section, such as constipation. These should be treated symptomatically. For management of a suspected drug overdose, contact your regional poison control centre. SULCRATE / SULCRATE SUSPENSION PLUS (sucralfate) Page 7 of 24 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Tablets: Each white, capsule-shaped, biconvex tablet, embossed with "SULCRATE" on one side and debossed with "HMR" on the other side, contains 1 g of sucralfate.
Available in bottles of 100 tablets.
Suspension:
Each 5 mL of off-white, creamy, suspension with a caramel odour contains 1 g of sucralfate. Available in bottles of 500 mL. 7 WARNINGS AND PRECAUTIONS General SULCRATE must not be administered intravenously. Inadvertent intravenous administration of insoluble sucralfate and its insoluble excipients may induce fatal complications including pulmonary and cerebral emboli.
Other severe complications including aluminum intoxication are reported after intravenous administration. The following should be taken into account before treating patients with SULCRATE (sucralfate): • Recurrence may be observed in patients after a successful course of treatment for gastric or duodenal ulcers.
While the treatment with sucralfate can result in complete healing of the ulcer, a successful course of treatment with sucralfate should not be expected to alter the underlying cause of ulcer disease. • Proper diagnosis is important since symptomatic response to sucralfate therapy does not rule out the presence of a gastric malignancy.
• Isolated reports of sucralfate tablet aspiration with accompanying respiratory complications have been received. Therefore, sucralfate tablets should be used with caution by patients who have known conditions that may impair swallowing, such as recent or prolonged intubation, tracheostomy, prior history of aspiration, dysphagia, or any other conditions that may alter gag and cough reflexes, or diminish oropharyngeal coordination or motility.
• Due to the carbohydrate content of sucralfate suspension excipients, episodes of hyperglycemia have been reported in diabetic patients. Close monitoring of glycemia in diabetic patients treated Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral use Tablet / 1 g Calcium carboxy-methylcellulose, hydrogenated vegetable oil, magnesium stearate and microcrystalline cellulose Oral use Oral Suspension 1 g/5 mL Butterscotch flavour, glycerine, sodium methylparaben, sodium phosphate monobasic, sodium propylparaben and xanthan gum SULCRATE / SULCRATE SUSPENSION PLUS (sucralfate) Page 8 of 24 with sucralfate suspension is recommended.
Adjustment of the anti-diabetic treatment dose during the use of sucralfate suspension might be necessary. Renal Chronic Renal Failure • Dialyzed Patients Sucralfate should be used with caution in patients with chronic renal failure.
When sucralfate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract (see 10 CLINICAL PHARMACOLOGY, Chronic Renal Failure and Dialysis Patients). Existing evidence indicates that patients with normal renal function receiving the recommended doses of sucralfate adequately excrete aluminum in the urine; however, patients with chronic renal failure or those receiving dialysis have impaired excretion of absorbed aluminum, and in these individuals, aluminum is known to accumulate in serum and in tissues.
In particular, dialysis patients are at greater risk as aluminum does not cross dialysis membranes of the dialysis machine since it is bound to plasma proteins, most notably albumin and transferrin. In patients with chronic renal failure undergoing dialysis, aluminum-related toxicity (encephalopathy and aluminum-related bone disease), associated with the administration of sucralfate and/or other sources of aluminum has been reported.
Consideration should therefore be given to the total daily load of aluminum before administering sucralfate in combination with other aluminum-containing medications, such as aluminum-containing antacids. • Nondialyzed Patients In a study of six nondialyzed chronic renal failure patients with glomerular filtration rates ranging from approximately 10 to 40% of normal, sucralfate administered at a dose of 1 g QID for three weeks resulted in elevated serum aluminum concentrations which plateaued at approximately 23 mcg/L after one week of treatment from a pretreatment level of 3 mcg/L.
Renal aluminum clearance increased in relation to the increase in serum levels and returned to baseline within two weeks following discontinuation of sucralfate as did serum aluminum concentrations. No adverse events were reported in these patients.
These data indicate that the use of sucralfate in nondialyzed chronic renal failure patients requires healthcare professional discretion since the excretion of absorbed aluminum may be impaired in these individuals. 1 Pregnant Women Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. 2 Breast-feeding It is unknown if SULCRATE tablets or SULCRATE SUSPENSION PLUS is excreted in human milk.
Precaution should be exercised because many drugs can be excreted in human milk. 3 Pediatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
1 Adverse Reaction Overview Cases of […]