Primalev

Generic Name: oxycodone and acetaminophen (Oral route)

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

Oral route(Tablet)

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg/day, and often involve more than one acetaminophen-containing product .

Commonly used brand name(s)

In the U.S.

• Endocet


• Magnacet


• Narvox


• Percocet


• Perloxx


• Primalev


• Roxicet


• Roxilox


• Tylox


• Xolox

Available Dosage Forms:

• Tablet


• Solution


• Capsule

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Oxycodone

Uses For Primalev

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 Primalev

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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone and acetaminophen combination 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 oxycodone and acetaminophen combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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.

Interactions with 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


• Aprobarbital


• Atazanavir


• Brofaromine


• Bromazepam


• Brotizolam


• Buprenorphine


• Buspirone


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorpromazine


• Chlorzoxazone


• Clarithromycin


• Clobazam


• Clonazepam


• Clorazepate


• Clorgyline


• Codeine


• Dantrolene


• Desflurane


• Dexmedetomidine


• Dezocine


• Diazepam


• Diphenhydramine


• Doxylamine


• Enflurane


• Erythromycin


• Escitalopram


• Estazolam


• Eszopiclone


• Ethchlorvynol


• Ethopropazine


• Fentanyl


• Flumazenil


• Flunitrazepam


• Fluphenazine


• Flurazepam


• Fluvoxamine


• Fospropofol


• Furazolidone


• Halazepam


• Halothane


• Hydrocodone


• Hydromorphone


• Hydroxyzine


• Indinavir


• Iproniazid


• Isocarboxazid


• Isoflurane


• Itraconazole


• Ketamine


• Ketazolam


• Ketoconazole


• Lazabemide


• Levorphanol


• Linezolid


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Mesoridazine


• Metaxalone


• Methdilazine


• Methocarbamol


• Methohexital


• Midazolam


• Moclobemide


• Morphine


• Morphine Sulfate Liposome


• Nalbuphine


• Nefazodone


• Nelfinavir


• Nialamide


• Nitrazepam


• Nitrous Oxide


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Pargyline


• Pentazocine


• Pentobarbital


• Perphenazine


• Phenelzine


• Phenobarbital


• Prazepam


• 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


• 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


• Isoniazid


• Miconazole


• Phenytoin


• Rifampin


• St John's Wort


• Voriconazole


• Warfarin


• Zidovudine

Interactions with Food/Tobacco/Alcohol

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

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


• Brain tumor, history of or


• Chronic obstructive pulmonary disease (COPD) or


• CNS depression or


• Cor pulmonale (serious heart condition) or


• Drug dependence, especially with narcotics, or history of or


• Enlarged prostate (BPH, prostatic hypertrophy) or


• Head injuries, history of 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—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.

• Hypotension (low blood pressure) or


• Pancreatitis (inflammation of the pancreas) or


• Seizures, history of or


• Stomach problems—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.

Proper Use of oxycodone and acetaminophen

This section provides information on the proper use of a number of products that contain oxycodone and acetaminophen. It may not be specific to Primalev. Please read with care.

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.

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

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—One capsule every 6 hours as needed.
    
    
    • 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. 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—One tablet every 6 hours as needed. However, the dose is usually not more than 6 to 12 tablets per day.
    
    
    • 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 Primalev

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.

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.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and 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, especially those containing acetaminophen (Tylenol (R)), and herbal or vitamin supplements.

Primalev 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


• 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


• hives or welts


• increase in heart rate


• increased blood pressure


• increased sweating


• increased thirst


• indigestion


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lightheadedness


• low body temperature


• 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


• shortness of breath


• skin blisters


• skin rash


• 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


• vomiting of blood


• weak or feeble pulse


• weakness or heaviness of the legs


• weight gain


• wheezing


• 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


• anxiety


• 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


• nervousness


• night blindness


• nightmares


• overbright appearance of lights


• passing gas


• rash


• red eye


• seeing, hearing, or feeling things that are not there


• seizures


• severe sleepiness


• shakiness


• sleepiness or unusual drowsiness


• sleeplessness


• slurred speech


• stomach discomfort, upset, or pain


• stomach fullness


• sweating


• swollen joints


• thirst


• trouble sleeping


• troubled breathing


• tunnel vision


• unable to sleep


• 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.

See also: Primalev side effects (in more detail)

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More Primalev resources

• Primalev Side Effects (in more detail)
• Primalev Use in Pregnancy & Breastfeeding
• Primalev Drug Interactions
• Primalev Support Group
• 1 Review for Primalev - Add your own review/rating

• Endocet MedFacts Consumer Leaflet (Wolters Kluwer)


• Endocet Prescribing Information (FDA)


• Endocet Consumer Overview


• Magnacet Prescribing Information (FDA)


• Primlev Prescribing Information (FDA)


• Roxicet Prescribing Information (FDA)


• Roxicet Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Roxicet Consumer Overview


• Tylox Prescribing Information (FDA)


• Tylox Consumer Overview

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