Acetaminophen ................................. 500 mg
Excipients q.s …………………………… 1 tablet
Tablet.
Product description
A capsule-shell , green-colored tablet, scored on one side, imprinted on the other side, undamaged edges.
Box of 10 blisters x 10 tablets. Bottle of 200 tablets.
Pharmacotherapeutic group: Other analgesics and antipyretics ATC code: N02BE01
Acetaminophen is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependant on the inhibition of prostaglandin synthesis. This inhibition appears, however to be on a selective basis.
Acetaminophen is rapidly and almost completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1 - 4 hours after therapeutic doses. Acetaminophen is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 - 100% of the drug may be recovered in the urine within the first day. However, practically no acetaminophen is excreted unchanged and the bulk is excreted after hepatic conjugation.
None.
Epidemiological studies on neurodevelopment in children exposed to acetaminophen in utero show inconclusive results. If clinically needed, acetaminophen can be used during pregnancy if clinically needed, however, as with any medicine it should be used at the lowest effective dose for the shortest possible time.
Acetaminophen is excreted in breast milk but not in a clinically significant amount in recommended dosages. Available published data do not contraindicate breastfeeding.
The speed of absorption of acetaminophen may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of acetaminophen with increased risk of bleeding; occasional doses have no significant effect.
Adverse events of acetaminophen from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class and frequency.
The following convention has been utilised for the classification of the undesirable effects: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from available data).
Adverse event frequencies have been estimated from spontaneous reports received through post-marketing data.
Blood and lymphatic system disorders:
Very rare: Thrombocytopenia, agranulocytosis.
Immune system disorders:
Very rare: Anaphylaxis, cutaneous hypersensitivity reactions including skin rashes, angioedema. Very rare cases of serious skin reactions have been reported.
Respiratory, thoracic and mediastinal disorders:
Very rare: Bronchospasm (There have been cases of bronchospasm with acetaminophen, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs).
Hepatobiliary disorders:
Very rare: Hepatic dysfunction.
Please inform your doctor of all undesirable effects upon drug administration.
Acetaminophen overdose may cause liver failure which may require liver transplant or lead to death.
Liver damage is possible in adults who have taken 10g or more of acetaminophen.
Ingestion of 5 g or more of acetaminophen may lead to liver damage if the patient has risk factors (see below):
Risk factors
- If the patient is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes. Or
- If the patient regularly consumes ethanol in excess of recommended amounts. Or
- If the patient is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of acetaminophen 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.
Management
Immediate treatment is essential in the management of acetaminophen overdose. Despite a lack of significant early symptoms, 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, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma acetaminophen 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 acetaminophen, 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 24h from ingestion should be discussed with the NPIS or a liver unit.
Store in dry places, not exceeding 30oC, protect from light.
Contains acetaminophen. Do not use with any other acetaminophen-containing products.
Underlying liver disease increases the risk or acetaminophen related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches become persistent.
Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.
Caution should be exercised in patients with glutathione depleted states, as the use of acetaminophen may increase the risk of metabolic acidosis.
Use with caution in patients with glutathione depletion due to metabolic deficiencies.
If symptoms persist, medical advice must be sought.
Keep out of the sight and reach of children.
The physician should warn patients of serious signs of skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell's syndrome, acute generalized exanthematous pustulosis (AGEP).
Excipients
Wheat starch in this medicine contains only very low levels of gluten and is very unlikely to cause problems if you have coeliac disease. If you have wheat allergy, you should not take this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, that is to say essentially "sodium-free".
Acetaminophen is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever, aches and pains of colds and flu. Also recommended for the symptomatic relief of pain due to non-serious arthritis.
Hypersensitivity to acetaminophen or any of the other constituents.
Oral administration only.
Adults, the elderly, and children aged 16 years and over: one or two tablets up to four times daily as required.
Children aged 10 - 15 years: one tablet up to four times daily as required.
Not suitable for children under 10 years of age.
Children should not be given acetaminophen for more than 3 days without consulting a doctor.
These doses should not be repeated more frequently than every four hours nor should more than four doses be given in a one-day period.
Or as directed by the physician.
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