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Thursday, January 20, 2011

US FDA limits dosage of acetaminophen to 325 mg per unit dosage form,Requires boxed warning on lables

US FDA puts a limit on content of acetaminophen to 325 mg per unit dose in prescription combination drug products . Requires boxed warning on labels of drug products about  risk of liver toxicity in higher dose of acetaminophen.

Acetaminophen also known as Paracetamol, is one of the most widely used drug to reduce pain and fever, its widely used in many OTC drugs and it is also combined with many other drugs for the same purpose, acetaminophen is known to cause liver injuries in higher dosage. Liver injury occurs when a patients take multiple products containing acetaminophen at one time and when the dose exceeds 4,000 milligrams within a 24-hour period, liver injury may require liver transplantation, liver damage due to drug toxicity may result in death.
To minimize the risk liver damages caused by acetaminophen over dosage US FDA has limited the dose of acetaminophen in prescription acetaminophen combination products to 325 mg of acetaminophen per tablet, capsule, or any other dosage unit.

US FDA has responded to the reduce risk of acetaminophen liver toxicity, as there were some reports about liver injuries associated with acetaminophen liver toxicity, FDA responded in a precise manner to take care of health of US citizens by limiting dose of acetaminophen in prescription combination product, and has also asked pharma companies to put a boxed warning on product about risk of liver toxicity in higher dose.
US FDA mentioned in their press release that OTC drugs containing acetaminophen are not affected by this action. US FDA has taken this action to make prescription combination pain medications containing acetaminophen safer for patients to use.

The process of elimination of higher dose prescription combination acetaminophen drug products is scheduled to phase over the period of three years. US FDA has notified Patients and health care professionals about of the new requirement on acetaminophen content and of the labeling change as well, through a drug safety communication issued by CDER. US FDA stated in their press release that the prescription acetaminophen combination drug products with acetaminophen content not exceeding 325 mg of acetaminophen per tablet are too effective in treating pain. FDA has published list of Prescription Drug products marketed USA which contains acetaminophen, and list of manufacturers and their products affected with this new regulation one can see them on US FDA’s website.

Information about Acetaminophen:
Acetaminophen also known as paracetamol IUPAC Name N-(4-hydroxyphenyl) acetamide ,
N-acetyl-para-aminophenol (APAP). Most widely used drug world wide as, anti-inflammatory, antipyretic and analgesic , used to relive fever and body pain , headache and it is combined with opoid analgesics to manage surgical pains as well. It produces analgesic effect with in 10 to 15 minutes after oral administration.its halflife is about 1-4 Hours.

Mode of action of Acetaminophen
Acetaminophen belongs non steroidal analgesics group belonging to class aniline derivatives.
Acetaminophen is believed impart anti-inflamatory action by blocking prostaglandin bio-synthesis prostaglandins are responsible for process of inflammation and for reducing the threshold level of stimuli for perception of pain and rise in body temperature. Acetaminophen blocks cyclooxigenase enzyme (COX) (COX2), an enzyme system responsible for formation of prostaglandin from arachidonic acid , this property of blocking cyclooxigenase enzyme can be attributed to the molecular resemblance of paracetamol molecule to peculiar –(CH2)3-COOH acid moiety in arachidonic acid (structural activity relationship, SAR). Which serves as base for competitive inhibition of cyclooxygenase enzyme, there by bringing inhibition of prostaglandin synthesis and work as anti-inflammatory agent. Acetaminophen exhibit different levels of analgesic, anti-inflammatory, antipyretic and antiplatelet actions.

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