Paracetamol Tablets

Each Paracetamol Tablets contains Paracetamol 500mg.
ACTIONS :
Paracetamol has analgesic and antipyretic actions.
INDICATIONS :
Mild to moderate pain. For symptomatic relief of fever in children and adults. (Additional therapy to treat the cause of pain or fever should be instituted when necessary).

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APIS

Active Pharmaceutical Ingredient	Latin Name	Molecular Formula	Defination	Structural Formula
Paracetamol Tablets	Paracetamolum Tabulettae	C8H9NO2	N-(4-Hydroxy-phenyl)-acetamide

API mixing

Filling

Vial sterilization

Details

Paracetamol Tablet Pharmacotherapy Protocol

Dosage Regimen
Adult Patients:
500-1000 mg q4-6h (max 4000 mg/24h)

Pediatric Population:

≥6-12 years: 250-500 mg

1-5 years: 120-250 mg

3-12 months: 60-120 mg

Neonates <3 months: 10 mg/kg (5 mg/kg if hyperbilirubinemia)
Repeat dosing interval: ≥4 hours

Toxicological Profile
Exceeding 10 g/24h induces dose-dependent hepatocyte necrosis. Clinical hepatotoxicity typically manifests 48-96 hours post-ingestion with:

Right upper quadrant tenderness

Transaminase elevation (AST/ALT >1000 IU/L)

Coagulopathy (INR >1.5)

Risk Stratification

High-risk groups:

Chronic alcohol users: >6 g/24h

Malnourished patients: >8 g/24h

Pediatrics: >150 mg/kg single dose

Toxicokinetic Parameters

Latent phase (0-24h): Gastrointestinal distress (nausea/vomiting in 85% cases)

Hepatic phase (24-72h):

AST/ALT elevation precedes clinical symptoms

Peak hepatotoxicity at 72-96h

Mortality rate: 3.2% untreated (95%CI 2.8-3.6%)

Clinical Monitoring Protocol

Serial LFTs q6h for first 24h

INR monitoring q12h

NAC antidote administration within 8h post-ingestion

Safety Precautions

Pediatric dosing frequency: ≤4 administrations/24h

Contraindicated in severe hepatic impairment (Child-Pugh C)

Avoid concomitant NSAIDs in renal compromised patients

Recautions :

Paracetamol should be given with care to patients with impaired kidney or liver function.

Side Effects :

Side effects are rare. Liver damage may occur during prolonged use or overdosage.

Rashes, blood disorders and acute pancreatitis may also occur.

Interactions :

Paracetamol should also be given with care to patients taking other drugs that affect the liver (eg. Heptic enzyme inducers, hepatotoxic drugs, anticoagulants) and those with alcohol dependence. Avoid use of alcohol if taking more than an occasional 1 or 2 doses because there is an increased risk of liver toxicity.

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