OmeVel

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

OmeVel: 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. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Use in the elderly
14. Drug interactions
15. Analogs
16. Terms and conditions of storage
17. Terms of dispensing from pharmacies
18. Reviews
19. Price in pharmacies

Latin name: Omevel

ATX code: A02BC01

Active ingredient: omeprazole (Omeprazole)

Manufacturer: OOO Velpharm (Russia)

Description and photo update: 2019-08-10

OmeVel is a drug that reduces the secretion of hydrochloric acid in the stomach.

Release form and composition

The drug is produced in the form of enteric capsules: hard gelatinous, size No. 2, white body, yellow cap; the contents of the capsules are almost white or white pellets (10 pieces in a blister, in a cardboard box 1, 2 or 3 blisters; 10, 20, 30 pieces in a polymer can, in a cardboard box 1 can. Each the pack also contains instructions for the use of OmeVel).

1 capsule contains:

active substance: pellets with omeprazole - 233 mg (corresponds to the content of omeprazole in the amount of 20 mg);
additional components: hypromellose (hydroxypropyl methylcellulose), acrylic coating L30D, mannitol, calcium carbonate, sugar syrup (sucrose), sugar pellets (sucrose), potassium hydrogen phosphate, macrogol-6000, sodium lauryl sulfate, povidone K-30, titanium dioxide, sodium hydroxide, talc, polysorbate-80;
capsule shell: gelatin, titanium dioxide; additionally for the cap - quinoline yellow dye, sunset yellow dye.

Pharmacological properties

Pharmacodynamics

Omeprazole is a racemic mixture of two enantiomers. The drug helps to reduce the production of hydrochloric acid due to the specific suppression of the proton pump of the gastric parietal cells. After a single use, it has a quick effect and causes a reversible inhibition of the production of hydrochloric acid.

As part of the group of weak bases, the active substance enters an active phase in the acidic medium of the cell tubules of the parietal layer of the gastric mucosa, where it inhibits the enzyme hydrogen-potassium adenosine triphosphatase (H ⁺ / K ⁺ -ATP-ase) - a proton pump. The effect of OmeVel on the last phase of hydrochloric acid production is dose-dependent and demonstrates inhibition of both basal and stimulated secretion, regardless of the nature of the stimulating factor.

After oral administration of omeprazole 1 time per day, there is a rapid and effective decrease in the daytime and nighttime production of hydrochloric acid, reaching its maximum during 4 days of the course of treatment. In the presence of a duodenal ulcer, the use of the drug at a dose of 20 mg leads to a steady decrease by at least 80% in 24-hour gastric acidity. At the same time, a decrease in the average maximum content of hydrochloric acid by 70% is achieved within 24 hours after stimulation with pentagastrin. In patients with duodenal ulcer disease, oral daily intake of omeprazole at a dose of 20 mg provides an acidity value at a pH level> 3 for about 17 hours.

The degree of suppression of hydrochloric acid production is proportional to the area under the concentration-time curve (AUC) of omeprazole and is not proportional to its actual concentration in the blood at a given time. During therapy with OmeVel, tachyphylaxis was not observed.

The active substance in vitro exhibits a bactericidal effect against Helicobacter pylori. With the combined use of omeprazole with antibacterial agents, the elimination of Helicobacter pylori is accompanied by rapid relief of symptoms, intensive healing of defects in the mucous membrane of the gastrointestinal tract (GIT) and the achievement of long-term remission of peptic ulcer disease, which reduces the risk of complications in the form of bleeding as effectively as conducting a permanent maintenance therapy.

Pharmacokinetics

The drug is rapidly absorbed from the gastrointestinal tract, its maximum plasma concentration (C _max) is recorded 1–2 hours after administration. Absorption of omeprazole takes place in the small intestine, usually within 3-6 hours. After a single oral administration, the bioavailability is approximately 40%, and with regular use once a day, it rises to 60%. Simultaneous intake with food does not affect the bioavailability of the drug.

With plasma proteins, the connection of omeprazole is on average 95%, the volume of distribution is about 0.3 l / kg. The metabolic transformation of the active substance takes place entirely in the liver. The main isoenzymes responsible for the course of its metabolism include CYP2C19 and CYP3A4. With the participation of the isoenzyme CYP2C19, the main metabolite of the drug, hydroxyomeprazole, is formed. The sulfide and sulfone metabolites do not interfere with the production of hydrochloric acid.

The half-life (T _1/2) of the drug is approximately 40 minutes (varies in the range of 30–90 minutes). On average, 80% of the dose taken is excreted in the form of metabolites in the urine, the rest in the feces.

Indications for use

In adults:

ulcerative defects of the stomach and duodenum 12 - treatment and prevention;
erosive and ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) - treatment and prevention;
eradication of Helicobacter pylori against the background of gastric ulcer and duodenal ulcer - as part of a combination treatment;
symptomatic gastroesophageal reflux disease (GERD); reflux esophagitis;
Zollinger-Ellison syndrome;
dyspepsia due to acidity.

In pediatrics (with a child's body weight over 20 kg):

GERD therapy - in children over 2 years old;
eradication of Helicobacter pylori, which caused ulcerative lesions of the duodenum (as part of complex treatment) - in children over 4 years old.

Contraindications

Absolute:

glucose-galactose malabsorption;
deficiency of sucrase / isomaltase;
intolerance to fructose;
combined use with clarithromycin in the presence of liver failure;
simultaneous reception with erlotinib, atazanavir, posaconazole, Hypericum perforatum (St. John's wort);
children under 2 years of age - with the treatment of GERD;
children under 4 years of age - in the treatment of duodenal ulcer associated with Helicobacter pylori;
the child's body weight is less than 20 kg;
children and adolescents up to 18 years old - with therapy for all other indications;
hypersensitivity to any of the constituents of the drug.

Relative (OmeVel capsules should be taken with extreme caution):

swallowing disorder;
failure of liver and / or kidney function;
osteoporosis;
significant spontaneous weight loss;
vomiting mixed with blood, repeated vomiting;
discoloration of stool (tarry stools);
simultaneous use with the following drugs: itraconazole, digoxin, diazepam, tacrolimus, voriconazole, clopidogrel, phenytoin, ketoconazole, saquinavir, cilostazol, warfarin, rifampicin, clarithromycin, Hypericum perforatum drugs.

OmeVel, instructions for use: method and dosage

OmeVel capsules are taken orally, in the morning 30 minutes before meals. They should be swallowed whole without chewing or crushing the contents, drinking plenty of water.

It is impossible to dissolve the drug in milk or carbonated drinks. In cases where the patient has difficulty swallowing the capsule whole, you can open it and stir the contents in a slightly acidified liquid, juice or fruit puree. The resulting mixture must be consumed within 30 minutes after preparation.

The recommended dosage regimen of OmeVel in adult patients (frequency of administration - 1 time per day):

peptic ulcer of the duodenal ulcer during the period of exacerbation: in a daily dose of 20 mg, usually for 2 weeks; if necessary, it is allowed to increase the course by another 2 weeks; in case of insufficient response to therapy, the dose is increased to 40 mg per day for 4 weeks;
peptic ulcer in the acute phase; reflux esophagitis: in a daily dose of 20 mg, usually for 4 weeks, if after the completion of the first course it is not possible to achieve complete healing of the ulcer / cure of esophagitis, an additional 4-week course is carried out; in the presence of a peptic ulcer that is resistant to treatment or a severe form of esophagitis, the dose is increased to 40 mg per day, the desired result of therapy in most cases is achieved within 8 weeks;
peptic ulcer of the stomach and duodenal ulcer in order to prevent relapse: in a daily dose of 20 mg, if necessary, the dose is increased to 40 mg;
ulcerative and erosive defects of the stomach and duodenum, caused by the use of NSAIDs for therapy and for prophylaxis in patients at risk (over the age of 60 years; having indications in the history of ulcerative erosive lesions of the stomach and duodenum 12): in a daily dose of 20 mg, the course is 4 weeks, in the absence of healing, the treatment is extended for another 4 weeks;
peptic ulcer and 12 duodenal ulcer associated with Helicobacter pylori: the following eradication regimens are shown (course of treatment 1 week) - 1000 mg amoxicillin, 500 mg clarithromycin, 20 mg omeprazole, 2 times a day at the same time; metronidazole 400/500 mg (or tinidazole 500 mg), clarithromycin 250/500 mg, omeprazole 20 mg, 2 times a day at the same time; amoxicillin 500 mg with metronidazole 400/500 mg (or with tinidazole 500 mg) both 3 times a day, in combination with omeprazole at a dose of 40 mg once a day; in the case when after the therapy the patient remains Helicobacter pylori-positive, with each treatment regimen it is possible to prescribe a second course;
GERD (symptomatic treatment): in a daily dose of 20 mg, if necessary, individual dose titration is possible; if the symptoms of the disease persist after the completion of 4 weeks of a continuous course of therapy, additional examination is required;
non-ulcer dyspepsia: the maximum permissible daily dose is 20 mg, the maximum course is 2 weeks; if after the therapy there is no relief of symptoms, or they become more pronounced, you should consult a specialist;
Zollinger-Ellison syndrome: the dose is determined individually, the initial daily dose may be 60 mg, if necessary, the dose may be increased to 80-120 mg; if a daily dose exceeding 80 mg is prescribed, it must be divided into 2 doses.

The recommended dosage regimen of OmeVel in children (frequency of administration - 1 time per day):

GERD (treatment in children after 2 years with a body weight of more than 20 kg): in a daily dose of 20 mg for 4–8 weeks, if necessary, an increase in the dose to 40 mg is allowed; in pediatric practice for the treatment of GERD, the recommended daily dose of omeprazole is 0.7–3.3 mg per 1 kg of body weight, if symptoms persist after 2–4 weeks, additional examination is required;
peptic ulcer of 12 duodenal ulcer caused by H. pylori (treatment in children after 4 years): in a daily dose of 20 mg in combination with antibacterial agents; in pediatric practice, the recommended daily dose of omeprazole in H. pylori eradication regimens is 1–2 mg / kg.

Side effects

blood and lymphatic system: rarely - hypochromic microcytic anemia in children; extremely rarely - pancytopenia, leukopenia, reversible thrombocytopenia, agranulocytosis;
immune system: extremely rarely - fever, rash, fever, bronchospasm, angioedema, allergic vasculitis, anaphylactic reactions or shock;
nervous system: often - lethargy, drowsiness, headache (these disorders can be aggravated with prolonged therapy); infrequently - dizziness, insomnia; rarely - confusion, paresthesia, hallucinations, are observed mainly in elderly patients or against the background of a severe course of the disease; extremely rarely - anxiety, depression, especially in the elderly or in severe illness;
hearing organ and labyrinthine disorders: infrequently - hearing impairments, including ringing in the ears; vertigo (usually goes away after treatment is completed);
organ of vision: infrequently - visual disturbances, including a decrease in the acuity and clarity of visual perception, a decrease in visual fields (as a rule, they disappear after the termination of therapy);
skin and subcutaneous tissues: infrequently - rash, itching, urticaria, increased sweating, alopecia, photosensitivity, erythema multiforme; extremely rare - toxic epidermal necrolysis, Stevens-Johnson syndrome;
musculoskeletal system and connective tissue: infrequently - fractures of the bones of the wrist, vertebrae, femoral head; rarely - arthralgia, myalgia; extremely rare - muscle weakness;
hepatobiliary system: infrequently - changes in indicators of the activity of liver enzymes (are reversible); extremely rare - jaundice, liver failure, hepatitis, encephalopathy in patients with background liver damage;
kidneys and urinary tract: rarely - interstitial nephritis;
digestive tract: often - flatulence, nausea, constipation, diarrhea, vomiting, abdominal pain (as a rule, the severity of these phenomena increases with continued treatment); rarely - a violation of taste, microscopic colitis, a change in the color of the tongue to brown-black and the occurrence of benign cysts of the salivary glands when taken in combination with clarithromycin (the disorders are reversible after the end of the course); extremely rare - dryness of the oral mucosa, candidiasis, stomatitis, pancreatitis;
general disorders: infrequently - peripheral edema (usually disappear after stopping treatment); rarely, hyponatremia; extremely rare - gynecomastia; with an unknown frequency - hypomagnesemia.

Overdose

Symptoms of an OmeVel overdose include the following effects: increased sweating, drowsiness, agitation, dry mouth, vomiting, diarrhea, nausea, abdominal pain, blurred vision, headache, dizziness, depression, confusion, arrhythmias.

There is no specific antidote, hemodialysis is ineffective. In case of overdose, symptomatic treatment is recommended.

special instructions

Before starting a course of therapy with OmeVel, with an existing or suspected gastric ulcer, it is necessary to exclude the presence of a malignant neoplasm, since treatment with omeprazole can mask its symptoms and delay the correct diagnosis.

As a result of a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A (CgA) increases, which can affect the results of examinations in order to detect neuroendocrine tumors. In order to prevent this effect 5 days before the study of the CgA level, you should temporarily stop taking OmeVel.

In the course of treatment in the presence of severe hepatic insufficiency, liver enzyme parameters should be monitored regularly.

The drug contains sodium, this should be borne in mind by persons on a controlled sodium diet.

In the treatment of erosive and ulcerative defects caused by the use of NSAIDs, it is required, if possible, to limit or stop taking the latter in order to enhance the effect of antiulcer therapy.

According to research data, against the background of prolonged (more than 1 year) maintenance treatment with omeprazole, the threat of fractures of the femoral head, wrist bones and vertebrae is aggravated, mainly in elderly patients or with existing predisposing factors. If there is a risk of osteoporosis, an adequate intake of calcium and vitamin D should be ensured.

In patients taking OmeVel for more than 1 year, as with therapy with other proton pump inhibitors, severe hypomagnesemia may occur. Persons receiving treatment with the drug for a long time, especially in combination with digoxin or other drugs that can lower the plasma magnesium content in the blood (including diuretics), need to regularly monitor the concentration of magnesium.

OmeVel, like other acidity lowering agents, can help reduce the absorption of vitamin B ₁₂ (cyanocobalamin). This must be taken into account during a prolonged course of therapy for patients with a lack of vitamin B ₁₂ in the body or with risk factors for impaired absorption.

In patients receiving drugs that are inhibitors of gastric secretion for a long time, the development of glandular cysts in the stomach was more often recorded. These effects are associated with physiological changes due to the suppression of the production of hydrochloric acid and in the course of further therapy undergo a reverse development.

A decrease in acid secretion in the stomach contributes to an increase in the growth of normal intestinal microflora, and as a consequence, to a small extent, aggravates the risk of developing intestinal infections caused by bacteria of the genus Campylobacter spp., Salmonella spp. and possibly Clostridium difficile.

Influence on the ability to drive vehicles and complex mechanisms

Against the background of treatment with OmeVel, patients who drive vehicles or engage in potentially hazardous activities need to be especially careful due to the possible development of disorders of the organ of vision and the nervous system.

Application during pregnancy and lactation

According to research results, no negative effects of omeprazole on the course of pregnancy and / or on the health of the fetus and newborn have been identified. OmeVel can be used with caution during pregnancy.

It has been established that omeprazole is excreted in breast milk, however, if taken in therapeutic doses, an undesirable effect on the child is unlikely.

Pediatric use

For children and adolescents under 18 years of age, the use of OmeVel is contraindicated, with the exception of the treatment of duodenal ulcers caused by Helicobacter pylori in children over 4 years of age weighing more than 20 kg, and the treatment of GERD in children over 2 years of age weighing more than 20 kg. For other indications, the safety and efficacy of using OmeVel in children and adolescents has not been established.

With impaired renal function

In the presence of functional disorders of renal function, correction of the dosage regimen of OmeVel is not required.

For violations of liver function

In the presence of violations of the liver, the metabolism of the drug slows down, as a result, its bioavailability increases. Patients with hepatic insufficiency are recommended to take OmeVel 10–20 mg, the daily dose should not be higher than 20 mg.

Use in the elderly

In elderly people, 75–79 years and older, the rate of biotransformation of omeprazole is slightly reduced, which does not require a change in the dosage regimen of OmeVel.

Drug interactions

nelfinavir: simultaneous use with omeprazole at a dose of 40 mg per day reduced the exposure of this substance by about 40% and the average exposure of the active metabolite M8 by 75-90%; the interaction may have involved the mechanism of suppression of CYP1C19; this combination is contraindicated;
atazanavir: combination therapy of omeprazole at a daily dose of 40 mg with atazanavir 300 mg / ritonavir 100 mg caused a decrease in atazanavir exposure to 75%; increasing the dose of atazanavir to 400 mg did not compensate for the effect of omeprazole on atazanavir exposure; the use by healthy volunteers of omeprazole at a daily dose of 20 mg with atazanavir at a dose of 400 mg and ritonavir at a dose of 100 mg provided an average of 30% reduction in atazanavir exposure, and was comparable to the exposure with a single dose of atazanavir 300 mg and ritonavir 100 mg; this combination is not recommended;
clopidogrel: according to the results of a five-day crossover clinical study of the use of clopidogrel at 75 mg per day (in a loading dose of 300 mg) and the combination of clopidogrel with omeprazole at 80 mg, the effect of the active metabolite of clopidogrel with combined administration decreased on days 1 and 5, respectively, by 46 and 42 %, and the average time of inhibition of platelet aggregation by 47 and 30%, respectively; in another study, it was found that taking clopidogrel and omeprazole at different times cannot prevent their interaction, which is presumably caused by the inhibitory effect of omeprazole on CYP2C19; there is conflicting evidence of the clinical impact of these pharmacokinetic / pharmacodynamic interactions on the occurrence of severe cardiovascular lesions;
digoxin: the combination of this substance with omeprazole (20 mg per day) led to an increase in the bioavailability of digoxin by 10%; although against the background of treatment with omeprazole, glycosidic intoxication is rarely observed, enhanced control is recommended, especially when treating elderly patients;
vitamin K antagonists (including R-warfarin), diazepam, cilostazol, phenytoin (drugs whose metabolism occurs with the participation of the isoenzyme CYP2C19): omeprazole is a moderate inhibitor of CYP2C19, which can lead to a deterioration in metabolism and an increase in the systemic exposure of these drugs;
phenytoin: it is recommended that during the first 2 weeks after the start of combination therapy and when adjusting doses of phenytoin, monitor the concentration of the latter in plasma; control and further change in the dose of phenytoin is required before the end of therapy with OmeVel;
cilostazol: in the course of a clinical study, against the background of the combined use of this substance with omeprazole at a dose of 40 mg, an increase in AUC and C _{max of} cilostazol was recorded by 26 and 18%, respectively, and in one of its active metabolites - by 69 and 29%, respectively;
erlotinib, posaconazole, itraconazole, ketoconazole: there was a significant decrease in the absorption of these substances and a deterioration in their clinical efficacy;
tacrolimus: there was a decrease in the serum concentration of this substance; it is required to carefully monitor the level of tacrolimus, creatinine clearance and, if necessary, adjust the dose of the drug;
saquinavir: the combination of omeprazole with saquinavir / ritonavir was well tolerated in patients with human immunodeficiency virus (HIV) infection, and a decrease in the plasma saquinavir content was determined to about 70%;
clarithromycin, voriconazole and other substances capable of inhibiting CYP3A4 and CYP2C19 isoenzymes: a decrease in the serum level of omeprazole is possible due to an increase in its metabolic rate;
metronidazole, amoxicillin: no changes in the content of omeprazole in plasma were recorded;
S-warfarin, metoprolol, estradiol, diclofenac, piroxicam, phenacetin, naproxen, budesonide: no clinically significant interaction was detected;
propranolol, theophylline, lidocaine, ethanol, quinidine, caffeine, antacids: no effect of omeprazole on these drugs was found.

Analogs

OmeVel's analogs are Omeprazole, Gastrozol, Losec, Omez, Ortanol, Omitox, Romesek, Promez, Helicid, Ultop, Cisagast, etc.

Terms and conditions of storage

Store in a place out of the reach of children, protected from light, at a temperature not exceeding 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about OmeVel

Currently, on specialized sites there are no reviews about OmeVel from specialists or patients, on the basis of which it would be possible to realistically assess the effectiveness and disadvantages of this drug.

Price for OmeVel in pharmacies

The price of OmeVel, enteric capsules, can be 130–140 rubles. per package containing 30 pcs.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, 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!