Omeprazole STADA

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Omeprazole STADA: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Use in childhood
10. In case of impaired renal function
11. For violations of liver function
12. Use in the elderly
13. Drug interactions
14. Analogs
15. Terms and conditions of storage
16. Terms of dispensing from pharmacies
17. Reviews
18. Price in pharmacies

Latin name: Omeprazole Stada

ATX code: A02BC01

Active ingredient: omeprazole (omeprazole)

Producer: Skopinsky pharmaceutical plant (Russia), Hemofarm, LLC (Russia)

Description and photo update: 28.11.2018

Omeprazole STADA is a drug that helps to reduce the secretion of gastric glands.

Release form and composition

Dosage form - enteric capsules: hard gelatinous, size No. 1, orange, the capsules contain spherical pellets of white with a creamy shade or white (in a cardboard box 1-3, 5, 8 or 10 blisters of 10 capsules and instructions for use Omeprazole STADA).

Composition of 1 capsule:

active substance: omeprazole - 20 mg (omeprazole pellets - 235.29 mg);
auxiliary components: calcium carbonate - 8 mg, hypromellose - 20.59 mg, copolymer (1: 1) of ethyl acrylate and methacrylic acid - 58.82 mg, sodium hydroxide - 0.35 mg, talc - 0.14 mg, cetyl alcohol - 1.76 mg, povidone - 0.61 mg, polysorbate 80 - 0.71 mg, propylene glycol - 1.91 mg, diethyl phthalate - 5.88 mg, titanium dioxide - 0.42 mg, mannitol - 40 mg, sucrose - 64, 31 mg, sodium hydrogen phosphate - 2.99 mg, sodium lauryl sulfate - 0.8 mg, lactose - 8 mg;
capsule shell: gelatin, titanium dioxide, yellow sunset dye.

Pharmacological properties

Pharmacodynamics

Omeprazole is a benzimidazole derivative, a specific inhibitor of the proton pump (H + / K + -ATPase enzyme). The substance is characterized by a highly selective mechanism for suppressing the secretion of hydrochloric acid in the stomach.

Omeprazole is a weak base. It is concentrated and converted into an active form in the very acidic environment of the secretory tubules of parietal cells, where the substance inhibits the proton pump, thereby blocking the final stage of hydrochloric acid synthesis. The effect of omeprazole is dose-dependent, while effective suppression of both basal and stimulated secretion of hydrochloric acid is provided, regardless of the etiology of the stimulating factor.

The antisecretory effect of omeprazole after oral administration develops within the first hour, the maximum is noted after 2 hours, the effect lasts 24 hours. When the drug is taken once a day, effective and rapid suppression of the daily (day and night) secretion of hydrochloric acid is ensured. The maximum effect of therapy is observed after 4 days of admission. The secretory activity of the exocrine glands of the stomach after the withdrawal of omeprazole in 3-5 days is fully restored.

Omeprazole at a dose of 20 mg in patients with duodenal ulcer leads to a sustained decrease in intragastric acidity by at least 80% (according to the 24-hour pH meter). At the same time, there is a decrease in the average maximum concentration of hydrochloric acid after stimulation with pentagastrin by 70%. When taken daily, omeprazole helps maintain an intragastric pH ≥ 3 on average for 17 hours a day.

With GERD (gastroesophageal reflux disease), as a result of therapy, there is a decrease in the effect of hydrochloric acid on the esophagus.

When treated with omeprazole, tachyphylaxis is not observed. In 3-4 days after discontinuation of the drug, secretory activity is completely restored without rebound syndrome.

In relation to Helicobacter pylori (Helicobacter pylori), omeprazole has a bactericidal effect. Eradication of bacteria against the background of taking the drug in combination with agents with antibacterial action is accompanied by the following effects: rapid relief of symptoms, high degree of healing of defects in the mucous membrane of the stomach and duodenum, prolonged remission of peptic ulcer disease, a decrease in the likelihood of complications (in the form of gastrointestinal bleeding). At the same time, there is no need for constant maintenance therapy.

Due to a decrease in the secretion of hydrochloric acid in the blood plasma, an increase in the concentration of chromogranin A occurs. This may be important when examining patients in order to identify neuroendocrine tumors.

Pharmacokinetics

Omeprazole is rapidly absorbed from the gastrointestinal tract; the maximum plasma concentration in the blood is reached on average in 2 hours. Absorption takes place in the small intestine for 3–6 hours. After a single dose, the bioavailability is approximately 40%, after 3-5 days of administration once a day, it increases to 60%. Food intake has no effect on this indicator. There is a correlation between inhibition of hydrochloric acid secretion and AUC (area under the concentration-time curve).

Omeprazole binds to plasma proteins at about 95%. The volume of distribution is 0.34 l / kg.

Metabolism of omeprazole occurs in the liver in full with the participation of isoenzymes CYP2C19 (to a greater extent) and CYP3A4, resulting in the formation of six metabolites that do not have pharmacological activity; the main metabolite is hydroxyomeprazole.

Due to the presence of a high degree of affinity of the substance for the CYP2C19 isoenzyme, there may be a competitive interaction with other drugs, in the metabolism of which this isoenzyme is involved. Also, the severity of the antisecretory effect, depending on the polymorphism of the CYP2C19 gene, may have different variability.

Omeprazole is excreted in the form of metabolites: up to 80% - by the kidneys, 20-30% - through the intestines with bile. T _1/2 (half-life) - from 30 to 90 minutes.

In patients over 65, there is a slight decrease in the metabolism of omeprazole.

Excretion of the substance in chronic renal failure decreases in proportion to the decrease in creatinine clearance.

In chronic liver diseases, its function is impaired, and the metabolism of omeprazole decreases, bioavailability increases to 100%, clearance decreases to 70 ml / min, and T _{1/2 is} lengthened to 180 minutes. There was no tendency to cumulation of omeprazole when taken once a day.

In the case of the use of omeprazole in children over the age of 1 year in compliance with the recommended doses, the plasma concentration in the blood is similar to that in adults.

Indications for use

Adults:

eradication of Helicobacter pylori in patients with gastric ulcer and duodenal ulcer (as part of combination therapy);
peptic ulcer of the stomach and duodenum (therapy and prevention);
symptomatic gastroesophageal reflux disease (GERD);
reflux esophagitis;
ulcers and erosion of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAID-associated) (therapy and prevention);
Zollinger-Ellison syndrome;
dyspepsia, the development of which is associated with high acidity.

Children:

from 2 years old and weighing more than 20 kg: reflux esophagitis, symptomatic therapy of heartburn and sour eructation in GERD;
from 4 years: eradication of Helicobacter pylori in children with duodenal ulcer (as part of combination therapy).

Contraindications

Absolute:

deficiency of isomaltase / sucrase, lactase; intolerance to fructose, lactose, glucose-galactose malabsorption (Omeprazole STADA contains lactose and sucrose);
combination therapy with the following drugs: nelfinavir, atazanavir, posaconazole, erlotinib, high-dose methotrexate;
individual intolerance to the components of the drug, as well as substituted benzimidazoles.

Relative (STADA Omeprazole capsules are prescribed under medical supervision):

liver failure;
combination therapy with the following drugs: clopidogrel, saquinavir, tacrolimus, digoxin, as well as drugs that, with prolonged use, can cause hypomagnesemia;
long-term use of omeprazole (from 1 year) in high doses, especially in elderly patients and patients with osteoporosis (associated with the risk of fractures of the hip, spine, wrist bones).

Omeprazole STADA, instructions for use: method and dosage

Omeprazole STADA is taken orally, preferably on an empty stomach (before breakfast), possibly with food. The capsule must be swallowed whole (without chewing the capsule and its contents) with 100 ml of water.

For patients with difficulty swallowing, it is permissible to take Omeprazole STADA in one of the following ways:

the contents of the capsules are swallowed after opening or resorption;
the contents of the capsule are mixed with a slightly acidic liquid (yogurt, juice, but not with carbonated water or milk). The resulting suspension must be taken within 30 minutes, after taking it, it is recommended to pour the liquid into the same glass half of its volume, shake it and drink (to be sure that the full dose is taken).

Adults

Duodenal ulcer

In case of exacerbation of duodenal ulcer, Omeprazole STADA is prescribed 1 time per day, 1 capsule for 14 days. If complete healing has not come, the treatment is extended for the same period. With a low sensitivity to therapy, the daily dose is doubled. Ulcer healing is usually achieved within 4 weeks.

If it is impossible to carry out the eradication of Helicobacter pylori or Helicobacter pylori-negative patients for the prevention of relapse, Omeprazole STADA is prescribed 1 time per day, 1 capsule for a course of 28 days. If necessary, a single dose is doubled.

Stomach ulcer

In case of exacerbation of gastric ulcer Omeprazole STADA is prescribed 1 time per day for 1 capsule for 28 days. If complete healing has not come, the treatment is extended for the same period. With a low sensitivity to therapy, the daily dose is doubled, and the duration of administration is up to 8 weeks.

For the prevention of relapse, Omeprazole STADA is prescribed 1 time per day, 1 capsule for a course of 28 days. If necessary, a single dose is doubled.

Peptic ulcer and duodenal ulcer for the eradication of Helicobacter pylori (combination therapy)

Antibacterial drugs for combination therapy are selected according to regional and national guidelines for bacterial resistance and duration of treatment.

Three-component therapy (course of 7 days) can be carried out according to one of the following schemes:

20 mg of Omeprazole STADA + 500 mg of clarithromycin + 1000 mg of amoxicillin: 2 times a day;
20 mg of Omeprazole STADA + 250 or 500 mg of clarithromycin + 400 or 500 mg of metronidazole or 500 mg of tinidazole: 2 times a day;
40 mg of Omeprazole STADA: 1 time per day; 500 mg amoxicillin + 400 or 500 mg metronidazole or 500 mg tinidazole: 3 times a day.

Two-component therapy (course of 14 days) can be carried out according to one of the following schemes:

20-40 mg of Omeprazole STADA + 750 mg of amoxicillin: 2 times a day;
40 mg Omeprazole STADA: 1 time per day; Clarithromycin 500 mg: 3 times daily.

If, after the end of treatment according to any of the indicated schemes, the test for Helicobacter pylori is positive, the therapy can be repeated.

Reflux esophagitis

With an exacerbation of reflux esophagitis, Omeprazole STADA is prescribed 1 capsule 1 time per day. Healing usually occurs in 4 weeks. If complete healing has not occurred during this period, the drug is used again according to the same scheme.

In severe reflux esophagitis, Omeprazole STADA should be used 1 time per day, 2 capsules for 8 weeks.

In the stage of remission, maintenance therapy is carried out: the drug is taken for a long time, 1 capsule 1 time a day. The dose can be doubled if necessary.

Symptomatic gastroesophageal reflux disease

For the treatment of symptomatic gastroesophageal reflux disease, Omeprazole STADA is prescribed 1 capsule 1 time per day for a course of 28 days. If symptoms persist during this period, further evaluation is recommended.

NSAID-associated ulcers and erosion of the stomach and duodenum

In the presence of NSAID-associated gastric ulcers, duodenal ulcers or gastroduodenal erosions in patients with ongoing or discontinued NSAID therapy, Omeprazole STADA is usually prescribed 1 capsule 1 time per day for a course of 28 days. In case of insufficient effectiveness, the use of the drug can be extended for the same period.

For prophylactic purposes, Omeprazole STADA should be taken 1 capsule 1 time per day.

Acid-related dyspepsia

For the treatment of dyspepsia associated with high acidity, Omeprazole STADA is prescribed 1 capsule 1 time per day for a course of 14-28 days.

Zollinger-Ellison syndrome

The dosage regimen of Omeprazole STADA in Zollinger-Ellison syndrome is selected individually, based on the initial level of gastric secretion. Therapy usually starts with taking 3 capsules 1 time per day, according to indications the dose can be increased to 4-6 capsules, in such cases it is divided into 2 doses.

The duration of the course is determined individually.

Children

Symptomatic therapy of acid reflux and heartburn in GERD; reflux esophagitis

Children from 2 years old and weighing more than 20 kg Omeprazole STADA is prescribed 1 capsule 1 time per day. If necessary, the dose can be doubled.

Course duration:

heartburn / sour belching with GERD: 14–28 days; if during this time the symptoms do not go away, an additional examination is prescribed;
reflux esophagitis: 28–56 days.

Eradication of Helicobacter pylori in duodenal ulcer (combination therapy)

When choosing antibacterial agents and the duration of treatment (usually 7 days, but in some cases the course is extended up to 14 days), national / regional recommendations regarding bacterial resistance should be taken into account.

The scheme of drug therapy in children from 4 years of age (2 times a day for a course of 7 days):

weight 31–40 kg: 20 mg Omeprazole STADA + 750 mg amoxicillin + 7.5 mg / kg clarithromycin;
weight from 40 kg: 20 mg of Omeprazole STADA + 1000 mg of amoxicillin + 500 mg of clarithromycin.

Features of use in patients with impaired liver function

The daily dose of Omeprazole STADA in case of impaired liver function should not exceed 20 mg, since in such patients the bioavailability and T _{1/2 of} omeprazole increase.

Side effects

Possible adverse reactions (> 10% - very often;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare; with an unknown frequency - determine the frequency based on available data is not possible):

nervous system: often - headache; infrequently - drowsiness, paresthesia, dizziness, vertigo, insomnia; rarely - reversible confusion, aggressiveness, agitation, depression and hallucinations (mainly against the background of severe concomitant somatic diseases), encephalopathy (against the background of a burdened history of severe liver disease);
endocrine system: rarely - gynecomastia;
digestive system: often - nausea, abdominal pain, diarrhea, constipation, bloating, vomiting; infrequently - increased activity of liver enzymes; rarely - microscopic colitis, lack of appetite, a feeling of dry mouth, taste disturbance, stomatitis, candidiasis of the gastrointestinal tract, hepatitis (including jaundice, in patients with a history of severe liver disease), liver failure, gastric glandular cysts during a long course (due to inhibition of hydrochloric acid secretion; reversible, benign);
genitourinary system: rarely - proteinuria, hematuria, urinary tract infection;
hematopoietic organs: rarely - thrombocytopenia, leukopenia; very rarely - pancytopenia, agranulocytosis;
musculoskeletal system: infrequently - fracture of the bones of the wrist, hip, vertebrae; rarely - myalgia, arthralgia; very rarely - muscle weakness;
allergic reactions: rarely - interstitial nephritis, bronchospasm, angioedema, fever, anaphylactic reaction / shock;
skin and subcutaneous tissues: infrequently - itching, dermatitis, urticaria; rarely - photosensitivity, alopecia; very rarely - Stevens-Johnson syndrome, exudative erythema multiforme, toxic epidermal necrolysis;
others: infrequently - malaise; rarely - peripheral edema, blurred vision, hyponatremia, excessive sweating; with an unknown frequency - hypomagnesemia (including associated with hypokalemia), hypocalcemia (associated with severe hypomagnesemia).

Overdose

When adults take omeprazole in a single dose of 560 mg, symptoms of moderate intoxication are observed. There is information about taking a single dose of 2400 mg, which did not lead to the development of any severe toxic symptoms. With an increase in the dose of omeprazole, the rate of its elimination does not change, therefore, specific treatment is not required.

The main symptoms are diarrhea, tachycardia, dizziness, confusion, depression, apathy, headache, nausea, flatulence, vomiting.

Therapy: symptomatic, if necessary, gastric lavage is prescribed, the use of activated carbon. Hemodialysis is not effective enough. There is no specific antidote.

special instructions

In patients with symptoms such as repeated vomiting, significant spontaneous weight loss, vomiting with blood or melena, dysphagia, as well as with or suspected gastric ulcer, malignant neoplasms should be excluded before the appointment of Omeprazole STADA, since therapy can smooth out symptomatology and delay the correct diagnosis.

When treating patients with a reduced supply of vitamin B ₁₂ in the body or with the presence of risk factors for impaired absorption of this vitamin, it should be borne in mind that with prolonged therapy, its absorption decreases.

In patients who receive omeprazole STADA for a long time (at least for three months, usually within a year), severe hypomagnesemia was recorded, manifested in the form of fatigue, seizures, delirium, dizziness, ventricular arrhythmia. Usually, these symptoms stop after discontinuation of the drug and administration of drugs containing magnesium. When planning long-term treatment, as well as against the background of combined use with digoxin or other drugs that can lead to hypomagnesemia (including diuretics), it is necessary to first assess the magnesium content in the blood and periodically monitor this indicator during therapy.

It is also necessary to take into account that long-term use of Omeprazole STADA (more than one year) increases the risk of fractures of the wrist, hip and vertebrae associated with osteoporosis, mainly in the presence of other risk factors for the disease or in the elderly. A causal relationship between the use of Omeprazole STADA and fractures has not been established, however, if there are risks of osteoporosis / fractures, appropriate treatment should be prescribed in accordance with the latest clinical guidelines.

Against the background of prolonged use of omeprazole, there is a slight increase in the frequency of formation of glandular cysts in the stomach. These changes are reversible and benign, and should be considered as a physiological consequence of the pronounced inhibition of hydrochloric acid secretion.

With a decrease in acidity during therapy with STADA Omeprazole, an increase in the number of bacteria that are present in the gastrointestinal tract in normal conditions occurs; at the same time, there is a slight increase in the risk of gastrointestinal infections caused by bacteria of the genus Campylobacter spp., Salmonella spp. or Clostridium difficile (in hospitalized patients).

In some cases, both in adults and in children, long-term use of omeprazole is accompanied by an increase in the number of enterochromaffin-like cells, which is probably associated with an increase in the plasma concentration of gastrin in the blood (it has no clinical significance).

When examining a patient in order to detect neuroendocrine tumors 5 days before the study of the concentration of chromogranin A (CgA), the use of Omeprazole STADA should be temporarily discontinued. If during this time the CgA concentration has not returned to normal, the test is repeated 14 days after discontinuation of therapy.

Patients with diabetes mellitus should take into account that 1 capsule of Omeprazole STADA contains 64.31 mg of sucrose.

Influence on the ability to drive vehicles and complex mechanisms

Patients during the period of use of Omeprazole STADA when driving vehicles should be careful, since the development of such adverse reactions as dizziness, drowsiness and blurred vision is possible.

Pediatric use

Omeprazole STADA capsules are used to treat children:

from 2 years old and weighing more than 20 kg: reflux esophagitis, symptomatic therapy of heartburn and sour eructation in GERD;
from 4 years: eradication of Helicobacter pylori in children with duodenal ulcer (as part of combination therapy).

With impaired renal function

Patients with impaired renal function do not need to adjust the dose of the drug.

For violations of liver function

The daily dose of Omeprazole STADA in patients with impaired hepatic function should not exceed 20 mg.

Use in the elderly

Elderly patients do not need to adjust the dose of Omeprazole STADA.

Drug interactions

Omeprazole can change the bioavailability of drugs, the absorption of which depends on the acidity (pH) of the medium. Possible interactions:

posaconazole, itraconazole, ketoconazole, erlotinib: their absorption is reduced, which may cause their insufficient clinical effectiveness; the combination of omeprazole with posaconazole and erlotinib is contraindicated;
atazanavir, nelfinavir: their plasma concentration is significantly reduced (interaction at the level of the CYP2C19 isoenzyme is possible), which can lead to a decrease in their therapeutic efficacy and the emergence of resistance; the combination is not recommended;
digoxin: its absorption and bioavailability increase; with combined use, care must be taken, especially in elderly patients, and the plasma concentration of digoxin in the blood must be monitored;
clopidogrel: there is a pharmacokinetic and pharmacodynamic interaction at the level of the isoenzyme CYP2C19, while the pharmacological activity of clopidogrel decreases due to a decrease in the content of its active metabolite in blood plasma;
iron salts, vitamin B ₁₂ (cyanocobalamin): their absorption is reduced.

When combined with drugs metabolized by the isoenzyme CYP2C19, a decrease in their metabolism and an increase in action may be observed. This is due to the fact that omeprazole is a moderate inhibitor of the isoenzyme CYP2C19. Possible interactions:

phenytoin: monitoring the condition of patients taking omeprazole and phenytoin is necessary; a dose reduction of phenytoin may be required; there is no information confirming the change in the plasma concentration of phenytoin in the blood against the background of long-term combined use of these drugs;
warfarin and other vitamin K antagonists: it is necessary to monitor the INR (international normalized ratio); some patients require dose reduction of these drugs; there is no information confirming the change in the coagulation time during long-term combined therapy;
saquinavir: the combination requires caution; an increase in the plasma concentration of saquinavir in the blood is possible, which is associated with the likelihood of prolongation of the QT interval and PR on the ECG;
cilostazol: the maximum concentration and AUC of cilostazol and one of its active metabolites increases; the mechanism of interaction is unclear;
methotrexate: its plasma concentration in the blood increases; if it is necessary to treat with methotrexate in high doses, taking omeprazole should be temporarily stopped;
tacrolimus: its plasma concentration in the blood increases; during the period of therapy, careful monitoring of this indicator is required, as well as monitoring of renal function; the dose of tacrolimus can be adjusted if indicated.

When combined with drugs that inhibit the isoenzymes CYP2C19 and CYP3A4, the plasma concentration of omeprazole in the blood may increase. Possible interactions:

voriconazole: AUC of omeprazole increases significantly; if necessary, combined use, the daily dose of omeprazole should not exceed 20 mg;
clarithromycin: the plasma concentration of both drugs increases;
erythromycin: the plasma concentration of omeprazole is increased.

With the simultaneous use of omeprazole with drugs that induce isoenzymes CYP2C19 and / or CYP3A4 (drugs St. John's wort, rifampicin), there is a decrease in the plasma concentration of omeprazole in the blood, which is associated with the acceleration of its metabolism.

Analogs

Omeprazole STADA analogues are: Pleom-20, Omizak, Romesek, Omal, Gastrozol, Omitox, Losek, Zhelkizol, Omeprazole, Ultop, Helicid, Promez, Ulkozol, Tsisagast, Ortanol.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews of Omeprazole STADA

Reviews of Omeprazole STADA are predominantly positive. It is characterized as an inexpensive, effective drug with a quick and mild effect. Also indicate a convenient dosing regimen. There are almost no reported side effects.

Price for Omeprazole STADA in pharmacies

The approximate price for Omeprazole STADA (30 capsules) is 41–70 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!