API

Paracetamol (125mg)

Drug classification

Analgesic; specific subclass: non-opioid analgesic and antipyretic.

Dosage form

Dispersible tablet containing 125 mg paracetamol.

API strength per dosage

Dose

P 125 Tablet DT (Paracetamol 125mg) is typically used in children; dosing is weight-based (10–15 mg/kg per dose every 4–6 hours, maximum 60 mg/kg/day or 4 g/day). Use with caution in hepatic or severe renal impairment; dose adjustment or increased dosing interval may be required. Not routinely used in adults due to low strength.

Mechanism of action

Paracetamol inhibits prostaglandin synthesis by blocking cyclooxygenase (COX), primarily COX-2, in the central nervous system. This reduces the formation of prostaglandins involved in pain and fever, resulting in analgesic and antipyretic effects. It has minimal anti-inflammatory action due to weak peripheral COX inhibition.

Indications

Pain reliefTreatment of Fever

Side effects

Indigestion Stomach pain Nausea Vomiting

Pregnancy category

Paracetamol is generally considered safe in pregnancy when used at recommended doses; use the lowest effective dose for the shortest duration necessary. Consult a healthcare provider.

Precautions

Hepatic impairment, renal impairment, chronic alcohol use, malnutrition, risk of overdose, monitor liver function in prolonged use, avoid concurrent hepatotoxic drugs, assess for allergic reactions, adjust dose in children as per weight, do not exceed recommended daily dose, monitor for signs of toxicity.

Contraindications

Hypersensitivity to paracetamol, severe hepatic impairment, acute liver failure, known glucose-6-phosphate dehydrogenase deficiency, severe renal impairment.