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Indications/Uses
For lowering of fever accompanying influenza, common colds, tonsillitis, measles, pneumonia and other infections. Also for the relief of painful conditions including headache, dysmenorrhea, rheumatism, arthritis and other muscle skeletal disorders.
Soln for IV infusion: For the short-term treatment of moderate pain, particularly after surgery and of fever.
Soln for IV infusion: For the short-term treatment of moderate pain, particularly after surgery and of fever.
Dosage/Direction for Use
Tablet: Adult: For mild cases:1 tablet; For moderate to severe cases: 2 tablet (3 to 4 times a day or as prescribed by the physicians).
Oral Drops: Infants below 6 months: 0.3-0.6 mL; 6 months to 1 year: 0.6-1.2 mL; Children 1-2 years: 1.2-1.8mL (Every 4 to 6 hours or as prescribed by the physicians).
Syrup: Infants: 2.5 mL (½ tsp.); 1-3 yrs: 5.0 mL (1 tsp); 3-6 yrs: 10 mL (2 tsp) (3 to 4 times a day or as prescribed by the physician).
Children 7-12 yrs: 5-10mL (1 to 2 tsp); 2-6 yrs: 2-6 mL (½ to 1 tsp).
Soln for IV infusion: Paracetamol is given by intravenous infusion over 15 minutes; dosage may be calculated by weight as follows: patients weighing over 50 kg, single doses of 1 g every 4 or more hours, to a maximum of 4 g daily; from 33 to 50 kg, single doses of 15 mg/kg every 4 or more hours, to a maximum of 60 mg/kg or 3 g daily (whichever is less) or as prescribed by the physician.
Oral Drops: Infants below 6 months: 0.3-0.6 mL; 6 months to 1 year: 0.6-1.2 mL; Children 1-2 years: 1.2-1.8mL (Every 4 to 6 hours or as prescribed by the physicians).
Syrup: Infants: 2.5 mL (½ tsp.); 1-3 yrs: 5.0 mL (1 tsp); 3-6 yrs: 10 mL (2 tsp) (3 to 4 times a day or as prescribed by the physician).
Children 7-12 yrs: 5-10mL (1 to 2 tsp); 2-6 yrs: 2-6 mL (½ to 1 tsp).
Soln for IV infusion: Paracetamol is given by intravenous infusion over 15 minutes; dosage may be calculated by weight as follows: patients weighing over 50 kg, single doses of 1 g every 4 or more hours, to a maximum of 4 g daily; from 33 to 50 kg, single doses of 15 mg/kg every 4 or more hours, to a maximum of 60 mg/kg or 3 g daily (whichever is less) or as prescribed by the physician.
Overdosage
Soln for IV infusion: Liver damage is possible in adults who have taken 10 g or more of Paracetamol. Ingestion of 5 g or more of Paracetamol may lead to liver damage if the patient has risk factors (see as follows).
Risk Factors: If the patient A, is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's Wort or other drugs than induce liver enzymes. Or B, regularly consumes ethanol in excess of recommended amounts or C, is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV, starvation, cachexia.
Symptoms of Paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms of patients should be referred to hospital urgently for immediate medical attention.
Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of Paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required, the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
Risk Factors: If the patient A, is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's Wort or other drugs than induce liver enzymes. Or B, regularly consumes ethanol in excess of recommended amounts or C, is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV, starvation, cachexia.
Symptoms of Paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms of patients should be referred to hospital urgently for immediate medical attention.
Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of Paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required, the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
Administration
May be taken with or without food.
Contraindications
Soln for IV infusion: Known hypersensitivity to paracetamol or other constituents in the solution.
Warnings
Soln for IV infusion: Massive overdose may cause hepatic necrosis and less frequently, renal damage. Lesser overdoses frequently cause reversible jaundice.
Special Precautions
Paracetamol should be given with care to patients with impaired kidney and liver function.
Adverse Reactions
Soln for IV infusion: Adverse effects of paracetamol are rare and usually mild, although haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Skin rashes and other hypersensitivity reactions occur occasionally.
Hypotension has been reported rarely with parenteral use. Overdosage with paracetamol can result in severe liver damage and sometimes acute renal tubular necrosis. Prompt treatment with acetylcysteine or methionine is essential.
Hypotension has been reported rarely with parenteral use. Overdosage with paracetamol can result in severe liver damage and sometimes acute renal tubular necrosis. Prompt treatment with acetylcysteine or methionine is essential.
Drug Interactions
Soln IV for infusion: The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes. The absorption of paracetamol may be accelerated by drugs such as metoclopramide. Excretion may be affected and plasma concentrations altered when given with probenecid. Colestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacokinetics: Soln for IV infusion: Paracetamol is readily absorbed from the GI tract with peak plasma concentrations occurring about 10 to 60 minutes after oral doses. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. The elimination half-life of paracetamol varies from about 1 to 3 hours.
Paracetamol is metabolised mainly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. A minor hydroxylated metabolite (N-acetyl-p-benzoquinoneimine), is usually produced in very small amounts by cytochrome P450 isoenzymes (mainly CYP2E1 and CYP3A4) in the liver and kidney. It is usually detoxified by conjugation with glutathione but may accumulate after paracetamol overdosage and cause tissue damage.
Paracetamol is metabolised mainly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. A minor hydroxylated metabolite (N-acetyl-p-benzoquinoneimine), is usually produced in very small amounts by cytochrome P450 isoenzymes (mainly CYP2E1 and CYP3A4) in the liver and kidney. It is usually detoxified by conjugation with glutathione but may accumulate after paracetamol overdosage and cause tissue damage.
MedsGo Class
Analgesics (Non-Opioid) & Antipyretics
Features
Brand
Anaseran
Full Details
Dosage Strength
500 mg
Drug Ingredients
- Paracetamol
Drug Packaging
Tablet 100's
Generic Name
Paracetamol
Dosage Form
Tablet
Registration Number
DR-XY18300
Drug Classification
Over-The-Counter (OTC)