Sucrate 200 mlOral Suspension

Generic

Sucralfate

Indications

Sucralfate is approved for the treatment of- in adults and adolescents over the age of 14 years.

• Ulcer in the duodenum
• a stomach ulcer
• Gastritis on a long-term basis
• The prevention of gastrointestinal bleeding caused by stress ulceration in critically sick patients.

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 & Administration

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.

Sucralfate should be taken on an empty stomach. Antacid should not be administered within 30 minutes of Sucralfate.

Interaction

Sucralfate may decrease the bioavailability of some medications, including fluoroquinolones like Ciprofloxacin and Norfloxacin, tetracycline, ketoconazole, sulpiride, digoxin, warfarin, phenytoin, theophylline, levothyroxine, quinidine, and H2 antagonists. 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, most likely as a result of these drugs being bound by Sucralfate in the gastrointestinal tract. Because Sucralfate has the potential to affect the absorption of some medicines from the gastrointestinal tract, it should be taken separately from other treatments where changes in bioavailability are thought to be essential for concomitantly administered pharmaceuticals. Sucralfate should not be used in conjunction with citrate preparations. Co-administration of citrate preparations with sucralfate may raise aluminium concentrations in the blood. The process might be related to aluminum chelation, which is thought to enhance 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 administered too close together.

Contraindications

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

Side Effects

The most frequent adverse event was headache (3.4%), followed by nausea (2.3%), stomach discomfort (2.3%), constipation (1.1%), diarrhea (1.1%), and urticaria (1.1%). (1.1 percent ). The majority of individuals who reported bezoars had underlying medical problems that may lead to bezoar development (such as delayed stomach emptying) or were receiving enteral tube feedings at the same time. Hyperglycemia has been found in diabetic patients.

Pregnancy & Lactation

Sucralfate's safety in pregnant women has not been proved, and it should be used only if obviously necessary. It is unknown if this medication is excreted in human milk. Sucralfate should be provided with caution to breastfeeding mothers.

Precautions & Warnings

Sucralfate should be taken with care in individuals with kidney disease due to the risk of increased aluminum absorption. Sucralfate is not advised for usage in dialysis patients. Sucralfate should be used with extreme caution and only for short-term therapy in individuals with severe or chronic renal impairment. Aluminium is absorbed in small amounts through the gastrointestinal tract, and it can accumulate. In individuals with chronic renal failure, aluminum osteodystrophy, osteomalacia, encephalopathy, and anaemia have been observed. Laboratory testing for aluminium, phosphate, calcium, and alkaline phosphatase is suggested for individuals with impaired renal function due to excretion impairment. Concurrent use of other aluminum-containing medicines is not advised due to the increased risk of aluminum absorption and toxicity. Sucralfate-related bezoars have been documented, primarily in critically sick patients in intensive care units. The majority of these patients (including neonates, for 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 concurrent enteral tube feeding.

Therapeutic Class

Chelating complex

Storage Conditions

Store in a cool and dry place, protected from light.

Pharmaceutical Name

ACME Laboratories Ltd.