Source: Marketing Authorisation Holder Revision Year: 2023 Publisher: Oethmaan Biosims (Pty) Ltd, 207A Sherwood House, Greenacres Office Park, c/o Victory and Rustenberg Roads, Victory Park, Johannesburg, 2195
The relief of mild to moderate pain and fever such as headaches, toothache and pain associated with colds and flu.
Children 6-12 years: ½ - 1 tablet every 6 hours. Not more than 4 doses to be taken in any 24-hour period.
Children over 12 years: 1 tablet every 4-6 hours. Not more than 4 tablets to be taken in any 24-hour period.
Adults: 1-2 tablets every 4-6 hours. Not more than 8 tablets to be taken in any 24-hour period.
DO NOT EXCEED THE RECOMMENDED DOSE.
Children under 6 years: Not recommended.
Donapan should be taken orally. The tablets should be swallowed with liquid and should not be chewed.
Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person directly to a hospital. A delay in starting treatment may mean that the antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed.
Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5-10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrition, and with the use of medicines that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepine.
Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and possibly abdominal pain. Mild symptoms during the first two days of acute poisoning, do not reflect the potential seriousness of the overdosage.
Liver damage may become apparent 12 to 48 hours, or later after ingestion, initially by elevation of the serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of the prothrombin time. Liver damage may lead to encephalopathy, coma and death.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac arrhythmias have been reported.
After maternal overdosage during pregnancy, foetal metabolism of paracetamol that crosses the placenta can produce hepatotoxic metabolites, causing foetal hepatotoxicity.
Although evidence is limited it is recommended that any adult person who has ingested 5-10 grams or more of paracetamol (or a child who has had more than 140 mg/kg) within the preceding four hours, should have the stomach emptied by lavage (emesis may be adequate for children) and a single dose of 50 g activated charcoal given via the lavage tube. Ingestion of amounts of paracetamol smaller than this may require treatment in patients susceptible to paracetamol poisoning (see above). In patients who are stuperose or comatose endotracheal intubation should precede gastric lavage in order to avoid aspiration.
N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible preferably within eight hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken.
IV: An initial dose of 150 mg/kg N-acetylcysteine in 200 ml dextrose injection given intravenously over 15 minutes, followed by an infusion of 50 mg/kg in 500 ml dextrose injection over the next four hours, and then 100 mg/kg in 1000 ml dextrose injection over the next sixteen hours. The volume of intravenous fluid should be modified for children.
Oral: Although the oral formulation is not the treatment of choice, 140 mg/kg dissolved in water may be administered initially, followed by 70 mg/kg every four hours for seventeen doses.
A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours may be misleading.
Patients at risk of liver damage, and hence requiring continued treatment with N-acetylcysteine, can be identified according to their 4-hour plasma paracetamol level. The plasma paracetamol level can be plotted against time since ingestion in the nomogram below.
* Nomogram reproduced from the Guidelines for the Management of Acute Paracetamol Overdose produced by the Medicines Information Centre, UCT.
The nomogram should be used only in relation to a single acute ingestion. Those, whose plasma paracetamol levels are above the “normal treatment line”, should continue N-acetylcysteine treatment with 100 mg/kg IV over sixteen hours repeatedly until recovery. Patients with increased susceptibility to liver damage as identified above, should continue treatment if concentrations are above the “high risk treatment line” (refer to paracetamol nomogram above). Prothrombin index correlates best with survival.
Monitor all patients with significant ingestions for at least ninetysix hours.
Hepatic tests must be carried out at the beginning of treatment and repeated every 24 hours. In most cases hepatic transaminases return to normal in one to two weeks with full restitution of the liver function. In very severe cases, however, liver transplantation may be necessary.
4 years (proposed).
Store at or below 30°C.
Protect from light and moisture.
Store in the original package/container.
Keep the blister in the carton until required for use.
Donapan is packed in a blister comprising of plain aluminium foil with VMCH coating and clear transparent PVC film and placed in a preprinted carton along with a patient information leaflet.
Pack sizes: 20 and 100 tablets.
Not all pack sizes may be marketed.
No special requirements.
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