Omeprazole capsules 40mg, Teva No. 28

• Peptic ulcer of the stomach and duodenum in the acute phase (including associated with Helicobacter pylori),

• reflux esophagitis,

• Zollinger-Ellison syndrome,

• erosive and ulcerative lesions of the stomach and duodenum associated with the use of NSAIDs.

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Individual. When taken orally, a single dose is 20-40 mg. The daily dose is 20-80 mg; the frequency of use is 1-2 times / day. The duration of treatment is 2-8 weeks.

1 capsule contains:

active substance: omeprazole - 40.00 mg
excipients: sugar crumbs [sucrose, starch syrup] 1912.00 mg, sodium carboxymethyl starch type A 8.40 mg, sodium lauryl sulfate 11.96 mg, povidone 19.00 mg, potassium oleate 2.576 mg, oleic acid 0.428 mg, hypromellose 12.00 mg, methacrylic acid and ethyl acrylate copolymer [1: 1] 81.82 mg triethyl citrate 9.38 mg, titanium dioxide (E171) 3.00 mg, talc 0.38 mg.
Cellulose capsule: carrageenan 0.283 mg, potassium chloride 0.397 mg, titanium dioxide (E171) 5.40 mg, hypromellose 78.07 mg, water 4.50 mg, sunset yellow dye (E110) 0.702 mg, charming red dye (E129) 0.144 mg, brilliant blue dye (E133) 0.504 mg.
The composition of the white ink used to write on the capsules (for all dosages): shellac 11-13%, ethanol 15-18%, isopropanol 15-18%, propylene glycol 1-3%, butanol 4-7%, povidone 10-13 %, sodium hydroxide 0, m5 - 0.1%, titanium dioxide- (E 7) -32-36-%.

• Chronic liver disease (including history),

• childhood,

• hypersensitivity to omeprazole.

Clinical and pharmacological group: N + -K + -ATPase inhibitor. Antiulcer drug

Pharmaco-therapeutic group: Stomach glands secretion lowering agent - proton pump inhibitor

pharmachologic effect

Inhibitor of H + -K + -ATPase. Inhibits the activity of H + -K + -ATPase in the parietal cells of the stomach and thereby blocks the final stage of the secretion of hydrochloric acid. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. Due to a decrease in acid secretion, it reduces or normalizes the effect of acid on the esophagus in patients with reflux esophagitis.

Omeprazole has a bactericidal effect on Helicobacter pylori. Eradication of H. pylori with the simultaneous use of omeprazole and antibiotics allows you to quickly stop the symptoms of the disease, achieve a high degree of healing of the damaged mucosa and persistent long-term remission, and reduce the likelihood of bleeding from the gastrointestinal tract.

Pharmacokinetics

When taken orally, it is rapidly absorbed from the gastrointestinal tract. Penetrates into the parietal cells of the gastric mucosa. Plasma protein binding is about 95%, mainly with albumin. Biotransformed in the liver. It is excreted by the kidneys - 72-80%, with feces - about 20%. T1 / 2 0.5-1 hours. In patients with chronic liver diseases, T1 / 2 increases to 3 hours.

Indications

• Peptic ulcer of the stomach and duodenum in the acute phase (including associated with Helicobacter pylori),

• reflux esophagitis,

• Zollinger-Ellison syndrome,

• erosive and ulcerative lesions of the stomach and duodenum associated with the use of NSAIDs.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Individual. When taken orally, a single dose is 20-40 mg. The daily dose is 20-80 mg; the frequency of use is 1-2 times / day. The duration of treatment is 2-8 weeks.

Side effect

From the digestive system: rarely - nausea, diarrhea, constipation, abdominal pain, flatulence.

From the side of the central nervous system: rarely - headache, dizziness, weakness.

From the hematopoietic system: in some cases - anemia, eosinopenia, neutropenia, thrombocytopenia.

From the urinary system: in some cases - hematuria, proteinuria.

From the musculoskeletal system: in some cases - arthralgia, muscle weakness, myalgia.

Allergic reactions: rarely - skin rash.

Contraindications for use

• Chronic liver disease (including history),

• childhood,

• hypersensitivity to omeprazole.

Application during pregnancy and lactation

During pregnancy and lactation, use is possible depending on the dosage form used.

Application for violations of liver function

Contraindicated in chronic liver diseases (including history).

Application in children

Due to the lack of experience in clinical use, omeprazole is not recommended for use in children.

special instructions

Before starting therapy, it is necessary to exclude the possibility of a malignant process (especially with a stomach ulcer), because treatment with omeprazole can mask symptoms and delay correct diagnosis.

Against the background of the use of omeprazole, it is possible to distort the results of laboratory tests of liver function and indicators of the concentration of gastrin in the blood plasma.

Drug interactions

With simultaneous use, cases of the development of symptoms of the toxic effect of benzodiazepines have been described, which is associated with inhibition of the activity of CYP3A isoenzymes and, apparently, CYP2C9.

When used simultaneously with atracurium besylate, the effects of atracurium besylate are prolonged.

With the simultaneous use of tripotassium dicitrate with bismuth, an undesirable increase in the absorption of bismuth is possible.

With simultaneous use with digoxin, a slight increase in the concentration of omeprazole in the blood plasma is possible.

With simultaneous use with disulfiram, a case of impaired consciousness and catatonia has been described; with indinavir - a decrease in the concentration of indinavir in the blood plasma is possible; with ketoconazole - a decrease in the absorption of ketoconazole.

With prolonged simultaneous use with clarithromycin, there is an increase in the concentration of omeprazole and clarithromycin in the blood plasma.

Cases of a decrease in the excretion of methotrexate from the body in patients receiving omeprazole have been described.

When used simultaneously with theophylline, a slight increase in the clearance of theophylline is possible.

It is believed that with the simultaneous use of high doses of omeprazole and phenytoin, an increase in the concentration of phenytoin in blood plasma is possible.

Cases of an increase in the concentration of cyclosporine in the blood plasma have been described with simultaneous use with cyclosporine.

With simultaneous use with erythromycin, a case of an increase in the concentration of omeprazole in the blood plasma has been described, while the effectiveness of omeprazole decreased.

Contacts for inquiries

TEVA (Israel)