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SULCRATE is a brand name for Sucralfate, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SULCRATE (sucralfate) Tablets is indicated for: • the treatment of duodenal and non-malignant gastric ulcer. • for the prophylaxis of duodenal ulcer recurrence SULCRATE SUSPENSION PLUS is indicated for: • the treatment of duodenal ulcer and for the prophylaxis of gastrointestinal hemorrhage due to stress ulceration in…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Use caution when prescribing/administering this drug in pregnant or pediatric patients, or patients of childbearing potential (see 7 WARNINGS AND PRECAUTIONS). • Tablets In the case of gastric ulcers, an alternative treatment should be considered if no objective improvement is observed following 6 weeks of SULCRATE therapy.
However, patients with a large gastric ulcer that has demonstrated a progressive healing tendency may require an additional 6 weeks of treatment. • Suspension SULCRATE suspension must not be administered intravenously. Duration of continuous treatment in patients with chronic renal failure receiving dialysis should be evaluated by periodic monitoring of serum aluminum levels, due to the possibility of aluminum accumulation in these patients (see 7 WARNINGS AND PRECAUTIONS).
According to information widely available in the literature, patients with serum aluminum concentrations that approach 100 SULCRATE / SULCRATE SUSPENSION PLUS (sucralfate) Page 5 of 24 mcg/L should be carefully monitored for symptoms of aluminum toxicity and treatment should be discontinued if such symptoms appear.
There is no evidence to indicate that patients with chronic renal failure, who do not require dialysis, are at risk of developing aluminum toxicity while receiving the recommended doses of sucralfate. Healthcare professional discretion should be exercised when considering the duration of treatment (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment • Duodenal ulcer Tablets: The recommended adult oral dosage one tablet of 1 g four times a day. In duodenal ulcers, while healing with SULCRATE often occurs within two to four weeks, treatment should be continued for a maximum of 8 to 12 weeks unless healing has been demonstrated by X-Ray and/or endoscopic examination.
Suspension:
The recommended adult dose of SULCRATE SUSPENSION PLUS for the treatment of (acute) duodenal ulcer is 2 g (10 mL) twice a day. • Non-malignant gastric ulcer The recommended adult oral dosage is one tablet of 1 g four times a day. • Prophylaxis of duodenal ulcer recurrence Tablets: For the prophylaxis of duodenal ulcer recurrence, the recommended dosage is one tablet of 1 g twice daily, on an empty stomach.
Treatment may be continued for up to one year. For relief of pain, antacids may be added to the treatment. However, antacids should not be taken within ½ half hour before or after SULCRATE intake. • Prophylaxis of gastrointestinal hemorrhage due to stress ulceration Suspension: For the prophylaxis of gastrointestinal hemorrhage due to stress ulceration, administer 1 g (5 mL) orally or via nasogastric tube four to six times a day.
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.
). • Tablets In the case of gastric ulcers, an alternative treatment should be considered if no objective improvement is observed following 6 weeks of SULCRATE therapy. However, patients with a large gastric ulcer that has demonstrated a progressive healing tendency may require an additional 6 weeks of treatment.
• Suspension SULCRATE suspension must not be administered intravenously. Duration of continuous treatment in patients with chronic renal failure receiving dialysis should be evaluated by periodic monitoring of serum aluminum levels, due to the possibility of aluminum accumulation in these patients (see 7 WARNINGS AND PRECAUTIONS).
According to information widely available in the literature, patients with serum aluminum concentrations that approach 100 SULCRATE / SULCRATE SUSPENSION PLUS (sucralfate) Page 5 of 24 mcg/L should be carefully monitored for symptoms of aluminum toxicity and treatment should be discontinued if such symptoms appear.
There is no evidence to indicate that patients with chronic renal failure, who do not require dialysis, are at risk of developing aluminum toxicity while receiving the recommended doses of sucralfate. Healthcare professional discretion should be exercised when considering the duration of treatment (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment • Duodenal ulcer Tablets: The recommended adult oral dosage one tablet of 1 g four times a day. In duodenal ulcers, while healing with SULCRATE often occurs within two to four weeks, treatment should be continued for a maximum of 8 to 12 weeks unless healing has been demonstrated by X-Ray and/or endoscopic examination.
Suspension:
The recommended adult dose of SULCRATE SUSPENSION PLUS for the treatment of (acute) duodenal ulcer is 2 g (10 mL) twice a day. • Non-malignant gastric ulcer The recommended adult oral dosage is one tablet of 1 g four times a day. • Prophylaxis of duodenal ulcer recurrence Tablets: For the prophylaxis of duodenal ulcer recurrence, the recommended dosage is one tablet of 1 g twice daily, on an empty stomach.
Sucralfate is contraindicated in: • Patients who are hypersensitive to sucralfate or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sucralfate in Canada.
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To prevent clogging of the nasogastric tube flush with 10 mL of water following each administration. The duration of treatment for prophylaxis of stress ulceration must be individually determined. Treatment should be continued for as long as one or more of the risk factors for stress ulceration is present but normally not for more than 14 days.
Health Canada has not authorized an indication for pediatric use. 1 Pediatrics. 4 Administration • Duodenal ulcer Tablets: The SULCRATE tablets are administered four times a day, one hour before meals and at bedtime, on an empty stomach.
For duodenal ulcer, SULCRATE may also be administered as two 1 g tablets twice daily, on waking and at bedtime on an empty stomach.
Suspension:
SULCRATE SUSPENSION PLUS (10 mL) is administered twice a day on waking and at bedtime on an empty stomach. • Non-malignant gastric ulcer Tablets: The SULCRATE tablets are administered four times a day, one hour before meals and at bedtime, on an empty stomach.
• Prophylaxis of duodenal ulcer recurrence Tablets: For the prophylaxis of duodenal ulcer recurrence, the tablets must be administered on an empty stomach. If antacids are added to the treatment, the antacids should not be taken within half hour before or after SULCRATE intake.
• Prophylaxis of gastrointestinal hemorrhage due to stress ulceration Suspension: Administer 1 g (5 mL) orally or via nasogastric tube. To prevent clogging of the nasogastric tube flush with 10 mL of water following each administration.
5 Missed Dose In the event that a dose is missed, the patient should take the missed dose as soon as they remember. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regular time.
The patient should not take two doses at the same time.
• 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 […]
Treatment may be continued for up to one year. For relief of pain, antacids may be added to the treatment. However, antacids should not be taken within ½ half hour before or after SULCRATE intake. • Prophylaxis of gastrointestinal hemorrhage due to stress ulceration Suspension: For the prophylaxis of gastrointestinal hemorrhage due to stress ulceration, administer 1 g (5 mL) orally or via nasogastric tube four to six times a day.
To prevent clogging of the nasogastric tube flush with 10 mL of water following each administration. The duration of treatment for prophylaxis of stress ulceration must be individually determined. Treatment should be continued for as long as one or more of the risk factors for stress ulceration is present but normally not for more than 14 days.
Health Canada has not authorized an indication for pediatric use. 1 Pediatrics. 4 Administration • Duodenal ulcer Tablets: The SULCRATE tablets are administered four times a day, one hour before meals and at bedtime, on an empty stomach.
For duodenal ulcer, SULCRATE may also be administered as two 1 g tablets twice daily, on waking and at bedtime on an empty stomach.
Suspension:
SULCRATE SUSPENSION PLUS (10 mL) is administered twice a day on waking and at bedtime on an empty stomach. • Non-malignant gastric ulcer Tablets: The SULCRATE tablets are administered four times a day, one hour before meals and at bedtime, on an empty stomach.
• Prophylaxis of duodenal ulcer recurrence Tablets: For the prophylaxis of duodenal ulcer recurrence, the tablets must be administered on an empty stomach. If antacids are added to the treatment, the antacids should not be taken within half hour before or after SULCRATE intake.
• Prophylaxis of gastrointestinal hemorrhage due to stress ulceration Suspension: Administer 1 g (5 mL) orally or via nasogastric tube. To prevent clogging of the nasogastric tube flush with 10 mL of water following each administration.
5 Missed Dose In the event that a dose is missed, the patient should take the missed dose as soon as they remember. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regular time.
The patient should not take two doses at the same time. 5 OVERDOSAGE Overdosage has never been observed with SULCRATE and appears to be unlikely since, using maximal doses of up to 12 g/kg/body weight in a variety of animal species, a lethal dose could not be established.
Overdosage is likely to be associated with symptoms similar to those described in the