P - Caution when used during pregnancy
L - Caution when used during lactation
Sucralfate (sold as Sucrafil in India); is an oral gastrointestinal medication primarily indicated for the treatment of active duodenal ulcers. Sucralfate is also used for the treatment of gastroesophageal reflux disease (GERD) and stress ulcers. Unlike the other classes of medications used for treatment of peptic ulcers, sucralfate is a sucrose sulfate-aluminium complex that binds to the hydrochloric acid in the stomach and acts like an acid buffer with cytoprotective properties.
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Sucralfate protects GI lining against peptic acid, pepsin and bile salts by binding with positively-charged proteins in exudates forming a viscous paste-like adhesive substance thus forming a protective coating.
Onset
1-2 hours
Duration
6 hours.
Absorption
<5% after oral admin.
Distribution
Acts locally at ulcer sites; unbound in GI tract to aluminum and sucrose sulfate.
Excretion
Mainly in the urine.
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Constipation, diarrhoea, nausea, dizziness, dry mouth. GI disturbances, rash, pruritus, headache, vertigo, back pain, drowsiness.
Duodenal ulcer is a chronic, recurrent disease. While short-term 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 posthealing frequency or severity of duodenal ulceration.
Overdosage
Sucralfate is poorly absorbed from the GI tract thus the risk from overdosage is minimal.
Systemic aluminum toxicity may occur in patients with chronic renal failure. Neonates, children; pregnancy and lactation.
Avoid antacids within 30 minutes of sucralfate admin. May reduce absorption of tetracyclines, ranitidine, ketoconazole, theophylline, phenytoin, cimetidine and digoxin (ensure a dosing interval of at least 2 hours between admin of sucralfate and other non-antacid medications).
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Oral
Peptic Ulcer
Adult: 1 g 4 times daily or 2 g bid for 4-8 weeks, may extend up to 12 weeks if necessary. Maintenance dose of 1 g bid may be given to prevent the recurrence of duodenal ulcers. Max: 8 g daily.
Child: 1 month-2 years: 250 mg 4-6 times daily; 2-12 years: 500 mg 4-6 times daily and 12-18 years: 1 g 4-6 times daily.
Oral
Chronic Gastritis
Adult: 1 g 4 times daily or 2 g bid for 4-8 weeks, may extend up to 12 weeks if necessary. Maintenance dose of 1 g bid may be given to prevent the recurrence of duodenal ulcers. Max: 8 g daily.
Child: 1 month-2 years: 250 mg 4-6 times daily; 2-12 years: 500 mg 4-6 times daily and 12-18 years: 1 g 4-6 times daily.
Oral
Prophylaxis of Gastrointestinal Haemorrhage from Stress Ulceration
Adult: 1 g 6 times daily. Not to exceed 8 g daily.
Child: 1 month-2 years: 250 mg 4-6 times daily; 2-12 years: 500 mg 4-6 times daily and 12-18 years: 1 g 4-6 times daily.
Should be taken on an empty stomach. (Take on an empty stomach 1 hour before or 2 hours after meals.)
Caution when used during pregnancy
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Caution when used during lactation
Safety and efficacy not established.
Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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Oral
Store at 20-25°C
Oral
Store at 20-25°C
You will hear from us only if the bid amount matches the minimum threshold and intended usage match our vision. You can resubmit another bid.