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Oxycodone and acetaminophen (Oral route)

Pronunciation:

a-seet-a-MIN-oh-fen, ox-i-KOE-done hye-droe-KLOR-ide

Brand Names:

  • Endocet
  • Magnacet
  • Narvox
  • Percocet
  • Perloxx
  • Primalev
  • Roxicet
  • Roxilox
  • Tylox
  • Xolox

Dosage Forms:

  • Tablet
  • Solution
  • Tablet, Extended Release
  • Capsule

Warnings:

Oral route(Tablet;Tablet, Extended Release)

Oxycodone hydrochloride/acetaminophen exposes patients to the risk of addiction, abuse, or misuse. This may lead to overdose and/or death. Assess this risk in all patients prior to use and monitor regularly thereafter. Respiratory depression, which may be life-threatening or severe, may occur. Advise patients to swallow oxycodone hydrochloride/acetaminophen extended-release tablets whole and monitor closely during initiation and with dosage increases. Fatal overdoses of oxycodone may occur with accidental ingestion, especially in children. Prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome. If prolonged use is required in a pregnant woman, advise the patient of the risk to fetus (extended-release tablets) . Oxycodone hydrochloride/acetaminophen contains acetaminophen which as been associated with acute liver failure at times resulting in liver transplantation and death. Most of these cases are associated with the use of acetaminophen doses greater than the daily limit and with use of more than 1 acetaminophen-containing product .

Classifications:

Therapeutic—

Opioid/Acetaminophen Combination

Chemical—

Oxycodone

Uses of This Medicine:

Oxycodone and acetaminophen combination is used to relieve moderate to moderately severe pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

Oxycodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

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.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of oxycodone and acetaminophen combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone and acetaminophen solution and tablets in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Appropriate studies have not been performed on the relationship of age to the effects of oxycodone and acetaminophen capsules in the pediatric population. Safety and efficacy have not been established.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

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.

Other medicines—

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.

  • Naltrexone

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.

  • Acetophenazine
  • Adinazolam
  • Alfentanil
  • Alprazolam
  • Amobarbital
  • Anileridine
  • Atazanavir
  • Brofaromine
  • Bromazepam
  • Brotizolam
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbinoxamine
  • Carisoprodol
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpromazine
  • Chlorzoxazone
  • Clarithromycin
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Clorgyline
  • Codeine
  • Crizotinib
  • Dabrafenib
  • Dantrolene
  • Desflurane
  • Dexmedetomidine
  • Dezocine
  • Diazepam
  • Diphenhydramine
  • Dixyrazine
  • Doxylamine
  • Enflurane
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Fentanyl
  • Flumazenil
  • Flunitrazepam
  • Fluphenazine
  • Flurazepam
  • Fluvoxamine
  • Fospropofol
  • Furazolidone
  • Halazepam
  • Halothane
  • Hydrocodone
  • Hydromorphone
  • Hydroxyzine
  • Imatinib
  • Indinavir
  • Iproniazid
  • Isocarboxazid
  • Isoflurane
  • Itraconazole
  • Ketamine
  • Ketazolam
  • Ketoconazole
  • Lazabemide
  • Levorphanol
  • Linezolid
  • Lorazepam
  • Lormetazepam
  • Meclizine
  • Medazepam
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Metopimazine
  • Midazolam
  • Mitotane
  • Moclobemide
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nefazodone
  • Nelfinavir
  • Nialamide
  • Nitrazepam
  • Nitrous Oxide
  • Nordazepam
  • Opium
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Pargyline
  • Pentazocine
  • Pentobarbital
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenelzine
  • Phenobarbital
  • Piperaquine
  • Pipotiazine
  • Pixantrone
  • Prazepam
  • Primidone
  • Procarbazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propiomazine
  • Propofol
  • Propoxyphene
  • Quazepam
  • Ramelteon
  • Rasagiline
  • Remifentanil
  • Ritonavir
  • Saquinavir
  • Secobarbital
  • Selegiline
  • Sertraline
  • Sevoflurane
  • Sodium Oxybate
  • Sufentanil
  • Tapentadol
  • Telithromycin
  • Temazepam
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioproperazine
  • Thioridazine
  • Toloxatone
  • Tranylcypromine
  • Triazolam
  • Trifluoperazine
  • Triflupromazine
  • Trimeprazine
  • Zaleplon
  • Zolpidem

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.

  • Acenocoumarol
  • Carbamazepine
  • Fosphenytoin
  • Isoniazid
  • Lixisenatide
  • Miconazole
  • Perampanel
  • Phenytoin
  • Rifampin
  • St John's Wort
  • Voriconazole
  • Warfarin
  • Zidovudine

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
  • Tobacco

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.

  • Cabbage

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's disease (adrenal gland problem) or
  • Alcohol abuse, history of or
  • Breathing or lung problems (eg, asthma, chronic obstructive pulmonary disease [COPD], cor pulmonale) or
  • CNS depression or
  • Drug dependence, especially with narcotic abuse or dependence, or history of or
  • Enlarged prostate (BPH, prostatic hypertrophy) or
  • Hypothyroidism (an underactive thyroid) or
  • Hypovolemia (low blood volume) or
  • Kyphoscoliosis (curvature of the spine with breathing problems) or
  • Mental illness or
  • Problems with passing urine or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Asthma, severe or
  • Hypercarbia (high carbon dioxide in the blood), severe or
  • Paralytic ileus (bowels stop working and may be blocked) or
  • Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.
  • Brain tumor, history of or
  • Head injuries, history of or
  • Increased pressure in the head—Some of the side effects of oxycodone can cause serious problems in people who have these medical problems.
  • Hypotension (low blood pressure) or
  • Pancreatitis (inflammation of the pancreas) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Stomach or digestion problems—This medicine may mask the diagnosis of these conditions.

Proper Use of This Medicine:

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.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. 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, or dissolve 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. The second dose may be given as early as 8 hours after your first dose, and the following doses are given every 12 hours.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (solution):
      • Adults—5 milliliters (mL) or one teaspoonful every 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mL (12 teaspoonfuls) per day.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • Adults—1 tablet 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.

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.

Flush any unused capsules, liquid, or tablets down the toilet.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused tablets in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

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.

Do not use Xartermis™ XR if you have used an MAO inhibitor in the past 14 days. Using these medicine together may cause serious unwanted effects.

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.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis 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.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, irritability, nausea, restlessness, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects 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.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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 of This Medicine:

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:

More common
Abdominal or stomach pain
black, tarry stools
chills
dark urine
dizziness
fever
headache
itching
light-colored stools
loss of appetite
nausea
rash
unpleasant breath odor
unusual tiredness or weakness
vomiting of blood
yellow eyes or skin
Rare
Cough or hoarseness
fever with or without chills
general feeling of tiredness or weakness
lower back or side pain
painful or difficult urination
sore throat
sores, ulcers, or white spots on the lips or in the mouth
unusual bleeding or bruising
Incidence not known
Back, leg, or stomach pains
bleeding gums
bloating
blood in the urine or stools
blue lips and fingernails
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain or discomfort
clay-colored stools
cloudy urine
clumsiness
confusion
constipation
coughing that sometimes produces a pink frothy sputum
decrease in the frequency of urination
decrease in urine volume
decreased awareness or responsiveness
decreased frequency or amount of urine
decreased urination
difficult or labored breathing
difficult or painful urination
difficult, fast, noisy breathing, sometimes with wheezing
difficulty in passing urine (dribbling)
difficulty with swallowing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
dry mouth
extremely shallow or slow breathing
fainting
fast or deep breathing
fast, slow, irregular, pounding, or racing heartbeat or pulse
feeling of warmth
general body swelling
greatly decreased frequency of urination or amount of urine
increased sweating
increased thirst
indigestion
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
lightheadedness
muscle aches
muscle tremors
muscle weakness
nervousness
noisy breathing
nosebleeds
numbness or tingling in the hands, feet, or lips
pains in the stomach, side, or abdomen, possibly radiating to the back
pale skin
pinpoint red spots on the skin
pounding in the ears
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid, deep breathing
rapid, shallow breathing
redness of the face, neck, arms, and occasionally, upper chest
redness of the skin
restlessness
seizures
severe constipation
severe sleepiness
severe vomiting
shivering
skin blisters
skin rash, hives, or welts
sleepiness
slow or irregular breathing
sore throat
stomach cramps
stomach pain, continuing
sudden decrease in the amount of urine
sunken eyes
sweating
swelling in the legs and ankles
swelling of the face, fingers, or lower legs
thirst
tightness in the chest
tiredness
troubled breathing
unpleasant breath odor
upper right abdominal or stomach pain
vomiting
weak or feeble pulse
weakness or heaviness of the legs
weight gain
wrinkled skin

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

Symptoms of overdose
Bluish lips or skin
change in consciousness
cold, clammy skin
extreme sleepiness
general feeling of discomfort or illness
loss of consciousness
no blood pressure or pulse
not breathing
stopping of heart
unconsciousness

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
Incidence not known
Acid or sour stomach
agitation
bad or unusual or unpleasant (after) taste
belching
change in taste
cold sweats
constricted, pinpoint, or small pupils (black part of the eye)
continuing ringing or buzzing or other unexplained noise in the ears
cool, pale skin
depression
diarrhea
difficulty with moving
disturbed color perception
double vision
excess air or gas in the stomach or intestines
false or unusual sense of well-being
flushed, dry skin
fruit-like breath odor
full feeling
general feeling of discomfort or illness
halos around lights
hearing loss
heartburn
increased hunger
increased thirst
increased urination
indigestion
joint pain
lack or loss of strength
muscle cramps or spasms
muscle pain or stiffness
night blindness
nightmares
overbright appearance of lights
passing gas
red eye
seeing, hearing, or feeling things that are not there
seizures
shakiness
sleepiness or unusual drowsiness
slurred speech
stomach discomfort, upset, or pain
stomach fullness
sweating
swollen joints
thirst
trouble sleeping
tunnel vision
unexplained weight loss
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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.


Last Updated: 4/4/2014

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