Drugs List

Therapeutic Indications

Uses

Diarrhoea
Dyspepsia
Nausea

Contraindications

Children under 16 years
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

Breastfeeding
Coagulopathy
Diabetes mellitus
Gout
Haemophilia
Phenylketonuria
Pregnancy

Some formulations contain aspartame - caution in phenylketonuria
Advise patient not to take aspirin or salicylates during treatment
Advise patient to avoid oral tetracyclines within 2 hours of dose
Advise patient not to exceed stated dose

Pregnancy and Lactation

Pregnancy

Inorganic bismuth salts, formed from the metabolism of bismuth subsalicylate in the gastrointestinal tract, apparently present little or no risk to the foetus from normal therapeutic doses. The data available for bismuth in pregnancy is poor and the actual fetal risk cannot be determined. Although the risk may be small, significant fetal adverse effects have resulted from chronic exposure to salicylates. It is recommended that because of this, the use of bismuth subsalicylate during gestation be restricted to the first half of the pregnancy and then only in amounts that do not exceed the recommended doses (Briggs).

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Bismuth salts are poorly absorbed from the maternal gastrointestinal tract, however, significant levels of salicylate could be absorbed (Hale). It is therefore typically recommended that nursing mothers not use medication containing bismuth subsalicylate because small amounts of the medication are excreted in breast milk and pose a theoretical risk of Reye's syndrome to nursing children. Reye's syndrome is a very rare disease, which affects the brain and liver, and can be fatal.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Black faeces
Black tongue
Nausea
Vomiting

Presentation

Oral formulations of bismuth subsalicylate.

Drugs List

Therapeutic Indications

Uses

Diarrhoea
Dyspepsia
Nausea

Dosage

Adults

Elderly

Children

Contraindications

Children under 16 years
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

Breastfeeding
Coagulopathy
Diabetes mellitus
Gout
Haemophilia
Phenylketonuria
Pregnancy

Some formulations contain aspartame - caution in phenylketonuria
Advise patient not to take aspirin or salicylates during treatment
Advise patient to avoid oral tetracyclines within 2 hours of dose
Advise patient not to exceed stated dose

Pregnancy and Lactation

Pregnancy

Inorganic bismuth salts, formed from the metabolism of bismuth subsalicylate in the gastrointestinal tract, apparently present little or no risk to the foetus from normal therapeutic doses. The data available for bismuth in pregnancy is poor and the actual fetal risk cannot be determined. Although the risk may be small, significant fetal adverse effects have resulted from chronic exposure to salicylates. It is recommended that because of this, the use of bismuth subsalicylate during gestation be restricted to the first half of the pregnancy and then only in amounts that do not exceed the recommended doses (Briggs).

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Bismuth salts are poorly absorbed from the maternal gastrointestinal tract, however, significant levels of salicylate could be absorbed (Hale). It is therefore typically recommended that nursing mothers not use medication containing bismuth subsalicylate because small amounts of the medication are excreted in breast milk and pose a theoretical risk of Reye's syndrome to nursing children. Reye's syndrome is a very rare disease, which affects the brain and liver, and can be fatal.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Black faeces
Black tongue
Nausea
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

The MHRA have produced 'generic' overdose sections for the top ten drugs for which the NPIS received the greatest number of queries about management of overdose in 2002. This information is attached below:

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 (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.

Signs and Symptoms

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.

Treatment

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 (5.1 mmol/L), or lower concentrations 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.

Further Information

Last Full Review Date: April 2013

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Pepto-Bismol, 17.5mg/ml oral suspension. Procter & Gamble (Health & Beauty Care) Limited. August 2012

Summary of Product Characteristics: Pepto-Bismol Chewable Tablets. Procter & Gamble (Health & Beauty Care) Limited. June 2010

Summary of Product Characteristics: Pepti-Calm 525.6mg/30ml oral suspension. The Boots Company PLC. November 2009

https://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/Guidance/OverdosesectionsofSPCs/Genericoverdosesections/index.htm