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ACET is a brand name for Acetaminophen (also known as Paracetamol), supplied as a suppository. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ACET 120 / ACET 160 / ACET 325 / ACET 650 (acetaminophen suppositories) is indicated for the treatment of mild to moderate pain and the reduction of fever. 1.1 Pediatrics Pediatrics (1 to 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ACET in pediatric patients…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations A physician should be consulted for treatment regimens lasting longer than 5 days for pain and longer than 3 days for fever. ACET 120/160/325/650 (acetaminophen suppositories) Page 5 of 22 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.
2 Recommended Dose and Dosage Adjustment 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. Children 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. 4 Administration For rectal use only. Prior to administration wash hands with soap and water. Remove plastic wrapper and moisten suppository with cool water.
Have patient lie on side with bottom leg straight and upper leg bent up toward chest. Gently push the suppository as high as possible into rectum. Wash hands with soap and water. 5 Missed Dose If a dose is missed, patients are advised to take it as soon as they remember.
If it is almost time for the next dose, patients are advised to skip the missed dose and continue with the next scheduled dose.
1 Adverse Reaction Overview Although the incidence of adverse reactions is rare, the following adverse reactions may have clinical significance (possible signs and symptoms in parentheses): Agranulocytosis (unexplained sore throat and fever) Anemia (unusual tiredness or weakness) Dermatitis, allergic (skin rash, hives, or itching) Hepatitis (yellow eyes or skin) Renal colic (pain, severe and/or sharp, in lower back and/or side) with prolonged use of high doses in patients with severe renal function impairment.
Renal failure (sudden decrease in amount of urine) ACET 120/160/325/650 (acetaminophen suppositories) Page 10 of 22 Sterile pyuria (cloudy urine) Thrombocytopenia (usually asymptomatic: rarely, unusual bleeding or bruising; black, tarry stools; blood in urine or stools; pinpoint red spots on skin) .
2 Clinical Trial Adverse Reactions The clinical trial data on which the original indication was authorized is not available . 5 Post-Market Adverse Reactions This information is not available for this drug product.
1 Dosing Considerations A physician should be consulted for treatment regimens lasting longer than 5 days for pain and longer than 3 days for fever. ACET 120/160/325/650 (acetaminophen suppositories) Page 5 of 22 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.
2 Recommended Dose and Dosage Adjustment 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. Children 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. 4 Administration For rectal use only. Prior to administration wash hands with soap and water. Remove plastic wrapper and moisten suppository with cool water.
Have patient lie on side with bottom leg straight and upper leg bent up toward chest. Gently push the suppository as high as possible into rectum. Wash hands with soap and water. 5 Missed Dose If a dose is missed, patients are advised to take it as soon as they remember.
If it is almost time for the next dose, patients are advised to skip the missed dose and continue with the next scheduled dose. 5 OVERDOSAGE 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 potentially fatal.
ACET is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 hepatotoxicity is generally believed to occur only with ACET 120/160/325/650 (acetaminophen suppositories) Page 6 of 22 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.
For management of a suspected drug overdose, contact your regional poison control centre. ACET 120/160/325/650 (acetaminophen suppositories) Page 7 of 22 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging ACET 120: Each suppository, containing 120 mg acetaminophen, is individually sealed and available in boxes of 12.
ACET 160:
Each suppository, containing 160 mg acetaminophen, is individually sealed and available in boxes of 12.
ACET 325:
Each suppository, containing 325 mg acetaminophen, is individually sealed and available in […]