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®, 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

Acephen™ [OTC]; Apra Children's [OTC]; Aspirin Free Anacin® Maximum Strength
[OTC]; Cetafen Extra® [OTC]; Cetafen® [OTC]; Comtrex® Sore Throat Maximum
Strength [OTC]; FeverALL® [OTC]; Genapap™ Children [OTC]; Genapap™ Extra
Strength [OTC]; Genapapâ„¢ Infant [OTC]; Genapapâ„¢ [OTC]; Genebs Extra Strength
[OTC]; Genebs [OTC]; Infantaire [OTC]; Little Feversâ„¢ [OTC]; Mapap Children's [OTC];
Mapap Extra Strength [OTC]; Mapap Infants [OTC]; Mapap [OTC]; Nortemp Children's
[OTC]; Pain Eze [OTC]; Silapap® Children's [OTC]; Silapap® Infants [OTC]; Tycolene
Maximum Strength [OTC]; Tycolene [OTC]; Tylenol® 8 Hour [OTC]; Tylenol®
Arthritis Pain [OTC]; Tylenol® Children's with Flavor Creator [OTC]; Tylenol®
Children's [OTC]; Tylenol® Extra Strength [OTC]; Tylenol® Infants [OTC]; Tylenol®
Junior [OTC]; Tylenol® [OTC]; Valorin Extra [OTC]; Valorin [OTC]

Canadian Brand Names

Abenol®; Apo-Acetaminophen®; Atasol®; Novo-Gesic; Pediatrix; Tempra®;

Tylenol®

Pharmacologic Category

Analgesic, Miscellaneous

Use: Labeled Indications

Treatment of mild-to-moderate pain and fever (antipyretic/analgesic); does not have

antirheumatic or anti-inflammatory effects

Use: Dental

Treatment of postoperative pain

Dosing: Adults

Pain or fever: Oral, rectal: 325-650 mg every 4-6 hours or 1000 mg 3-4 times/day; do not
exceed 4 g/day.

Dosing: Elderly

Refer to adult dosing.

Dosing: Pediatric
Pain or fever: 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 doses may be used; see
table.

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.

Dosing: Renal Impairment

Clcr 10-50 mL/minute: Administer every 6 hours.

Clcr <10 mL/minute: Administer every 8 hours (metabolites accumulate).

Moderately dialyzable (20% to 50%)

Dosing: 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.

Calculations

 Creatinine Clearance: Adults

 Creatinine Clearance: Pediatrics
 Administration: Oral

Shake suspension well before pouring dose.

Dietary Considerations

Chewable tablets may contain phenylalanine (amount varies, ranges between 3-12 mg/tablet);
consult individual product labeling.

Storage

Do not freeze suppositories.

Contraindications

Hypersensitivity to acetaminophen or any component of the formulation

Allergy Considerations

 Acetaminophen Allergy/Hypersensitivity

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 â
‰¥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.
 Pregnancy Risk Factor

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.

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

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.

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)

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

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.

Monitoring: Lab Tests

Serum APAP levels with long-term use in patients with hepatic disease

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 (2-3 L/day of fluids) 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.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult
specific product labeling. [DSC] = Discontinued product

Caplet: 500 mg

Cetafen Extra® Strength, Genapap™ Extra Strength, Genebs Extra Strength, Mapap
Extra Strength, Tycolene Maximum Strength, Tylenol® Extra Strength: 500 mg

Caplet, extended release:

Tylenol® 8 Hour, Tylenol® Arthritis Pain: 650 mg

Capsule: 500 mg

Elixir: 160 mg/5 mL (120 mL, 480 mL, 3780 mL [DSC])

Apra Children’s: 160 mg/5 mL (120 mL, 480 mL, 3780 mL [DSC]) [alcohol free;
contains benzoic acid; cherry and grape flavors]
 Mapap Children's: 160 mg/5 mL (120 mL) [alcohol free; contains benzoic acid and
sodium benzoate; cherry flavor]

Gelcap:

Mapap Extra Strength, Tylenol® Extra Strength: 500 mg

Geltab:

Tylenol® Extra Strength: 500 mg

Liquid, oral: 500 mg/15 mL (240 mL)

Comtrex® Sore Throat Maximum Strength: 500 mg/15 mL (240 mL) [contains
sodium benzoate; honey lemon flavor]

Genapapâ„¢ Children: 160 mg/5 mL (120 mL) [contains sodium benzoate; cherry and
grape flavors]

Silapap®: 160 mg/5 mL (120 mL, 240 mL, 480 mL) [sugar free; contains sodium
benzoate; cherry flavor]

Tylenol® Extra Strength: 500 mg/15 mL (240 mL) [contains sodium benzoate; cherry
flavor]

Solution, oral: 160 mg/5 mL (120 mL, 480 mL)

Solution, oral [drops]: 80 mg/0.8 mL (15 mL) [droppers are marked at 0.4 mL (40 mg) and at
0.8 mL (80 mg)]

Genapapâ„¢ Infant: 80 mg/0.8 mL (15 mL) [fruit flavor]

Infantaire: 80 mg/0.8mL (15 mL, 30 mL)

Little Feversâ„¢: 80 mg/1 mL (30 mL) [alcohol free; contains propylene glycol, sodium
benzoate; berry flavor; packaged with dropper and forehead thermometer]

Silapap® Infant's: 80 mg/0.8 mL (15 mL, 30 mL) [contains sodium benzoate; cherry
flavor]

Suppository, rectal: 120 mg, 325 mg, 650 mg

Acephenâ„¢: 120 mg, 325 mg, 650 mg

FeverALL®: 80 mg, 120 mg, 325 mg, 650 mg

Mapap: 125 mg, 650 mg

Suspension, oral: 160 mg/5 mL (5 mL, 10 mL, 20 mL)

 Mapap Children's: 160 mg/5 mL (120 mL) [contains sodium benzoate; cherry flavor]

Nortemp Children’s: 160 mg/5 mL (120 mL) [alcohol free; contains sodium
benzoate; cotton candy flavor]

Tylenol® Children's: 160 mg/5 mL (120 mL, 240 mL) [contains sodium benzoate;
bubble gum yum, cherry blast, dye free cherry, grape splash, and very berry
strawberry flavors]

Tylenol® Children’s with Flavor Creator: 160 mg/5 mL (120 mL) [contains
sodium 2 mg/5 mL and sodium benzoate; cherry blast flavor; packaged with apple
(4), bubblegum (8), chocolate (4), & strawberry (4) sugar free flavor packets]

Suspension, oral [drops]:

Mapap Infants: 80 mg/0.8 mL (15 mL, 30 mL) [contains sodium benzoate; cherry
flavor]

Tylenol® Infants: 80 mg/0.8 mL (15 mL, 30 mL) [contains sodium benzoate; cherry,
dye free cherry, and grape flavors]

Tablet: 325 mg, 500 mg

Aspirin Free Anacin® Extra Strength, Genapap™ Extra Strength, Genebs Extra
Strength, Mapap Extra Strength, Pain Eze, Tylenol® Extra Strength, Valorin
Extra: 500 mg

Cetafen®, Genapap™, Genebs, Mapap, Tycolene, Tylenol®, Valorin: 325 mg

Tablet, chewable: 80 mg

Genapapâ„¢ Children: 80 mg [contains phenylalanine 6 mg/tablet; grape flavors] [DSC]

Mapap Children's: 80 mg [contains phenylalanine 3 mg/tablet; bubble gum, fruit, and

grape flavors]

Mapap Junior Strength: 160 mg [contains phenylalanine 12 mg/tablet; grape flavor]

Tablet, orally disintegrating: 80 mg, 160 mg

Tylenol® Children’s Meltaways: 80 mg [bubble gum, grape, and watermelon

flavors]

Tylenol® Junior Meltaways: 160 mg [bubble gum and grape flavors]

Generic Available

Yes: Excludes extended release products

 Pricing: U.S. (www.drugstore.com)

Tablet, controlled release (Tylenol Arthritis Pain)

650 mg (100): $19.99

Tablets (Acetaminophen)

500 mg (700): $38.99

Tablets (Tylenol)

325 mg (100): $16.99

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)
 Dental Health Professional Considerations
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.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported (see Dental Comment)

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

None reported

Mental Health: Effects on Psychiatric Treatment

Barbiturates and carbamazepine may increase the hepatotoxic potential of acetaminophen

Anesthesia and Critical Care Concerns/Other Considerations

Avoid excessive doses of acetaminophen particularly in patients with a significant alcohol

history or poor nutritional habits. 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. Other patients may be limited to <4 g/day. Susceptibility
to acetaminophen hepatotoxicity may be due to induction of hepatic enzymes caused by
chronic alcohol ingestion, depletion of glutathione, malnutrition, and impaired
glucuronidation caused by fasting.
 Index Terms

APAP; N-Acetyl-P-Aminophenol; Paracetamol

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International Brand Names

A-Mol (TH); Acamol (CN, IL); Acamol To-Go (IL); Acamoli Baby (IL); Acamoli Forte
suppositories for Kids (IL); Acenol (PL); Acet (PH); ACET suppositories (SG); Acetalgin
(CH); Acetamol (IT); Adinol (MX); Adorem (CO); Afebrin (HK, ID); Afebryl (LU);
Alvedon (SE); Amol (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY,
YE); Anadin (PL); Anadin dla dzieci (PL); Analgiser (AE, BH, CY, EG, IL, IQ, IR, JO, KW,
LB, LY, OM, QA, SA, SY, YE); Analphen (MX); Antidol (PL, TW); APAP (PL); Arfen
(BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, MY, NE, NG, SC, SD,
SL, SN, TN, TZ, UG, ZA, ZM, ZW); Atamel (PE); ben-u-ron (HU); Ben-U-Ron (PT);
Benuron (JP, PL); Biogesic (ID, PH, TH); Biogesic Suspension (HK); Biopain (PH); Bodrex
(ID); Calapol (ID); Calodol (PH); Calpol (AE, BB, BF, BH, BJ, BM, BS, BZ, CI, CY, EG,
ET, GH, GM, GN, GY, IE, IL, IN, IQ, IR, JM, JO, JP, KE, KW, LB, LR, LY, MA, ML, MR,
MU, MW, NE, NG, NL, OM, PL, PR, QA, SA, SC, SD, SL, SN, SR, SY, TH, TN, TT, TZ,
UG, YE, ZA, ZM, ZW); Causalon (AR); Cemol (TH); Children's S Tylenol (KP); Christamol
(HK); Claradol (MA); Codipar (PL); Crocin (IN); Croix Blanche (LU); Curpol (LU);
Dafalgan (BE, LU, PL); Dafalgan odis (LU); Daga (TH); Denamol (TH); Dirox (AR);
Dismifen (MX); Dol-Stop (LU); Dolex (UY); Dolgesic (ES); Doliprane (FR, MA, PL);
Dolitabs (FR); Dolofen (CO); Dolomol (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM,
QA, SA, SY, YE); Dolorol (ZA); Dolprone (LU); Doluvital (MX); Dolviran (MX); Dymadon
(AU); Efferalgan (HU, LU, PL); Efferalgan 500 (CR, DO, EE, GT, HN, NI, PA, SV);
Efferalganodis (FR); Enelfa (LU); Etoran (PL); Europain (HK); Expandol (FR); Febridol
(AU); Fepril (MY); Fervex (BR); Filanc (MX); Gelocatil (ES); Geluprane 500 (FR);
Grippostad (PL); Gunaceta (ID); Hedex (IE); Itamol (ID); Itamol Forte (ID); Kamolas (ID);
Kyofen (CO); Lekadol (HR, PL); Lemgrip (BE, LU); Lexalgin (PH); Lonarid mono (LU);
Lotemp (TH); Lupocet (HR); Maganol (ID); Malidens (IN); Mebinol (PE); Mejoralito Junior
(MX); Mejoralito Pediátrico (MX); Metagesic (PH); Mexalen (AT, CZ, HN, HU); Minopan
(KP); Momentum (LU); Mypara (TH); Nalgesik (ID); Napafen (EC); Napamol (ZA); Napran
(PH); Naprex (ID); NEBS (JP); Nektol 500 (PH); Neuridon (LU); Nilapur (ID); Nordinet
Infantil (MX); Novo-Gesic (PL); Pacimol (IN); Pamol (DK); Panadol (AE, AU, BE, BF, BG,
BH, BJ, CH, CI, CL, CN, CY, EE, EG, ET, FI, FR, GB, GH, GM, GN, GR, HK, HU, ID, IE,
IL, IQ, IR, JO, KE, KP, KW, LB, LR, LU, LY, MA, ML, MR, MU, MW, NE, NG, NL, OM,
PK, PL, QA, SA, SC, SD, SL, SN, SY, TH, TN, TW, TZ, UG, UY, YE, ZA, ZM, ZW);
Panadol Actifast (MY, SG); Panadon (HR); Panamax (AU); Panodil (DK, NO, SE);
Paracemol (PL); Paracenol (PL); Paracet (NO); Paracetamol (HR, PL); Paracetamol
Pharmavit (HU); Paracetamol-ratiopharm (LU); Parageniol (PY); Paragin (TH); Parahexal
(AU); Paramidol (PE); Paramol (IL, PL, TW); Parapaed (DE); Parapaed Junior (NZ);
Parapaed Six Plus (NZ); Parcemol (HK); Parcemol Forte (HK); Parvid (PH); Paximol (SG);
Pe-Tam (LU); Pedipan (KP); Penral-Night (KP); Perdolan Mono (LU); Perfalgan (PL);
Pharmacen-M (MX); Pinex (NO); Plicet (HR, PL); Poro (MY, PH, SG); Puernol (IT);
Raperon (KP); Rapidol (CN); Reliv (SE); Remedol (BB, BM, BS, BZ, GY, JM, NL, PR, SR,
TT); Revanin (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG,
SC, SD, SL, SN, TN, TZ, UG, ZA, ZM, ZW); Rhinapen elixir (KP); Rubophen (HU);
Salzone (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD,
SL, SN, TN, TZ, UG, ZA, ZM, ZW); Saridon (CO); Sedalito (MX); Sensamol (IL); Serimol
(HK); Sinedol (DO, MX); Supadol mono (LU); Suspen ER (KP); Tabcin (PL); Tamifen
(EC); Tazamol (PL); Tempra (EC, GR, ID, JP, LU, MX, TH); Tempte (TW); Turpan (ID);
Tylenol (AT, BR, CH, DE, FR, JP, KP, MX, PH, PT, TH, VE); Tylenol 8-hour (TH); Tylenol
Acetaminophen Extended Relief (CL); Tylenol Extra Fuerte (PY); Tylenol Forte (AE, BH,
CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, PL, QA, SA, SY, YE); Tylex (CR, DO, GT, HN,
MX, NI, PA, SV); Winadol (CO, VE); Xebramol (TH); XL-Dol Infantil (MX); Zydinol (PH)