Product Elements:
Oxycodone and acetaminophen oxycodone and acetaminophen cellulose, microcrystalline oxycodone hydrochloride oxycodone acetaminophen acetaminophen povidone, unspecified crospovidone (15 mpa.s at 5%) starch, corn silicon dioxide stearic acid 512
Drug Interactions:
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) concomitantly with oxycodone and acetaminophen tablets may exhibit an additive cns depression. when such combined therapy is contemplated, the dose of one or both agents should be reduced. the concurrent use of anticholinergics with opioids may produce paralytic ileus. agonist/antagonist analgesics (i.e., pentazocine, 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. these agonist/antagonist analgesics may reduce the analgesic effect of oxycodone or may precipitate
Read more... withdrawal symptoms.
Drug/drug interactions with acetaminophen alcohol, ethyl â hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen. anticholinergics â the onset of acetaminophen effect may be delayed or decreased slightly, but the ultimate pharmacological effect is not significantly affected by anticholinergics. oral contraceptives â increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen. charcoal (activated) â reduces acetaminophen absorption when administered as soon as possible after overdose. beta blockers (propanolol) â propanolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen. therefore, the pharmacologic effects of acetaminophen may be increased. loop diuretics â the effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease
Read more...plasma renin activity. lamotrigine â serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects. probenecid â probenecid may increase the therapeutic effectiveness of acetaminophen slightly. zidovudine â the pharmacologic effects of zidovudine may be decreased because of enhanced nonhepatic or renal clearance of zidovudine.
Boxed Warning:
Boxed warning warning 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 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
Indications and Usage:
Indications and usage oxycodone and acetaminophen tablets usp are indicated for the relief of moderate to moderately severe pain.
General Precautions:
General opioid analgesics should be used with caution when combined 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 â the administration of oxycodone and acetaminophen tablets 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. oxycodone may
Read more...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, a compound with a structure similar to morphine and oxycodone. the frequency of this possible cross-sensitivity is unknown.
Dosage and Administration:
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. oxycodone 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 mg 1 tablet every 6 hours as needed for pain 12 tablets oxycodone and acetaminophen tablets 7.5 mg/325 mg 1 tablet every 6 hours as needed for pain 8 tablets oxycodone and acetaminophen tablets 10 mg/325 mg 1 tablet every 6 hours as needed for pain 6 tablets
Contraindications:
Contraindications oxycodone and acetaminophen tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product. oxycodone 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. oxycodone is contraindicated in the setting of suspected or known paralytic ileus.
Adverse Reactions:
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 overdosage). the most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. these 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. other adverse reactions include euphoria, dysphoria, constipation, and pruritus. hypersensitivity reactions may include: skin eruptions, urticarial, erythematous skin reactions. hematologic reactions may include: thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. rare cases of agranulocytosis have likewise been associated with acetaminophen use. in high doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necr
Read more...osis. renal tubular necrosis and hypoglycemic coma 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 Interactions:
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) concomitantly with oxycodone and acetaminophen tablets may exhibit an additive cns depression. when such combined therapy is contemplated, the dose of one or both agents should be reduced. the concurrent use of anticholinergics with opioids may produce paralytic ileus. agonist/antagonist analgesics (i.e., pentazocine, 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. these agonist/antagonist analgesics may reduce the analgesic effect of oxycodone or may precipitate
Read more... withdrawal symptoms.
Drug/drug interactions with acetaminophen alcohol, ethyl â hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen. anticholinergics â the onset of acetaminophen effect may be delayed or decreased slightly, but the ultimate pharmacological effect is not significantly affected by anticholinergics. oral contraceptives â increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen. charcoal (activated) â reduces acetaminophen absorption when administered as soon as possible after overdose. beta blockers (propanolol) â propanolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen. therefore, the pharmacologic effects of acetaminophen may be increased. loop diuretics â the effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease
Read more...plasma renin activity. lamotrigine â serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects. probenecid â probenecid may increase the therapeutic effectiveness of acetaminophen slightly. zidovudine â the pharmacologic effects of zidovudine may be decreased because of enhanced nonhepatic or renal clearance of zidovudine.
Use in Pregnancy:
Pregnancy teratogenic effects. pregnancy category c â animal reproductive studies have not been conducted with oxycodone and acetaminophen. it is also not known whether oxycodone and acetaminophen tablets can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. oxycodone 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 â 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.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients have not been established.
Geriatric Use:
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 when compared to younger patients.
Overdosage:
Overdosage following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen.
Description:
Description each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 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 .........................................................................10 mg* acetaminophen usp .........................................................................................325 mg *10 mg oxycodone hcl is equivalent to 8.9637 mg of oxycodone. all strengths of oxycodone and acetaminophen tablets usp also contain the following inactive ingredients: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. oxycodone, 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. it is derived from the opium alkaloid thebaine. oxycodone hydrochloride may be represented by the following structural formula: [oxycodone chemical structure] 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. it may be represented by the following structural formula: [acetaminophen chemical structure]
Pharmacokinetics:
Pharmacokinetics absorption and distribution â the mean absolute oral bioavailability of oxycodone in cancer patients was reported to be about 87%. oxycodone has been shown to be 45% bound to human plasma proteins in vitro. the volume of distribution after intravenous administration is 211.9 ± 186.6 l. absorption of acetaminophen is rapid and almost complete from the gi tract after oral administration. with overdosage, absorption is complete in 4 hours. acetaminophen is relatively uniformly distributed throughout most body fluids. binding of the drug to plasma proteins is variable; only 20% to 50% may be bound at the concentrations encountered during acute intoxication.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility carcinogenesis â animal studies to evaluate the carcinogenic potential of oxycodone and acetaminophen have not been performed. mutagenesis â 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 â animal studies to evaluate the effects of oxycodone on fertility have not been performed.
How Supplied:
How supplied each oxycodone and acetaminophen tablet usp 5 mg/325 mg contains oxycodone hydrochloride 5 mg (equivalent to 4.4815 mg oxycodone) and acetaminophen 325 mg. it is available as a round, white scored tablet debossed with a 512 identification number. bottles of 100 . . . . . . . . . . . . . . . . . . . . . ndc 0406-0512-01 bottles of 500 . . . . . . . . . . . . . . . . . . . . . ndc 0406-0512-05 unit dose (10 x 10). . . . . . . . . . . . . . . . . ndc 0406-0512-62 each oxycodone and acetaminophen tablet usp 7.5 mg/325 mg contains oxycodone hydrochloride 7.5 mg (equivalent to 6.7228 mg oxycodone) and acetaminophen 325 mg. it is available as a white to off-white caplet shaped tablet debossed with âm522â on one side and â7.5/325â on the other side. bottles of 100 . . . . . . . . . . . . . . . . . . . . . ndc 0406-0522-01 bottles of 500 . . . . . . . . . . . . . . . . . . . . . ndc 0406-0522-05 unit dose (10 x 10). . . . . . . . . . . . . . . . . ndc 0406-0522-
Read more...62 each oxycodone and acetaminophen tablet usp 10 mg/325 mg contains oxycodone hydrochloride 10 mg (equivalent to 8.9637 mg oxycodone) and acetaminophen 325 mg. it is available as a white to off-white caplet shaped tablet debossed with âm523â on one side and â10/325â on the other side. bottles of 100 . . . . . . . . . . . . . . . . . . . . . ndc 0406-0523-01 bottles of 500 . . . . . . . . . . . . . . . . . . . . . ndc 0406-0523-05 unit dose (10 x 10). . . . . . . . . . . . . . . . . ndc 0406-0523-62 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. mallinckrodt, the âmâ brand mark and the mallinckrodt pharmaceuticals logo are trademarks of a mallinckrodt company. © 2015 mallinckrodt. mallinckrodt inc. hazelwood, mo 63042 usa printed in u.s.a. rev 11/2015 mallinckrodt⢠pharmaceuticals
Information for Patients:
Information for patients/caregivers do not take oxycodone and acetaminophen tablets usp if you are allergic to any of its ingredients. if you develop signs of allergy such as a rash or difficulty breathing stop taking oxycodone and acetaminophen tablets usp and contact your healthcare provider immediately. do not take more than 4000 milligrams of acetaminophen per day. call your doctor if you took more than the recommended dose. 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. in 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. instead, they must consult wi
Read more...th 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.g., driving, operating heavy machinery). patients should not combine oxycodone and acetaminophen 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, 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 become 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. patients 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. they should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
Spl Patient Package Insert:
Interactions with mixed agonist/antagonist opioid analgesics agonist/antagonist analgesics (i.e., 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. in this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in these patients.
Package Label Principal Display Panel:
Package label. principal display panel #60 67296-0355