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Chemical
nameAcetamide, N - (4 -
hydroxyphenyl).
CategoryAnalgesic - Antipyretic.
Mechanism of
action
Acetaminophen may act predominantly by inhibiting
prostaglandin synthesis in the central nervous system (CNS) and, to a
lesser extent, through a peripheral action by blocking pain - impulse
generation. Acetaminophen probably produces antipyresis by acting
centrally on the hypothalamic heat - regulating center to produce
peripheral vasodilation resulting in increased blood flow through the
skin, sweating, and heat loss. The central action probably involves
inhibition of prostaglandin synthesis in the hypothalamus.
IndicationsAcetaminophen is indicated to relieve mild
to moderate pain and reduce fever. It provides symptomatic relief only;
additional therapy to treat the cause of the pain or fever should be
instituted when necessary.
Precautions to
considerAcetaminophen
should be given with care to patients with impaired kidney or liver
function. It also should be given with care in viral hepatitis,
alcoholism and sensitivity to acetaminophen or aspirin.
Pregnancy / Breast -
feeding
Problems in humans have not been documented. Although
controlled studies have not been done, it has been shown that
acetaminophen crosses the placenta. Risk - benefit must be considered.
Drug
interactions
Risk of hepatotoxicity with single toxic doses or
prolonged use of high doses of acetaminophen may be increased in
alcoholics or in patients regularly taking other hepatotoxic medications
or hepatic enzyme inducers. Chronic use of barbiturates (except
butalbital) or primidone has been reported to decrease the therapeutic
effects of acetaminophen. Concurrent chronic, high-dose administration
of acetaminophen with anticoagulants, cumarin or indandion-derivative may
increase the anticoagulant effects. Prolonged concurrent use of
acetaminophen and a salicylate or NSAIDs is not recommended (may increase
the risk of adverse renal effects).
Side / Adverse
effects
Those indicating need for medical
care: Agranulocytosis (unexplained sore throat and fever) - anemia
(unusual tiredness or weakness) - dermatitis, allergic (skin rash - hives,
or itching) - hepatitis (yellow eyes or skin) - renal colic (pain in lower
back) - renal failure (sudden decrease in amount of urine) - uremia -
sterile pyuria ( cloudy urine) - thrombocytopenia (blood in urine or
stools).
Signs and symptoms of overdose: These signs may
occur within the first hours after ingestion and persist for about 24
hours and include diarrhea, loss of appetite, nausea, vomiting, stomach
cramp or pain, increased sweating; hepatotoxicity may occur 2 to 4 days
after the overdose ingestion.
Administration and
dosage
Usual adult dose: 325 - 650 mg every four
hours, or 1 gram every six hours as needed, up to 4 grams daily (for short
therm therapy).
Usual pediatric dose: Infants up to 3
months of age - oral, 40 mg every four hours as needed. Infants 4 to 12
months of age - oral, 80 mg every four hours as needed. Children 1 to 2
years of age -oral, 120 mg every four hours as needed. Children 2 to 4
years of age - oral, 160 mg every four hours as needed. Children 4 to 6
years of age - oral, 240 mg every four hours as needed. Children 6 to 9
years of age - oralc 320 mg every four hours as needed. Children 9 to
11 years of age - oral, 320 to 400 mg every four hours as
needed. Children 11 to 12 years of age - oral, 320 to 480 mg every four
hours as needed.
How
suppliedBox of 100
tablets. Each tablet contains 325 mg acetaminophen.
StorageStore below 30° C, protect from direct light
and moisture. Oral drops should be protected from freezing.
References1 - USP DI Vol: 1 (1996). 2 - Drug facts
and comparisons (1994). 3 - USP 23 page: 16.
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