COMPOSITION: PARACETAMOL 125 MG
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Mild to Moderate Pain and Fever , Acute & Severe Pyrexia , High Fever with Headache , Body-ache / Migraine
Is a pain reliever and a fever reducer.
Paracetamol is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.
Mechanism of Action:
Paracetamol belongs to a class of drugs called analgesics and antipyretics. The exact mechanism of action of Paracetamol is not known. Paracetamol relieves pain by elevating the pain threshold, that is, by requiring a greater amount of pain to develop before a person feels it. It reduces fever through its action on the heat-regulating center of the brain.
Absorption: Incomplete; depends upon dosage form. Time to peak, serum: oral: 10-60 min; may be delayed in acute overdoses. Decreased rate of absorption with food.
Distribution: Present in most body tissues; crosses the placenta and enters the breast milk. Protein binding: 8-43% (at toxic doses).
Metabolism: Hepatic via glucuronic and sulphuric acid conjugation. At normal therapeutic levels, glucuronide metabolites are metabolised to reactive intermediate (acetylimidoquinone) which is conjugated with glutathione and inactivated; at toxic doses, glutathione conjugation is insufficient leading to increased acetylimidoquinone which may cause hepatic cell necrosis.
Excretion: Plasma half-life: 2.7 hr (adults); 1.5-2 hr (infants and children); 3.5 hr (neonates). Neonates, infants and children up 10 yr excrete less glucuronide than adults. Half-life may be longer after toxic doses. Excreted mainly via urine (2- 5% unchanged; 55% as glucuronide metabolites). Total body clearance: 18 l/hr.
● Allergic reactions
● Skin rashes
Very rare, blood dyscrasias.
Paracetamol is considered to be a suitable analgesic option in most people with liver disease. There is no increased risk of hepatotoxicity when licensed doses are used.
However, in people with acute severe hepatitis, a 50% reduction in paracetamol clearance, resulting in a longer half-life, has been observed.
● In acute mild hepatitis, the normal licensed dose can be used.
● In moderate or severe acute hepatitis, if serum bilirubin is greater than 300 micromoles/L or prothrombin time is greater than 3 seconds, reduce to a maximum of 1 g twice or three times a day.
Liver Failure, Liver Problems, Overdose of the Drug Paracetamol, Habit of Drinking Too Much Alcohol.
Renal or hepatic impairment; alcohol-dependent patients.
Reduced absorption of cholestyramine within one hour of administration. Accelerated absorption with metoclopramide. Decreased effect with barbiturates, carbamazepine, hydantoins, rifampicin and sulfinpyrazone. Paracetamol may increase effect of warfarin.
Paracetamol increases the risk of liver damage in chronic alcoholics. Increased risk of toxicity with other hepatotoxic drugs or drugs which induce microsomal enzymes e.g. Barbiturates, carbamazepine , hydantoins , rifampicin and sulfinpyrazone .