Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Private Bag X69, Bryanston 2021
GEN-PAYNE CAPSULES are indicated for the relief of mild to moderate pain of inflammatory origin with or without fever.
Use the lowest effective dose for the shortest possible duration of treatment.
One to two capsules four to six hourly and not more than six capsules per twenty-four hours.
Consult your doctor if no relief is obtained with the recommended dosage.
GEN-PAYNE CAPSULES are not recommended for children under twelve years of age.
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 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.
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. 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 1 000 ml dextrose injection over the next sixteen hours. The volume of intravenous fluid should be modified for children.
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. The nomogram should be used only in relation to a single acute ingestion.
A semi-logarithmic plot of plasma-paracetamol concentration against hours after ingestion. (Reference: Martindale):
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”. Prothrombin index correlates best with survival.
Monitor all patients with significant ingestions for at least ninety-six hours.
Symptoms of overdosage include excitement and, in children, convulsions may occur. Large doses produce respiratory depression.
Treatment of overdosage is symptomatic and supportive.
The most likely symptoms of overdosage are nausea, vomiting and tinnitus.
Treatment is symptomatic and supportive.
24 months.
Store at or below 25°C in well-closed containers.
A white high density polypropylene (HDPP) securitainer with a low density polyethylene (LDPE) snap on lid or a white high density polyethylene container with a high density polyethylene (HDPE) screw cap containing 30 capsules.
Push through clear PVC and aluminium blister packs of 10 capsules in unit cartons of 10, 30, 60 or 100 capsules.
Not all pack sizes may be marketed.
No special requirements.
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