Adult: Usual dose: 1 g 4 times daily for 4-8 weeks. Doses to be taken 1 hour before or 2 hours after each meal, and at bedtime. Alternatively, 2 g bid taken before breakfast in the morning and at bedtime. In resistant cases, therapy may be given for up to 12 weeks. Dosage and therapy recommendations may vary among individual products or between countries (refer to detailed product guideline).
Oral Duodenal ulcer
Adult: Short-term treatment of active cases: Usual dose: 1 g 4 times daily for 4-8 weeks. Doses to be taken 1 hour before or 2 hours after each meal, and at bedtime. Alternatively, 2 g bid taken before breakfast in the morning and at bedtime. In resistant cases, therapy may be given for up to 12 weeks. Maintenance treatment to prevent recurrence of duodenal ulcer: 1 g bid taken before breakfast in the morning and at bedtime. Dosage and therapy recommendations may vary among individual products or between countries (refer to detailed product guideline). Elderly: Initiate at the lower end of the dosage range.
Oral Prophylaxis of gastrointestinal haemorrhage from stress ulceration
Adult: Usual dose: 1 g 6 times daily. Max: 8 g daily. Dosage and therapy recommendations may vary among individual products or between countries (refer to detailed product guideline).
Administration
Should be taken on an empty stomach.
Special Precautions
Patient with diabetes mellitus; conditions that may impair swallowing (e.g. recent or long-term intubation, dysphagia, tracheostomy, history of aspiration), or other conditions that may alter gag/cough reflex or reduce oropharyngeal coordination or motility. Patients who are seriously ill, particularly those with delayed gastric emptying and concurrent enteral feedings. Treatment guidelines may vary among individual products (refer to product-specific recommendations). Renal impairment (e.g. chronic renal failure or those receiving dialysis). Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Increased risk of Al accumulation and toxicity such as Al osteodystrophy, osteomalacia and encephalopathy (in patients renal with impairment); bezoar formation and intestinal obstruction (in seriously ill patients); hyperglycaemia (susp); aspiration accompanied with respiration complications (tab). Ear and labyrinth disorders: Vertigo. Gastrointestinal disorders: Constipation, diarrhoea, flatulence, gastric discomfort, dry mouth, dyspepsia, nausea, vomiting. Immune system disorders: Hypersensitivity reactions (e.g. dyspnoea, urticaria, anaphylaxis). Musculoskeletal and connective tissue disorders: Back pain. Nervous system disorders: Dizziness, drowsiness, headache. Psychiatric disorders: Insomnia. Skin and subcutaneous tissue disorders: Pruritus, rash.
Monitor blood glucose levels in diabetic patients taking the oral susp. Monitor Al phosphate, Ca and alkaline phosphatase periodically, and signs of Al toxicity in patients with renal impairment.
Drug Interactions
May decrease the absorption of digoxin, quinidine, fluoroquinolones, tetracycline, ketoconazole, sulpiride, levothyroxine, phenytoin, ranitidine, cimetidine, warfarin and theophylline; consider dosing interval of at least 2 hours between sucralfate and other concomitant non-antacid drugs. May increase the total body burden of Al when concomitantly used with other preparation that contains Al (e.g. Al-containing antacids). If antacids are concurrently needed, a dosing interval of 30 minutes between sucralfate and antacids is recommended.
Action
Description: Sucralfate is a basic, Al complex of sucrose octasulfate. It binds with positively charged protein exudates at the ulcer site, forming a viscous paste-like ulcer-adherent complex. This complex acts as a protective barrier on the gastric lining against pepsin, peptic acid and bile salts. It also inhibits pepsin activity. Onset: 1-2 hours. Pharmacokinetics: Absorption: Minimally absorbed from the gastrointestinal tract (as sucrose sulfate). Small amounts of Al may be absorbed after sucralfate administration. Distribution: Locally acts to ulcer sites; unbound in the gastrointestinal tract to Al and sucrose octasulfate. Excretion: Mainly via urine (small amounts of sulfated disaccharide).
Chemical Structure
Sucralfate Source: National Center for Biotechnology Information. PubChem Database. Sucralfate, CID=121494085, https://pubchem.ncbi.nlm.nih.gov/compound/Sucralfate (accessed on Jan. 31, 2020)
Storage
Tab: Store between 15-30°C. Oral susp: Store between 20-25°C. Do not freeze.
A02BX02 - sucralfate ; Belongs to the class of other drugs used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
References
Anon. Sucralfate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 17/06/2021.Anon. Sucralfate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 24/05/2021.Buckingham R (ed). Sucralfate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 24/05/2021.Iselpin 1 g Tablet (Pfizer, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 24/05/2021.Joint Formulary Committee. Sucralfate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 24/05/2021.Mylan New Zealand Ltd. Carafate 1 g Tablet data sheet 07 December 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 24/05/2021.Sucralfate Suspension (Par Pharmaceutical Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 24/05/2021.Sucralfin 1 g Tablet and 1 g/10 mL Suspension (Endure Medical, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 17/06/2021.Ulcefate Tablet and Suspension (Siam Pharmaceutical Co., Ltd.). MIMS Thailand. http://www.mims.com/thailand. Accessed 17/06/2021.Ulcron Tablet and Suspension (Coronet Crown PT). MIMS Indonesia. http://www.mims.com/indonesia. Accessed 17/06/2021.
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