ACET Suppository Ref.[27536] Active ingredients: Paracetamol

Warnings

Acetaminophen poisoning can result in severe hepatic damage.

Precautions / Adverse reactions

When used as directed, acetaminophen is virtually free of severe toxicity or side effects. The incidence of gastrointestinal upset is less than after salicylate administration. If a rare sensitivity reaction occurs, usually manifested by a rash or urticaria, discontinue use of the drug.

Drug Interactions and/or Related Problems:

Risk of hepatotoxicity with single toxic doses or prolonged use of high doses of acetaminophen may be increased in alcoholics or in patients regularly taking other hepatotoxic medications or hepatic enzyme inducers.

Concurrent chronic high-dose administration of acetaminophen may increase the anticoagulant effect of anticoagulants, coumarin or andantino-derivative.

Prolonged concurrent use of acetaminophen and anti-inflammatory drugs, nonsteroidal (NSAIDs) or aspirin or other salicylates is not recommended because recent evidence suggests that chronic high-dose administration of combined analgesics significantly increases the risk of analgesic nephropathy, renal papillary necrosis, end-stage renal disease, and cancer of the kidney or urinary bladder.

Diflusinal may increase the plasma concentration of acetaminophen by 50%, leading to increased risk of acetaminophen-induced hepatotoxicity.

Acetaminophen may competitively inhibit the hepatic glucoronidation and decrease the clearance of zidovudine; zidovudine may also inhibit the hepatic glucoronidation of acetaminophen.

Diagnostic interference:

Acetaminophen may cause false measurements in blood glucose determinations. Administration of acetaminophen prior to pancreatic function tests using bentiromide will invalidate test results.

Acetaminophen may cause falsely increased serum uric acid determinations when the phosphotungstate uric acid test method is used.

Acetaminophen may cause false positive results in qualitative screening tests of urine 5Bhydroxyindoleacetic acid (5-HIAA) determinations using nitrosonaphthol reagent.

In alcoholic patients taking hepatic enzyme inducers, or patients with pre-existing hepatic disease, when single toxic doses of acetaminophen are taken (or with prolonged use of lower doses), prothrombin time, serum bilirubin concentrations, serum lactate dehydrogenase activity, and serum transaminase activity may beincreased.

Although the incidence of adverse effects is rare, the following adverse effects 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, oritching)
• Hepatitis (yellow eyes orskin)
• Renal colic (pain, severe and/or sharp, in lower back and/or side) with prolonged use of high doses in patients with severe renal functionimpairment.
• Renal failure (sudden decrease in amount of urine):-uremia may result, especially with prolonged use of high doses in patients with severe renal function impairment; also although a causal association has not been established a retrospective study has suggested that long term daily use of acetaminophen may be associated with an increased risk of chronic renal disease (analgesic nephropathy) in individuals without pre-existing renal function impairment.
• Sterile pyuria (cloudy urine)
• Thrombocytopenia (usually asymptomatic: rarely, unusual bleeding or bruising;black, tarry stools; blood in urine or stools; pinpoint red spots onskin)