Narvox

Name: Narvox

Commonly used brand name(s)

In the U.S.

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

Available Dosage Forms:

  • Tablet
  • Solution
  • Tablet, Extended Release
  • Capsule

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Oxycodone

Uses For Narvox

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.

Precautions While Using Narvox

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 are using or 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.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may reduce infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

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.

Narvox Side Effects

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
  • decreased awareness or responsiveness
  • decreased frequency or amount of urine
  • 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
  • feeling of warmth
  • general body swelling
  • 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 or shallow breathing
  • redness of the face, neck, arms, and occasionally, upper chest
  • restlessness
  • seizures
  • severe constipation
  • severe sleepiness
  • severe vomiting
  • skin blisters
  • skin rash, hives, or welts
  • sleepiness
  • sore throat
  • stomach cramps
  • sunken eyes
  • sweating
  • swelling of the face, fingers, lower legs, or ankles
  • thirst
  • tightness in the chest
  • tiredness
  • vomiting
  • weakness or heaviness of the legs
  • weight gain

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
  • low blood pressure or pulse
  • slow breathing
  • 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 feeling
Incidence not known
  • Acid or sour stomach
  • agitation
  • bad, 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 urination
  • indigestion
  • joint pain
  • lack or loss of strength
  • muscle cramps or spasms
  • muscle pain or stiffness
  • night blindness
  • nightmares
  • overbright appearance of lights
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shakiness
  • sleepiness or unusual drowsiness
  • slurred speech
  • stomach discomfort, upset, or pain
  • 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.

For Healthcare Professionals

Applies to acetaminophen / oxycodone: oral capsule, oral solution, oral tablet, oral tablet extended release

General

The most commonly reported adverse events have included lightheadedness, dizziness, drowsiness, sedation, nausea, and vomiting.[Ref]

Respiratory

Common (1% to 10%): Cough
Frequency not reported: Apnea, respiratory arrest, respiratory depression, hiccups
Postmarketing reports: Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, hypoventilation, laryngeal edema[Ref]

Hepatic

Oxycodone-acetaminophen:
Postmarketing reports: Transient elevations of hepatic enzymes, increased bilirubin, hepatic failure, jaundice, hepatotoxicity, hepatic disorder, hepatitis

Acetaminophen:
Frequency not reported: Hepatic necrosis[Ref]

At high doses, the most serious acetaminophen related adverse event is a dose-dependent, potentially fatal hepatic necrosis.[Ref]

Hypersensitivity

Frequency not reported: Skin eruptions, urticaria, erythematous skin reactions
Postmarketing reports: Anaphylaxis, allergic reaction, angioedema[Ref]

Dermatologic

Common (1% to 10%): Rash, blister, excoriation, pruritus, erythema
Frequency not reported: Dermatitis, ecchymosis, hyperhidrosis
Postmarketing reports: Urticaria, flushing, increased sweating[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 13%)
Common (1% to 10%): Headache, somnolence
Frequency not reported: Lightheadedness, dizziness, drowsiness, sedation, migraine, myoclonus, paresthesia, tremor
Postmarketing reports: Stupor, cerebral edema, coma, subdural or intracranial hemorrhage, seizures

Opioids:
Postmarketing reports: Serotonin syndrome[Ref]

Psychiatric

Frequency not reported: Euphoria, dysphoria, insomnia, altered mood, sleep disorder, withdrawal syndrome
Postmarketing reports: Agitation, confusion, anxiety, mental impairment, drug dependence, drug abuse, depression, nervousness, hallucination, suicide[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 31%)
Common (1% to 10%): Vomiting, constipation, dry mouth, dyspepsia, diarrhea
Frequency not reported: Esophageal spasm, oropharyngeal pain, throat irritation
Postmarketing reports: Abdominal pain, abdominal distention, flatulence, gastrointestinal disorder, pancreatitis, intestinal obstruction, ileus, thirst[Ref]

Hematologic

Oxycodone-acetaminophen:
Frequency not reported: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia

Acetaminophen:
Rare (0.01% to 0.1%): Agranulocytosis[Ref]

Renal

Postmarketing reports: Renal insufficiency and failure[Ref]

Cardiovascular

Common (1% to 10%): Edema
Frequency not reported: Hypotension, chest discomfort
Postmarketing reports: Tachycardia, dysrhythmias, orthostatic hypotension, bradycardia, palpitations, hypertension[Ref]

Metabolic

Frequency not reported: Decreased appetite
Postmarketing reports: Hypoglycemia, hyperglycemia, acidosis, alkalosis, hyperkalemia, dehydration

Musculoskeletal

Postmarketing reports: Rhabdomyolysis, myalgia

Ocular

Postmarketing reports: Miosis, visual disturbances, red eye

Genitourinary

Common (1% to 10%): Dysuria
Frequency not reported: Urinary retention, interstitial nephritis, proteinuria, decreased urine flow

Other

Postmarketing reports: Malaise, asthenia, fatigue, fever, hypothermia, accidental overdose, non-accidental overdose, hearing loss, tinnitus[Ref]

Endocrine

Adrenal insufficiency and androgen deficiency have been reported with opioid use, most often with chronic use.

Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency

Some side effects of Narvox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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