Description
Release form
Capsules
packaging 14 pcs
Pharmacological action
Pharmacodynamics. It 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 process of hydrochloric acid formation 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 quick and effective inhibition of day and night secretion of hydrochloric acid. The maximum effect is achieved within 4 days. In patients with peptic ulcer of the duodenum, taking 20 mg of omeprazole supports intragastric acidity at a pH 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 mucous membrane and persistent long-term remission and reduce the likelihood of bleeding from the gastrointestinal tract (GIT), and also eliminates the need for prolonged antiulcer therapy.
Pharmacokinetics
Absorption and distribution. After taking the drug inside, omeprazole is rapidly absorbed from the small intestine, the maximum concentration in the blood plasma (Cmax) is reached after 0.5-3.5 hours.
Bioavailability is 30-40%, with liver failure – 100%. Binding to blood plasma proteins (albumin and acidic α 1-glycoprotein) is about 90%.
Metabolism and excretion. (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.
Half-life (T1 / 2) – 0.5-1 h , with liver failure -3 hours. Ground clearance of 300-600 ml / min.
It is excreted by the kidneys (70-80%) and through the intestines (20-30%) as metabolites.
Pharmacokinetics in special clinical cases. In chronic renal failure, excretion decreases in proportion to a decrease in creatinine clearance.
In the elderly, elimination of omeprazole decreases, bioavailability increases.
Indications
peptic ulcer of the stomach and duodenum, including relapse prevention
gastroesophageal reflux disease (GERD), reflux esophagitis, including prevention of recurrence of
erosive and ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs)
erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori (as a part of the combination therapy) associated with permissible gastric secretion.
Contraindications
Hypersensitivity to omeprazole or any of the drug components fructose intolerance sucrose deficiency / isomaltose glucose-galactose malabsorption combined use with clarithromycin in patients with liver failure, atazanavir, St. John’s wort the period of breastfeeding is the age of 18 years.
Precautions
Lack of liver function, renal failure, simultaneous use with clarithromycin.
Use during pregnancy and lactation
Use of omeprazole during pregnancy and breastfeeding is contraindicated due to insufficient data on efficacy and safety in this category of patients.
Special instructions
Before starting therapy, it is necessary to exclude the presence of a malignant process in the upper gastrointestinal tract, because taking Omeprazole-Teva may mask symptoms and delay the correct diagnosis.
Decreased gastric acidity, including when using proton pump blockers, increases the number of bacteria in the digestive tract, which increases the risk of gastrointestinal infections.
In patients with severe hepatic insufficiency, it is necessary to regularly monitor liver enzyme parameters during treatment with Omeprazole-Teva.
Omeprazole-Teva contains sucrose and is therefore contraindicated in patients with congenital disorders of carbohydrate metabolism (fructose intolerance, sucrose / isomaltose deficiency, glucose-galactose malabsorption).
In the treatment of erosive and ulcerative lesions associated with NSAIDs, the possibility of limiting or stopping NSAIDs should be carefully considered to increase the effectiveness of antiulcer therapy.
The drug contains sodium, which should be taken into account in patients on a controlled sodium diet.
The risk to benefit ratio of long-term (over 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, femoral head, mainly in elderly patients, as well as in the presence of predisposing factors. Patients at risk of developing osteoporosis should ensure adequate intake of vitamin D and calcium.
There are reports of severe hypomagnesemia in patients receiving proton pump inhibitor therapy, including omeprazole, over 1 year old.
A patient receiving omeprazole therapy for a long time, especially in combination with digoxin or other drugs that reduce the magnesium content in the blood plasma (diuretics), requires regular monitoring of the magnesium content.
Composition
1 capsule contains:
Active ingredient: omeprazole 20.00 mg
Excipients: sugar grits [sucrose, starch syrup] 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 (E171) 1 , 50 mg, talc 0.19 mg.
Cellulose capsule: carrageenan 0, 185 mg, potassium chloride 0.265 mg, titanium dioxide (E171) 3.60 mg, hypromellose 52.05 mg, water 3, 00 mg, dye sunny sunset yellow (E110) 0.468 mg, dye red charming (E129) 0.096 mg, dye brilliant blue (E133) 0.336 mg.
Dosage and administration
Inside, in the morning before eating, or while eating, with a little water, do not chew the contents of the capsule.
Adults
With exacerbation of peptic ulcer of the stomach, duodenum and reflux esophagitis
20 mg once a day. The course of treatment is 4-8 weeks. In some cases, a dose increase of up to 40 mg per day is possible.
With maintenance of GERD tolerance for the prevention of
recurrence, 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 NSAIDs (including for the prevention of relapse)
10-20 mg per day.
With Zollinger-Ellison Syndrome
Dose is set individually. The recommended starting dose is 60 mg once daily. If necessary, the dose is increased to 80-120 mg per day, then this case should be divided into two doses.
Erosive-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 peptic ulcer of the stomach and / or duodenum in the acute stage, prolongation of omeprazole monotherapy is possible.
In elderly patients, dose adjustment is not required.
Dose adjustment is not required in patients with impaired renal function.
In patients with liver failure, the maximum daily dose is 20 mg.
If you have difficulty swallowing an entire capsule, you can swallow its contents after opening or absorbing the capsule, you can also mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension for 30 minutes.
Side effects of
From the blood and lymphatic system: rarely – hypochromic microcytic anemia in children is very rare – reversible thrombocytopenia, leukopenia, pancytopenia, agranulocytosis.
On the part of the immune system: very rarely – full, fever, angioedema, narrowing of the bronchi, allergic vasculitis, fever, anaphylactic shock.
From the nervous system: often – headache, dizziness, insomnia, drowsiness, lethargy (these side effects tend to worsen with prolonged therapy): rarely – paresthesia, confusion, hallucinations, especially in elderly patients or in severe cases of the disease rarely anxiety, depression, especially in elderly patients or in severe cases of the disease.
From the side of the organ of vision: infrequently – visual disturbances, incl. decreased visual fields, decreased visual acuity and clarity (usually disappear after discontinuation of therapy).
On the part of the organ of hearing and labyrinth disorders: infrequently, impaired auditory perception, incl. 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 – a perversion of taste (usually disappears after discontinuation of therapy) rarely – a discoloration of the tongue to brown-black and the appearance of benign salivary gland cysts when used with clarithromycin (the phenomena are reversible character after stopping therapy) very rarely – dry mouth, stomatitis, candidiasis, pancreatitis.
On the part of the liver and biliary tract: infrequently – changes in liver enzymes (reversible) are very rare – hepatitis, jaundice, liver failure, encephalopathy, especially in patients with liver diseases.
From the skin and subcutaneous tissues: infrequent rash, itching, alopecia, erythema multiforme, photosensitivity, increased sweating is very rare – Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the side of musculoskeletal and connective tissue: infrequently – fractures of the vertebrae, bones of the wrist, femoral head (see section Special instructions) rarely – myalgia, arthralgia very rarely – muscle weakness.
From 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 (see Special instructions), gynecomastia.
Drug Interactions
With simultaneous use with omeprazole, ketoconazole absorption may decrease.
With simultaneous use with omeprazole, the bioavailability of digoxin is increased by 10% due to an increase in pH.
Omeprazole may decrease the absorption of vitamin B12 with prolonged use.
Omeprazole should not be used concomitantly with St. John’s wort preparations due to pronounced clinical significant interaction.
With the simultaneous use of omeprazole and clarithromycin, their plasma concentrations increase.
With simultaneous administration with omeprazole, the mode area of the concentration-time curve of atazanavir decreases by 75%, therefore, their simultaneous use is contraindicated.
With simultaneous use 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 CYP2C19 isoenzyme. Reduced doses of these drugs may be required. When using omeprazole with caffeine, propranolol, theophylline, metoprolol, lidocaine, quinidine, erythromycin, phenacetin, estradiol, amoxicillin, naproxen, piroxicam and antacids, no clinically significant interaction was established.
Overdose
Symptoms: impaired vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.
Treatment: carrying out symptomatic therapy, hemodialysis is not effective enough. The specific antidote is unknown.
Storage conditions
Do not store above 25 ° C.
shelf life
2 years
Deystvuyushtee substance
Omeprazole
Terms and conditions
Prescription
dosage form
capsules
Possible product names
Omeprazole-Teva enteric capsules 20 mg 14 pcs.
Teva Pharmaceutical Enterprises Co., Ltd., Israel
