Acetaminophen
Generic Name: acetaminophen (oral) (a SEET a MIN oh
fen)
Chemical formula: C8H9NO2
Drug bank ID: DB00316
ATC code(s): N02BE01, N02BE51, N02BE71
Drug bank ID: DB00316
ATC code(s): N02BE01, N02BE51, N02BE71
What is acetaminophen?
Acetaminophen is a
pain reliever and a fever reducer.
Acetaminophen
is used to treat many conditions such as headache, muscle aches, arthritis,
backache, toothaches, colds, and fevers.
Acetaminophen
may also be used for purposes not listed in this medication guide.
Common Over-the-Counter
Brand Name Medicines Containing Acetaminophen:
ü Actifed
ü Anacin
ü Benadryl
ü Cepacol
ü Contac
ü Coricidin
ü Dayquil
ü Dimetapp
ü Dristan
ü Excedrin
ü Feverall
ü Formula 44
ü Goody’s
ü Powders Liquiprin
ü Midol
ü Nyquil
ü Panadol
ü Robitussin
ü Aspirin-Free Singlet
ü Sinutab
ü Sudafed
ü Theraflu
ü Triaminic
ü TYLENOL
ü Vanquish
ü Vicks
ü Zicam
Important information
You should not use acetaminophen if you have
severe liver disease.
There are many brands and forms of
acetaminophen available and not all brands are listed on this leaflet.
Do not take more of this
medication than is recommended. An overdose of acetaminophen can damage your
liver or cause death. Call your doctor at once if you have nausea, pain in your
upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or
jaundice (yellowing of your skin or eyes).
Do not take this medication without a doctor's
advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink
more than 3 alcoholic beverages per day. You may not be able to take this
medicine. Avoid drinking alcohol. It may increase your risk of liver damage
while taking acetaminophen.
Ask a doctor or pharmacist before using any other cold, allergy,
pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is
contained in many combination medicines. Taking certain products together can
cause you to get too much acetaminophen which can lead to a fatal overdose.
Check the label to see if a medicine contains acetaminophen or APAP.
In
rare cases, acetaminophen may cause a severe skin reaction. Stop taking this
medicine and call your doctor right away if you have skin redness or a rash
that spreads and causes blistering and peeling.
Before taking this medicine
You
should not take acetaminophen if you are allergic to it, or if you have severe
liver disease.
Do not take this medication without a doctor's advice if you
have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3
alcoholic beverages per day. You may not be able to take acetaminophen.
Your
doctor will determine whether acetaminophen is safe for you to use during
pregnancy. Do not use this medicine without the advice of your doctor if you
are pregnant.
Acetaminophen
can pass into breast milk and may harm a nursing baby. Tell your doctor if you
are breast-feeding a baby.
Do
not give this medicine to a child younger than 2 years old without the advice
of a doctor.
How should I take acetaminophen?
Use
acetaminophen exactly as directed on the label, or as prescribed by your
doctor. Do not use in larger or smaller amounts or for longer than recommended.
Do
not take more of this medication than is recommended. An overdose of
acetaminophen can damage your liver or cause death.
Measure
liquid medicine with a special dose-measuring spoon or medicine cup, not with a
regular table spoon. If you do not have a dose-measuring device, ask your
pharmacist for one.
If
you are treating a child, use a pediatric form of acetaminophen. Use only the
special dose-measuring dropper or oral syringe that comes with the specific
pediatric form you are using. Carefully follow the dosing directions on the
medicine label.
Acetaminophen
made for infants is available in two different dose concentrations, and each
concentration comes with its own medicine dropper or oral syringe. These dosing
devices are not equal between the different concentrations. Using the wrong
device may cause you to give your child an overdose of acetaminophen. Never mix
and match dosing devices between infant formulations of acetaminophen.
You
may need to shake the liquid before each use. Follow the directions on the
medicine label.
The
chewable tablet must be chewed thoroughly before you swallow it.
Make
sure your hands are dry when handling the acetaminophen disintegrating tablet.
Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow
the tablet whole. Allow it to dissolve in your mouth without chewing.
To
use the acetaminophen effervescent granules, dissolve one packet of the
granules in at least 4 ounces of water. Stir this mixture and drink all of it
right away. To make sure you get the entire dose, add a little more water to
the same glass, swirl gently and drink right away.
Stop
taking acetaminophen and call your doctor if:
·
you still have a fever after 3 days of
use;
·
you still have pain after 7 days of use
(or 5 days if treating a child);
·
you have a skin rash, ongoing headache,
or any redness or swelling; or
·
if your symptoms get worse, or if you
have any new symptoms.
This
medication can cause unusual results with certain lab tests for glucose (sugar)
in the urine. Tell any doctor who treats you that you are using acetaminophen.
Store
at room temperature away from heat and moisture.
What happens if I miss a dose?
Since
acetaminophen is taken as needed, you may not be on a dosing schedule. If you
are taking the medication regularly, take the missed dose as soon as you
remember. Skip the missed dose if it is almost time for your next scheduled dose.
Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek
emergency medical attention or call the Poison Help line at 1-800-222-1222. An
overdose of acetaminophen can be fatal.
The
first signs of an acetaminophen overdose include loss of appetite, nausea,
vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may
include pain in your upper stomach, dark urine, and yellowing of your skin or
the whites of your eyes.
What should I avoid?
Ask
a doctor or pharmacist before using any other cold, allergy, pain, or sleep
medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many
combination medicines. Taking certain products together can cause you to get
too much acetaminophen which can lead to a fatal overdose. Check the label to
see if a medicine contains acetaminophen or APAP.
Avoid
drinking alcohol. It may increase your risk of liver damage while taking
acetaminophen.
Acetaminophen side effects
Get
emergency medical help if you have any signs of an allergic reaction to
acetaminophen: hives; difficulty breathing; swelling of your face, lips,
tongue, or throat.
In
rare cases, acetaminophen may cause a severe skin reaction that can be fatal.
This could occur even if you have taken acetaminophen in the past and had no
reaction. Stop taking this medicine and call your doctor right away if you have
skin redness or a rash that spreads and causes blistering and peeling. If you
have this type of reaction, you should never again take any medicine that
contains acetaminophen.
Stop
taking this medication and call your doctor at once if you have:
·
nausea, upper stomach pain, itching, loss
of appetite;
·
dark urine, clay-colored stools; or
·
jaundice (yellowing of the skin or eyes).
This
is not a complete list of side effects and others may occur. Call your doctor
for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
See also: Side effects (in more detail)
Acetaminophen dosing information
Usual Adult Dose for Fever:
IV:
Adults and adolescents weighing 50 kg and over: 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 4000 mg per day. Adults and adolescents weighing under 50 kg: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day. Orally or Rectally: General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours No dose adjustment is required when converting between oral and IV acetaminophen dosing in adults and adolescents. The maximum daily dose of acetaminophen is based on all routes of administration (i.e. intravenous, oral, and rectal) and all products containing acetaminophen.
Usual Adult Dose for Pain:
IV:
Adults and adolescents weighing 50 kg and over: 1000 mg every 6 hours or 650 mg
every 4 hours, with a maximum single dose of 1000 mg, a minimum dosing interval
of 4 hours, and a maximum daily dose of acetaminophen of 4000 mg per day.
Adults and adolescents weighing under 50 kg: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day.
Orally or Rectally:
General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours No dose adjustment is required when converting between oral and IV acetaminophen dosing in adults and adolescents. The maximum daily dose of acetaminophen is based on all routes of administration (i.e. intravenous, oral, and rectal) and all products containing acetaminophen.
Usual Pediatric Dose for Fever:
Preterm neonates 28 to 32 weeks:
IV loading dose: 20 mg/kg followed by 10 mg/kg/dose every 12 hours Oral: 10 to 12 mg/kg/dose every 6 to 8 hours Maximum oral daily dose: 40 mg/kg/day Rectal: 20 mg/kg/dose every 12 hours Maximum rectal daily dose: 40 mg/kg/day Preterm neonates 32 to 37 weeks and term neonates less than 10 days: IV loading dose: 20 mg/kg followed by 10 mg/kg/dose every 6 hours Oral: 10 to 15 mg/kg/dose every 6 hours Maximum daily dose: 60 mg/kg/day Rectal: Loading dose: 30 mg/kg; then 15 mg/kg/dose every 8 hours Maximum daily dose: 60 mg/kg/day
hat other drugs will affect acetaminophen?
Other
drugs may interact with acetaminophen, including prescription and
over-the-counter medicines, vitamins, and herbal products. Tell each of your
health care providers about all medicines you use now and any medicine you
start or stop using.
In Summary
More frequently reported side effects include: fever. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to acetaminophen: capsule, capsule liquid filled,
elixir, liquid, powder, powder for solution, solution, suppository, suspension,
syrup, tablet, tablet chewable, tablet disintegrating, tablet effervescent,
tablet extended release
Major Side Effects
You should check with your doctor immediately if any of these
side effects occur when taking acetaminophen:
Rare
·
Bloody or black, tarry stools
·
bloody or cloudy urine
·
fever with or without chills (not present
before treatment and not caused by the condition being treated)
·
pain in the lower back and/or side
(severe and/or sharp)
·
pinpoint red spots on the skin
·
skin rash, hives, or itching
·
sore throat (not present before treatment
and not caused by the condition being treated)
·
sores, ulcers, or white spots on the lips
or in the mouth
·
sudden decrease in the amount of urine
·
unusual bleeding or bruising
·
unusual tiredness or weakness
·
yellow eyes or skin
If any of the following symptoms of overdose occur while taking
acetaminophen, get emergency help immediately:
Symptoms
of overdose:
·
Diarrhea
·
increased sweating
·
loss of appetite
·
nausea or vomiting
·
stomach cramps or pain
·
swelling, pain, or tenderness in the
upper abdomen or stomach area
1. Kurtovic J, Riordan SM
"Paracetamol-induced hepatotoxicity at recommended dosage." J Intern
Med 253 (2003): 240-3
2. McJunkin B, Barwick KW, Little WC, Winfield JB "Fatal
massive hepatic necrosis following acetaminophen overdose." JAMA 236
(1976): 1874-5
3. Minton NA, Henry JA, Frankel RJ "Fatal paracetamol
poisoning in an epileptic." Hum Toxicol 7 (1988): 33-4
4. Cheung L, Meyer KC "Acetaminophen poisoning and liver
function." N Engl J Med 331 (1994): 1311-2
5. Rumore MM, Blaiklock RG "Influence of age-dependent
pharmacokinetics and metabolism on acetaminophen hepatotoxicity." J Pharm
Sci 81 (1992): 203-7
6. Kumar S, Rex DK "Failure of physicians to recognize
acetaminophen hepatotoxicity in chronic alcoholics." Arch Intern Med 151
(1991): 1189-91
7. Block R, Jankowski JA, Lacoux P, Pennington CR "Does
hypothermia protect against the development of hepatitis in paracetamol
overdose?" Anaesthesia 47 (1992): 789-91
8. Hartleb M "Do thyroid hormones promote hepatotoxicity to
acetaminophen?" Am J Gastroenterol 89 (1994): 1269-70
9. Lee WM "Acute liver failure." Am J Med 96 (1994):
3-9
10. Whitcomb DC, Block GD "Association of acetaminopphen
hepatotoxicity with fasting and ethanol use." JAMA 272 (1994): 1845-50
11. Kaysen GA, Pond SM, Roper MH, Menke DJ, Marrama MA
"Combined hepatic and renal injury in alcoholics during therapeutic use of
acetaminophen." Arch Intern Med 145 (1985): 2019-23
12. Mofenson HC, Caraccio TR, Nawaz H, Steckler G
"Acetaminophen induced pancreatitis." Clin Toxicol 29 (1991): 223-30
13. Singer AJ, Carracio TR, Mofenson HC "The temporal
profile of increased transaminase levels in patients with acetaminophen-induced
liver dysfunction." Ann Emerg Med 26 (1995): 49-53
14. Keays R, Harrison PM, Wendon JA, et al "Intravenous
acetylcysteine in paracetamol induced fulminant hepatic failure: a prospective
controlled trial." BMJ 303 (1991): 1026-9
15. Bonkovsky HL "Acetaminophen hepatotoxicity, fasting,
and ethanol." JAMA 274 (1995): 301
16. Brotodihardjo AE, Batey RG, Farrell GC, Byth K
"Hepatotoxicity from paracetamol self-poisoning in Western Sydney: a
continuing challenge." Med J Aust 157 (1992): 382-5
17. Lee WM "Medical progress: drug-induced
hepatotoxicity." N Engl J Med 333 (1995): 1118-27
18. Keaton MR "Acute renal failure in an alcoholic during
therapeutic acetaminophen ingestion." South Med J 81 (1988): 1163-6
19. Johnson GK, Tolman KG "Chronic liver disease and
acetaminophen." Ann Intern Med 87 (1977): 302-4
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poisoning and liver function." N Engl J Med 331 (1994): 1310-1
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