Xartemix XR (Oral)

Oxycodone and acetaminophen mix is utilized to eliminate discomfort serious enough to call for opioid therapy and when various other discomfort medications did not function well sufficient or can not be endured.

Acetaminophen is utilized to relieve discomfort and decrease fever in individuals. It does not come to be addictive when taken for a long period of time. However acetaminophen might trigger various other undesirable effects when taken in large doses, including liver damages.

Oxycodone belongs to the group of medicines called narcotic anesthetics (pain medications). It acts on the central nerves (CNS) to alleviate pain.

When oxycodone is utilized for a long period of time, it might become habit-forming, creating mental or physical dependence. Nevertheless, people that have continuing pain should not let the concern of dependancy maintain them from utilizing narcotics to ease their discomfort. Mental reliance (addiction) is not most likely to take place when narcotics are made use of for this objective. Physical dependancy may result in withdrawal adverse effects if therapy is quit instantly. However, extreme withdrawal negative effects can typically be stopped by gradually reducing the dosage over a period of time before treatment is quit totally.

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

It is very crucial that your medical professional inspect your progression while you are taking this medicine, particularly within the very first 24 to 72 hours of therapy. This will permit your medical professional to see if the medicine is functioning appropriately and to decide if you ought to continue to take it. Blood and pee examinations may be required to look for unwanted results.

It is against the law and dangerous for anybody else to use your medicine. Keep your extra medication in a risk-free and safe area. People who are addicted to medicines may intend to swipe it.

Contact your medical professional prior to using this medication with alcohol or other medications that influence the main nerve system (CNS). This medicine will contribute to the results of alcohol and various other CNS downers (medications that can make you drowsy or much less sharp). Some examples of CNS downers are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or resting medication, various other prescription discomfort medication or narcotics, medication for seizures or barbiturates, muscle mass depressants, or anesthetics, including some dental anesthetics. Additionally, there might be a higher danger of liver damages if you drink three or more alcohols while you are taking acetaminophen. Do not consume alcohol liquors.

If you believe you or another person may have taken an overdose of this medication, get emergency assistance at once. Your physician might additionally provide naloxone to deal with an overdose. Indications of an overdose include: severe wooziness or weakness, sluggish heart beat or breathing, seizures, problem breathing, and cold, clammy skin. Call your doctor right now if you observe these symptoms.

This medication may be habit-forming. If you really feel that the medicine is not working too, do not utilize more than your suggested dosage. Call your doctor for directions.

Do not use this medicine if you are making use of or have actually made use of an MAO inhibitor (eg, isocarboxazid [Marplan ®], linezolid [Zyvox ®], phenelzine [Nardil ®], selegiline [Eldepryl ®], tranylcypromine [Parnate ®] within the previous 14 days. Utilizing these medication together may cause serious undesirable impacts.

This medicine may trigger sleep-related breathing troubles (eg, rest apnea, sleep-related hypoxemia). Your medical professional may lower your dosage if you have rest apnea (stop breathing for short periods throughout rest) while using this medicine.

Wooziness, faintness, or fainting might occur when you get up unexpectedly from an existing or resting placement. Standing up slowly may help reduce this trouble. Likewise, relaxing for a while might ease the dizziness or faintness.

This medication might make you woozy, sluggish, or lightheaded. Do not drive or do anything else that might be dangerous till you know just how this medication influences you.

Check with your physician right away if you have discomfort or inflammation in the top stomach, pale stools, dark urine, loss of appetite, nausea, uncommon fatigue or weakness, or yellow eyes or skin. These can be signs of a major liver issue.

Severe skin reactions (eg, intense generalised exanthematous pustulosis, Stevens-Johnson disorder, and toxic epidermal necrolysis) can accompany this medicine. Get in touch with your medical professional today if you have blistering, peeling off, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscular tissue discomfort red aggravated eyes, red skin sores, commonly with a purple center, aching throat, sores, abscess, or white spots in the mouth or on the lips, or uncommon fatigue or weak point while you are using this medicine.

This medicine may cause significant allergic reactions, including anaphylaxis, which can be life-threatening and calls for prompt medical attention. Call your physician as soon as possible if you have a breakout, itching, hoarseness, difficulty breathing, difficulty ingesting, or any kind of swelling of your hands, face, or mouth while you are utilizing this medication.

Utilizing narcotics for a long time can cause severe constipation. To stop this, your doctor may route you to take laxatives, consume a lot of liquids, or increase the quantity of fiber in your diet plan. Be sure to comply with the instructions thoroughly, due to the fact that proceeding constipation can cause a lot more significant troubles.

If you have been using this medicine regularly for several weeks or longer, do not transform your dose or suddenly stop utilizing it without contacting your doctor. Your physician might want you to slowly minimize the amount you are using prior to quiting it totally. This may help avoid worsening of your condition and lower the possibility of withdrawal signs, consisting of belly cramps, stress and anxiety, high temperature, impatience, nausea, uneasyness, dripping nose, sweating, shakes, or problem with resting.

Using this medication while you are pregnant may cause serious unwanted results, consisting of neonatal withdrawal disorder in your newborn baby. Tell your medical professional right away if you believe you are pregnant or if you prepare to become pregnant while using this medicine.

For nursing mommies:

• Talk to your medical professional if you have any kind of questions regarding taking oxycodone or concerning exactly how this medication might impact your baby.
• Call your doctor if you end up being extremely exhausted and have difficulty caring for your baby.
• Your infant should normally registered nurse every 2 to 3 hours and should not sleep for more than 4 hours each time.
• Check with your physician or healthcare facility emergency room immediately if your child reveals indications of raised drowsiness (greater than normal), problem breastfeeding, difficulty breathing, or limpness. These may be signs of an overdose and need prompt clinical attention.

Prior to you have any type of clinical tests, tell the medical physician accountable that you are taking this medication. The results of some tests might be impacted by this medicine.

Check with your doctor right away if you have anxiousness, restlessness, a fast heart beat, high temperature, sweating, muscular tissue convulsions, jerking, queasiness, vomiting, looseness of the bowels, or see or listen to points that are not there. These may be signs and symptoms of a severe problem called serotonin syndrome. Your risk may be greater if you likewise take particular other medicines that influence serotonin degrees in your body.

Using excessive of this medication might trigger inability to conceive (not able to have youngsters). Talk with your doctor before utilizing this medicine if you plan to have kids.

This medication may create adrenal gland troubles. Consult your doctor as soon as possible if you have darkening of the skin, looseness of the bowels, dizziness, fainting, loss of appetite, mental depression, nausea or vomiting, skin rash, unusual fatigue or weak point, or vomiting.

Do not take various other medications unless they have been talked about with your physician. This consists of prescription or nonprescription (over the counter [OTC] medicines and organic or vitamin supplements.

In making a decision to utilize a medication, the risks of taking the medication needs to be considered versus the excellent it will certainly do. This is a choice you and your doctor will certainly make. For this medicine, the complying with should be considered:

Allergies

Inform your medical professional if you have ever had any type of unusual or allergic reaction to this medication or any type of other medications. Additionally tell your health care specialist if you have any other types of allergies, such as to foods, dyes, chemicals, or animals. For non-prescription products, checked out the tag or bundle active ingredients thoroughly.

Pediatric

Ideal research studies have not been done on the relationship of age to the effects of oxycodone and acetaminophen combination in the pediatric population. Use Xartemis ™ is not suggested in youngsters. Safety and security and efficiency have actually not been developed.

Geriatric

Suitable researches performed to date have not demonstrated geriatric-specific troubles that would certainly restrict the usefulness of oxycodone and acetaminophen mix extended-release tablet computer, solution, or tablet in the senior. Nevertheless, elderly clients are most likely to have age-related kidney, heart, lung, or liver issues, which might need care and a change in the dosage for people getting this medicine.

Ideal research studies have not been executed on the partnership old to the results of oxycodone and acetaminophen combination capsules in the pediatric population. Safety and security and effectiveness have actually not been established.

Breast Feeding

There are no ample researches in ladies for figuring out baby risk when utilizing this medicine during breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine while breastfeeding.

Interactions with Medicines

Although certain medications must not be utilized with each other in all, in various other situations two various medications might be made use of with each other also if a communication might take place. In these instances, your medical professional might wish to alter the dose, or other precautions may be required. When you are taking this medication, it is particularly important that your health care professional recognize if you are taking any one of the medications listed here. The complying with communications have actually been selected on the basis of their prospective importance and are not always all-encompassing.

Utilizing this medicine with any of the following medications is not recommended. Your doctor might determine not to treat you with this medicine or transform several of the various other medications you take.

• Levoketoconazole
• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

Using this medicine with any one of the complying with medicines is typically not advised, but might be needed in many cases. If both medications are suggested together, your physician might alter the dosage or exactly how frequently you make use of one or both of the medicines.

• 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

Using this medicine with any one of the following medicines may create an enhanced danger of particular adverse effects, yet using both medications may be the best treatment for you. If both medications are suggested together, your medical professional may change the dose or just how frequently you utilize one or both of the medications.

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

Interactions with Food/Tobacco/Alcohol

Certain medications need to not be utilized at or around the moment of eating food or consuming particular sorts of food because interactions may take place. Making use of alcohol or cigarette with specific medications may likewise cause interactions to take place. The adhering to communications have been chosen on the basis of their prospective significance and are not necessarily extensive.

Using this medicine with any of the following is generally not advised, yet may be inescapable in some cases. If used with each other, your physician might change the dosage or exactly how commonly you utilize this medication, or offer you unique directions concerning using food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice
• Tobacco

Utilizing this medicine with any one of the following may cause an increased threat of particular negative effects but might be unavoidable in many cases. If made use of with each other, your doctor might change the dosage or exactly how often you utilize this medicine, or offer you special instructions about using food, alcohol, or tobacco.

• Cabbage

Other Medical Problems

The visibility of other medical problems may affect the use of this medicine. See to it you inform your medical professional if you have any kind of other clinical problems, specifically:

• Addison illness (adrenal gland trouble) or
• Alcohol misuse, background of or
• Brain growth, history of or
• Breathing or lung problems (eg, reduced oxygen degrees, rest apnea) or
• Chronic obstructive pulmonary disease (COPD) or
• Cor pulmonale (severe heart issue) or
• Drug reliance, specifically with numbing misuse or reliance, or background of or
• Gallbladder disease or
• Head injury, background of or
• Hypothyroidism (an underactive thyroid) or
• Hypovolemia (reduced blood volume) or
• Kyphoscoliosis (curvature of the spinal column with breathing troubles) or
• Mental health issue or
• Problems with passing urine or
• Prostatic hypertrophy (enlarged prostate, BPH) or
• Trouble ingesting or
• Weakened physical condition-- Use with caution. May rise danger for even more significant side effects.

• Asthma, acute or severe or
• Lung condition or breathing problems (eg, asthma, breathing clinical depression), extreme or
• Stomach or digestive tract obstruction (eg, paralytic ileus), understood or thought-- Should not be utilized in people with these problems.

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

• Kidney illness or
• Liver disease-- Use with care. The results might be raised due to slower removal of the medication from the body.

Along with its necessary impacts, a medicine may trigger some unwanted impacts. Although not all of these side effects may take place, if they do happen they may require clinical attention.

Contact your medical professional promptly if any one of the adhering to side effects happen:

Extra common

• Black, tarry feceses
• cools
• dark urine
• lightheadedness
• fever
• headache
• itchiness, skin breakout
• light-colored stools
• anorexia nervosa
• queasiness
• belly pain
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Uncommon

• Cough
• high temperature with or without chills
• basic sensation of tiredness or weak point
• hoarseness
• lower back or side pain
• painful or challenging peeing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• uncommon bleeding or wounding

Occurrence not known

• Back, leg, or tummy pains
• bleeding gum tissues
• bloating
• blood in the pee or stools
• blue lips and finger nails
• obscured vision
• burning, creeping, itching, numbness, tingling, "pins and needles", or prickling sensations
• upper body discomfort, discomfort, or tightness
• over cast urine
• clumsiness
• complication
• irregularity
• coughing that often generates a pink foamy spit
• darkening of the skin
• decreased awareness or responsiveness
• reduced regularity or quantity of pee
• looseness of the bowels
• tough, quick, noisy breathing
• difficulty in passing urine (dripping).
• difficulty with ingesting.
• lightheadedness, fatigue, or faintness when getting up unexpectedly from a lying or sitting setting.
• sleepiness.
• dry mouth.
• very superficial or sluggish breathing.
• fainting.
• quick or deep breathing.
• quick, slow-moving, uneven, battering, or competing heartbeat.
• sensation of heat.
• general body swelling.
• hives or welts.
• enhanced sweating.
• increased thirst.
• indigestion.
• big, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genital areas.
• lightheadedness.
• psychological clinical depression.
• muscular tissue aches, shakes, or weakness.
• nervousness.
• nosebleeds.
• discomforts in the tummy, side, or abdominal area, possibly radiating to the back.
• light skin.
• pinpoint red spots on the skin.
• battering in the ears.
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue.
• fast, deep or superficial breathing.
• redness of the face, neck, arms, and periodically, upper breast.
• uneasyness.
• seizures.
• extreme irregular bowel movements.
• extreme drowsiness.
• extreme throwing up.
• skin blisters.
• sleepiness.
• tummy cramps.
• sunken eyes.
• sweating.
• swelling of the face, fingers, reduced legs, or ankle joints.
• thirst.
• tiredness.
• difficulty breathing.
• vomiting.
• weak point or heaviness of the legs.
• weight gain.

Obtain emergency situation help promptly if any one of the complying with signs of overdose take place:.

Signs of overdose.

• Bluish lips or skin.
• change in consciousness.
• cold, clammy skin.
• extreme drowsiness.
• general sensation of pain or ailment.
• loss of consciousness.
• reduced blood pressure or pulse.
• slow breathing.
• unconsciousness.

Some adverse effects may happen that typically do not require clinical focus. These negative effects might disappear throughout therapy as your body adjusts to the medication. Also, your healthcare specialist might be able to inform you about means to stop or decrease some of these negative effects. Contact your health care professional if any of the following negative effects continue or are bothersome or if you have any kind of inquiries about them:.

A lot more typical.

• Relaxed and tranquil sensation.

Incidence not known.

• Agitation.
• poor, unusual or undesirable (after) preference.
• belching.
• adjustment in preference.
• fears.
• constricted, pinpoint, or tiny pupils (black component of the eye).
• proceeding ringing or humming or other unexplained noise in the ears.
• cool, light skin.
• depression.
• trouble with relocating.
• disrupted shade assumption.
• dual vision.
• excess air or gas in the belly or bowels.
• incorrect or unusual feeling of health.
• purged, dry skin.
• fruit-like breath smell.
• full feeling.
• basic feeling of pain or illness.
• halos around lights.
• hearing loss.
• heartburn.
• raised hunger.
• enhanced peeing.
• acid indigestion.
• joint discomfort.
• lack or loss of strength.
• muscular tissue pains, convulsions, discomfort, or tightness.
• night blindness.
• nightmares.
• overbright appearance of lights.
• seeing, hearing, or feeling things that are not there.
• seizures.
• shakiness.
• slurred speech.
• inflamed joints.
• difficulty sleeping.
• tunnel vision.
• unexplained weight management.
• unusual sleepiness, dullness, fatigue, weakness, or sensation of slowness.

Opposite side results not listed might likewise happen in some clients. If you discover any various other impacts, check with your healthcare expert.

Call your medical professional for medical advice concerning side effects. You may report adverse 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.