Doctors prescribe Primalev to relieve moderate to moderately severe pain.

Learn More about Primalev Uses

Other, off label uses for this medicine

The acetaminophen contained in Primalev reduces fever. More Off-Label Uses for Primalev


Primalev is a brand name preparation containing oxycodone and acetaminophen. This medication is available as a tablet, intended for oral use.

Each tablet contains 300 mg of acetaminophen and 5 mg, 7.5 mg or 10 mg of oxycodone hydrochloride. The typical dosage for adults is one tablet every six hours as needed for pain. The maximum daily dosage for the 5 mg dose is 12 tablets, eight tablets for the 7.5 mg preparation and 6 tablets of the 10 mg dosage.

A pediatrician can determine if Primalev is appropriate for a child. Always administer medications to a child exactly as his doctor prescribes. Do not give a child Primalev without the consent of his pediatrician.

Take Primalev with a full glass of water to prevent choking.

Physicians should taper the doses for patients who have taken Primalev for more than a few weeks when the individual no longer needs the medication. Taking opioids such as Primalev for a long time puts consumers at special risk for withdrawal symptoms once they stop taking this opioid pain reliever.

Stop taking Primalev when you no longer need it to relieve pain or when a doctor suggests you discontinue this medication.

Primalev is available only with a doctor's prescription. The U.S. Drug Enforcement Agency, or DEA, does not allow refills on Primalev prescriptions; the physician must write a new prescription each time she determines the patient needs this medication.

Doctors normally suggest patients take Primalev when they first start feeling pain rather than on a regular schedule, so missing a dose is not usually a problem. If your prescription dictates that you take Primalev on a schedule and you miss a dose, take the missed dose as soon as you can. If it is nearly time for another dose and you can tolerate the pain, skip the missed dose and resume your normal schedule. Never take two doses at once. Read More about Primalev Administration and Dosage


The oxycodone in Primalev changes the way your brain perceives pain. When the cells of your body are injured or ill, they release chemicals, called prostaglandins, which bind with the pain receptors in nerve endings and send pain signals to your brain. Your brain reacts by perceiving pain.

Primalev interrupts prostaglandins from binding with pain receptors in a way that prevents them from attaching to receptors and sending the message of pain. The opioid component of Primalev instead sends messages of euphoria and relaxation.

The acetaminophen in Primalev eases pain and reduces fever by blocking the production of prostaglandins.

The opioids in Primalev affect the respiratory system. Primalev depresses the part of the brain responsible for breathing in a way that can make the brain simply forget to breathe. Opioids also depress the cough center in the brain, reducing the urge to cough out excess phlegm or foreign objects.

The opioid oxycodone found in Primalev acts on smooth muscle organs, like those in your intestines, in a way that slows down your digestive tract and causes constipation. To soften stools and ease constipation, drink six to eight full glasses of water each day you take Primalev. Speak to a doctor or nutritionist about various ways to increase your intake of dietary fiber, known to ease constipation. Do not use a laxative or stool softener without first discussing it with a healthcare provider.

More about How Primalev Works


Do not take Primalev if you are allergic to oxycodone, acetaminophen or other component of this medication. Tell the prescribing physician if you have ever suffered an allergic reaction to other opioid medications, such as codeine or morphine. An allergic reaction is a serious, life threatening medical emergency that requires immediate attention.

Symptoms of an allergic reaction include:

  • Rash
  • Hives
  • Itching
  • Difficulty Breathing
  • Swelling of the Face, Mouth, Lips or Tongue

Primalev can make you dizzy or drowsy and affect your ability to make quick decisions. Do not drive a motor vehicle or operate other machinery until you know how this medication affects you.

Do not drink alcoholic beverages or use products that contain alcohol while taking Primalev. Consuming alcohol while taking opioids may cause serious adverse reactions, such as damage to your liver or even death. Read the labels of foods, beverages and medications to determine if it contains alcohol. Consult with your pharmacist if you are not sure if a product contains alcohol.

Tell the prescribing physician if you normally drink more than three alcoholic beverages per day. It is important the doctor knows if you have ever had cirrhosis, sometimes called alcoholic liver disease - it may be dangerous for you to take Primalev or other medications containing acetaminophen. Chronic alcoholics should not consume more than 2000 mg of acetaminophen in a single day.

Primalev is associated with opioid abuse, dependence or addiction, especially if you take high doses or use this medication continually for more than a few weeks. Uncomfortable and persistent withdrawal symptoms or cravings associated with addiction makes it difficult to stop taking Primalev. Do not use large doses or use Primalev more frequently than prescribed to reduce your risk for dependence, addiction and other side effects.

Tell the prescribing physician if your current Primalev dose no longer relieves your pain, as this is a sign that your body is growing tolerant to Primalev. Your healthcare provider may adjust your dosing schedule or recommend a different treatment for your pain.

Primalev may affect the results of certain laboratory tests, especially the urine test for sugar. Tell the phlebotomist or laboratory technician about using Primalev before submitting urine sample or getting your blood drawn.

Medical History

You may not be able to take Primalev if you have a history of certain medical conditions. Your illness or treatment for that illness may change the way Primalev works in your body. Primalev may worsen your condition or affect your treatment.

Tell your physician about any significant illnesses or conditions, including:

  • Addison's Disease or Other Adrenal Gland Disorder
  • Asthma
  • Breathing Disorders
  • COPD
  • Curvature of the Spine
  • Enlarged Prostate
  • Epilepsy or Other Seizure Disorder
  • History of Drug or Alcohol Addiction
  • History of Head Injury or Brain Tumor
  • Intestinal Disorder
  • Kidney Disease
  • Liver Disease
  • Low Blood Pressure
  • Mental Illness
  • Pancreas Disorder
  • Sleep Apnea
  • Stomach Disorder
  • Underactive Thyroid
  • Urinary Problems

Read More about Primalev Precautions


Acetaminophen, like that found in Primalev, has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most cases of liver injury were associated with using more than 4000 mg of acetaminophen per day and frequently involved more than one acetaminophen-containing product.

Patients with known hypersensitivity or allergies to oxycodone, acetaminophen or to other opioids should not use Primalev.

Individuals with significant respiratory depression should not use Primalev in unmonitored settings or the absence of resuscitative equipment. Those suffering acute or severe bronchial asthma or hypercarbia should not use Primalev. Individuals who have suffered the serious digestive problem known as paralytic ileus should not use Primalev.


The FDA has classified Primalev as a pregnancy category C, which means medical scientists do not yet know how this drug affects an unborn baby but this drug can cause breathing problems and withdrawal symptoms in a newborn. Tell your healthcare provider if you are pregnant or plan on becoming pregnant while taking Primalev. If you become pregnant while taking Primalev, notify your doctor immediately. She will discuss the benefits and risks of taking this medication while pregnant.

The oxycodone and acetaminophen in Primalev passes from the mother to her breast milk and onto a nursing baby. Do not take Primalev while breastfeeding.

Sudden Cessation

Do not stop taking Primalev suddenly or change your dose significantly unless directed to do so by a doctor. Discontinuing Primalev abruptly, or consuming smaller doses than normal, will result in unpleasant withdrawal symptoms in a person who has grown dependent upon opioids. Taper off gradually from Primalev by taking smaller doses increasingly further apart. If you find it difficult to discontinue Primalev use, you may be dependent on opioids and require the help of detoxification specialists.

More Warnings about Using Primalev

Drug Interactions

Primalev may interact with other medications in unexpected or unfavorable ways. Give the prescribing physician and pharmacist a list of all your medications, including prescriptions, over-the-counter products, vitamins, supplements and herbal remedies. Do not start, stop or change the way you take any prescription or non-prescription preparation while you take Primalev without first discussing it with your doctor.

Tell your doctor and pharmacist if you are taking:

  • Glycopyrrolate (Robinul)
  • Mepenzolate (Cantil)
  • Atropine (Donnatal and Others)
  • Benztropine (Cogentin)
  • Dimenhydrinate (Dramamine)
  • Methscopolamine (Pamine)
  • Scopolamine (Transderm-Scop)
  • Darifenacin (Enablex)
  • Flavoxate (Urispas)
  • Oxybutynin (Ditropan and Oxytrol)
  • Tolterodine (Detrol)
  • Solifenacin (Vesicare)
  • Ipratropium (Atrovent)
  • Tiotropium (Spiriva)
  • Dicyclomine (Bentyl)
  • Hyoscyamine (Anaspaz, Cystospaz, Levsin and Others)
  • Propantheline (Pro-Banthine)

More Drug Interactions

Side effects

All medications, including Primalev, may cause adverse reactions in some consumers. Most side effects are not serious and go away after continued use. Some side effects are serious medical emergencies.

Continue using Primalev but contact the prescribing physician if the non-serious side effects become intolerable or if they do not disappear on their own. Common side effects include:

  • Blurred Vision
  • Constipation
  • Dizziness
  • Drowsiness
  • Dry Mouth
  • Mild Nausea
  • Upset Stomach
  • Vomiting

Some adverse reactions are a serious medical emergency. Stop taking this medication and consult a physician immediately if you experience serious side effects. Serious side effects include:

  • Clay-Colored Stools
  • Confusion
  • Dark Urine
  • Fainting
  • Itching
  • Lightheadedness
  • Loss of Appetite
  • Seizure
  • Severe Nausea
  • Shallow Breathing
  • Slow Heartbeat
  • Unusual Thoughts or Behavior
  • Upper Stomach Pain
  • Urinary Problems
  • Yellowing of the Skin or Eyes

Learn More about Primalev Side Effects


A person can overdose on either the acetaminophen or oxycodone contained in Primalev. Symptoms of opioid overdose are different from symptoms of acetaminophen overdose.

Overdose is a serious, life-threatening emergency that requires immediate professional attention. If you believe you or someone you know has taken too much medication, contact poison control center at 1-800-222-1222 or go to a nearby emergency department.

Emergency department doctors and nurses administer drugs such as naloxone to lower Primalev levels in the blood. They will also administer other emergency, life-saving treatments as necessary, such as establishing an airway to help the patient breathe, pumping excess medication from the stomach or performing CPR as necessary.

Opioid overdose symptoms include:

  • 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
  • No Pulse
  • Not Breathing
  • Unconsciousness

Symptoms of acetaminophen overdose come in two waves. The first symptoms of acetaminophen overdose include:

  • Confusion
  • Loss of Appetite
  • Nausea
  • Stomach Pain
  • Sweating
  • Vomiting
  • Weakness

Later symptoms may include:

  • Dark Urine
  • Upper Abdominal Pain
  • Yellowing of the Skin or Eyes

Learn More about Primalev Overdose


The U.S. Drug Enforcement Agency, or DEA, has classified Primalev as a schedule II controlled substance, which means it is associated with a high risk for abuse. One active ingredient in Primalev, oxycodone, is a favorite among recreational users. Abusers purchase opioids such as Primalev illicitly on the street, by giving phony prescriptions to pharmacies or getting prescriptions from multiple doctors. Some acquire oxycodone by stealing it from friends, family members or even pharmacies and hospitals. The DEA calls these processes "diversion" because of the way it diverts legal prescription drugs to illegal use.

Recreational users rarely target acetaminophen because it provides no pleasant euphoric effect but, since acetaminophen is a common ingredient in many opioid preparations and over-the-counter medications, inadvertent acetaminophen abuse can lead to dangerous liver disease and overdose.

Long-term Primalev abuse leads to physical dependence and addiction to opioids in some people, especially if these individuals use large doses to get high or administer the drugs intravenously.

Read More about Primalev Abuse


There have been some reports of psychosis associated with Primalev withdrawal.

Withdrawal symptoms are a predictable and normal consequence for a dependent person whose level of opioids suddenly drops. Withdrawal causes a variety of physical symptoms that can last five or more days as the individual's body gradually adjusts to lower opioid levels. Psychological symptoms of withdrawal may last much longer and be more devastating.

A human body conforms to the presence of certain foreign substances, including the opioids in Primalev, by adjusting its own chemical balance. With prolonged use, the body becomes dependent on a certain level of the drug to feel "normal." If the level of Primalev plummets, the dependent individual's body struggles to maintain chemical balance, resulting in uncomfortable, flu-like symptoms known as withdrawal.

Medical professionals know that withdrawal symptoms are a physiological process and not as an indicator of a person's moral character. You might grow physically dependent on Primalev whether you have been taking it according to a doctor's prescription or if you have been using it illegally to get high.

Withdrawal symptoms vary in severity and duration from person to person and depend on how long the person took the drug and the dosages he normally consumed. Withdrawal symptoms are usually relentless enough to prevent even the most determined and disciplined people from quitting opioid use without the help of trained professionals.

Withdrawal symptoms include:

  • Abdominal Cramps
  • Agitation
  • Anxiety
  • Blurred Vision
  • Goose Bumps
  • Insomnia
  • Restlessness
  • Sweating
  • Tremor
  • Vomiting

More about Primalev Withdrawal


Detoxification is the process of reducing the level of opioids in a person's body. Detoxification happens either because the individual took a lower dose of Primalev or because he took a medication to reduce opioid levels drastically.

Detoxification causes uncomfortable withdrawal symptoms in the dependent individual. The withdrawal process is especially lengthy and painful if you attempt self-detoxification without the aid of medicine and highly trained professionals.

Standard detoxification methods include the use of medications to treat the ensuing withdrawal symptoms, such as drugs to calm anxiety, ease diarrhea, quiet tremors and help the patient sleep. While standard detoxification shortens withdrawal time and relieves physical withdrawal symptoms, the patient still faces demoralizing psychological symptoms that often hampers successful recovery.

Rapid detox is the most efficient and humane way to detoxify the Primalev-dependent body. During rapid detox, board certified anesthesiologists administer sedatives and anesthesia to the individual alongside the standard medications to lower his opioid levels. This patient rests in a comfortable "twilight sleep" during detoxification before awakening without any memory of the withdrawal process. Learn More about Primalev Detoxification Programs


Keep Primalev at room temperature, away from moisture and heat. Keep this and all medications away from animals and children.

Do not share Primalev with others, even if they express symptoms similar to your own. It is illegal to give a prescription medication to another person.

Dispose of Primalev when you no longer need it to control your pain or when a doctor tells you to discontinue this medication. Flush unused Primalev tablets down the toilet. Read More about Storing Primalev


  • Primalev