GENERIC NAME: sucralfate

BRAND NAME: Carafate

DRUG CLASS AND MECHANISM: Sucralfate is a unique oral drug. Chemically, it is a complex of the disaccharide sugar, sucrose, combined with sulfate and aluminum. It is minimally absorbed into the body, and its actions are entirely on the lining of the stomach and duodenum. Although its mechanism is not entirely understood, the following actions are thought to be important for its beneficial effects:

1. sucralfate binds to the surface of ulcers (attaching to exposed proteins) and coats the ulcer, thus protecting the ulcer surface to some extent from further injury by acid and pepsin;
2. sucralfate directly inhibits pepsin (an enzyme that breaks apart proteins) in the presence of stomach acid;
3. sucralfate binds bile salts coming from the liver via the bile thus protecting the stomach lining from injury caused by the bile acids;
4. sucralfate may increase prostaglandin production, and prostaglandins are known to protect the lining of the stomach. Sucralfate was approved by the FDA in 1981.

PRESCRIPTION: yes

GENERIC AVAILABLE: yes

PREPARATIONS: Oblong tablets (pink): 1 gram; pink- colored suspension (1 gram per 2 teaspoonsful).

STORAGE: Tablets and suspension should be kept at room temperature, between 15° and 30°C (59-86°F). The suspension should not be frozen and should be shaken prior to each use.

PRESCRIBED FOR: Sucralfate is used for the treatment of peptic ulcer disease and to prevent recurrent ulcers after healing of the ulcer has been achieved. It also has been used to relieve or prevent the ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs) but is less effective than misoprostol (Cytotec). Sucralfate also is used in the treatment of patients with gastroesophageal reflux disease (GERD) who are prone to get ulcers in the esophagus, and to prevent ulcers associated with high degrees of physical stress (e.g. extensive burns, surgery, and overwhelming infection.) among hospitalized patients.

DOSING: Sucralfate generally is given four times daily for treating ulcerations and twice daily for preventing ulcers. It is recommended that it be taken on an empty stomach, at least one hour prior to meals, for best coating of the ulcers.

DRUG INTERACTIONS: Sucralfate reduces the absorption of many drugs when taken at the same time as the other drugs. These drugs include: cimetidine (Tagamet), digoxin (Lanoxin), ketoconazole (Nizoral), levothyroxine (Synthroid), phenytoin (Dilantin), quinidine (Quinidex, Quinaglute), ranitidine (Zantac), tetracycline, theophylline (Theo-Dur, Uniphyl, others), and all of the fluoroquinolone antibiotics, including ciprofloxacin (Cipro), norfloxacin (Noroxin), ofloxacin (Floxin), and lomefloxacin (Maxaquin). All of these medications should be taken at least two hours prior to the sucralfate. It is possible, if not likely, that many other drugs will interact similarly with sucralfate. Therefore, it probably is prudent to take all medications at least 2 hours prior to sucralfate.

PREGNANCY: Sucralfate itself is not teratogenic in animals, even in doses considerably higher than those used in humans. Although some animal data demonstrate concern for the effects of aluminum during pregnancy, all human data show no ill-effect on the fetus. Sucralfate is considered safe during pregnancy.

NURSING MOTHERS: Minimal if any sucralfate penetrates into breast milk because so little is absorbed from the gastrointestinal tract. Although there is no data, sucralfate is considered safe in nursing mothers.

SIDE EFFECTS: Sucralfate is well tolerated. Constipation is the most frequent side effect and occurs in 1 of every 50 patients who take sucralfate.

Reference: FDA Prescribing Information