Percocet 5 MG / 325 MG Oral Tablet
Generic Name: OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
Brand Name: PERCOCET
- Substance Name(s):
- OXYCODONE HYDROCHLORIDE
Misuse, Abuse and Diversion of Opioids Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing PERCOCET tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Concerns about misuse, addiction, and diversion should not prevent the proper management of pain. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product. Administration of PERCOCET (Oxycodone and Acetaminophen Tablets, USP) tablets should be closely monitored for the following potentially serious adverse reactions and complications: Respiratory Depression Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in PERCOCET tablets, as with all opioid agonists. Elderly and debilitated patients are at particular risk for respiratory depression as are non-tolerant patients given large initial doses of oxycodone or when oxycodone is given in conjunction with other agents that depress respiration. Oxycodone should be used with extreme caution in patients with acute asthma, chronic obstructive pulmonary disorder (COPD), cor pulmonale, or preexisting respiratory impairment. In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose. In case of respiratory depression, a reversal agent such as naloxone hydrochloride may be utilized (see OVERDOSAGE). Head Injury and Increased Intracranial Pressure The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Oxycodone produces effects on pupillary response and consciousness which may obscure neurologic signs of worsening in patients with head injuries. Hypotensive Effect Oxycodone may cause severe hypotension particularly in individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs which compromise vasomotor tone such as phenothiazines. Oxycodone, like all opioid analgesics of the morphine-type, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. Oxycodone may produce orthostatic hypotension in ambulatory patients. Hepatotoxicity Precaution should be taken in patients with liver disease. Hepatotoxicity and severe hepatic failure occurred in chronic alcoholics following therapeutic doses.
Interactions with Other CNS Depressants Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, centrally-acting anti-emetics, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with PERCOCET tablets may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
Signs and Symptoms Serious overdose with PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is characterized by signs and symptoms of opioid and acetaminophen overdose. Oxycodone overdosage can be manifested by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, pupillary constriction (pupils may be dilated in the setting of hypoxia), and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. In acute acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and thrombocytopenia may also occur. In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams and fatalities with less than 15 grams. Plasma acetaminophen levels >300 mcg/ml at 4 hours post-ingestion were associated with hepatic damage in 90% of patients; minimal hepatic damage is anticipated if plasma levels at 4 hours are <120 mcg/ml or <30 mcg/ml at 12 hours after ingestion. Importantly, young children seem to be more resistant than adults to the hepatotoxic effect of an acetaminophen overdose. Despite this, the measures outlined below should be initiated in any adult or child suspected of having ingested an acetaminophen overdose. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Treatment Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. Supportive measures (including oxygen, intravenous fluids, and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation. The opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids including oxycodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered (usual initial adult dose 0.4 mg-2 mg) preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. Opioid antagonists should not be administered in the absence of clinically significant respiratory of circulatory depression secondary to oxycodone overdose. In patients who are physically dependent on any opioid agonist including oxycodone, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Please see the prescribing information for the specific opioid antagonist for details of their proper use. Gastric emptying and/or lavage may be useful in removing unabsorbed drug. This procedure is recommended as soon as possible after ingestion, even if the patient has vomited spontaneously. After lavage and/or emesis, administration of activated charcoal, as a slurry, is beneficial, if less than three hours have passed since ingestion. Charcoal adsorption should not be employed prior to lavage and emesis. If an acetaminophen overdose is suspected, the stomach should be promptly emptied by lavage. A serum acetaminophen assay should be obtained as soon as possible, but no sooner than 4 hours following ingestion. Liver function studies should be obtained initially and repeated at 24-hour intervals. The antidote N-acetylcysteine (NAC) should be administered as early as possible, preferably within 16 hours of the overdose ingestion, but in any case within 24 hours. As a guide to treatment of acute ingestion, the acetaminophen level can be plotted against time since ingestion on a nomogram (Rumack-Matthew). The upper toxic line on the nomogram is equivalent to 200 mcg/ml at 4 hours while the lower line is equivalent to 50 mcg/ml at 12 hours. If serum level is above the lower line, and entire course of N-acetylcysteine treatment should be instituted. NAC therapy should be withheld if the acetaminophen level is below the lower line. The toxicity of oxycodone and acetaminophen in combination is unknown.
Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: Oxycodone Hydrochloride, USP 2.5 mg* Acetaminophen, USP 325 mg *2.5 mg oxycodone HCl is equivalent to 2.2409 mg of oxycodone. Oxycodone Hydrochloride, USP 5 mg* Acetaminophen, USP 325 mg *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone. Oxycodone Hydrochloride, USP 7.5 mg* Acetaminophen, USP 325 mg *7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone. Oxycodone Hydrochloride, USP 7.5 mg* Acetaminophen, USP 500 mg *7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone. Oxycodone Hydrochloride, USP 10 mg* Acetaminophen, USP 325 mg *10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone. Oxycodone Hydrochloride, USP 10 mg* Acetaminophen, USP 650 mg *10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone. All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg and the 7.5 mg/500 mg strengths contain FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg and the 10 mg/650 mg strengths contain D&C Yellow No. 10 Aluminum Lake. Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4•HCl and the molecular weight 351.83. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula: Acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula: Oxycodone Hydrochloride Structural Formula Acetaminophen Structural Formula
PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows: 2.5 mg/325 mg Pink, oval, tablet debossed with “PERCOCET” on one side and “2.5” on the other. Bottles of 100 NDC 63481-627-70 5 mg/325 mg Blue, round, tablet, debossed with “PERCOCET” and “5” on one side and bisect on the other. Bottles of 100 NDC 63481-623-70 Bottles of 500 NDC 63481-623-85 Unit dose package of 100 tablets NDC 63481-623-75 7.5 mg/325 mg Peach, oval-shaped, tablet debossed with “PERCOCET” on one side and “7.5/325” on the other. Bottles of 100 NDC 63481-628-70 7.5 mg/500 mg Peach, capsule-shaped, tablet debossed with “PERCOCET” on one side and “7.5” on the other. Bottles of 100 NDC 63481-621-70 10 mg/325 mg Yellow, capsule-shaped, tablet debossed with “PERCOCET” on one side and “10/325” on the other. Bottles of 100 NDC 63481-629-70 10 mg/650 mg Yellow, oval, tablet debossed with “PERCOCET” on one side and “10” on the other. Bottles of 100 NDC 63481-622-70 Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317 PERCOCET® is a Registered Trademark of Endo Pharmaceuticals Inc. Copyright © Endo Pharmaceuticals Inc. 2006 Printed in U.S.A. 2000055/November, 2006
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.
INDICATIONS AND USAGE
PERCOCET is indicated for the relief of moderate to moderately severe pain.
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Pregnancy Teratogenic Effects Pregnancy Category C Animal reproductive studies have not been conducted with PERCOCET. It is also not known whether PERCOCET can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. 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.
Nursing Mothers Ordinarily, nursing should not be undertaken while a patient is receiving PERCOCET tablets because of the possibility of sedation and/or respiratory depression in the infant. Oxycodone is excreted in breast milk in low concentrations, and there have been rare reports of somnolence and lethargy in babies of nursing mothers taking an oxycodone/acetaminophen product. Acetaminophen is also excreted in breast milk in low concentrations.
INFORMATION FOR PATIENTS
Information for Patients/Caregivers The following information should be provided to patients receiving PERCOCET tablets by their physician, nurse, pharmacist, or caregiver: Patients should be aware that PERCOCET tablets contain oxycodone, which is a morphine-like substance. Patients should be instructed to keep PERCOCET tablets in a secure place out of the reach of children. In the case of accidental ingestions, emergency medical care should be sought immediately. When PERCOCET tablets are no longer needed, the unused tablets should be destroyed by flushing down the toilet. Patients should be advised not to adjust the medication dose themselves. Instead, they must consult with their prescribing physician. Patients should be advised that PERCOCET tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery). Patients should not combine PERCOCET tablets with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless under the recommendation and guidance of a physician. When co-administered with another CNS depressant, PERCOCET tablets can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death. The safe use of PERCOCET tablets during pregnancy has not been established; thus, women who are planning to become pregnant or are pregnant should consult with their physician before taking PERCOCET tablets. Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue PERCOCET tablets because of the potential for serious adverse reactions to nursing infants. Patients who are treated with PERCOCET tablets for more than a few weeks should be advised not to abruptly discontinue the medication. Patients should consult with their physician for a gradual discontinuation dose schedule to taper off the medication. Patients should be advised that PERCOCET tablets are a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
DOSAGE AND ADMINISTRATION
Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. PERCOCET tablets are given orally. Percocet 2.5 mg/325 mg The usual adult dosage is one or 2 tablets every 6 hours. The total daily dose of acetaminophen should not exceed 4 grams. Percocet 5 mg/325 mg; Percocet 7.5 mg/500 mg; Percocet 10 mg/650 mg The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. Percocet 7.5 mg/325 mg; Percocet 10 mg/325 mg The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. Strength Maximal Daily Dose Percocet 2.5 mg/325 mg 12 Tablets Percocet 5 mg/325 mg 12 Tablets Percocet 7.5 mg/325 mg 8 Tablets Percocet 7.5 mg/500 mg 8 Tablets Percocet 10 mg/325 mg 6 Tablets Percocet 10 mg/650 mg 6 Tablets Cessation of Therapy In patients treated with PERCOCET tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.