Sucralfate

Sucralfate should only be used with caution in patients with renal dysfunction, due to the possibility of increased aluminium absorption. Sucralfate is not recommended for use in individuals on dialysis.

In patients with severe or chronic renal impairment, sucralfate should be used with extreme caution and only for shortterm treatment. Small amounts of aluminium are absorbed through the gastrointestinal tract and aluminium may accumulate. Aluminium osteodystrophy, osteomalacia, encephalopathy, and anaemia have been reported in patients with chronic renal impairment. For patients with impairment of renal function, laboratory testing such as aluminium, phosphate, calcium, and alkaline phosphatase is recommended to be periodically performed due to excretion impairment. The concomitant use of other aluminium containing medications is not recommended in view of the enhanced potential for aluminium absorption and toxicity.

Sucralfate should not be co-administered with citrate preparations. Co-administration citrate preparations with sucralfate may increase the blood concentrations of aluminium. The mechanism may be due to chelation of aluminium, which is assumed to increase its absorption.

Concomitant administration of sucralfate may reduce the bioavailability of certain drugs including fluoroquinolones such as ciprofloxacin and norfloxacin, tetracycline, ketoconazole, sulpiride, digoxin and warfarin. The bioavailability of these agents may be restored by separating the administration of these agents from sucralfate by two hours. This interaction appears to be non systemic in origin presumably resulting from these agents being bound by sucralfate in the gastrointestinal tract. Because of the potential of sucralfate to alter the absorption of some drugs from the gastrointestinal tract, the separate administration of sucralfate from that of other agents should be considered when alterations in bioavailability are felt to be critical for concomitantly administered drugs.

Concomitant administration of sucralfate may reduce the bioavailability of certain drugs including fluoroquinolones such as phenytoin, theophylline, levothyroxine, quinidine and H₂ antagonists. The bioavailability of these agents may be restored by separating the administration of these agents from sucralfate by two hours. This interaction appears to be non systemic in origin presumably resulting from these agents being bound by sucralfate in the gastrointestinal tract. Because of the potential of sucralfate to alter the absorption of some drugs from the gastrointestinal tract, the separate administration of sucralfate from that of other agents should be considered when alterations in bioavailability are felt to be critical for concomitantly administered drugs.

The administration of sucralfate and enteral feeds by nasogastric tube should be separated by one hour in patients receiving sucralfate for the prophylaxis of stress ulceration. In rare cases bezoar formation has been reported when sucralfate and enteral feeds have been given too closely together.

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.

It is not known whether sucralfate is excreted in human milk. Caution should be exercised when sucralfate is administered to breast-feeding women.

Do not drive if you feel dizzy or drowsy.

Immune system disorders

Not know (cannot be estimated from the available data): Anaphylactic reaction including pruritus, urticaria, oedema, dyspnoea

Nervous system disorders

Not known (cannot be estimated from the available data): Dizziness, headache, drowsiness

Ear and labyrinth disorders

Not known (cannot be estimated from the available data): Vertigo

Gastrointestinal disorders

Common (≥1% and <10%): Constipation

Uncommon (≥0.1% and <1%): Dry mouth, nausea,

Rare (≥0.01% and <0.1%): Bezoar formation¹

Not known (cannot be estimated from the available data): Diarrhoea, vomiting, gastric discomfort, indigestion, flatulence

Skin and subcutaneous tissue disorders

Rare (≥0.01% and <0.1%): Rash

Musculoskeletal and connective tissue disorders

Not known (cannot be estimated from the available data): Back pain

Injury, poisoning and procedural complications

Not known (cannot be estimated from the available data): Osteodystrophy², osteomalacia², encephalopathy², anaemia²

¹ Reported in patients with impaired gastric emptying, patients with enteral tube feeding or low birth weight infants.
² Reported in patients with chronic renal impairment.