STOPAYNE Tablet Ref.[50682] Active ingredients: Caffeine Codeine Meprobamate Paracetamol

Posology

DO NOT EXCEED THE RECOMMENDED DOSE.

Adult dosage: Two tablets three or four times a day as required. Do not use continuously for more than ten days without consulting your doctor.

Special populations

No information available.

Paediatric population

No information available.

Method of administration

Oral.

In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre. Symptoms of overdosage include nausea and vomiting. Liver damage, which may be fatal, may only appear after a few days. Kidney failure has been described following acute intoxication.

Acute meprobamate overdosage can produce stupor, coma, convulsions, shock, circulatory and respiratory collapse. Because meprobamate is rapidly absorbed from the gastrointestinal tract, gastric lavage must be carried out shortly after ingestion and must be thorough.

In paracetamol overdose prompt treatment is essential. 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 to 10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrition, and with the use of medicine 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 sever liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac arrhythmias have been reported.

Treatment for paracetamol overdosage

Although evidence is limited it is recommended that any adult person who has ingested 5 to 10 g 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 (IV) 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, The Complete Drug Reference.

Those whose plasma paracetamol levels are above the “normal treatment line”, should continue Nacetylcysteine 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.

For overdose with an extended/modified release preparation the value of the nomogram is unknown. As there is no information on the plasma levels of paracetamol after an overdose of extended/modified release paracetamol preparations, all patients with suspected or known overdose with such preparations should receive N-acetylcysteine. Because of lack of data for extended/modified release formulations, a level below the “treatment line” of the nomogram may not exclude the possibility of toxicity.

Monitor all patients with significant ingestions for at least ninety-six hours.

3 years.

Store at or below 25°C.

Protect from light and moisture.

PVC/PVDC/Aluminium blister strips in an outer carton.

or

White HDPE bottles with white HDPE screw caps in an outer carton.

Pack sizes: 100 or 1 000 tablets.

Not all pack sizes may be marketed.

No special requirements.