Ulsec 1000 tablet

Generic

Sucralfate

Indications

Sucralfate is used to treat duodenal ulcers in adults and adolescents over the age of 14. Ulcer in the stomach Chronic gastritis is a condition in which the stomach lining becomes inflame The prevention of gastrointestinal hemorrhage in critically ill patients due to stress ulceration.

Pharmacology

Sucralfate is non-systemic since it is absorbed very slowly from the gastrointestinal tract. The tiny amount absorbed is mostly excreted in the urine. Sucralfate accelerates gastric and duodenal ulcer healing by forming a chemical complex that binds to the ulcer site and forms a protective barrier. Sucralfate also blocks the action of pepsin and bile.

Dosage

Duodenal ulcer, gastric ulcer, chronic gastritis-

• Adults: The usual dose is Sucralfate 2 gm twice daily to be taken on rising and at bedtime or Sucralfate 1 gm four times a day to be taken 1 hour before meals and at bedtime. Maximum daily dose is 8 gm but up to twelve weeks may be necessary in resistant cases.
• Pediatric population: The safety and efficacy of Sucralfate in children under 14 years of age has not been established.
• Elderly: There are no special dosage requirements for elderly patients but as with all medicines the lowest effective dose should be used.

Prophylaxis of gastrointestinal hemorrhage from stress ulceration-

• Adults: The usual dose is Sucralfate 1 gm orally or via a nasogastric tube 4 to 6 times a day. To prevent clogging of the nasogastric tube flush with 10 ml of water following each administration. The duration of treatment for prophylaxis of stress ulceration must be individually determined. Treatment should be continued for as long as one or more of the risk factors for stress ulceration is present but normally not for more than 14 days.

Administration

Sucralfate should be taken first thing in the morning on an empty stomach. Sucralfate should not be used within 30 minutes after taking an antacid.

Interaction

Sucralfate may lower the bioavailability of some medicines, such as fluoroquinolones like Ciprofloxacin and Norfloxacin, Tetracycline, Ketoconazole, Sulpiride, Digoxin, Warfarin, Phenytoin, Theophylline, Levothyroxine, Quinidine, and H2 antagonists, when used together. By separating the delivery of these agents from Sucralfate by two hours, the bioavailability of these drugs can be restored. This interaction appears to be non-systemic in nature, owing to the fact that these agents are bound to Sucralfate in the gastrointestinal tract.Because Sucralfate has the potential to modify the absorption of some medications from the gastrointestinal tract, separate administration of Sucralfate from other agents should be considered where bioavailability of concomitantly administered drugs is a concern. Sucralfate and citrate preparations should not be taken together. Citrate preparations given together with sucralfate may raise aluminum levels in the blood.The mechanism could be due to aluminum chelation, which is thought to improve absorption. In patients taking Sucralfate 1 g for the prevention of stress ulcers, the administration of Sucralfate 1 g and enteral meals through nasogastric tube should be separated by one hour. Bezoar development has been described in rare cases when Sucralfate and enteral meals were given too close together.

Contraindications

Sucralfate tablets and suspension are not recommended for people who are allergic to sucralfate.

Side Effects

Headache (3.4 percent) was the most prevalent adverse event, followed by nausea (2.3 percent), stomach discomfort (2.3 percent), constipation (1.1 percent), diarrhea (1.1 percent), and urticaria (1.1 percent) (1.1 percent ). The majority of patients who reported bezoars had underlying medical problems that could predispose to the production of bezoars (such as delayed stomach emptying) or were receiving enteral tube feedings at the same time. In diabetic patients, episodes of hyperglycemia have been described.

Pregnancy & Lactation

Sucralfate's safety in pregnant women has not been demonstrated, so it should only be used if absolutely necessary. This medication is not known to be excreted in human milk. Sucralfate should be provided with caution to breast-feeding mothers.

Precautions & Warnings

Because of the risk of increased aluminum absorption, sucralfate should only be administered with caution in individuals with renal impairment. Sucralfate should not be used by people who are on dialysis. Sucralfate should be used with extreme caution and only for short-term treatment in patients with severe or chronic renal impairment. Aluminum is absorbed in small amounts through the gastrointestinal tract and can build up. Aluminium osteodystrophy, osteomalacia, encephalopathy and anaemia have been reported in patients with chronic renal impairment. For patients with impairment of renal function, laboratory testing such as aluminium, phosphate, calcium and alkaline phosphatase is recommended to be periodically performed due to excretion impairment. The concomitant use of other aluminium containing medications is not recommended in view of the enhanced potential for aluminium absorption and toxicity. Bezoars have been reported after administration of sucralfate mainly to severely ill patients in intensive care units. The majority of these patients (including neonates in whom sucralfate is not recommended) had underlying conditions that may predispose to bezoar formation (such as delayed gastric emptying due to surgery, drug therapy or diseases that reduce motility) or were receiving concomitant enteral tube feeding.

Therapeutic Class

Chelating complex

Storage Conditions

Store in a cold, dry, and light-protected location.

Pharmaceutical Name

Asiatic Laboratories Limited