Acetaminophen

Acetaminophen
Generic Name: acetaminophen (oral) (a SEET a MIN oh fen)




Chemical formula: C8H9NO2
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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