greater risk of liver damages if you consume three or even more alcoholic beverages while you are taking acetaminophen. Do not drink alcohols.

If you assume you or someone else might have taken an overdose of this medicine, obtain emergency aid at the same time. Your medical professional may likewise provide naloxone to deal with an overdose. Indicators of an overdose consist of: extreme wooziness or weak point, slow-moving heartbeat or breathing, seizures, problem breathing, and cold, clammy skin. Call your physician immediately if you observe these symptoms.

This medication may be addictive. If you feel that the medication is not working also, do not use greater than your suggested dosage. Call your physician for guidelines.

Do not use this medication if you are using or have utilized an MAO prevention (eg, isocarboxazid [Marplan ®], linezolid [Zyvox ®], phenelzine [Nardil ®], selegiline [Eldepryl ®], tranylcypromine [Parnate ®] within the previous 14 days. Making use of these medicine together may create significant unwanted impacts.

This medication might create sleep-related breathing problems (eg, rest apnea, sleep-related hypoxemia). Your physician might lower your dosage if you have rest apnea (stop breathing for brief periods during rest) while utilizing this medicine.

Wooziness, lightheadedness, or fainting may happen when you get up all of a sudden from a lying or resting setting. Getting up gradually might aid reduce this issue. Also, lying down for some time might eliminate the dizziness or lightheadedness.

This medication may make you lightheaded, sleepy, or lightheaded. Do not drive or do anything else that could be harmful up until you understand how this medicine influences you.

Consult your doctor right now if you have discomfort or tenderness in the top stomach, pale feceses, dark pee, anorexia nervosa, nausea or vomiting, unusual fatigue or weakness, or yellow eyes or skin. These can be signs of a severe liver issue.

Major skin reactions (eg, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and harmful epidermal necrolysis) can occur with this medication. Get in touch with your doctor today if you have blistering, peeling off, or helping to loosen of the skin, cools, coughing, looseness of the bowels, itching, joint or muscular tissue discomfort red irritated eyes, red skin sores, typically with a purple center, aching throat, sores, abscess, or white areas in the mouth or on the lips, or uncommon fatigue or weakness while you are using this medication.

This medicine may trigger significant allergic reactions, consisting of anaphylaxis, which can be life-threatening and requires prompt clinical focus. Call your doctor right now if you have a breakout, itching, hoarseness, difficulty breathing, difficulty swallowing, or any swelling of your hands, face, or mouth while you are utilizing this medication.

Making use of narcotics for a long time can cause serious irregular bowel movements. To stop this, your medical professional might guide you to take laxatives, consume a lot of fluids, or increase the quantity of fiber in your diet regimen. Be sure to follow the directions thoroughly, since continuing irregular bowel movements can cause a lot more serious problems.

If you have been using this medication on a regular basis for numerous weeks or longer, do not alter your dosage or all of a sudden stop using it without consulting your doctor. Your doctor may want you to progressively reduce the quantity you are using prior to stopping it entirely. This may help avoid getting worse of your condition and reduce the opportunity of withdrawal signs and symptoms, consisting of tummy aches, stress and anxiety, fever, irritation, nausea, uneasyness, runny nose, sweating, tremblings, or problem with sleeping.

Utilizing this medication while you are expectant might trigger significant unwanted impacts, consisting of neonatal withdrawal syndrome in your newborn baby. Inform your doctor right away if you believe you are expecting or if you plan to become pregnant while using this medication.

For nursing mommies:

• Talk to your doctor if you have any kind of concerns regarding taking oxycodone or about exactly how this medication may influence your infant.
• Call your physician if you come to be incredibly exhausted and have problem looking after your baby.
• Your baby must generally nurse every 2 to 3 hours and must not sleep for greater than 4 hours each time.
• Check with your medical professional or health center emergency room instantly if your baby reveals indications of enhanced drowsiness (more than typical), trouble nursing, problem breathing, or limpness. These may be signs and symptoms of an overdose and require immediate clinical interest.

Prior to you have any kind of clinical tests, inform the clinical physician accountable that you are taking this medicine. The outcomes of some examinations may be affected by this medicine.

Check with your physician right now if you have anxiety, uneasyness, a fast heartbeat, high temperature, sweating, muscle mass spasms, shivering, nausea, throwing up, diarrhea, or see or hear points that are not there. These might be signs and symptoms of a severe problem called serotonin syndrome. Your danger might be higher if you additionally take specific various other medicines that impact serotonin degrees in your body.

Using way too much of this medication might cause infertility (not able to have children). Talk with your physician prior to utilizing this medicine if you prepare to have youngsters.

This medication might trigger adrenal gland problems. Consult your doctor right away if you have dimming of the skin, looseness of the bowels, dizziness, fainting, loss of appetite, psychological clinical depression, nausea or vomiting, skin breakout, uncommon exhaustion or weak point, or vomiting.

Do not take other medications unless they have actually been reviewed with your doctor. This consists of prescription or nonprescription (over-the-counter [OTC] medications and natural or vitamin supplements.

In making a decision to utilize a medicine, the threats of taking the medicine needs to be evaluated versus the great it will do. This is a decision you and your medical professional will certainly make. For this medicine, the complying with need to be thought about:

Allergies

Inform your medical professional if you have ever had any kind of uncommon or allergy to this medication or any kind of various other medicines. Likewise tell your healthcare specialist if you have any type of various other kinds of allergies, such as to foods, dyes, chemicals, or animals. For non-prescription items, read the label or bundle active ingredients thoroughly.

Pediatric

Ideal research studies have actually not been executed on the partnership of age to the results of oxycodone and acetaminophen mix in the pediatric populace. Use Xartemis ™ is not recommended in children. Safety and effectiveness have not been developed.

Geriatric

Ideal research studies carried out to date have actually not shown geriatric-specific troubles that would certainly limit the efficiency of oxycodone and acetaminophen mix extended-release tablet, service, or tablet computer in the elderly. Nonetheless, elderly individuals are most likely to have age-related kidney, heart, lung, or liver troubles, which might require caution and a modification in the dose for people receiving this medication.

Suitable research studies have actually not been performed on the relationship old to the impacts of oxycodone and acetaminophen combination capsules in the pediatric population. Safety and security and efficiency have actually not been developed.

Breast Feeding

There are no appropriate studies in women for determining infant danger when utilizing this medication throughout breastfeeding. Evaluate the possible benefits against the possible threats before taking this medication while breastfeeding.

Interactions with Medicines

Although particular medicines ought to not be made use of together at all, in other situations two various medicines may be made use of together also if a communication might happen. In these cases, your physician might want to change the dosage, or various other precautions may be essential. When you are taking this medication, it is specifically crucial that your medical care professional understand if you are taking any of the medications listed below. The following communications have been picked on the basis of their potential significance and are not always extensive.

Utilizing this medication with any of the complying with medicines is not suggested. Your physician may determine not to treat you with this drug or change several of the other medicines you take.

• Levoketoconazole
• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

Utilizing this medicine with any of the complying with medicines is generally not suggested, however may be needed sometimes. If both medications are prescribed with each other, your medical professional may alter the dose or just how commonly you make use of one or both of the medications.

• Abiraterone Acetate
• Acepromazine
• Aclidinium
• Adagrasib
• Alfentanil
• Almotriptan
• Alosetron
• Alprazolam
• Alvimopan
• Amantadine
• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Apalutamide
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Armodafinil
• Asciminib
• Asenapine
• Atazanavir
• Atropine
• Avacopan
• Baclofen
• Belladonna
• Belzutifan
• Benperidol
• Bentazepam
• Benzhydrocodone
• Benzphetamine
• Benztropine
• Berotralstat
• Biperiden
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cenobamate
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Cimetidine
• Cinacalcet
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clemastine
• Clidinium
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Cloxazolam
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclopentolate
• Cyclosporine
• Cyproheptadine
• Dabrafenib
• Dantrolene
• Daridorexant
• Darifenacin
• Darunavir
• Delavirdine
• Delorazepam
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diacetylmorphine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Dicyclomine
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Dimenhydrinate
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Elagolix
• Eletriptan
• Enflurane
• Enzalutamide
• Erdafitinib
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fedratinib
• Fenfluramine
• Fentanyl
• Fesoterodine
• Fexinidazole
• Flavoxate
• Flibanserin
• Fluconazole
• Flunitrazepam
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Glycopyrrolate
• Glycopyrronium Tosylate
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Homatropine
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Hydroxyzine
• Hyoscyamine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Ipratropium
• Iproniazid
• Isocarboxazid
• Isoflurane
• Isoniazid
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lanreotide
• Larotrectinib
• Lasmiditan
• Lefamulin
• Lemborexant
• Lenacapavir
• Letermovir
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Loprazolam
• Lorazepam
• Lorcaserin
• Lorlatinib
• Lormetazepam
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Medazepam
• Melitracen
• Melperone
• Mepenzolate
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaclazepam
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Methylnaltrexone
• Metoclopramide
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirabegron
• Mirtazapine
• Mitotane
• Mobocertinib
• Moclobemide
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Nalorphine
• Naloxone
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nialamide
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nordazepam
• Nortriptyline
• Octreotide
• Olanzapine
• Omaveloxolone
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxitropium Bromide
• Oxybutynin
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Pimozide
• Pinazepam
• Pipenzolate Bromide
• Piperacetazine
• Pipotiazine
• Pirenzepine
• Piritramide
• Pirtobrutinib
• Pixantrone
• Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Procyclidine
• Promazine
• Promethazine
• Propantheline
• Propiverine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Ritlecitinib
• Ritonavir
• Rizatriptan
• Rolapitant
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• Solifenacin
• Sotorasib
• Stramonium
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Taurursodiol
• Telaprevir
• Telithromycin
• Temazepam
• Terbinafine
• Terodiline
• Tetrazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Thiothixene
• Tianeptine
• Tilidine
• Tiotropium
• Tizanidine
• Tocilizumab
• Tolonium Chloride
• Tolterodine
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trihexyphenidyl
• Trimeprazine
• Trimipramine
• Trofinetide
• Tropicamide
• Trospium
• Tryptophan
• Tucatinib
• Umeclidinium
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Voxelotor
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Utilizing this medication with any of the following medicines might create a boosted risk of certain adverse effects, but making use of both medications might be the best treatment for you. If both medicines are suggested with each other, your doctor may alter the dosage or how frequently you make use of one or both of the medicines.

• Acenocoumarol
• Carbamazepine
• Fosphenytoin
• Lixisenatide
• Phenytoin
• St John's Wort
• Warfarin
• Zidovudine

Interactions with Food/Tobacco/Alcohol

Particular medicines ought to not be made use of at or around the time of consuming food or eating specific kinds of food because communications may happen. Making use of alcohol or tobacco with specific medications may also create communications to happen. The following interactions have been selected on the basis of their possible significance and are not necessarily complete.

Utilizing this medicine with any of the complying with is typically not suggested, however might be inevitable sometimes. If made use of together, your medical professional might transform the dosage or how typically you utilize this medication, or offer you unique instructions about using food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice
• Tobacco

Utilizing this medication with any one of the complying with may create a boosted danger of particular negative effects but might be inescapable in some cases. If utilized together, your doctor may alter the dose or just how usually you utilize this medicine, or give you unique directions about the use of food, alcohol, or tobacco.

• Cabbage

Other Medical Problems

The existence of other medical issues might influence making use of this medicine. Ensure you inform your physician if you have any type of other clinical problems, specifically:

• Addison disease (adrenal gland issue) or
• Alcohol misuse, background of or
• Brain lump, background of or
• Breathing or lung issues (eg, reduced oxygen levels, sleep apnea) or
• Chronic obstructive lung illness (COPD) or
• Cor pulmonale (significant heart problem) or
• Drug reliance, specifically with narcotic misuse or reliance, or history of or
• Gallbladder illness or
• Head injury, background of or
• Hypothyroidism (an underactive thyroid) or
• Hypovolemia (low blood quantity) or
• Kyphoscoliosis (curvature of the spine with breathing troubles) or
• Mental health issue or
• Problems with passing pee or
• Prostatic hypertrophy (enlarged prostate, BPH) or
• Trouble swallowing or
• Weakened physical problem-- Use with care. May boost threat for even more significant adverse effects.

• Asthma, severe or severe or
• Lung disease or breathing problems (eg, bronchial asthma, respiratory clinical depression), serious or
• Stomach or bowel blockage (eg, paralytic ileus), recognized or believed-- Should not be utilized in patients with these conditions.

• Hypotension (low high blood pressure) or
• Pancreatitis (swelling of the pancreatic) or
• Seizures, history of-- Use with care. May make these conditions even worse.

• Kidney condition or
• Liver disease-- Use with caution. The results may be increased as a result of slower removal of the medication from the body.

Along with its necessary impacts, a medication might cause some undesirable results. Although not all of these adverse effects may occur, if they do occur they may need clinical attention.

Contact your doctor promptly if any one of the following side effects happen:

A lot more usual

• Black, tarry stools
• chills
• dark pee
• dizziness
• high temperature
• frustration
• irritation, skin rash
• light-colored stools
• anorexia nervosa
• nausea
• belly discomfort
• undesirable breath odor
• unusual fatigue or weakness
• throwing up of blood
• yellow eyes or skin

Uncommon

• Cough
• high temperature with or without cools
• basic feeling of tiredness or weak point
• hoarseness
• lower back or side pain
• agonizing or difficult urination
• aching throat
• sores, ulcers, or white areas on the lips or in the mouth
• uncommon bleeding or bruising

Incidence not known

• Back, leg, or belly pains
• hemorrhaging gums
• bloating
• blood in the urine or stools
• blue lips and finger nails
• obscured vision
• burning, creeping, itching, tingling, prickling, "pins and needles", or tingling sensations
• chest discomfort, discomfort, or rigidity
• gloomy pee
• clumsiness
• confusion
• constipation
• coughing that in some cases creates a pink frothy sputum
• darkening of the skin
• lowered recognition or responsiveness
• decreased regularity or amount of urine
• looseness of the bowels
• difficult, quick, loud breathing
• difficulty in passing urine (dripping).
• problem with ingesting.
• lightheadedness, fatigue, or impaired thinking when standing up suddenly from an existing or sitting setting.
• drowsiness.
• completely dry mouth.
• very shallow or sluggish breathing.
• fainting.
• quick or deep breathing.
• quick, slow-moving, irregular, battering, or racing heartbeat.
• sensation of heat.
• general body swelling.
• hives or welts.
• increased sweating.
• raised thirst.
• indigestion.
• huge, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genital areas.
• lightheadedness.
• mental depression.
• muscle pains, shakes, or weakness.
• anxiety.
• nosebleeds.
• discomforts in the belly, side, or abdominal area, perhaps radiating to the back.
• light skin.
• determine red areas on the skin.
• battering in the ears.
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue.
• rapid, deep or shallow breathing.
• inflammation of the face, neck, arms, and sometimes, top breast.
• uneasyness.
• seizures.
• extreme constipation.
• severe drowsiness.
• extreme throwing up.
• skin blisters.
• sleepiness.
• belly aches.
• sunken eyes.
• sweating.
• swelling of the face, fingers, lower legs, or ankle joints.
• thirst.
• fatigue.
• trouble breathing.
• vomiting.
• weakness or heaviness of the legs.
• weight gain.

Get emergency assistance immediately if any one of the complying with signs of overdose happen:.

Signs of overdose.

• Bluish lips or skin.
• modification in consciousness.
• cold, clammy skin.
• extreme sleepiness.
• general feeling of discomfort or illness.
• loss of consciousness.
• low blood pressure or pulse.
• slow-moving breathing.
• unconsciousness.

Some side effects may happen that generally do not require clinical interest. These adverse effects might disappear throughout treatment as your body adjusts to the medication. Likewise, your healthcare expert might have the ability to tell you about methods to avoid or lower some of these adverse effects. Talk to your healthcare specialist if any one of the complying with negative effects continue or are irritating or if you have any type of questions concerning them:.

Extra common.

• Relaxed and calm sensation.

Incidence not known.

• Agitation.
• bad, uncommon or unpleasant (after) preference.
• belching.
• change in taste.
• fears.
• restricted, pinpoint, or little students (black component of the eye).
• continuing buzzing or buzzing or various other unexplained noise in the ears.
• cool, pale skin.
• clinical depression.
• difficulty with relocating.
• disrupted color understanding.
• double vision.
• excess air or gas in the stomach or bowels.
• incorrect or uncommon feeling of health.
• flushed, completely dry skin.
• fruit-like breath odor.
• complete sensation.
• general sensation of pain or disease.
• halos around lights.
• hearing loss.
• heartburn.
• increased hunger.
• enhanced peeing.
• indigestion.
• joint discomfort.
• lack or loss of stamina.
• muscle mass cramps, spasms, discomfort, or stiffness.
• night blindness.
• problems.
• overbright look of lights.
• seeing, hearing, or really feeling points that are not there.
• seizures.
• restlessness.
• slurred speech.
• swollen joints.
• trouble sleeping.
• tunnel vision.
• unusual weight-loss.
• uncommon drowsiness, monotony, tiredness, weakness, or feeling of sluggishness.

Other side effects not noted might likewise take place in some people. If you notice any type of other impacts, contact your health care specialist.

Call your doctor for medical guidance regarding negative effects. You may report negative effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Endocet.
• Magnacet.
• Narvox.
• Percocet.
• Perloxx.
• Primalev.
• Roxicet.
• Roxilox.
• Tylox.
• Xartemix XR.
• Xolox.

In Canada.

• oxyCODONE/ACET.
• Rivacocet.
• Teva-Oxycocet.

Available Dosage Forms:.

• Tablet.
• Solution.

Restorative Class: Opioid/Acetaminophen Combination.

Chemical Class: Oxycodone.

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 and cause mental or physical dependence. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of oxycodone and acetaminophen combination. This medicine should also come with a Medication Guide. 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.

You may take this medicine with or without food.

Measure the oral liquid using the patient cup that comes with the package.

Swallow the extended-release tablet whole with water. Do not crush, break, chew, dissolve, snort, or inject it. Do not pre-soak, lick, or wet the tablet before placing it in your mouth. Do not give this medicine by feeding tubes.

Check with your doctor first before changing dosage forms (eg, capsules, extended-release tablets, tablets). These forms are very different from each other.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

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 moderate to moderately severe pain: For oral dosage form (capsules): Adults—1 capsule every 6 hours as needed. Children—Use and dose must be determined by your doctor. For oral dosage form (extended-release tablets): Adults—2 tablets every 12 hours as needed. Children—Use is not recommended. For oral dosage form (solution): Adults—5 milliliters (mL) or 1 teaspoon every 6 hours as needed. Your doctor may adjust the dose as needed. However, the dose is usually not more than 60 mL (12 teaspoons) per day. Children—Use and dose must be determined by your doctor. For oral dosage form (tablets): Adults—1 or 2 tablets every 6 hours as needed. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of Percocet®, skip the missed dose and go back to your regular dosing schedule.

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.

Oxycodone and acetaminophen combination can cause serious unwanted effects or fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic 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.