Product Dossier

CARBOSORB

Product Dossier for CARBOSORB (activated charcoal, sorbitol, Phebra). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

Carbosorb XS is a suspension containing activated charcoal 0.2 g/mL and sorbitol 0.283 g/mL. Each bottle contains 50 g of activated charcoal and 70.75 g sorbitol in 250 mL of suspension. Carbosorb XS is a black viscous suspension.

Approved indications

— Treatment of poisoning and drug overdosage by oral ingestion.

Dosing overview

Carbosorb XS should be administered as soon as possible after oral ingestion of the poison, ideally within one hour, as activated charcoal can only adsorb that portion of the drug not absorbed from the gastrointestinal tract. Carbosorb XS may be administered orally or by nasal or orogastric tube. Prior to administration, the container should be shaken vigorously for a minimum of 30 seconds. For adults and children 12 years and over, a single dose based on 1 g activated charcoal (equivalent to 5 mL Carbosorb XS suspension) per kg bodyweight is recommended, to a maximum dose of 50 g. For children 1 to 11 years, a single dose based on 1 g activated charcoal (equivalent to 5 mL Carbosorb XS suspension) per kg bodyweight is recommended, to a maximum dose of 50 g. Recommendations as to absolute dosage regimens are difficult to make due to individual patient variations in type of poisoning and patient weight and age. Certain patients may require repeat doses of activated charcoal due to pharmacokinetic properties of the ingested drug or poison, particularly those poisoned with sustained or slow release formulations or drugs subject to gastrointestinal dialysis. Repeat dose activated charcoal should be considered in patients who have ingested a life threatening amount of carbamazepine, dapsone, phenobarbitone, quinine or theophylline.

Key safety warnings

Aspiration of activated charcoal and gastric contents is a potentially serious complication. Patients who have an absent or impaired gag reflex, are comatose or drowsy, or have ingested large amounts of CNS depressant drugs or drugs that may cause seizures require airway protection, for example in the form of a cuffed endotracheal tube, to protect against aspiration. Cases of aspiration pneumonia and fatalities have been reported with the use of activated charcoal slurry for poisoning. There has been one report of bronchiolitis obliterans and a few reports of progressive respiratory failure resulting in death, due to aspiration of activated charcoal. Several documented case reports of serious gastrointestinal adverse effects have been associated with repeat dose activated charcoal, including intestinal obstructions and charcoal bezoan formation. Fatalities have occurred. Carbosorb XS should be used with extreme caution in patients with ileus, decreased or absent bowel sounds, or who have ingested a large amount of drugs that may impair peristalsis. The presence of sorbitol in Carbosorb XS may produce diarrhoea, resulting in disturbance of fluid and electrolyte balance. There have been case reports of dehydration and electrolyte imbalance in adults. There have also been a few case reports of serious dehydration and electrolyte imbalance in infants and young children, resulting in permanent disability and fatality, attributed to excessive repeat doses of sorbitol cathartic.

Contraindications

Carbosorb XS is contraindicated in poisoning with strong acids and alkalis and for those poisons for which its adsorptive capacity is too low, including ferrous sulphate and other iron salts, cyanides, tolbutamide and other sulphonylureas, malathion, dicophane, lithium, ethanol, methanol, ethylene glycol and hydrocarbons. Carbosorb XS is contraindicated in patients who have an unprotected airway or a gastrointestinal tract that is not anatomically intact. It is also contraindicated in patients who have significant fluid or electrolyte abnormalities. Carbosorb XS is contraindicated in infants less than 1 year of age.

Regulatory history

Carbosorb XS (activated charcoal 50 g/250 mL and sorbitol 70.75 g/250 mL suspension) was first listed on the Australian Register of Therapeutic Goods on 25 July 2018.