Omeprazol-Teva enteric-soluble capsules 20mg, 14pcs

Composition

Active ingredient:

omeprazole 20.00 mg;

Auxiliary substances:  

sugar nibs [sucrose, starch syrup] of 96.00 mg,

carboximetilkrahmal sodium type And 4.20 mg,

sodium lauryl sulfate of 5.98 mg,

povidone 9,50 mg,

potassium oleate 1,287 mg,

oleic acid 0,214 mg,

hypromellose 6,00 mg,

melacelboi acid and ethylacrylate copolymer [1: 1] of 40.91 mg,

triethylcitrate of 4.69 mg,

titanium dioxide (E 171) 1,50 mg,

talc 0,19 mg

Cellulose capsule:

carrageenan 0.185 mg, potassium chloride 0.265 mg, titanium dioxide (E 171) 3.60 mg, hypromellose 52.05 mg, water 3.00 mg, sunset yellow dye (E 110) 0.468 mg charming red dye (E 129) 0.096 mg, diamond blue dye (E 133) 0.336 mg

Pharmacological action

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 hydrochloric acid secretion. This leads to a decrease in 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 It has a bactericidal effect on Helicobacter pylori. H. pylori eradication with the simultaneous use of omeprazole and antibiotics can 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 gastrointestinal bleeding.

Pharmacokinetics

When taken orally, it is rapidly absorbed from the gastrointestinal tract. Penetrates the parietal cells of the gastric mucosa. Binding to plasma proteins is about 95%, mainly with albumins. Biotransformed in the liver. Excreted by the kidneys-72-80%, with feces-about 20%. T1/2 0.5-1 h. In patients with chronic liver disease, T1 / 2 increases to 3 hours.

Indications

Acute gastric and duodenal ulcers (including those associated with Helicobacter pylori), reflux esophagitis, Zollinger – Ellison syndrome, erosive and ulcerative lesions of the stomach and duodenum associated with NSAIDs.

Contraindications

Chronic liver diseases( including in the anamnesis), hypersensitivity to omeprazole.

Side effects

Blood and lymphatic system disorders:  rarely-hypochromic microcytic anemia in children; very rare-reversible thrombocytopenia, leukopenia, pancytopenia, agranulocytosis.

From the immune system:  very rarely – fullness, fever, angioedema, narrowing of the bronchi, allergic vasculitis, fever, anaphylactic shock.

Nervous system disorders: often – headache, dizziness, insomnia, drowsiness, lethargy (the listed side effects tend to worsen with long-term therapy): rarely-paresthesia, confusion, hallucinations, especially in elderly patients or in severe cases of the disease; very rarely-anxiety, depression, especially in elderly patients or in severe cases of the disease.

From the side of the visual organ: infrequently-visual disturbances, including reduced visual fields, decreased visual acuity and clarity (usually disappear after discontinuation of therapy).

Hearing disorders and labyrinth disorders: infrequently-disorders of auditory perception, including “tinnitus” (usually disappear after discontinuation of therapy).

From the gastrointestinal tract: often – nausea, vomiting, flatulence, constipation, diarrhea, stomach pain (in most cases, the severity of these events increases with the continuation of therapy); rarely, dysgeusia (usually held after cessation of therapy); rarely – color change language to brown-black and the appearance of benign cysts of the salivary glands with the simultaneous use with clarithromycin (phenomena are reversible after cessation of therapy); very rarely – dry mucous membranes of the mouth, stomatitis, candidiasis, pancreatitis.

Liver and biliary tract disorders: infrequently-changes in the indicators of “liver” enzymes (reversible); very rarely-hepatitis, jaundice, liver failure, encephalopathy, especially in patients with liver diseases.

Skin and subcutaneous tissue disorders: infrequently-rash, pruritus, alopecia, erythema multiforme, photosensitization, increased sweating; very rarely-Stevens-Johnson syndrome, toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders: infrequently-fractures of the vertebrae, wrist bones, femoral head; rarely-myalgia, arthralgia; very rarely-muscle weakness.

From the side of the kidneys and urinary tract: rarely-interstitial nephritis.

General disorders and disorders at the injection site:  infrequently-peripheral edema (usually disappears after discontinuation of therapy); rarely-hyponatremia; very rarely-hypomagnesemia, gynecomastia.

Interaction

Concomitant use with omeprazole may decrease ketoconazole absorption.

When used concomitantly with omeprazole, the bioavailability of digoxin increases by 10% due to an increase in pH. Omeprazole may reduce the absorption of vitamin B12 with prolonged use.

Omeprazole should not be used concomitantly with St. John’s wort preparations due to the pronounced clinically significant interaction.

With the simultaneous use of omeprazole and clarithromycin, their plasma concentrations increase.

When co-administered with omeprazole, the area of the concentration-time curve modes of atazanavir decreases by 75%, so their simultaneous use is contraindicated.

When used concomitantly with omeprazole, it is possible to slow the elimination of warfarin, diazepam and phenytoin, as well as imipramine, clomipramine, citalopram, hexabarbital, disulfiram, since omeprazole is biotransformed in the liver with the participation of the CYP2C19 isoenzyme. It may be necessary to reduce the doses of these drugs.

No clinically significant interactions were found when omeprazole was co-administered with caffeine, propranolol, theophylline, metoprolol, lidocaine, quinidine, erythromycin, phenacetin, estradiol, amoxicillin, naproxen, piroxicam, and antacids.

How to take, course of use and dosage

Inside, in the morning before meals or even during meals, with a small amount of water; the contents of the capsule should not be chewed.

Adults

With exacerbation of gastric ulcer, duodenal ulcer and reflux esophagitis

20 mg once a day. The course of treatment is 4-8 weeks. In some cases, it is possible to increase the dose to 40 mg per day. With maintenance therapy for GERD to prevent relapses

10-20 mg for 26-52 weeks, depending on the clinical effect, with severe esophagitis – for life. In the treatment of erosive and ulcerative lesions of the stomach and duodenum associated with the use of NSAIDs (including for the prevention of relapses)

10-20 mg per day.

For Zollinger-Ellison syndrome

The dose is set individually. The recommended starting dose is 60 mg once a day. If necessary, the dose is increased to 80-120 mg per day, in which case it should be divided into two doses.

Erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori

20 mg 2 times a day in combination with antibacterial drugs for 7 days. In patients with acute gastric and/or duodenal ulcers, omeprazole monotherapy may be prolonged.

No dose adjustment is required in elderly patients.

No dose adjustment is required in patients with renal insufficiency.

In patients with hepatic insufficiency, the maximum daily dose is 20 mg.

If you have difficulty swallowing a whole capsule, you can swallow its contents after opening or resorbing the capsule, or you can mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension for 30 minutes.

Overdose

Symptoms:  visual disturbances, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.

Treatment: conducting symptomatic therapy, hemodialysis is not effective enough. The specific antidote is not known.

Special instructions

Before starting therapy, it is necessary to exclude the presence of a malignant process in the upper gastrointestinal tract, since taking Omeprazole-Teva may mask the symptoms and delay the correct diagnosis.

Reducing stomach acidity, including when using proton pump blockers, increases the number of bacteria in the gastrointestinal tract, which increases the risk of gastrointestinal infections.

In patients with severe hepatic insufficiency, it is necessary to regularly monitor the indicators of “liver” enzymes during therapy with Omeprazole-Teva.

Omeprazole-Teva contains sucrose and is therefore contraindicated in patients with congenital disorders of carbohydrate metabolism (fructose intolerance, sucrose/isomaltose insufficiency, glucose-galactose malabsorption).

When treating erosive and ulcerative lesions associated with NSAIDs, careful consideration should be given to limiting or discontinuing NSAIDs to improve the effectiveness of anti-ulcer therapy.

The drug contains sodium, which should be taken into account in patients who are on a controlled sodium diet.

The risk-benefit ratio of long-term (more than 1 year) maintenance therapy with Omeprazole-Teva should be regularly evaluated. There is evidence of an increased risk of fractures of the vertebrae, wrist bones, and femoral head, mainly in elderly patients, as well as in the presence of predisposing factors. Patients at risk of developing osteoporosis should be given adequate intake of vitamin D and calcium.

Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors, including omeprazole, for more than 1 year.

Patients receiving omeprazole therapy for a long time, especially in combination with digoxin or other drugs that reduce the content of magnesium in the blood plasma (diuretics), regular monitoring of magnesium content is required.

Storage conditions

 In a dark place, at a temperature not exceeding 25 °C.

Shelf life

2 years

Active ingredient

Omeprazole

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

Nursing mothers as prescribed by a doctor, Children as prescribed by a doctor, Adults as prescribed by a doctor, Pregnant women as prescribed by a doctor

Indications

Reflux esophagitis, Gastrointestinal infections caused by Helicobacter pylori, Gastric ulcer and duodenal ulcer