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In adults and adolescents (≥12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 g over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: anorexia, nausea, vomiting, diaphoresis, pallor and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Serious toxicity or fatalities have been extremely infrequent following an acute paracetamol overdose in young children, possibly because of differences in the way they metabolize paracetamol.
Table 1 shows the clinical events associated with paracetamol overdose that if seen with overdose are considered expected, including fatal events due to fulminant hepatic failure or its sequelae. (See Table 1.)
Click on icon to see table/diagram/imageThe following clinical events are sequelae to acute hepatic failure and may be fatal. If these events occur in the setting of acute hepatic failure associated with paracetamol overdose (adults and adolescents: >12 years of age: >7.5 g within 8 hours; children <12 years of age: >150 mg/kg within 8 hours), they are considered expected. Expected sequelae to acute hepatic failure associated with paracetamol overdose include the following: Bacterial infection, fungal infection, sepsis, coagulopathy, disseminated intravascular coagulation, thrombocytopenia, hypoglycemia, hypophosphatemia, lactic acidosis, metabolic acidosis, brain oedema, coma (with massive paracetamol overdose or multiple drug overdose), encephalopathy, cardiomyopathy, hypotension, respiratory failure, gastrointestinal hemorrhage, pancreatitis, acute kidney injury, and multiple organ dysfunction syndrome.
Blood and Lymphatic Disorders: Hemolytic anaemia (in patients with glucose-6-phosphate dehydrogenase [G6PD] deficiency): Hemolysis has been reported in patients with G6PD deficiency, with use of paracetamol in overdose.
Phenylephrine: Overdosage may result in vomiting, central nervous system stimulation (such as nervousness, anxiety, restlessness, dizziness and tremor), seizures, palpitations, hypertension, headache (a possible symptom of hypertension), cerebral hemorrhage and paresthesia.
Sinutab Cold Plus: No overdose-associated ADRs were identified for the combination of chlorpheniramine, paracetamol, and phenylephrine from review of post-marketing safety data.
The information presented as follows describes overdose with the single active ingredients.
Chlorpheniramine: Overdosage of an H1 receptor antagonist may result in depressed level of consciousness, hyperthermia, anticholinergic syndrome (mydriasis, flushing, pyrexia, dry mouth, urinary retention, gastrointestinal sounds abnormal), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, confusional state, hallucination, psychotic disorder, seizure, or arrhythmia. Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma, or seizures.
Paracetamol: Hepatobiliary Disorders: If a paracetamol extended release product is involved or if the exact formulation is not known, it is recommended to obtain an additional plasma paracetamol level 4 to 6 hours following the initial paracetamol level as these levels will continue to rise with the extended release products and may alter treatment decisions.
In adults and adolescents (≥12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 g over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: anorexia, nausea, vomiting, diaphoresis, pallor and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Serious toxicity or fatalities have been extremely infrequent following an acute paracetamol overdose in young children, possibly because of differences in the way they metabolize paracetamol.
Table 2 shows the clinical events associated with paracetamol overdose that if seen with overdose are considered expected, including fatal events due to fulminant hepatic failure or its sequelae. (See Table 2.)
Click on icon to see table/diagram/imageThe following clinical events are sequelae to acute hepatic failure and may be fatal. If these events occur in the setting of acute hepatic failure associated with paracetamol overdose (adults and adolescents: >12 years of age: >7.5 g within 8 hours; children <12 years of age: >150 mg/kg within 8 hours), they are considered expected.
Expected sequelae to acute hepatic failure associated with paracetamol overdose include the following: Bacterial infection, fungal infection, sepsis, coagulopathy, disseminated intravascular coagulation, thrombocytopenia, hypoglycemia, hypophosphatemia, lactic acidosis, metabolic acidosis, brain oedema, coma (with massive paracetamol overdose or multiple drug overdose), encephalopathy, cardiomyopathy, hypotension, respiratory failure, gastrointestinal haemorrhage, pancreatitis, acute kidney injury, and multiple organ dysfunction syndrome.
Blood and Lymphatic Disorders: Hemolytic anaemia (in patients with glucose-6-phosphate dehydrogenase [G6PD] deficiency): Hemolytic has been reported in patients with G6PD deficiency, with use of paracetamol in overdose.
Phenylephrine: Overdosage may result in vomiting, central nervous system stimulation (such as nervousness, anxiety, restlessness, dizziness and tremor), seizures, palpitations, hypertension, headache (a possible symptom of hypertension), cerebral hemorrhage and paresthesia.
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