ACET Suppository Ref.[27536] Active ingredients: Paracetamol

Adults and Children over 12 years: One suppository (650 mg) every 4-6 hours. Maximum daily dosage is 6 suppositories.

Infants under 1 year: Use only on the advice of a physician.

Infants 1 to 2 years: One suppository (120 mg) every 4 hours. Maximum daily dosage is 5 suppositories.

Children 2 to 4 years: One suppository (160 mg) every 4 hours. Maximum daily dosage is 6 suppositories.

Children 4 to 6 years: One suppository (325 mg) every 6 hours. Maximum daily dosage is 4 suppositories.

Children 6 to 12 years: One suppository (325 mg) every 4 hours. Maximum daily dosage is 6 suppositories.

A physician should be consulted for treatment regimens lasting longer than 5 days.

The inherency in the rectal route of administration to an erratic absorption, lower blood concentrations and the possibility of lower bioavailability in some patients relative to the oral route of administration makes more frequent rectal administration acceptable when deemed necessary by the prescriber.

Symptoms and treatment of overdosage

Overdose

In adults hepatotoxicity may occur after ingestion of a single dose of 10 to 15 g (200 to 250 mg/kg) of acetaminophen; a dose of 25 g or more is potentiallyfatal.

In adults, cases of non-fatal overdose (ranging from 12.5 to 31.5 g) have been reported; and one death after ingestion of 30 g of acetaminophen has been reported. A 13 year old child is reported to have died after ingesting 15 g.

Symptoms

The first 2 days of acute poisoning by acetaminophen do not reflect the potential seriousness of the intoxication, and hepatoxicity is generally believed to occur only with acute overdosage. Nausea, vomiting, anorexia and abdominal pain occur during the initial 24 hours and may persist for a week or more. Liver injury may become manifest the second day, initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. Alkaline phosphatase activity and serum albumin concentration may remain normal. The hepatotoxicity may progress to encephalopathy, coma and death. Liver biopsy reveals centrilobular necrosis with sparing of the periportal area. In nonfatal cases, the hepatic lesions are reversible over a period of weeks or months. Transient azotemia is apparent in most patients and acute renal failure occurs in some. Hypoglycemia may occur, but glycosuria and impaired glucose tolerance have also been reported. Both metabolic acidosis and metabolic alkalosis have been noted, cerebral edema and non-specific myocardial depression have also occurred.

Since acetaminophen is metabolized primarily by the liver, in cases of acute poisoning following oral ingestion, prolongation of the plasma half-life beyond 3 hours may be indicative of liver injury. Hepatic necrosis should be anticipated if the half-life exceeds 4 hours, and hepatic coma is likely if the half-life is greater than 12 hours following oral ingestion. A single determination of serum acetaminophen concentration is a less reliable predictor of hepatic injury. However, only minimal liver damage has developed when the serum concentration was below 120 mcg/mL at 4 hours, or less than 50 mcg/mL at 12 hours after ingestion of the drug. Encephalopathy should be anticipated if serum bilirubin concentration exceeds 4 mg/100 mL during the first 5 days.

Treatment

Early diagnosis is vital in the treatment of overdose with acetaminophen. Vigorous supportive therapy is essential when intoxication is severe. Procedures to limit continuing absorption of the drug must be initiated promptly. When the oral route of administration is used, induction of vomiting or gastric lavage should be performed and should be followed by oral administration of activated charcoal (50 gm). Hemodialysis, if it can be initiated within the first 12 hrs, has been advocated for all patients with a plasma concentration of acetaminophen greater than 120 mcg/mL, 4 hrs after drug ingestion. If administered within the first few hours, ingestion of sulphydryl compounds, which replenish glutathione, have been shown to effectively prevent or reduce the hepatotoxic effects of acetaminophen. N-acetylcysteine, available commercially as a sterile 20% solution has been shown to be particularly effective and well tolerated when given orally as a 5% solution diluted with cola, fruit juice, or water. The accepted treatment regimen is a loading dose of 140 mg/kg followed by 70 mg/kg every 4 hrs for 17 doses or until plasma concentrations of acetaminophen are indicative of a low risk to hepatotoxicity.

Store between 15°C and 25°C.