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TEVA-SUCRALFATE 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: AND CLINICAL USE TEVA-SUCRALFATE (sucralfate) is indicated in the treatment of duodenal and nonmalignant gastric ulcer. TEVA-SUCRALFATE is also indicated for the prophylaxis of duodenal ulcer recurrence. CONTRAINDICATIONS There are no known contraindications to the use of sucralfate. However, when considering the use…
Verbatim from this product's HC label. Tap a section to expand.
Very few side effects have been reported with sucralfate. The reactions associated with this drug have generally been mild and have rarely led to the discontinuation of therapy. 6% of the patients treated with sucralfate. Other side effects that have been reported in association with sucralfate included diarrhea, nausea, vomiting, flatulence, gastric discomfort, indigestion, dry mouth, skin rash, pruritus, back pain, dizziness, headache, sleepiness and vertigo.
SYMPTOMS AND TREATMENT OF OVERDOSAGE Overdosage with sucralfate has never been observed. A lethal dose could not be established using maximal doses of up to 12 g/kg body weight in various animal species; therefore, overdosage appears to be unlikely.
It is likely that overdosage would be associated with symptoms similar to those described in ADVERSE REACTIONS, such as constipation, and symptomatic treatment would be indicated. DOSAGE AND ADMINISTRATION Treatment of Duodenal and Non Malignant Gastric Ulcer The recommended adult oral dosage for duodenal and non malignant gastric ulcer is one 1 g tablet four times daily, one hour before meals and at bedtime.
TEVA-SUCRALFATE (sucralfate) should be taken on an empty stomach. For duodenal ulcer, TEVA- SUCRALFATE may also be administered as two 1 g tablets twice daily, on waking and at bedtime on an empty stomach. Antacids may be added to the treatment regimen for the relief of pain.
However, antacids should not be taken within one-half hour before or after sucralfate. With duodenal ulcers, healing often occurs within 2 to 4 weeks; however, treatment should be continued for 8 to 12 weeks unless healing has been demonstrated by x-ray and/or endoscopic examinations.
With non malignant gastric ulcers, an alternate treatment should be considered if an objective improvement is not observed after 6 weeks of therapy. However, a longer treatment period may be required in patients with a large gastric ulcer that has demonstrated a progressive healing tendency.
6 Prophylaxis of Duodenal Ulcer The recommended dosage for the prophylaxis of duodenal ulcer recurrence is one tablet of 1 g twice daily on an empty stomach. Treatment may be continued for up to one year. 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 PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Current evidence indicates that patients with serum aluminum concentrations that approach 100 μg/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 failure, who do not require dialysis, are at risk of developing aluminum toxicity while receiving the recommended doses of sucralfate.
Physician discretion should be exercised when considering the duration of treatment (see PRECAUTIONS). 7 PHARMACEUTICAL INFORMATION DRUG SUBSTANCE: Proper Name: Sucralfate Chemical Name: α-D-Glucopyranoside,β-D-fructofuranosyl- octakis(hydrogen sulfate), aluminum complex.
Structural Formula: (R is SO3(A12(OH)% (H20)y]) Molecular Formula:
C12HmAI160nS8 Description: Sucralfate is an aluminum metal salt of a sulfated disaccharide. It is a whitish or white, odourless, amorphous powder which is soluble in dilute hydrochloric acid and sodium hydroxide, but practically insoluble in water, boiling water, ethanol or chloroform.
The pH is in the range of 5-6.
STABILITY AND STORAGE RECOMMENDATIONS:
Store at 15-30°C. Unit dose strips should be stored at 15-25°C and protected from high humidity. AVAILABILITY OF DOSAGE FORMS TEVA-SUCRALFATE (sucralfate) is available as white, capsule-shaped, bi-convex compressed tablets, one side plain, the other side engraved with novo inside a raised border.
Each tablet contains 1 g sucralfate.
Supplied:
Bottles of 100 and 500 and in boxes of 100 as unit dose strips. 8 PHARMACOLOGY Distinct morphologic and functional changes are produced in the normal gastric mucosa by sucralfate including mucus release, changes in ion transport and increased release of luminal prostaglandins.
Several studies have demonstrated that sucralfate can increase the synthesis and release of prostaglandin E2 from the mucosa, which may partially explain its cytoprotective properties. Polysaccharide sulfates possess an inhibitory action on the proteolytic actions of pepsin and a preventative action on experimental peptic ulcerations.
Sucralfate is a disaccharide sulfate which has demonstrated strong antipepsin and antiulcer action. In contrast to the more polymerized saccharides, sucralfate is devoid of any anticoagulant activity. The enhanced antiulcerogenic activity is also more pronounced with the aluminum salt of sucralfate.
Sucralfate has no apparent effect on the cardiovascular system, the central nervous system, or on the hematopoietic system, including blood coagulation factors. Antiulcerogenic Activity In rat studies, single doses of sucralfate 150 to 250 mg/kg reduced the incidence and size of ulcer lesions induced by pyloric ligation.
In other studies in rats using restraint and stress models, a similar level of prophylaxis was observed with single doses of 200 to 2000 mg/kg. The drug was also effective in reducing the number of hemorrhagic areas. The promotion of mucosal regenerating activity of sucralfate 1000 mg/kg was demonstrated in rats with thermocautery-induced ulcers.
Also, sucralfate was found to hinder the digestion of gastric mucosa by gastric juice in vitro. Sucralfate was reported to promote mucosal regeneration in rats with clamping/cortisone induced ulcers. It was reported that the administration of sucralfate was associated with an increase of 161% in the healing index as measured by the degree of contraction of the ulcer, a 132% increase in the mucosal regeneration index and a 100% increase […]