PARAFAST

Each uncoated tablets contains:

(Paracetamol IP 500 mg)

Tablet for Oral Use

According to its FDA labeling, Paracetamol’s exact mechanism of action has not been fully established. Despite this, it is often categorized alongside NSAIDs (nonsteroidal anti-inflammatory drugs) due to its ability to inhibit the cyclooxygenase (COX) pathways. It is thought to exert central actions which ultimately lead to the alleviation of pain symptoms.

The antipyretic actions of acetaminophen are likely attributed to direct action on heat-regulating centers in the brain, resulting in peripheral vasodilation, sweating, and loss of body heat.

Absorption: Acetaminophen has 88% oral bioavailability and reaches its highest plasma concentration 90 minutes after ingestion.

Distribution: Volume of distribution is about 0.9L/kg. 10 to 20% of the drug is bound to red blood cells. Acetaminophen appears to be widely distributed throughout most body tissues except in fat.

Metabolism &Excretion: Acetaminophen is mainly metabolized in the liver by first-order kinetics and its metabolism comprised of 3 pathways: conjugation with glucuronide, conjugation with sulfate, and oxidation through the cytochrome P450 enzyme pathway, mainly CYP2E1. Acetaminophen metabolites are mainly excreted in the urine. Less than 5% is excreted in the urine as free (unconjugated) acetaminophen and at least 90% of the administered dose is excreted within 24 hours.

Half Life: After an oral dose, the half-life can range from 4 to 8 hours depending on the severity of injury to the liver, as it heavily metabolizes acetaminophen.

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

ADVERSE REACTION:

• Skin rash, hypersensitivity reactions
• Nephrotoxicity (elevations in BUN, creatinine)
• Hematological: anemia, leukopenia, neutropenia, pancytopenia
• Metabolic and electrolyte

Additional adverse effects of Acetaminophen administered