Sucralfate

Registered South African indications:

• Gastric and duodenal ulcers
• Chronic gastritis
• Reflux oesophagitis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Breastfeeding
• Renal impairment
• Dialysis
• Severely ill patients in intensive care units
• Risk factors for bezoar formation
• Impaired swallowing (tab)
• Phosphate deficiencies
• Delayed gastric emptying
• Galactose intolerance (tab)
• Lapp lactase deficiency (tab)
• Glucose-galactose malabsorption (tab)  
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab, eft, sus

Reflux oesophagitis

• Oral (tab, eft, sus): 1g, 6hrly

Dosages taken 1hr before meals and at bedtime

Healing duodenal ulcer (endoscopically proven)
- Maintenance treatment 

• Oral (tab, eft, sus): 1g, 12hrly; Treatment duration: 1 year

Take dosages 30min before breakfast and 30min before supper

Chronic gastritis
Gastric ulcer
Symptomatic relief of subjective symptoms associated with gastric ulcer

• Oral (tab, eft, sus): 1g, 6-8hrly OR 2g, 12hrly; Treatment duration: 4-12 weeks Max: 8g/24hrs

Dosages taken 1hr before meals and at bedtime

See additional prescribing points for administration directions

Not established for use in children below 14 years

Pregnancy

• Safe; no evidence of risk in studies
• 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. Safety in pregnant women has not been established and sucralfate should be used during pregnancy only if clearly needed

Breastfeeding

• Caution
• It is not known whether this drug is excreted in human milk. Caution should be exercised when sucralfate is administered to breastfeeding women

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended 

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Headache
• Drowsiness
• Encephalopathy 

Gastrointestinal Disorders

• Constipation
• Dry mouth
• Nausea and vomiting
• Bezoar formation
• Diarrhoea
• Gastric discomfort
• Indigestion
• Flatulence

Endocrine and Metabolic Disorders

• Osteodystrophy
• Osteomalacia

Musculoskeletal Disorders

• Back pain

Skin and Subcutaneous Tissue Disorders

• Rash

Immune, Blood and Lymphatic System Disorders

• Anaphylactic reactions
• Anaemia 

Sensory Disorders

• Vertigo

• Fluoroquinolones
• Tetracycline
• Ketoconazole
• Sulpiride
• Digoxin
• Warfarin
• Phenytoin
• Theophylline
• Levothyroxine
• Quinidine 
• Antihistamines
• Citrate preparations
• Enteral feeds
• Aluminium containing agents

None routine. Specific cases may require

• Serum aluminium 
• Serum phosphate
• Serum calcium
• Serum alkaline phosphatase 

Administration directions

• Tablet can be divided into smaller halves before swallowing or mixed with water
• Dissolve effervescent tablet in water

Sucralfate forms a protective barrier over the ulcer lesion giving sustained protection against the penetration and action of gastric acid, pepsin and bile. Sucralfate also directly inhibits pepsin activity and absorbs bile salts and has weak antacid activity.

Tablet 1g

• Ulsanic (Pharmacare)

Tablet effervescent 1g

• Ulsanic effervescent (Pharmacare)

Suspension (per 5ml) 1g

• Ulsanic suspension (Pharmacare)