Sucralfate oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of sucralfate.
Drugs List
Therapeutic Indications
Uses
Chronic gastritis
Duodenal ulcer
Gastric ulcer
Prophylaxis of gastro-intestinal haemorrhage from stress ulceration
Dosage
Adults
Duodenal Ulcer, Gastric Ulcer and Chronic Gastritis
2g twice daily to be taken on rising and at bedtime, or 1g four times a day to be taken 1 hour before meals and at bedtime.
Maximum daily dose is 8g.
Four to six weeks of treatment is usually required for ulcer healing, but up to twelve weeks may be necessary in resistant cases.
Prophylaxis of Gastrointestinal Haemorrhage from Stress Ulceration
1g six times daily.
Maximum daily dose is 8g.
Children
Children aged 14 years to 18 years
See Dosage; Adult
The following unlicensed alternative dosing schedule may be suitable:
Children aged 12 to 14 years: 1g four to six times a day.
Children aged 2 to 12 years: 500mg four to six times a day.
Children aged 1 month to 2 years: 250mg four to six times a day.
Patients with Renal Impairment
Glomerular filtration rate between 20 to 50ml/minute: 4g daily.
Glomerular filtration rate between 10 to 20ml/minute: 2g to 4g daily.
Glomerular filtration rate below 10ml/minute: 2g to 4g daily.
Contraindications
Neonates under 1 month
Renal dialysis
Precautions and Warnings
Children 1 month to 14 years
Severe illness
Breastfeeding
Decreased gastrointestinal motility
Delayed gastric emptying
Renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Not licensed for use in children under 14 years
Contains hydroxybenzoate
Administer nasogastric feeding 1 hour before or after sucralfate
Risk of aluminium accumulation in renal impairment
May affect the absorption of concomitant oral drugs
The formation of bezoar has been reported when sucralfate and enteral feeds have been given too closely together.
Periodically perform laboratory testing of aluminium, phosphate, calcium and alkaline phosphatase in patients with renal impairment due to excretion impairment. In patients with severe or chronic renal impairment, sucralfate should be used with extreme caution and only for short-term treatment. Small amounts of aluminium are absorbed through the gastrointestinal tract and aluminium may accumulate.
Sucralfate must not be inadvertently administered intravenously as it may induce fatal complications such as pulmonary and cerebral emboli and aluminium intoxication.
Pregnancy and Lactation
Pregnancy
Sucralfate is considered safe to use during pregnancy.
The manufacturer recommends sucralfate is not used in pregnancy unless clearly needed. Teratogenicity studies in mice, rats and rabbits at doses up to 50 times the human dose have revealed no evidence of harm to the foetus. The absorption of sucralfate from the gastrointestinal tract is negligible (Schaefer 2015). No adverse effects during pregnancy are anticipated.
There is consensus, that sucralfate and antacids may be used during all phases of pregnancy and have been widely prescribed without evidence of adverse effects. The potential foetal toxicity of sucralfate relates to its aluminium content though there is no evidence that normal doses of aluminium-containing medications such as sucralfate present a risk to the foetus in women with normal renal function (Briggs 2015).
Lactation
Use sucralfate with caution during breastfeeding.
The manufacturer advises caution if sucralfate is used when breastfeeding. At the time of writing there is no information on the use of sucralfate during breastfeeding. Minimal excretion of sucralfate into breast milk should be expected as only small amounts of this drug are absorbed systemically.
Side Effects
Anaemia
Anaphylactic reaction
Back pain
Bezoar formation
Constipation
Diarrhoea
Dizziness
Drowsiness
Dry mouth
Dyspnoea
Encephalopathy
Flatulence
Gastric discomfort
Headache
Indigestion
Nausea
Oedema
Osteomalacia
Pruritus
Rash
Renal rickets
Urticaria
Vertigo
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 ).
Further Information
Last Full Review Date: September 2020
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Sucralfate 1g/5ml Oral Suspension. OPD Laboratories Ltd. Revised November 2013.
The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C. and Dunleavy, A. Radcliffe Publishing Ltd, London.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 September 2020.
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