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Special Alerts
McNeil Consumer Healthcare OTC Products: Voluntary Recall - January 2010
McNeil Consumer Healthcare has expanded a previous recall to include specific lots of certain additional OTC products. For information on returning the recalled products, contact McNeil Consumer Healthcare at (800) 222-6036.
For additional information and a link to the full list of recalled products and lot numbers, please refer to http://www.fda.gov/Safety/Recalls/ucm197746.htm .
Children's and Infants' Tylenol® Products: Recall Due to Potential Manufacturing Problems - September 2009
McNeil Consumer Healthcare, in conjunction with the U.S. Food and Drug Administration (FDA), has issued a voluntary, cautionary recall of certain lots of Children's and Infants' Tylenol® manufactured between April and June 2008. The manufacturer states that one of the inactive ingredients did not meet internal testing requirements and the gram-negative bacteria Burkholderia cepacia was detected. The contaminated material was not used in the final product and the finished product did meet all specifications. Parents and caregivers should be advised to contact their healthcare providers if they have concerns. If an affected product is found, contact McNeil Customer Care Center at 1-800-962-5357 to receive a coupon for a new bottle.
For additional information and a full list of the recalled product lots, please refer to:
http://www.tylenolprofessional.com/assets/TYLENOL_Letter_091809.pdf
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183924.htm
Acetaminophen Concentrated Drops (16 ounce) Recall Due to Potential For Overdosing - July 2009
Brookstone Pharmaceuticals, with awareness of the U.S. Food and Drug Administration (FDA), has issued a voluntary recall of all lots of concentrated acetaminophen drops (80 mg/0.8 mL) in 16 ounce bulk containers. The manufacturer states this is a cautionary measure to minimize confusion between this bulk container of the concentrated acetaminophen preparation and the bulk container of the regular strength acetaminophen liquid preparations (160 mg/15 mL), and to limit the risk of potential dosing errors.
For additional information, please refer to http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172252.htm
Medication Safety Issues
Sound-alike/look-alike issues:
Acephen® may be confused with AcipHex®
FeverALL® may be confused with Fiberall®
Tylenol® may be confused with atenolol, timolol, Tuinal®, Tylenol® PM, Tylox®
International issues:
Paralen® [Czech Republic] may be confused with Aralen® which is a brand name for chloroquine in the U.S.
Duorol® may be confused with Diuril® which is a brand name for chlorothiazide in the U.S.
Duplicate therapy issues: This product contains acetaminophen, which may be a component of combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
Pronunciation
(a seet a MIN oh fen)
U.S. Brand Names
Index Terms
Generic Available
Yes: Excludes extended release products
Canadian Brand Names
Pharmacologic Category
Use: Labeled Indications
Treatment of mild-to-moderate pain and fever (analgesic/antipyretic); does not have antirheumatic or anti-inflammatory effects
Use: Dental
Treatment of postoperative pain
Pregnancy Risk Factor
B
Pregnancy Considerations
Acetaminophen crosses the placenta. It is generally considered to be safe for use during pregnancy when used at therapeutic doses for short periods of time.
Lactation
Enters breast milk/compatible
Breast-Feeding Considerations
Acetaminophen is found in breast milk. The AAP considers acetaminophen to be “compatible” with breast-feeding.
Contraindications
Hypersensitivity to acetaminophen or any component of the formulation
Warnings/Precautions
Concerns related to adverse effects:
• Hepatotoxicity: May cause severe hepatic toxicity on acute overdose; in addition, chronic daily dosing in adults has resulted in liver damage in some patients.
Disease-related concerns:
• Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ?3 alcoholic drinks/day may increase the risk of liver damage.
• G6PD deficiency: Use with caution in patients with known G6PD deficiency.
Other warnings/precautions:
• Dosage limit: Limit dose to <4 g/day.
• Self-medication (OTC use): When used for self-medication, patients should be instructed to contact healthcare provider if used for fever lasting >3 days or for pain lasting >10 days in adults or >5 days in children.
Adverse Reactions
Frequency not defined.
Dermatologic: Rash
Endocrine & metabolic: May increase chloride, uric acid, glucose; may decrease sodium, bicarbonate, calcium
Hematologic: Anemia, blood dyscrasias (neutropenia, pancytopenia, leukopenia)
Hepatic: Bilirubin increased, alkaline phosphatase increased
Renal: Ammonia increased, nephrotoxicity with chronic overdose, analgesic nephropathy
Miscellaneous: Hypersensitivity reactions (rare)
Metabolism/Transport Effects
Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Drug Interactions
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.
Food: Rate of absorption may be decreased when given with food.
Herb/Nutraceutical: St John's wort may decrease acetaminophen levels.
Storage
Do not freeze suppositories.
Mechanism of Action
Inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation; produces antipyresis from inhibition of hypothalamic heat-regulating center
Pharmacodynamics/Kinetics
Onset of action: <1 hour
Duration: 4-6 hours
Absorption: Incomplete; varies by dosage form
Protein binding: 8% to 43% at toxic doses
Metabolism: At normal therapeutic dosages, hepatic to sulfate and glucuronide metabolites, while a small amount is metabolized by CYP to a highly reactive intermediate (acetylimidoquinone) which is conjugated with glutathione and inactivated; at toxic doses (as little as 4 g daily) glutathione conjugation becomes insufficient to meet the metabolic demand causing an increase in acetylimidoquinone concentration, which may cause hepatic cell necrosis
Half-life elimination: Prolonged following toxic doses
Neonates: 2-5 hours
Adults: 1-3 hours (may be increased in elderly; however, this should not affect dosing)
Time to peak, serum: Oral: 10-60 minutes; may be delayed in acute overdoses
Excretion: Urine (2% to 5% unchanged; 55% as glucuronide metabolites; 30% as sulphate metabolites)
Dosage
Oral, rectal:
Children <12 years: 10-15 mg/kg/dose every 4-6 hours as needed; do not exceed 5 doses (2.6 g) in 24 hours; alternatively, the following age-based doses may be used; see table.
Acetaminophen Dosing
Age
Dosage
(mg)
Age
Dosage
(mg)
0-3 mo
40
4-5 y
240
4-11 mo
80
6-8 y
320
1-2 y
120
9-10 y
400
2-3 y
160
11 y
480
Table has been converted to the following text.
Acetaminophen Dosing
• 0-3 months: 40 mg
• 4-11 months: 80 mg
• 1-2 years: 120 mg
• 2-3 years: 160 mg
• 4-5 years: 240 mg
• 6-8 years: 320 mg
• 9-10 years: 400 mg
• 11 years: 480 mg
Note: Higher rectal doses have been studied for use in preoperative pain control in children. However, specific guidelines are not available and dosing may be product dependent. The safety and efficacy of alternating acetaminophen and ibuprofen dosing has not been established.
Adults: 325-650 mg every 4-6 hours or 1000 mg 3-4 times/day; do not exceed 4 g/day
Dosing interval in renal impairment:
Clcr 10-50 mL/minute: Administer every 6 hours
Clcr <10 mL/minute: Administer every 8 hours (metabolites accumulate)
Hemodialysis: Moderately dialyzable (20% to 50%)
Dosing adjustment/comments in hepatic impairment: Use with caution. Limited, low-dose therapy is usually well tolerated in hepatic disease/cirrhosis. However, cases of hepatotoxicity at daily acetaminophen dosages <4 g/day have been reported. Avoid chronic use in hepatic impairment.
Dental Usual Dosing
Postoperative pain: Oral, rectal:
Children <12 years: 10-15 mg/kg/dose every 4-6 hours as needed; do not exceed 5 doses (2.6 g) in 24 hours; alternatively, the following age-based doses may be used
Adults: 325-650 mg every 4-6 hours or 1000 mg 3-4 times/day; do not exceed 4 g/day
Administration: Oral
Shake suspension well before pouring dose.
Monitoring Parameters
Relief of pain or fever
Reference Range
Therapeutic concentration (analgesic/antipyretic): 10-30 mcg/mL
Toxic concentration (acute ingestion) with probable hepatotoxicity: >200 mcg/mL at 4 hours or 50 mcg/mL at 12 hours after ingestion
Test Interactions
Increased chloride, bilirubin, uric acid, glucose, ammonia (B), chloride (S), uric acid (S), alkaline phosphatase (S), chloride (S); decreased sodium, bicarbonate, calcium (S)
Dietary Considerations
Some products may contain phenylalanine.
Patient Education
Take exactly as directed; do not increase dose or frequency. Most adverse effects are related to excessive use. Take with food or milk. While using this medication, avoid or limit alcohol to <3 drinks/day and avoid other prescription or OTC medications that contain acetaminophen. Maintain adequate hydration unless instructed to restrict fluid intake. This medication will not reduce inflammation; consult prescriber for anti-inflammatory, if needed. Report unusual bleeding (stool, mouth, urine) or bruising; unusual fatigue and weakness; change in elimination patterns; or change in color of urine or stool.
Anesthesia and Critical Care Concerns/Other Considerations
Evidence-Based Information: The 2002 ACCM/SCCM guidelines for analgesia (critically-ill adult) recommend prescribing <2 g/day for patients with a significant alcohol history or those with malnutrition. All other patients should be limited to ?4 g/day when used for acute pain or fever (American Pain Society, 2008). If possible, long-term administration of acetaminophen should not exceed 3000 mg/day, based on evidence demonstrating an increased risk of hepatotoxicity compared to patients not receiving acetaminophen (Watkins, 2006). Susceptibility to acetaminophen hepatotoxicity may be due to induction of hepatic enzymes caused by chronic alcohol ingestion and/or concurrent use of cytochrome P450 1A2/2E1 inducers (eg, isoniazid), and impaired glucuronidation caused by fasting (American Pain Society, 2008; Brackett, 2000; Zenger, 2004).
Dental Health: Effects on Dental Treatment
No significant effects or complications reported (see Dental Health Professional Considerations)
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Dental Comment
Hepatotoxicity caused by acetaminophen is potentiated by chronic ethanol consumption. People who consume ethanol at the same time that they use acetaminophen, even in therapeutic doses, are at risk of developing hepatotoxicity.
A study by Hylek, et al, suggested that the combination of acetaminophen with warfarin (Coumadin®) may cause enhanced anticoagulation. The following recommendations have been made by Hylek, et al, and supported by an editorial in JAMA by Bell.
Dose and duration of acetaminophen should be as low as possible, individualized, and monitored.
The study by Hylek reported that for patients who reported taking the equivalent of at least 4 regular strength (325 mg) tablets for longer than a week, the odds of having an INR >6.0 were increased 10-fold above those not taking acetaminophen. Risk decreased with lower intakes of acetaminophen reaching a background level of risk at a dose of 6 or fewer 325 mg tablets per week.
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
Barbiturates and carbamazepine may increase the hepatotoxic potential of acetaminophen
Nursing: Physical Assessment/Monitoring
Assess patient for history of liver disease or ethanol abuse (acetaminophen and excessive ethanol may have adverse liver effects). Assess other medications patient may be taking for additive or adverse interactions. Assess knowledge/teach patient appropriate use. Teach patient to monitor for adverse reactions and appropriate interventions to reduce side effects.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Caplet, oral: 500 mg
Cetafen® Extra: 500 mg
Genapap™ Extra Strength: 500 mg [DSC]
Genebs Extra Strength: 500 mg
Mapap Extra Strength: 500 mg
Pain Eze: 650 mg
Tycolene Maximum Strength: 500 mg [DSC]
Tylenol®: 325 mg
Tylenol® Extra Strength: 500 mg
Caplet, extended release, oral:
Tylenol® 8 Hour: 650 mg
Tylenol® Arthritis Pain Extended Relief: 650 mg
Captab, oral: 500 mg
Elixir, oral:
Apra: 160 mg/5 mL (118 mL) [ethanol free; contains benzoic acid, propylene glycol, sodium benzoate, sucrose; grape flavor] [DSC]
Apra: 160 mg/5 mL (118 mL, 473 mL, 3785 mL) [ethanol free; contains propylene glycol, sodium benzoate, sucrose; cherry flavor] [DSC]
Mapap Children's: 160 mg/5 mL (118 mL, 480 mL) [ethanol free; contains benzoic acid, propylene glycol, sodium benzoate; cherry flavor]
Gelcap, oral:
Tylenol® Extra Strength: 500 mg [contains benzyl alcohol]
Geltab, oral:
Excedrin® Tension Headache: 500 mg [contains caffeine 65 mg/geltab]
Tylenol® Extra Strength: 500 mg [contains benzyl alcohol]
Liquid, oral:
APAP 500: 500 mg/5 mL (237 mL) [ethanol free, sugar free; cherry flavor]
Silapap Children's: 160 mg/5 mL (118 mL, 237 mL, 473 mL) [ethanol free, sugar free; contains propylene glycol, sodium benzoate; cherry flavor]
Tylenol® Extra Strength: 500 mg/15 mL (240 mL) [ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]
Solution, oral: 160 mg/5 mL (5 mL, 10 mL, 20 mL, 118 mL, 473 mL)
Solution, oral [drops]: 80 mg/0.8 mL (15 mL)
Genapap™ Infant: 80 mg/0.8 mL (15 mL) [ethanol free; contains propylene glycol; fruit flavor] [DSC]
Infantaire: 80 mg/0.8mL (15 mL, 30 mL)
Little Fevers™: 80 mg/1 mL (30 mL) [dye free, ethanol free, gluten free; contains propylene glycol, sodium benzoate; berry flavor]
Silapap Infant's: 80 mg/0.8 mL (15 mL, 30 mL) [ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]
Suppository, rectal: 120 mg (12s, 50s, 100s); 325 mg (12s); 650 mg (12s, 50s, 100s)
Acephen™: 120 mg (6s [DSC], 12s, 50s, 100s); 325 mg (6s, 12s, 50s, 100s); 650 mg (12s, 50s, 100s, 500s)
FeverALL®: 120 mg (6s, 12s, 50s); 325 mg (6s, 12s, 50s); 650 mg (12s, 50s, 500s); 80 mg (6s, 50s)
Mapap: 125 mg (12s)
Suspension, oral: 160 mg/5 mL (5 mL, 10 mL, 20 mL)
Mapap Children's: 160 mg/5 mL (118 mL) [ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]
Nortemp Children's: 160 mg/5 mL (118 mL) [ethanol free; contains propylene glycol, sodium benzoate; cotton candy flavor]
Tylenol® Children's Suspension: 160 mg/5 mL (120 mL) [ethanol free; contains propylene glycol, sodium benzoate; bubblegum, strawberry, grape flavors]
Tylenol® Children's Suspension: 160 mg/5 mL (60 mL, 120 mL, 240 mL [DSC]) [ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]
Tylenol® Children's Suspension: 160 mg/5 mL (120 mL) [dye free; ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]
Suspension, oral [drops]:
Mapap Infant's: 80 mg/0.8 mL (15 mL, 30 mL) [ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]
Tylenol® Infant's Concentrated: 80 mg/0.8 mL (15 mL, 30 mL) [ethanol free; contains sodium benzoate; cherry, grape flavors]
Tylenol® Infant's Concentrated: 80 mg/0.8 mL (30 mL) [dye free; ethanol free; contains propylene glycol; cherry flavor]
Tablet, oral: 325 mg, 500 mg
Aspirin Free Anacin® Extra Strength: 500 mg
Cetafen®: 325 mg
Genapap™: 325 mg [DSC]
Genapap™ Extra Strength: 500 mg
Genebs: 325 mg [DSC]
Genebs Extra Strength: 500 mg
Mapap: 325 mg
Tycolene: 325 mg [DSC]
Tylenol®: 325 mg
Valorin Extra®: 500 mg [sugar free]
Valorin®: 325 mg [sugar free]
Tablet, chewable, oral: 80 mg
Mapap Children's: 80 mg [bubblegum flavor] [DSC]
Mapap Children's: 80 mg [fruit flavor]
Mapap Children's: 80 mg [contains phenylalanine 3 mg/tablet; grape flavor] [DSC]
Mapap Junior Strength: 160 mg [contains phenylalanine 12 mg/tablet; grape flavor]
Tablet, orally disintegrating, oral: 80 mg, 160 mg, 325 mg, 500 mg
Tylenol® Children's Meltaways: 80 mg [bubblegum, grape flavors]
Tylenol® Jr. Meltaways: 160 mg [bubblegum, grape flavors]
Pricing: U.S. (www.drugstore.com)
Tablet, controlled release (Tylenol 8 Hour)
650 mg (50): $16.00
Tablet, controlled release (Tylenol Arthritis Pain)
650 mg (100): $19.99
Tablets (Acetaminophen)
500 mg (700): $38.99
Tablets (Tylenol)
325 mg (100): $16.98
References
“American Academy of Pediatrics Committee on Drugs. Acetaminophen Toxicity in Children,” Pediatrics, 2001, 108(4):1020-4.
Anderson PO, Sauberan JB, Lane JR, et al, “Hydrocodone Excretion Into Breast Milk: The First Two Reported Cases,” Breastfeed Med, 2007, 2(1):10-4.
Barker JD Jr, de Carle DJ, and Anuras S, “Chronic Excessive Acetaminophen Use in Liver Damage,” Ann Intern Med, 1977, 87(3):299-301.
Birmingham PK, Tobin MJ, Fisher DM, et al, “Initial and Subsequent Dosing of Rectal Acetaminophen in Children: A 24-Hour Pharmacokinetic Study of New Dose Recommendations,” Anesthesiology, 2001, 94(3):385-9.
Bizovi K, Keys N, Rivas J, et al, “Tylenol® ER, Late Rise in APAP Level After Overdose,” Clin Toxicol, 1995, 33(5):510.
Brackett CC and Bloch JD, “Phenytoin as a Possible Cause of Acetaminophen Hepatotoxicity: Case Report and Review of the Literature,” Pharmacotherapy, 2000, 20(2):229-33.
Bradley JD, Brandt KD, Katz BP, et al, “Comparison of an Antiinflammatory Dose of Ibuprofen, an Analgesic Dose of Ibuprofen, and Acetaminophen in the Treatment of Patients With Osteoarthritis of the Knee,” N Engl J Med, 1991, 325(2):87-91.
Buck ML, “Perioperative Use of High-Dose Rectal Acetaminophen,” Pediatr Pharmacol (New York), 2001, 7(9). Available at: http://www.medscape.com/viewarticle/415082. Accessed November 6, 2003.
Burkhart KK, Janco N, Kulig KW, et al, “Cimetidine as Adjunctive Treatment for Acetaminophen Overdose,” Hum Exp Toxicol, 1995, 14(3):299-304.
Cetaruk E, Horowitz R, Hurlburt K, et al, “Tylenol® Extended Relief Overdose: A New Headache?” Clin Toxicol, 1995, 33(5):511.
Clissold SP, “Paracetamol and Phenacetin,” Drugs, 1986, 32(Suppl 4):46-59.
Dionne RA, Campbell RA, Cooper SA, et al, “Suppression of Postoperative Pain by Preoperative Administration of Ibuprofen in Comparison to Placebo, Acetaminophen, and Acetaminophen Plus Codeine,” J Clin Pharmacol, 1983, 23(1):37-43.
Douglas DR, Smilkstein MJ, and Sholar JB, “Overdose With Extended-Relief Acetaminophen: Is a New Approach Necessary?” Acad Emerg Med, 1995, 2:397.
“Drugs for Pain,” Med Lett Drugs Ther, 2000, 42(1085):73-8.
Graudins A, Aaron CK, and Linden CH, “Overdose of Extended-Release Acetaminophen,” N Engl J Med, 1995, 333(3):196.
Harrison PM, Keays R, Bray GP, et al, “Improved Outcome of Paracetamol-Induced Fulminant Hepatic Failure by Late Administration of Acetylcysteine,” Lancet, 1990, 335(8705):1572-3.
Jacobi J, Fraser GL, Coursin DB, et al, “Clinical Practice Guidelines for the Sustained Use of Sedatives and Analgesics in the Critically Ill Adult,” Crit Care Med, 2002, 30(1):119-41. Available at: http://www.sccm.org/pdf/sedatives.pdf. Accessed August 2, 2003.
Janes J and Routledge PA, “Recent Developments in the Management of Paracetamol (Acetaminophen) Poisoning,” Drug Saf, 1992, 7(3):170-7.
Jones AL, “Mechanism of Action and Value of N-Acetylcysteine in the Treatment of Early and Late Acetaminophen Poisoning: A Critical Review,” J Toxicol Clin Toxicol, 1998, 36(4):277-85.
Katzir Z, Baruch O, Hochman B, et al, “Spontaneous Remission of Paracetamol Induced Acute Renal Failure,” Clin Nephrol, 1995, 43(5):346.
Knoop KJ, Snook CP, Stephan M, et al, “Failure of N-Acetylcysteine (NAC) to Prevent Acetaminophen-Induced Renal Failure,” Vet Hum Toxicol, 1993, 35:336.
Lee WM, “Drug-Induced Hepatotoxicity,” N Engl J Med, 1995, 333(17):1118-27.
Lewis RK and Paloucek FP, “Assessment and Treatment of Acetaminophen Overdose,” Clin Pharm, 1991, 10(10):765-74.
Licht H, Seeff LB, and Zimmerman HJ, “Apparent Potentiation of Acetaminophen Hepatotoxicity by Alcohol,” Ann Intern Med, 1980, 92(4):511.
Mayoral CE, Marino RV, Rosenfeld W, et al, “Alternating Antipyretics: Is This an Alternative?” Pediatrics, 2000, 105(5):1009-12.
McClain CJ, Kromhout JP, Peterson FJ, et al, “Potentiation of Acetaminophen Hepatotoxicity by Alcohol,” JAMA, 1980, 244(3):251-3.
Mokhlesi B, Leikin JB, Murray P, et al, “Adult Toxicology in Critical Care: Part II: Specific Poisonings,” Chest, 2003, 123(3):897-922.
Murphy R, Swartz R, and Watkins PB, “Severe Acetaminophen Toxicity in a Patient Receiving Isoniazid,” Ann Intern Med, 1990, 113(110):799-800.
“Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain,” 6th ed, Glenview, IL: American Pain Society, 2008.
Rathmell JP, Viscomi CM, and Ashburn MA, “Management of Nonobstetric Pain During Pregnancy and Lactation,” Anesth Analg, 1997, 85(5):1074-87.
“Recommendations for the Medical Management of Osteoarthritis of the Hip and Knee: 2000 Update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines,” Arthritis Rheum, 2000, 43(9):1905-15.
Rose SR, “Subtleties of Managing Acetaminophen Poisoning,” Am J Hosp Pharm, 1994, 51(24):3065-8.
Singer AJ, Carracio TR, and Mofenson HC, “The Temporal Profile of Increased Transaminase Levels in Patients With Acetaminophen-Induced Liver Dysfunction,” Ann Emerg Med, 1995, 26(1):49-53.
Smilkstein MJ, Knapp GL, Kulig KW, et al, “Efficacy of Oral N-Acetylcysteine in the Treatment of Acetaminophen Overdose. Analysis of the National Multicenter Study (1976 to 1985),” N Engl J Med, 1988, 319(24):1557-62.
Stork CM, Rees S, Howland MA, et al, “Pharmacokinetics of Extended Relief vs Regular Release Tylenol® in a Simulated Human Overdose,” J Toxicol Clin Toxicol, 1996, 34(2):157-62.
Vale JA and Proudfoot AT, “Paracetamol (Acetaminophen) Poisoning,” Lancet, 1995, 346:547-52.
van der Steeg J, Akhtar J, Burkhart K, et al, “Initial Prothrombin Time as a Predictor of Acetaminophen-Induced Hepatotoxicity,” Clin Toxicol, 1995, 33(5):508-9.
Watkins PB, Kaplowitz N, Slattery JT, et al, “Aminotransferase Elevations in Healthy Adults Receiving 4 Grams of Acetaminophen Daily: A Randomized Controlled Trial,” JAMA, 2006, 296(1):87-93.
Watson WA, Vraa EP, and Neau SH, “Dissolution of Acetaminophen Tablets Under Overdose Conditions,” Ann Pharmacother, 1997, 31(10):1262-3.
Whitcomb DC and Block GD, “Association of Acetaminophen Hepatotoxicity With Fasting and Ethanol Use,” JAMA, 1994, 272(23):1845-50.
Williams HJ, Ward JR, Egger MJ, et al, “Comparison of Naproxen and Acetaminophen in a Two-Year Study of Treatment of Osteoarthritis of the Knee,” Arthritis Rheum, 1993, 36(9):1196-206.
Woo OF, Anderson IB, Kim SY, et al, “Shorter Duration of N-Acetylcysteine (NAC) for Acute Acetaminophen Poisoning,” Clin Toxicol, 1995, 33(5):508.
Yerman B, Tseng J, and Caravati EM, “Pediatric Acetaminophen Ingestion: A Prospective Study of Referral Criteria,” Clin Toxicol, 1995, 33(5):530.
Zenger F, Russmann S, Junker E, et al, “Decreased Glutathione in Patients With Anorexia Nervosa. Risk Factor for Toxic Liver Injury?” Eur J Clin Nutr, 2004, 58(2):238-43.
Zimmerman HJ and Maddrey WC, “Acetaminophen (Paracetamol) Hepatotoxicity With Regular Intake of Alcohol: Analysis of Instances of Therapeutic Misadventure,” Hepatology, 1995, 22(3):767-3.
International Brand Names
Lexi-Comp.com
Last full review/revision January 2010
Content last modified January 2010
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