International generic name
Drug form and composition
Gelatin capsules. One gelatin capsule contains 20 mg Omeprazole.
Sopral is indicated in cases of duodenal or stomach ulcer; gastroesophageal reflux disease; peptic ulcers associated with Helicobacter pylori infection, Zollinger-Ellison syndrome, multiple endocrine adenoma.
Dosage and administration
In duodenal, stomach ulcer and in gastroesophageal reflux, the drug dose is 20 - 40 mg given as a single daily dose for a period of 4 - 8 weeks. In gastritis states with hypersecretion (Zollinger-Ellison syndrome, multiple endocrine adenoma), generally, the initial dose is 60 mg once daily taken before meals. If necessary, doses up to 80 to 120 mg given 2 - 3 times daily can be used for a period of 4 to 8 weeks. For preventive aims against erosive esophagitis the drug is used in a dose of 20 mg once a day.
Hypersensitivity to the drug.
Special warnings and precautions
In patients with chronic liver diseases or renal failure, the drug should be used cautiously and in lower doses. In patients with ulcer the possible malignization of the ulcer must be excluded before the beginning of the treatment with Sopral (it can mask the symptoms of the malignant disease). Because of the lack of controlled clinical trials for efficacy and safety in pregnant and breast-feeding women and children, its use in these patients is not recommended.
Sopral influences the hepatic metabolism and it can increase the plasma concentration and prolong the elimination time of diazepam, anticoagulants, and phenytoin. Because of this their side effects can be potentiated. When used concurrently, Sopral decreases the resorption of ampicillin, ketoconazole and iron salts.
Sopral shows good tolerance, but in some patients the following reaction have been observed: nausea, vomiting, diarrhea, constipation, headache, dizziness, paresthesia, and sleep disturbances. Skin rash, hypoglycemia, etc. are observed relatively rarely, and these reactions most commonly disappear after dose reduction.
Sopral is an antiacid drug. It belongs to the group of the proton pump inhibitors. This is an enzyme system which participate in the terminal stage of acid secretion. Its blocking leads to a sharp reduction in the secretion of the hydrogen ions from the parietal cells of the stomach mucosa. The mechanism of drug action is blocking the sulfhydryl residues of the enzyme H+/K+ ATP-asa, leading to decrease in basal and stimulated gastric acid secretion. After a single dose of 20 mg this secretion is inhibited for approximately 24 hours, and gastrin levels are increased during the first weeks.
28 gelatin capsules of 20 mg (calendar package).