Sucralfate, sold under various brand names, is a medication used to treat Peptic ulcer, gastroesophageal reflux disease (GERD), radiation proctitis, and gastritis and to prevent .[ Its usefulness in people infected by H. pylori is limited.][ It is used by mouth (for upper GIT ulcers) and rectally (for radiation proctitis).]
Common side effects include constipation.[ Serious side effects may include bezoar formation and encephalopathy.][ Use appears to be safe in pregnancy and breastfeeding.][ How it works is unclear but is believed to involve binding to the ulcer and protecting it from further damage.][
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Sucralfate was approved for medical use in the United States in 1981.[ It is available as a generic medication.]
In 2022, it was the 214th most commonly prescribed medication in the United States, with more than 1million prescriptions.
Medical uses
Sucralfate is used for the treatment of active
Peptic ulcer not related to the use of nonsteroidal anti-inflammatory drugs (NSAIDs), as the mechanism behind these ulcers is due to acid oversecretion.
It is not FDA approved for
Peptic ulcer, but is widely used because of evidence of efficacy.
The use for sucralfate in peptic ulcer disease has diminished recently, but it is still the preferred agent for
stress ulcer prevention.
Sucralfate has also been used for the following conditions:
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Active Peptic ulcer not related to NSAID use
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Maintenance therapy for resolved Peptic ulcer
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Peptic ulcer not related to NSAID use and gastritis due to GERD—Triple combination therapy with lansoprazole + cisapride + sucralfate can significantly improve and quality of life and was more cost-effective than ranitidine combination group.
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Aphthous ulcer and stomatitis due to radiation or chemotherapy—The 2013 guidelines of the International Society of Oral Oncology does not recommended sucralfate for the prevention of oral mucositis in head and neck cancer patients receiving radiotherapy or chemoradiation due to a lack of efficacy found in a randomized controlled trial.
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Gastro-esophageal reflux disease during pregnancy—First-line drug therapy combined with lifestyle and diet modification.
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Stress ulcer prophylaxis—The use of sucralfate rather than H2 antagonists for stress ulcer prophylaxis, and measures to prevent aspiration, such as continuous glottic suctioning, have been shown to reduce the risk of ventilator-associated pneumonia (VAP).
Sucralfate is less effective for prophylaxis against gastrointestinal bleeding than either a PPI or H2-blocker. For that reason, it is not commonly used for stress ulcer prophylaxis.
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Prevention of Stenosis formation—Sucralfate has an inhibitory effect on stricture formation in experimental corrosive burns and can be used in the treatment of corrosive esophagus burns to enhance mucosal healing and suppress stricture formation
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Proctitis from ulcerative colitis
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Rectal bleeding due to proctitis from radiation to treat Cervical cancer, Prostate cancer, and colon.
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Grade 1 bleeding experienced immediate relief with sucrasulfate enema for 1 month.
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Grade 2 bleeding, sucrasulfate enema] and/or coagulation were effective.
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Grade 3 bleeding lasted for 1 year despite frequent transfusions and coagulation.
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Grade 2 and 3 rectal bleeding occurred in 8.5% of people. The most significant risk factor was the ICRU-CRBED. Prompt treatment with a combination of sucrasulfate enema and coagulation is effective in controlling Grade 1 and 2 rectal bleeding without the development of fistula or stricture.
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Treatment of anastomotic ulcer after gastric bypass surgery
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Sucralfate suspension is recommended by the US-based National Capital Poison Center (Poison Control) as an intervention for known or suspected button battery ingestions to reduce the risk and severity of injury to the esophagus prior to the battery's endoscopic removal.
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Protection against ventilator-associated pneumonia - Reductions in gastric acidity and volumes increase bacterial overgrowth and the incidence of ventilator-associated pneumonia. Sucralfate may be considered to have the advantage over H2-blockers and PPIs in this regard because sucralfate does not change the pH of gastric fluid. A majority of meta-analyses found that sucralfate therapy decreased the incidence of ventilator-associated pneumonia compared to H2-antagonists.
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Side effects
The most common
adverse effect seen is
constipation (2–3%). Less commonly reported side effects (<0.5%) include
flatulence,
headache,
hypophosphatemia,
xerostomia (dry mouth), and
bezoar formation.
Use of this drug is not recommended for people with chronic kidney failure, as it might cause aluminium accumulation and toxicity.
A few well-controlled studies have been carried out investigating the safety and efficacy of sucralfate in children and pregnant women (Pregnancy Category B).
Mechanism of action
Sucralfate is a locally acting substance that in an acidic environment (pH < 4) reacts with hydrochloric acid in the stomach to form a cross-linking, viscosity, paste-like material capable of acting as an buffering agent for as long as 6 to 8 hours after a single dose. It also attaches to on the surface of ulcers, such as albumins and fibrinogen, to form stable insoluble complexes. These complexes serve as protective barriers at the ulcer surface, preventing further damage from acid, pepsin, and bile.[ In addition, sucralfate prevents back diffusion of , and absorbs both pepsin and . ]
It has been thought that sucralfate also stimulates the production of prostaglandin E2, epidermal growth factors (EGF), bFGF, and gastric juice.
Pharmacokinetics
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Onset: 1–2 hr (initial onset for peptic ulcer disease (PUD))
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Absorption: <5% Orally
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Duration: Up to 6 hours due to high affinity for defective mucosa (Peptic Ulcer)
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Bioavailability: 5%, sucralfate is considered non-systemic, sucrose octasulfate: 5%, aluminum: 0.005%
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Metabolism: Not metabolized, excreted unchanged in urine
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Excretion: Primarily in feces as unchanged drug
Society and culture
Brand names
Brand names include Carafate in the US, Sucramal in Italy, Sucrafil, Sufrate, Sucralpro, Sucralcoat, Pepsigard, Sucral, Hapifate, Sucralpro tablets and Sucralpro cream in India, Sutra or Musin in parts of South-East Asia, Sulcrate in Canada, Discral (sucralfato) in México, Ulsanic in South Africa and Israel, Andapsin in Sweden, Antepsin in Turkey, Sucracell in India, and Ulsidex in Indonesia