GASTALFET 1000 LET

For the treatment of duodenal ulcer, gastric ulcer and chronic gastritis.

Chelating complex

Sucralfate binds to duodenal and gastric ulcers and to gastric erosions produced by ethanol and anti-inflammatory drugs. The affinity of sucralfate for defective mucosa is explained by the drug's viscous adhesiveness and the formation of polyvalent bridges between the negatively charged sucralfate polyanions and positively charged proteins present in high concentrations in mucosal lesions. Sucralfate also buffers acid, inhibits the action of pepsin, and adsorbs bile salts. These properties of sucralfate enable the drug to act as an effective barrier to the penetration of acid, pepsin, and bile salts

Adult: Usual dose 1 gm 4 times daily to be taken 1 hour before meals and at bed time. Maximum daily dose is 8 gm. Four to six weeks treatment is usually needed for ulcer healing but upto twelve weeks may be necessary in resistant cases. Antacids may be used as required for relief of pain, but should not be taken half an hour before or after Gastalfet. Elderly: There are no special dosage requirements for elderly patients but as with all medicines the lowest effective dose should be used. children: Safety and efficacy in children have not been established

Concomitant administration of Ulfate 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 Ulfate by two hours. Co-administration of citrate preparations with Ulfate may increase the blood concentrations of aluminium.

In patients with severe or chronic renal impairment, Ulfate should be used with extreme caution and only
for short-term treatment. Small amounts of aluminium from Sucralfate 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 incidence and severity of side effects from sucralfate are very low. Mild side effect like constipation has been reported in some patients.

Although animal studies show no evidence of foetal malformation, safety in pregnant women has not been established and Sucralfate should be used in 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 nursing mothers.

In a clinical trial overdose with Sucralfate 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 g/kg body weight, could not find a lethal dose.

Store in a cool and dry place, away from light & moisture. Keep out of the reach of children.

P© L©

Each 5 ml Suspension contains Sucralfate USP 1 gm.