.................Mg Acetaminophen USP ...................... 5 mg oxycodone HCl is equivalent to 4.Of oxycodone.Oxycodone Hydrochloride USP ..................7.Acetaminophen USP ...................... 7.Oxycodone HCl is equivalent to 6.Of oxycodone.Oxycodone Hydrochloride USP ..................7.Acetaminophen USP ...................... 7.Oxycodone HCl is equivalent to 6.Of oxycodone.Oxycodone Hydrochloride USP ..................10 mg Acetaminophen USP ......................325 mg 10 mg oxycodone HCl is equivalent to 8.Of oxycodone.All strengths of oxycodone and acetaminophen tablets USP also contain the following inactive ingredients: crospovidone NF, microcrystalline cellulose NF, povidone USP, pregelatinized starch NF, silicon dioxide NF and stearic acid NF.14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste.Is derived from the opium alkaloid thebaine.Hydrochloride 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.May be represented by the following structural formula: CLINICAL PHARMACOLOGY CENTRAL NERVOUS SYSTEM Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia.Pharmacological effects of oxycodone include anxiolysis, euphoria and feelings of relaxation.Are mediated by receptors (notably Ој and Оє) in the central nervous system for endogenous opioid-likepounds such as endorphins and enkephalins.Produces respiratory depression through direct activity at respiratory centers in the brain stem and depresses the cough reflex by direct effect on the center of the medulla.Is a non-opiate, non-salicylate analgesic and antipyretic.Site and mechanism for the analgesic effect of acetaminophen has not been determined.Antipyretic effect of acetaminophen is aplished through the inhibition of endogenous pyrogen action on the hypothalamic heat-regulating centers.GASTROINTESTINAL TRACT AND OTHER SMOOTH MUSCLE Oxycodone reduces motility by increasing smooth muscle tone in the stomach and duodenum.The small intestine, digestion of food is delayed by decreases in propulsive contractions.Opioid effects include contraction of biliary tract smooth muscle, spasm of the Sphincter of Oddi, increased ureteral and bladder sphincter tone, and a reduction in uterine tone.SYSTEM Oxycodone may produce a release of histamine and may be associated with orthostatic hypotension, and other symptoms, such as pruritus, flushing, red eyes, and sweating.PHARMACOKINETICS Absorption and Distribution - The mean absolute oral bioavailability of oxycodone in cancer patients was reported to be about 87%.Been shown to be 45% bound to human plasma proteins in vitro.Of distribution after intravenous administration is 211.L.Of acetaminophen is rapid and almostplete from the GI tract after oral administration.Overdosage, absorption isplete in 4 hours.Is relatively uniformly distributed throughout most body fluids.Of the drug to plasma proteins is variable; only 20% to 50% may be bound at the concentrations encountered during acute intoxication.METABOLISM AND ELIMINATION A high portion of oxycodone is N-dealkylated to noroxycodone during first-pass metabolism.Is formed by the O-demethylation of oxycodone.Metabolism of oxycodone to oxymorphone is catalyzed by CYP2D6.And conjugated noroxycodone, free and conjugated oxycodone, and oxymorphone are excreted in human urine following a single oral dose of oxycodone.8% to 14% of the dose is excreted as free oxycodone over 24 hours after administration.Oral dose of oxycodone, the mean SD elimination half-life is 3.Hours.Acetaminophen is metabolized in the liver via cytochrome P450 microsomal enzyme.80 to 85% of the acetaminophen in the body is conjugated principally with glucuronic acid and to a lesser extent with sulfuric acid and cysteine.Hepatic conjugation, 90 to 100% of the drug is recovered in the urine within the first day.4% of acetaminophen is metabolized via cytochrome P450 oxidase to a toxic metabolite which is further detoxified by conjugation with glutathione, present in a fixed amount.Is believed that the toxic metabolite NAPQI (N acetyl-p-benzoquinoneimine, N-acetylimidoquinone) is responsible for liver necrosis.Doses of acetaminophen may deplete the glutathione stores so that inactivation of the toxic metabolite is decreased.High doses, the capacity of metabolic pathways for conjugation with glucuronic acid and sulfuric acid may be exceeded, resulting in increased metabolism of acetaminophen by alternate pathways.INDICATIONS AND USAGE Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.CONTRAINDICATIONS Oxycodone and acetaminophen tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any otherponent of this product.Is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia.Is contraindicated in the setting of suspected or known paralytic ileus.WARNINGS MISUSE, ABUSE AND DIVERSION OF OPIOIDS Oxycodone is an opioid agonist of the morphine-type.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.Should be considered when prescribing or dispensing oxycodone and acetaminophen tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.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 oxycodone and acetaminophen tablets USP should be closely monitored for the following potentially serious adverse reactions andplications: RESPIRATORY DEPRESSION Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in oxycodone and acetaminophen tablets, as with all opioid agonists.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.Be used with extreme caution in patients with acute asthma, chronic obstructive pulmonary disorder (COPD), cor pulmonale, or preexisting respiratory impairment.Such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea.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 ).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.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 beenpromised by a depleted blood volume, or after concurrent administration with drugs whichpromise vasomotor tone such as phenothiazines.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.May produce orthostatic hypotension in ambulatory patients.HEPATOTOXICITY Precaution should be taken in patients with liver disease.Severe hepatic failure occurred in chronic alcoholics following therapeutic doses.PRECAUTIONS GENERAL Opioid analgesics should be used with caution whenbined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.Acute Abdominal Conditions - The administration of oxycodone and acetaminophen tablets USP or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.Oxycodone and acetaminophen 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 and acetaminophen tablets may obscure the diagnosis or clinical course in patients with acute abdominal conditions.May aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.Following administration of oxycodone and acetaminophen tablets, anaphylactic reactions have been reported in patients with a known hypersensitivity to codeine, apound with a structure similar to morphine and oxycodone.Frequency of this possible cross-sensitivity is unknown.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) coitantly with oxycodone and acetaminophen tablets may exhibit an additive CNS depression.Suchbined therapy is contemplated, the dose of one or both agents should be reduced.WITH MIXED AGONIST/ANTAGONIST OPIOID ANALGESICS Agonist/antagonist analgesics (i.Pentazocine, nalbuphine, and butorphanol) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone.This situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in these patients.AMBULATORY SURGERY AND POSTOPERATIVE USE Oxycodone and other morphine-like opioids have been shown to decrease bowel motility.Amon postoperativeplication, especially after intra-abdominal surgery with use of opioid analgesia.Be taken to monitor for decreased bowel motility in postoperative patients receiving opioids.Supportive therapy should be implemented.USE IN PANCREATIC/BILIARY TRACT DISEASE Oxycodone may cause spasm of the Sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.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).Dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist.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: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis.Symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.In general, opioids should not be abruptly discontinued (see ).FOR PATIENTS/CAREGIVERS The following information should be provided to patients receiving oxycodone and acetaminophen tablets by their physician, nurse, pharmacist, or caregiver: Patients should be aware that oxycodone and acetaminophen tablets contain oxycodone, which is a morphine-like substance.Patients should be instructed to keep oxycodone and acetaminophen tablets in a secure place out of the reach of children.The case of accidental ingestions, emergency medical care should be sought immediately.When oxycodone and acetaminophen 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.They must consult with their prescribing physician.Patients should be advised that oxycodone and acetaminophen tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.Driving, operating heavy machinery).Patients should notbine oxycodone and acetaminophen tablets with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless under the rmendation and guidance of a physician.With another CNS depressant, oxycodone and acetaminophen tablets can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death.The safe use of oxycodone and acetaminophen tablets during pregnancy has not been established; thus, women who are planning to be pregnant or are pregnant should consult with their physician before taking oxycodone and acetaminophen tablets.Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue oxycodone and acetaminophen tablets because of the potential for serious adverse reactions to nursing infants.Patients who are treated with oxycodone and acetaminophen tablets for more than a few weeks should be advised not to abruptly discontinue the medication.Should consult with their physician for a gradual discontinuation dose schedule to taper off the medication.Patients should be advised that oxycodone and acetaminophen tablets are a potential drug of abuse.Should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.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.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.Preliminary identification of opiates in urine involves the use of an immunoassay screening and thin-layer chromatography (TLC).Chromatography/mass spectrometry (GC/MS) may be utilized as a third-stage identification step in the medical investigational sequence for opiate testing after immunoassay and TLC.Of 6-keto opiates (e.Oxycodone) can further be differentiated by the analysis of their methoxime-trimethylsilyl (MO-TMS) derivative.DRUG/DRUG INTERACTIONS WITH OXYCODONE Opioid analgesics may enhance the neuromuscular-blocking action of skeletal muscle relaxants and produce an increase in the degree of respiratory depression.Patients receiving CNS depressants such as other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, centrally-acting anti-emetics, sedative-hypnotics or other CNS depressants (including alcohol) coitantly with oxycodone and acetaminophen tablets may exhibit an additive CNS depression.Therapy is contemplated, the dose of one or both agents should be reduced.Concurrent use of anticholinergics with opioids may produce paralytic ileus.Agonist/antagonist analgesics (i.Nalbuphine, naltrexone, and butorphanol) should be administered with caution to a patient who has received or is receiving a pure opioid agonist such as oxycodone.Analgesics may reduce the analgesic effect of oxycodone or may precipitate withdrawal symptoms.DRUG/DRUG INTERACTIONS WITH ACETAMINOPHEN Alcohol, ethyl- Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen.Anticholinergics- The onset of acetaminophen effect may be delayed or decreased slightly, but the ultimate pharmacological effect is not significantly affected by anticholinergics.Oral Contraceptives- Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen.Charcoal (activated)- Reduces acetaminophen absorption when administered as soon as possible after overdose.Beta Blockers (Propanolol)- Propranolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen.The pharmacologic effects of acetaminophen may be increased.Loop diuretics- The effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activity.Lamotrigine- Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects.Probenecid- Probenecid may increase the therapeutic effectiveness of acetaminophen slightly.Zidovudine- The pharmacologic effects of zidovudine may be decreased because of enhanced nonhepatic or renal clearance of zidovudine.DRUG/LABORATORY TEST INTERACTIONS Depending on the sensitivity/specificity and the test methodology, the individualponents of oxycodone and acetaminophen tablets USP may cross-react with assays used in the preliminary detection of cocaine (primary urinary metabolite, benzoylecgonine) or marijuana (cannabinoids) in human urine.More specific alternate chemical method must be used in order to obtain a confirmed analytical result.Confirmatory method is gas chromatography/mass spectrometry (GC/MS).Clinical considerations and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.May interfere with home blood glucose measurement systems; decreases of > 20% in mean glucose values may be noted.Appears to be drug, concentration and system dependent.MUTAGENESIS, IMPAIRMENT OF FERTILITY Carcinogenesis - Animal studies to evaluate the carcinogenic potential of oxycodone and acetaminophen have not been performed.Mutagenesis - Thebination of oxycodone and acetaminophen has not been evaluated for mutagenicity.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.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.PREGNANCY Teratogenic Effects.Category C- Animal reproductive studies have not been conducted with oxycodone and acetaminophen.Is also not known whether oxycodone and acetaminophen tablets can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.And acetaminophen tablets 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.Use during pregnancy may result in a physically drug-dependent fetus.The neonate may suffer severe withdrawal symptoms.LABOR AND DELIVERY Oxycodone and acetaminophen tablets are not rmended for use in women during and immediately prior to labor and delivery due to its potential effects on respiratory function in the newborn.NURSING MOTHERS Ordinarily, nursing should not be undertaken while a patient is receiving oxycodone and acetaminophen tablets because of the possibility of sedation and/or respiratory depression in the infant.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.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 oxycodone and acetaminophen tablets for geriatric patients, since clearance of oxycodone may be slightly reduced in this patient population whenpared 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.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.Should be used with caution in patients with renal impairment.ADVERSE REACTIONS Serious adverse reactions that may be associated with oxycodone and acetaminophen tablet use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (see ).The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting.Effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.Adverse reactions include euphoria, dysphoria, constipation, and pruritus.Reactions may include: Skin eruptions, urticarial, erythematous skin reactions.Reactions may include: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia.Of agranulocytosis have likewise been associated with acetaminophen use.High doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis.Renal tubular necrosis and hypoglycemica also may occur.Other adverse reactions obtained from postmarketing experiences with oxycodone and acetaminophen tablets are listed by organ system and in decreasing order of severity and/or frequency as follows: Body as a Whole Anaphylactoid reaction, allergic reaction, malaise, asthenia, fatigue, chest pain, fever, hypothermia, thirst, headache, increased sweating, accidental overdose, non-accidental overdose Cardiovascular Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia, palpitations, dysrhythmias Central and Peripheral Nervous System Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, seizures, anxiety, mental impairment, agitation, cerebral edema, confusion, dizziness Fluid and Electrolyte Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis Gastrointestinal Dyspepsia, taste disturbances, abdominal pain, abdominal distention, sweating increased, diarrhea, dry mouth, flatulence, gastro-intestinal disorder, nausea, vomiting, pancreatitis, intestinal obstruction, ileus Hepatic Transient elevations of hepatic enzymes, increase in bilirubin, hepatitis, hepatic failure, jaundice, hepatotoxicity, hepatic disorder Hearing and Vestibular Hearing loss, tinnitus Hematologic Thrombocytopenia Hypersensitivity Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid reaction Metabolic and Nutritional Hypoglycemia, hyperglycemia, acidosis, alkalosis Musculoskeletal Myalgia, rhabdomyolysis Ocular Miosis, visual disturbances, red eye Psychiatric Drug dependence, drug abuse, insomnia, confusion, anxiety, agitation, depressed level of consciousness, nervousness, hallucination, somnolence, depression, suicide Respiratory System Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, aspiration, hypoventilation, laryngeal edema Skin and Appendages Erythema, urticaria, rash, flushing Urogenital Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, urinary retention DRUG ABUSE AND DEPENDENCE Oxycodone and acetaminophen tablets are a Schedule II controlled substance.Is a mu-agonist opioid with an abuse liability similar to morphine.Like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.Drug addiction is defined as an abnormal,pulsive use, use for non-medical purposes of a substance despite physical, psychological, occupational or interpersonal difficulties resulting from such use, and continued use despite harm or risk of harm.Addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse ismon.Is relatively rare in patients with chronic pain but may be moremon in individuals who have a past history of alcohol or substance abuse or dependence.Refers to pain relief seeking behavior of patients whose pain is poorly managed.Considered an iatrogenic effect of ineffective pain management.Care provider must assess continuously the psychological and clinical condition of a pain patient in order to distinguish addiction from pseudoaddiction and thus, be able to treat the pain adequately.Physical dependence on a prescribed medication does not signify addiction.Dependence involves the occurrence of a withdrawal syndrome when there is sudden reduction or cessation in drug use or if an opiate antagonist is administered.Dependence can be detected after a few days of opioid therapy.Clinically significant physical dependence is only seen after several weeks of relatively high dosage therapy.Case, abrupt discontinuation of the opioid may result in a withdrawal syndrome.The discontinuation of opioids is therapeutically indicated, gradual tapering of the drug over a 2-week period will prevent withdrawal symptoms.Severity of the withdrawal syndrome depends primarily on the daily dosage of the opioid, the duration of therapy and medical status of the individual.The withdrawal syndrome of oxycodone is similar to that of morphine.Is characterized by yawning, anxiety, increased heart rate and blood pressure, restlessness, nervousness, muscle aches, tremor, irritability, chills alternating with hot flashes, salivation, anorexia, severe sneezing, lacrimation, rhinorrhea, dilated pupils, diaphoresis, piloerection, nausea, vomiting, abdominal cramps, diarrhea and insomnia, and pronounced weakness and depression.Behavior is verymon in addicts and drug abusers.Emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s).Shopping" to obtain additional prescriptions ismon among drug abusers and people suffering from untreated infection.Abuse and addiction are separate and distinct from physical dependence and tolerance.Should be aware that addiction may not be apanied by concurrent tolerance and symptoms of physical dependence in all addicts.Addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often inbination with other psychoactive substances.Like other opioids, has been diverted for non-medical use.Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.Like other opioid medications, oxycodone and acetaminophen tablets are subject to the Federal Controlled Substances Act.Chronic use, oxycodone and acetaminophen tablets should not be discontinued abruptly when it is thought that the patient has be physically dependent on oxycodone.INTERACTIONS WITH ALCOHOL AND DRUGS OF ABUSE Oxycodone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.OVERDOSAGE SIGNS AND SYMPTOMS Serious overdose with oxycodone and acetaminophen tablets USP is characterized by signs and symptoms of opioid and acetaminophen overdose.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 ora, skeletal muscle flaccidity, cold and clammy skin, pupillary constriction (pupils may be dilated in the setting of hypoxia), and sometimes bradycardia and hypotension.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.Necrosis, hypoglycemica and thrombocytopenia may also occur.Adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams and fatalities with less than 15 grams.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.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.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.Measures (including oxygen, intravenous fluids, and vasopressors) should be employed in the management of circulatory shock and pulmonary edema apanying overdose as indicated.Or arrhythmias may require cardiac massage or defibrillation.Opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids including oxycodone.An appropriate dose of naloxone hydrochloride should be administered (usual initial adult dose 0.To 2 mg) preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation.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.Antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose.Patients who are physically dependent on any opioid agonist including oxycodone, an abrupt orplete reversal of opioid effects may precipitate an acute abstinence syndrome.Severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered.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.Is rmended as soon as possible after ingestion, even if the patient has vomited spontaneously.Lavage and/or emesis, administration of activated charcoal, as a slurry, is beneficial, if less than three hours have passed since ingestion.Should not be employed prior to lavage and emesis.Acetaminophen overdose is suspected, the stomach should be promptly emptied by lavage.Serum acetaminophen assay should be obtained as soon as possible, but no sooner than 4 hours following ingestion.Function studies should be obtained initially and repeated at 24-hour intervals.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.A guide to treatment of acute ingestion, the acetaminophen level can be plotted against time since ingestion on a nomogram (Rumack-Matthew).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.Serum level is above the lower line, an entire course of N-acetylcysteine treatment should be instituted.Should be withheld if the acetaminophen level is below the lower line.The toxicity of oxycodone and acetaminophen inbination is unknown.DOSAGE AND ADMINISTRATION Dosage should be adjusted according to the severity of the pain and the response of the patient.May occasionally be necessary to exceed the usual dosage rmended below in cases of more severe pain or in those patients who have be tolerant to the analgesic effect of opioids.Pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule.And acetaminophen tablets are given orally.The total daily dose of acetaminophen should not exceed 4 grams.Strength Usual Adult Dosage Maximal Daily Dose Oxycodone and acetaminophen tablets 5 mg/325 mg1 tablet every 6 hours as needed for pain12 Tablets Oxycodone and acetaminophen tablets 7.Mg1 tablet every 6 hours as needed for pain8 Tablets Oxycodone and acetaminophen tablets 7.Mg1 tablet every 6 hours as needed for pain8 Tablets Oxycodone and acetaminophen tablets 10 mg/325 mg1 tablet every 6 hours as needed for pain6 Tablets Cessation of Therapy In patients treated with oxycodone and acetaminophen 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.HOW SUPPLIED Each oxycodone and acetaminophen tablet USP 5 mg/325 mg contains oxycodone hydrochloride 5 mg (equivalent to 4.And acetaminophen 325 mg.Is available as a round, white scored tablet debossed with a 512 identification number.Bottles of 100 ...........0406-0512-01 Bottles of 500 . .........NDC 0406-0512-05 Unit Dose (10x10).........NDC 0406-0512-62 Each oxycodone and acetaminophen tablet USP 7.Mg contains oxycodone hydrochloride 7.(equivalent to 6.Oxycodone) and acetaminophen 325 mg.Is available as a white to off-white caplet shaped tablet debossed with "M522" on one side and "7.The other side.Bottles of 100 .......... NDC 0406-0522-01 Unit Dose (10x10)........ .0406-0522-62 Each oxycodone and acetaminophen tablet USP 7.Mg contains oxycodone hydrochloride 7.(equivalent to 6.Oxycodone) and acetaminophen 500 mg.Is available as a white to off-white oval shaped tablet debossed with "M582" on one side and the other side is plain.Bottles of 100 ...........0406-0582-01 Unit Dose (10x10).........0406-0582-62 Each oxycodone and acetaminophen tablet USP 10 mg/325 mg contains oxycodone hydrochloride 10 mg (equivalent to 8.Oxycodone) and acetaminophen 325 mg.Is available as a white to off-white caplet shaped tablet debossed with "M523" on one side and "10/325" on the other side.Bottles of 100 .......... NDC 0406-0523-01 Unit Dose (10x10)........ .0406-0523-62 Store at 20 to 25C (68 to 77F) .Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).DEA Order Form Required.Mallinckrodt Inc.St.MO 63134 Printed in U. tyco Healthcare Mallinckrodt Rev 060107 Oxycodone and Acetaminophen (Oxycodone hydrochloride and Acetaminophen) PRODUCT INFO Product Code 0406-0512 Dosage Form TABLET Route Of Administration ORAL DEA Schedule CII INGREDIENTS Name (Active Moiety) Type Strength OXYCODONE HYDROCHLORIDE (Oxycodone) Active 5 MILLIGRAM In 1 TABLET ACETAMINOPHEN (Acetaminophen) Active 325 MILLIGRAM In 1 TABLET CROSPOVIDONE Inactive MICROCRYSTALLINE CELLULOSE Inactive POVIDONE Inactive PREGELATINIZED STARCH Inactive SILICON DIOXIDE Inactive STEARIC ACID Inactive IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color WHITE (WHITE) Score 2 Shape ROUND (ROUND) Symbol false Imprint Code 512 Coating false Size 12mm PACKAGING # NDC Package Description Multilevel Packaging 1 0406-0512-01 100 TABLET In 1 BOTTLE None 2 0406-0512-05 500 TABLET In 1 BOTTLE None 3 0406-0512-62 100 TABLET In 1 BLISTER PACK None Oxycodone and Acetaminophen (Oxycodone hydrochloride and Acetaminophen) PRODUCT INFO Product Code 0406-0522 Dosage Form TABLET Route Of Administration ORAL DEA Schedule CII INGREDIENTS Name (Active Moiety) Type Strength OXYCODONE HYDROCHLORIDE (Oxycodone) Active 7.In 1 TABLET ACETAMINOPHEN (Acetaminophen) Active 325 MILLIGRAM In 1 TABLET CROSPOVIDONE Inactive MICROCRYSTALLINE CELLULOSE Inactive POVIDONE Inactive PREGELATINIZED STARCH Inactive SILICON DIOXIDE Inactive STEARIC ACID Inactive IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color WHITE (Off White) Score 1 Shape OVAL (OVAL) Symbol false Imprint Code M522;7.Read more Copd patient benefits from treatment with seretide
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