Bismuth
Bismuth intoxication may present as an acute encephalopathy with confusion, myoclonic movements, tremor, dysarthria and walking and standing disorders. Bismuth intoxication may also cause gastrointestinal disturbances, skin reactions, discolouration of mucous membranes, and renal dysfunction as a result of acute tubular necrosis. Treatment includes gastric lavage, purgation and hydration. Chelating agents may be effective in the early stages following ingestion and haemodialysis may be necessary.
Salicylate
Overdose of Pepto-Bismol may also give symptoms of salicylate intoxification. Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (95.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.
If symptoms occur, use of Pepto-Bismol should be discontinued. Management of overdose is the same as that for salicylate overdose:
Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.
A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.
Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.
Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.
Management: Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.
Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1mmol/L), or lower cncentrations associated with severe clinical or metabolic features. Patients under ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
36 months
None stated.
Mannitol
Calcium carbonate
Povidone
Magnesium stearate
Talc
Peppermint flavour
Saccharin sodium
Aspartame
Amaranth, aluminium lake (E123)
Vanilla cream flavour
Gastrointestinal disorders:
Black tongue is common (>1/100, <1/10)
Black stool is very common (>1/10)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
There are no pre-clinical safety data of relevance to health professionals, other than those already included in other sections of the SPC
Pharmacotherapeutic code: ATC code A07B B
The demulcent base provides a protective coating of the lower oesophagus and a partial coating in the stomach which holds the bismuth subsalicylate in suspension.
Limited in vitro studies have shown BSS to have some activity against enteropathogens, ie Clostridium. Bacteroides, E. Coli, Salmonella Shigella, campoylobacter (Helicobacter) and Yersina, but not against anaerobes. There are insufficient data to determine whether these findings have any relevance to treatment outcomes in the patient population who may receive BSS.
Bismuth subsalicylate is converted to bismuth carbonate and sodium salicylate in the small intestine.
The oral bioavailability of bismuth administered as Bismuth subsalicylate is extremely low. Very little is known about bismuth distribution in human tissue. Renal clearance is the primary route of elimination for absorbed bismuth, however biliary clearance may also have a role. The remainder is eliminated as insoluble bismuth salts in the faeces. Following the maximum recommended daily adult dose, the mean biological half-life is approximately 33 hours and peak plasma bismuth levels remain below 35ppb.
Salicylate is absorbed from the intestine and rapidly distributed to all body tissues. Peak plasma levels after maximum recommended daily dosing are about 110 micrograms/ml. Salicylate is rapidly excreted from the body and has a mean biological half life of approximately 4 - 5.5 hours.
31/03/2016
Procter & Gamble (Health & Beauty Care) Limited
The Heights
Brooklands
Weybridge
Surrey
KT13 0XP
Do not store above 25°C.
12 or 24 tablets in a cellophane film, packed in an outer claycoat board carton
PL 00129/0143
None
15/06/2010
