DADRA
  Pharmaceuticals

 


   

Chemical name

Acetamide, N - (4 - hydroxyphenyl).

Category

Analgesic - 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.

Indications

Acetaminophen 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 consider

Acetaminophen 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 supplied

Box of 100 tablets.
Each tablet contains 325 mg acetaminophen.

Storage

Store below 30° C, protect from direct light and moisture.
Oral drops should be protected from freezing.

References

1 - USP DI Vol: 1 (1996).
2 - Drug facts and comparisons (1994).
3 - USP 23 page: 16.

   
 

 Home | About Us | Products | R&D | Import/Export | Contact Us
© 2006 All Rights Reserved.