Protecto Tablet

Protecto is indicated in adults and adolescents over 14 years old for treatment of-

• Duodenal ulcer
• Gastric ulcer
• Chronic gastritis
• The prophylaxis of gastrointestinal hemorrhage from stress ulceration in seriously ill patients.

Sucralfate is non-systemic as the drug is only minimally absorbed from the gastrointestinal tract. The minute amount which absorbed primarily excretes in the urine. Sucralfate promotes the healing of gastric and duodenal ulcers by the formation of a chemical complex that binds to the ulcer site to establish a protective barrier. Besides, Sucralfate inhibits the action of pepsin and bile.

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.

Concomitant administration of Protecto may reduce the bioavailability of certain drugs including Fluoroquinolones such as Ciprofloxacin and Norfloxacin, Tetracycline, Ketoconazole, Sulpiride, Digoxin, Warfarin, Phenytoin, Theophylline, Levothyroxine, Quinidine, and H2 antagonists. The bioavailability of these agents may be restored by separating the administration of these agents from Protecto by two hours. This interaction appears to be non-systemic in origin presumably resulting from these agents being bound by Protecto in the gastrointestinal tract. Because of the potential of Protecto to alter the absorption of some drugs from the gastrointestinal tract, the separate administration of Protecto from that of other agents should be considered when alterations in bioavailability are felt to be critical for concomitantly administered drugs. Protecto should not be co-administered with citrate preparations. Co-administration citrate preparations with Protecto may increase the blood concentrations of aluminium. The mechanism may be due to the chelation of aluminium which is assumed to increase its absorption. The administration of Protecto   1 g and enteral feeds by nasogastric tube should be separated by one hour in patients receiving Protecto 1 g for the prophylaxis of stress ulceration. In rare cases, bezoar formation has been reported when Protecto and enteral feeds have been given too closely together.

Sucralfate tablet and suspension are contraindicated in patients with hypersensitivity to sucralfate.

The most common adverse event was headache (3.4%) followed by nausea (2.3%), abdominal pain (2.3%), constipation (1.1%), diarrhea (1.1%), and urticaria (1.1%). The majority of patients who reported bezoars, had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings. Episodes of hyperglycemia have been reported in diabetic patient.

Safety in pregnant women has not been established and Sucralfate should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Caution should be exercised when Sucralfate is administered to breast-feeding women.

Protecto should only be used with caution in patients with renal dysfunction, due to the possibility of increased aluminium absorption. Protecto is not recommended for use in individuals on dialysis. In patients with severe or chronic renal impairment, Protecto should be used with extreme caution and only for short-term treatment. Small amounts of aluminium are absorbed through the gastrointestinal tract and aluminium may accumulate. 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 Protecto mainly to severely ill patients in intensive care units. The majority of these patients (including neonates in whom Protecto 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.

Pediatric Population: Protecto is not recommended for use in children under 14 years of age due to insufficient data on safety and efficacy.

In elderly patients: Dose adjustments are not necessary.

Renal Impairment: Protecto should be used with caution in renal insufficiency patients.

Effects on ability to drive and use machines: Patients should not be drive if feel dizzy or drowsy.

In a clinical trial on healthy men of overdose with Protecto, most cases remained asymptomatic but symptoms of abdominal pain, nausea, and vomiting were reported in a few cases. Acute oral toxicity studies in animals using doses up to 12 gm/kg body weight could not find a lethal dose. Risks associated with overdose should therefore be minimal.

Chelating complex

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