Seek emergency medical attention or call the Poison Help line at Overdose can cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma. The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting , stomach pain, sweating, and confusion or weakness. Do not drink alcohol. Dangerous side effects or death could occur. This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Dizziness or severe drowsiness can cause falls or other accidents. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen sometimes abbreviated as APAP is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. In rare cases, acetaminophen may cause a severe skin reaction that can be fatal.

This could occur even if you have taken acetaminophen in the past and had no reaction. Like other narcotic medicines, oxycodone can slow your breathing. Death may occur if breathing becomes too weak. Call your doctor at once if you have: Seek medical attention right away if you have symptoms of serotonin syndrome, such as: Serious side effects may be more likely in older adults and those who are overweight , malnourished, or debilitated.

Long-term use of opioid medication may affect fertility ability to have children in men or women. It is not known whether opioid effects on fertility are permanent. Common side effects include: This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. Narcotic opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use: Tell your healthcare provider right away if you have difficulty of breathing while taking this medication.

Symptoms may include skin reddening, rash, blisters, and the upper surface of the skin may become separated from the lower layers. This can occur even if you have taken acetaminophen in the past without any problems.

If you develop any skin rash or reaction while using a medication containing acetaminophen, including this medication, stop the medication and seek medical attention immediately.

If you have had a serious skin reaction with acetaminophen, do not take it or any products containing acetaminophen again. Doing so could cause you to have another serious skin reaction. In some cases, this may be harmful and your doctor may advise you to avoid certain foods.

Oxycodone may produce orthostatic hypotension in ambulatory patients. Hepatotoxicity 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 milligrams per day, and often involve more than one acetaminophen containing product.

The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen.

Instruct patients to seek medical attention immediately upon ingestion of more than milligrams of acetaminophen per day, even if they feel well. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Clinical signs including swelling of the face, mouth, and throat, respiratory distress, urticaria , rash, pruritus , and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention.

PERCOCET tablets should be given with caution to patients with CNS depression, elderly or debilitated patients, patients with severe impairment of hepatic, pulmonary, or renal function, hypothyroidism , Addison's disease, prostatic hypertrophy , urethral stricture, acute alcoholism, delirium tremens , kyphoscoliosis with respiratory depression, myxedema, and toxic psychosis.

Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings. Following administration of PERCOCET tablets, anaphylactic reactions have been reported in patients with a known hypersensitivity to codeine, a compound with a structure similar to morphine and oxycodone. The frequency of this possible cross-sensitivity is unknown. Ambulatory Surgery and Postoperative Use Oxycodone and other morphine-like opioids have been shown to decrease bowel motility.

Ileus is a common postoperative complication, especially after intra-abdominal surgery with use of opioid analgesia. Caution should be taken to monitor for decreased bowel motility in postoperative patients receiving opioids. Standard supportive therapy should be implemented. Opioids like oxycodone may cause increases in the serum amylase level.

Tolerance and Physical Dependence Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia in the absence of disease progression or other external factors. Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist.

Physical dependence and tolerance are not unusual during chronic opioid therapy. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: Other symptoms also may develop, including: Laboratory Tests Although oxycodone may cross-react with some drug urine tests, no available studies were found which determined the duration of detectability of oxycodone in urine drug screens.

However, based on pharmacokinetic data, the approximate duration of detectability for a single dose of oxycodone is roughly estimated to be one to two days following drug exposure. Urine testing for opiates may be performed to determine illicit drug use and for medical reasons such as evaluation of patients with altered states of consciousness or monitoring efficacy of drug rehabilitation efforts.

The preliminary identification of opiates in urine involves the use of an immunoassay screening and thin-layer chromatography TLC. The identities of 6-keto opiates e. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Animal studies to evaluate the carcinogenic potential of oxycodone and acetaminophen have not been performed.

Mutagenesis The combination of oxycodone and acetaminophen has not been evaluated for mutagenicity. Oxycodone alone was negative in a bacterial reverse mutation assay Ames , an in vitro chromosome aberration assay with human lymphocytes without metabolic activation and an in vivo mouse micronucleus assay. Oxycodone was clastogenic in the human lymphocyte chromosomal assay in the presence of metabolic activation and in the mouse lymphoma assay with or without metabolic activation.

Fertility Animal studies to evaluate the effects of oxycodone on fertility have not been performed. PERCOCET should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards. Nonteratogenic Effects Opioids can cross the placental barrier and have the potential to cause neonatal respiratory depression. Opioid use during pregnancy may result in a physically drug-dependent fetus.

After birth, the neonate may suffer severe withdrawal symptoms. Labor and Delivery PERCOCET tablets are not recommended for use in women during and immediately prior to labor and delivery due to its potential effects on respiratory function in the newborn. Acetaminophen is also excreted in breast milk in low concentrations. Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric Use Special precaution should be given when determining the dosing amount and frequency of PERCOCET tablets for geriatric patients, since clearance of oxycodone may be slightly reduced in this patient population when compared to younger patients. Hepatic Impairment In a pharmacokinetic study of oxycodone in patients with end-stage liver disease, oxycodone plasma clearance decreased and the elimination half-life increased. Care should be exercised when oxycodone is used in patients with hepatic impairment.

Renal Impairment In a study of patients with end stage renal impairment, mean elimination half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance. Oxycodone should be used with caution in patients with renal impairment. Signs and Symptoms Toxicity from oxycodone poisoning includes the opioid triad of: In severe overdosage, apnea , circulatory collapse, cardiac arrest, and death may occur. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur.

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