Product Description.:
Storage:
Store at room temperature (15 to 30?C).
Indications:
For fast, temporary relief from headaches, pain due to arthritis, muscle aches, sprains and menstrual cramps, and from fever or flu symptoms.
Directions:
Adults (12 years and older): 1-2 caplets every 4 hours as required, not to exceed 12 caplets (or 4000 mg acetaminophen) daily. It is hazardous to exceed the recommended dose unless directed by a physician. Use only on the advice of a physician.
Cautions:
Caution when used in patients with alcoholism, serious kidney or serious liver disease. Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive doses of acetaminophen, although reports of this event are rare. Reports usually involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Patients who regularly consume large amounts of alcohol should be cautioned not to exceed the recommended doses of acetaminophen.
Drug Interactions:
Patients who concomitantly medicate with warfarin-type anticoagulants and regular doses of acetaminophen have occasionally been reported to have unforeseen elevations in their INR.
Contraindications:
Hypersensitivity to acetaminophen.
Toxicity/Adverse Reactions:
The classic gastrointestinal irritation associated with NSAIDs, including ASA does not occur with acetaminophen. Sensitivity reactions are rare. Cross-reactivity in ASA sensitive persons has been rarely reported. If sensitivity is suspected, discontinue use of the drug.
Symptoms and Treatment of Overdose:
TYPICAL TOXIDROME:
Significant overdoses of acetaminophen may result in potentially fatal hepatotoxicity. Healthcare professionals should be mindful that there is no early presentation that is pathoneumonic for the overdose. A high degree of clinical suspicion must always be maintained.
Due to the wide availability of acetaminophen, it is commonly involved in single and mixed drug overdose situations and the practitioner should have a low threshold for screening for its presence in a patient's serum. Acute toxicity after single dose overdoses of acetaminophen can be anticipated when the overdose exceeds 150 mg/kg. Chronic alcohol abusers, cachectic individuals, and persons taking pharmacologic inducers of the hepatic P450 microsomal enzyme system may be at risk with lower exposures.
There have been rare reports of chronic intoxication in persons consuming in excess of 150 mg/kg of acetaminophen daily for several days.
SPECIFIC ANTIDOTE:
NAC (N-acetylcysteine) administered by either the i.v. or the oral route is known to be a highly effective antidote for acetaminophen poisoning. It is most effective when administered within 8 hours of a significant overdose but reports have indicated benefits to treatment initiated well beyond this time period. It is imperative to administer the antidote as early as possible in the time course of acute intoxication to reap the full benefits of the antidote's protective effects.
