Omeprazol-Teva enteric-soluble capsules 20mg, 28pcs

Composition

1 capsule contains: Active ingredient omeprazole 20.00 mg; excipients: granulated sugar [sucrose, starch molasses] 96.00 mg, sodium carboxymethyl starch type A 4.20 mg, sodium lauryl sulfate 5.98 mg, povidone 9.50 mg, potassium oleate 1.287 mg, oleic acid 0.214 mg, hypromellose 6.00 mg, melacrylic acid and ethyl acrylate copolymer [1: 1] 40.91 mg, triethyl citrate 4.69 mg, titanium dioxide (E 171) 1.50 mg, talcum powder 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, dye sunset yellow (E 110) 0.468 mg dye red charming (E 129) 0.096 mg, dye brilliant blue (E 133) 0.336 mg

Pharmacological action

Pharmacodynamics .

Inhibits the activity of H+ / K+ – ATPASE in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid secretion. The effect of omeprazole on the last stage of the hydrochloric acid formation process is dose-dependent and provides effective inhibition of basal and stimulated secretion, regardless of the nature of the stimulating factor.

When taken daily, omeprazole provides rapid and effective inhibition of day and night hydrochloric acid secretion. The maximum effect is achieved within 4 days. In patients with duodenal ulcer disease, taking 20 mg of omeprazole maintains intragastric acidity at a pH level of more than 3 for 17 hours.

The action of omeprazole together with antibacterial drugs leads to the eradication of Helicobacter pylori, which 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 (GIT), and also eliminates the need for long-term anti-ulcer therapy.

Pharmacokinetics

Suction and distribution. After taking the drug orally, omeprazole is rapidly absorbed from the small intestine, the maximum concentration in blood plasma (Cmax) is reached in 0.5-3.5 hours.

Bioavailability is 30-40%, with hepatic insufficiency-100%. Binding to plasma proteins (albumin and acidic aa1-glycoprotein) is about 90%.

Metabolism and elimination. (omeprazole is almost completely metabolized in the liver with the participation of the CYP2C19 enzyme system with the formation of six pharmacologically inactive metabolites (hydroxyomeprazole, sulfide and sulfone derivatives, etc. ). It is an inhibitor of the CYP2C19 isoenzyme.

The half-life (T1 / 2) is 0.5-1 h, with hepatic insufficiency-3 h. The clearance is 300-600 ml/min. It is excreted by the kidneys (70-80%) and through the intestines (20-30%) in the form of metabolites.

Pharmacokinetics in special clinical cases.

In chronic renal failure, excretion decreases in proportion to the decrease in creatinine clearance.

In the elderly, omeprazole elimination decreases, and bioavailability increases.

Indications

Use during pregnancy and lactation

The use of omeprazole during pregnancy and lactation is contraindicated due to insufficient data on efficacy and safety in this category of patients.

Contraindications

Hypersensitivity to omeprazole or any of the components of the drug; fructose intolerance; sucrose/isomaltose deficiency; glucose-galactose malabsorption; co-use with clarithromycin in patients with hepatic insufficiency, atazanavir, St. John’s wort; pregnancy, breastfeeding; age up to 18 years. With caution: insufficient liver function; insufficient renal function; concomitant use with clarithromycin.

Side effects

the Frequency of side effects is classified in accordance with the recommendations of the world health organization: very often – at least 10%; often – not less than 1% but < 10%; infrequently – no more than 0.1% but < 1%; rarely – not less than 0.01%, but less than 0.1%; very rarely (including isolated cases) – less than 0.01%. 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, abdominal pain (in most cases, the severity of these phenomena increases with the continuation of therapy); infrequently – taste distortion (usually passes after discontinuation of therapy); rarely – a change in the color of the tongue to brown-black and the appearance of benign salivary gland cysts when used simultaneously with clarithromycin (the phenomena are reversible after discontinuation of therapy); very rarely – dry mouth mucosa, 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 it, 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 acute peptic ulcer of the stomach, duodenum and reflux esophagitis, take 20 mg 1 time 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,10-20 mg is used to prevent relapses 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. In Zollinger-Ellisonadosis syndrome, it is established 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. Influence on the ability to drive vehicles and work with technicsaccounting the possibility of undesirable effects from the central nervous system and the visual organ, during treatment with omeprazole, care should be taken when driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

Store at a temperature not exceeding 25°C. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Omeprazole

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

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

Indications

Gastrointestinal infections caused by Helicobacter Pylori, Gastric and Duodenal ulcers, Reflux Esophagitis