5 ml of the suspension contains 1 g of sucralfate. Excipients with known effect: methyl parahydroxybenzoate (0.1 g / 100 g), propyl parahydroxybenzoate (0.05 g / 100 g), sorbitol (1.5 g / 100 g).
Action:
A complex compound of aluminum hydroxide and a basic aluminum salt of sucrose octasulfate with local shielding effect. In an acidic environment, sucralfate becomes highly polar and binds to the tissues of the ulcer bottom for about 12 hours, with relatively small binding to the normal mucous membrane of the stomach and duodenum. In the presence of hydrochloric acid, binds to positively charged groups of glycoproteins. It can form a complex gel-like connection with mucus molecules, which prevents the enzymatic breakdown of the latter by pepsin. It is believed that adherence to the granulation tissue prevents the diffusion of hydrogen ions to the bottom of the ulcer. In addition, it binds bile salts and pepsin and thus limits their damaging effects. Sucralfate increases the tissue concentration of endogenous prostaglandins and combines with the epidermal growth factor and other growth factors, involving them in the local mucosal defense reaction. In the presence of hydrochloric acid, the polymers of the drug molecules form a sticky paste coating the walls of the stomach; after 3 hours from serving in the stomach there is about 3% of the administered dose.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. It should not be used over a long period of time in patients with severe renal insufficiency, uremia or hypophosphataemia and in patients undergoing dialysis.
Precautions:
Special care should be taken when using sucralfate in patients with renal insufficiency. In patients with renal insufficiency, the renal excretion of aluminum decreases. Aluminum poorly penetrates through the dialysis membranes due to binding to serum albumin. In patients undergoing dialysis, the drug should only be used in case of absolute necessity and for a short period of time. The concentration of aluminum and phosphate in the serum should be controlled and the symptoms of aluminum accumulation (osteodystrophy, osteomalacia, encephalopathy) should be evaluated after the end of therapy. Antacids should be used 30 minutes before or after administration of sucralfate. Co-administration of other preparations containing aluminum is not recommended due to the possibility of increased absorption of aluminum and the possibility of toxicity. The preparation contains sorbitol - do not use in patients with rare hereditary fructose intolerance. The preparation contains parahydroxybenzoates - may cause allergic reactions (possible late-type reactions). The formation of bezoar after administration of sucralfate was reported mainly in seriously ill patients in intensive care units. The majority of patients (including newborns for whom sucralfate is not recommended) have conditions that may predispose to the formation of bezoaras (eg delayed gastric emptying due to the use of other medications, surgical procedures or diseases that reduce mobility), or have been nourished using an enteric tube. It is not recommended for use in children and adolescents under 14 years of age due to a lack of data on safety and efficacy.
Pregnancy and lactation:
It should not be used during pregnancy unless clearly necessary. Do not use during breast-feeding.
Side effects:
Common: constipation. Uncommon: diarrhea, vomiting, nausea, headache, increase in the concentration of aluminum and ionized Calcium and decrease in the concentration of organic phosphorus in the serum. Rarely: dizziness, insomnia, excessive drowsiness, dyspepsia, bloating, dry mouth, laryngitis, rhinitis, osteoporosis, osteopenia, face edema, pruritus, rash, hepatotoxicity, toxic kidney damage, bezoary.
Dosage:
Orally. Adults: 1 g 4 times a day (every 6 h) for 0.5-1 h before each meal and immediately before bedtime. The maximum daily dose is 8 g.Treatment should be continued for 4-6 weeks.Special groups of patients. In patients with renal insufficiency, the drug should be used with caution. No dosage adjustment is necessary for elderly patients. The safety and efficacy of the medicine in children up to 14 years of age has not been established.Method of administration. The drug drink plenty of water.
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