Omitox - Instructions For Use, Price, Reviews, Capsule Analogues

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

Omitox

Omitox: instructions for use and reviews

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

Latin name: Omitox

ATX code: A02BC01

Active ingredient: omeprazole (Omeprazole)

Manufacturer: Shreya Life Science Pvt. Ltd. (Shreya Life Sciences Pvt. Ltd.) (India)

Description and photo updated: 30.11.2018

Prices in pharmacies: from 110 rubles.

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Omitox is an antiulcer drug; a proton pump inhibitor (PPI).

Release form and composition

The preparation is produced in the form of capsules: opaque, hard gelatinous, with a body and a lid of a light cream color; the contents of the capsules are almost white granules (7 or 10 capsules in strips / blisters, in a cardboard box 1, 2, 3, 4 or 10 strips / blisters and instructions for using Omitox).

1 capsule contains:

• active substance: omeprazole - 10 or 20 mg;
• additional components: mareon, gelatin, purified water.

Pharmacological properties

Pharmacodynamics

Omeprazole inhibits hydrogen-potassium adenosine triphosphatase (H ⁺ / K ⁺ -ATP-ase) in the parietal cells of the stomach, an enzyme of the hydrolase class, which is a proton pump. The active substance thereby prevents the final stage of hydrochloric acid production; this effect causes a decrease in the level of basal and stimulated gastric secretion, regardless of the type of stimulus. After a single oral dose, the effect of omeprazole is manifested within the first hour and is noted within 24 hours, the maximum therapeutic effect is recorded after 2 hours. After the end of the use of Omitox, the complete restoration of secretory activity occurs in 3-5 days.

Pharmacokinetics

The active substance of Omitox is rapidly absorbed from the gastrointestinal tract (GIT), the maximum concentration (C _max) in the plasma is observed 0.5–1 hour after administration.

The bioavailability of omeprazole is approximately 30-40%. It binds to plasma proteins by almost 90%, biotransformation almost completely takes place in the liver.

The half-life (T _½) is 0.5–1 hour. The active substance is excreted by the kidneys, mostly in the form of metabolites.

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

With hepatic failure, T _½ is 3 hours, bioavailability is 100%.

In elderly patients, the excretion of omeprazole decreases, and the bioavailability increases.

Indications for use

For adults:

• peptic ulcer and 12 duodenal ulcer, including prevention of relapse;
• erosive and ulcerative defects of the stomach and duodenum 12 associated with Helicobacter pylori (as part of complex treatment);
• reflux esophagitis, gastroesophageal reflux disease (GERD), including relapse prevention;
• Zollinger-Ellison syndrome and other pathological processes caused by increased gastric secretion;
• erosive and ulcerative lesions of the stomach and duodenum, caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs).

For kids:

• peptic ulcer of 12 duodenal ulcer associated with Helicobacter pylori in children over 4 years of age (as part of complex treatment);
• GERD in children over 2 years of age.

Contraindications

Absolute:

• intolerance to lactose, fructose, impaired absorption of glucose / galactose or deficiency of lactase, sucrase / isomaltase (since the product contains lactose);
• age up to 2 years and body weight less than 10 kg - in the treatment of reflux esophagitis, symptomatic treatment of acid belching and heartburn caused by GERD;
• age up to 4 years or body weight less than 15 kg - in the treatment of duodenal ulcer caused by Helicobacter pylori;
• age up to 18 years for all indications, except for GERD and duodenal ulcer associated with Helicobacter pylori;
• simultaneous use with nelfinavir, erlotinib and posaconazole, as well as drugs including St. John's wort;
• combined administration with clarithromycin in patients with hepatic impairment;
• hypersensitivity to any of the constituents of the drug.

Relative (Omitox capsules should be used with extreme caution):

• failure of liver and / or kidney function;
• osteoporosis;
• pregnancy;
• simultaneous use with the following drugs: rifampicin, clopidogrel, clarithromycin, warfarin, itraconazole, diazepam, cilostazol, saquinavir, voriconazole, phenytoin, tacrolimus.

Omitox, instructions for use: method and dosage

Omitox is taken orally with a little water. Do not chew the contents of the capsule.

If it is difficult to swallow the whole capsule, the granules contained in it can be swallowed after resorption or opening of the capsule. Also, if necessary, the contents of the capsule can be mixed with yogurt, juice or other slightly acidified liquid, the resulting suspension should be taken within 30 minutes. Do not use Omitox with carbonated water or milk.

Recommended dosing regimen for adults Omitox:

• gastric ulcer: 20 mg 1 time per day, in the vast majority of patients, ulcer scarring is noted within 28 days of treatment; in resistant cases, to achieve healing, a second course of therapy is prescribed for 28 days at a dose of omeprazole up to 40 mg 1 time per day;
• duodenal ulcer: with an active ulcer, take 20 mg 1 time per day, ulcer healing usually occurs within 14 days of treatment; in the case of a resistant course of the disease, another course of 14 days is carried out using Omitox at a dose of 40 mg 1 time per day;
• peptic ulcer and 12 duodenal ulcer (anti-relapse therapy): 20 mg once a day, if necessary, the dose is increased to 40 mg at the same frequency of administration;
• erosive and ulcerative defects of the gastrointestinal tract associated with the intake of NSAIDs: 20 mg 1 time per day for 28 or 56 days (taking into account the response to the therapy);
• reflux esophagitis: 20 mg once a day; in most cases, within 28 days of admission, the desired result is achieved; in resistant cases, a second course of the same duration is carried out as the first; with a severe form of the disease, Omitox is prescribed at 40 mg 1 time per day; in the remission stage, for the prevention of relapses, take 20 mg once a day, for a long time (up to 6 months), if necessary, during the maintenance therapy, the dose is increased to 40 mg;
• symptomatic GERD: 20 mg 1 time per day, individual dose selection is also possible; if after 28 days of taking Omitox in a daily dose of 20 mg it is not possible to stop the symptoms of the disease, an additional examination should be carried out;
• eradication of Helicobacter pylori: the following three-component therapy regimens are usually prescribed (course - 7 days): 2 times a day (morning and evening) - omeprazole 20 mg + clarithromycin 500 mg and amoxicillin 1000 mg, or + clarithromycin 250 mg and metronidazole 400 mg, or + clarithromycin 500 mg and metronidazole 400 mg; or 1 time per day omeprazole 40 mg + 3 times a day amoxicillin 500 mg and metronidazole 400 mg. It is also possible to prescribe two-component therapy (course - 14 days): 2 times a day - omeprazole 20-40 mg + amoxicillin 750 mg; or omeprazole 40 mg once a day + clarithromycin 500 mg 3 times a day or amoxicillin 750-1500 mg twice a day; if necessary (with a positive test for Helicobacter pylori after treatment), a second course can be carried out;
• Zollinger-Ellison syndrome: the dose is determined individually, taking into account the initial level of gastric secretion, depending on clinical indications, therapy lasts as long as necessary; the initial dose is 60 mg per day daily, in case of severe disease or ineffectiveness of other therapeutic methods, the daily dose is increased to 80–120 mg, divided into 2 doses;
• dyspepsia caused by increased production of hydrochloric acid: in order to relieve pain and / or relieve feelings of discomfort in the epigastrium, with or without heartburn, appoint 20 mg 1 time per day; if symptoms persist after 28 days of treatment, additional testing is recommended.

In the treatment of GERD in children over 2 years old (with a body weight of more than 10 kg), Omitox is prescribed at a dose of 20 mg once a day, the course is 28–56 days. If necessary, it is allowed to increase the daily dose to 40 mg with the same frequency of administration.

In case of duodenal ulcer, excited by Helicobacter pylori, in children over 4 years old, Omitox is used 2 times a day in combination with two antibiotics, the course is 7 days. Single doses of drugs are set depending on the child's body weight:

• weight 15-30 kg: omeprazole - 10 mg, amoxicillin - 25 mg / kg, clarithromycin - 7.5 mg / kg;
• weight 31-40 kg: omeprazole - 20 mg, amoxicillin - 750 mg, clarithromycin - 7.5 mg / kg;
• weight over 40 kg: omeprazole - 20 mg, amoxicillin - 1000 mg, clarithromycin - 500 mg.

Side effects

• blood and lymphatic system: rarely - thrombocytopenia, leukopenia, in children - hypochromic microcytic anemia; extremely rare - pancytopenia, agranulocytosis;
• immune system: rarely - hypersensitivity reactions such as fever, anaphylactoid reactions / anaphylactic shock, angioedema; extremely rare - eosinophilia;
• nervous system: often - headache; infrequently - drowsiness / insomnia, dizziness, paresthesia; rarely - a violation of taste, agitation, depression, reversible confusion; extremely rarely - aggression, hallucinations; in patients with severe liver damage - encephalopathy;
• digestive system: often - flatulence, nausea, abdominal pain, vomiting, constipation / diarrhea; infrequently - increased activity of hepatic transaminases and alkaline phosphatase; rarely - stomatitis, dryness of the oral mucosa, gastrointestinal candidiasis, microscopic colitis, hepatitis (with or without jaundice); extremely rare - liver failure (in patients with a previous severe liver disease);
• metabolism and nutritional disorders: rarely - hyponatremia; with an unknown frequency - hypomagnesemia;
• respiratory system, chest and mediastinal organs: rarely - bronchospasm;
• musculoskeletal and connective tissue: infrequently - fracture of the vertebrae, hip, wrist bones; rarely - arthralgia, myalgia; extremely rare - muscle weakness;
• genitals and mammary gland: extremely rare - gynecomastia;
• kidneys and urinary tract: rarely - interstitial nephritis;
• skin and subcutaneous tissue: infrequently - itchy skin, skin rash, dermatitis, urticaria; rarely - alopecia, photosensitivity; extremely rare - toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative erythema multiforme;
• organ of vision: rarely - visual impairment;
• general disorders: infrequently - peripheral edema, malaise; rarely - increased sweating.

Cases of formation of gastric glandular cysts have been recorded during a long course of PPI treatment (they arise as a result of suppression of hydrochloric acid production and are benign).

Overdose

Symptoms of an Omitox overdose may include: drowsiness, headache, agitation, blurred vision, nausea, dry mouth, sweating, tachycardia. The specific antidote is unknown, if an overdose is suspected, symptomatic treatment is performed.

special instructions

Before you start taking Omitox, you should exclude the presence of a possible malignant disease in the upper gastrointestinal tract (especially with a stomach ulcer), since drug therapy, masking the symptoms, can delay the correct diagnosis. If, 5 days after the start of the course, there is no improvement in the condition or the attacks of heartburn become more severe, you must stop taking the drug and consult a doctor.

Patients over 45 years of age with symptoms of heartburn, or who have had heartburn for the first time, should take Omitox only after consulting a specialist.

Omitox should not be used without medical supervision if at least one of the following symptoms or conditions is present:

• fatigue, weight loss for no apparent reason and / or lack of appetite;
• history of gastric ulcer and / or duodenal ulcer;
• prolonged abdominal pain;
• frequent vomiting;
• melena / bloody vomiting / rectal bleeding;
• pain when swallowing / swallowing disorder;
• shortness of breath, chronic cough;
• jaundice;
• heartburn observed for more than three months;
• chest pain (especially radiating to the upper limbs or neck, or chest tightness) with sweating, shortness of breath, or dizziness;
• liver failure;
• a history of the next of kin for stomach / esophageal cancer.

PPIs, primarily when used for more than 12 months in high doses, may moderately increase the risk of fractures of the hip, vertebrae, and wrist bones, especially in elderly patients or with other risk factors. Observational studies suggest that PPIs may increase the overall risk of fracture by 10–40%. Patients at risk of developing osteoporosis should receive therapy according to the latest clinical guidelines.

Cases of severe hypomagnesemia were reported during treatment with omeprazole for at least 3 months. Manifestations of this complication can be dizziness, fatigue, convulsions, delirium, ventricular arrhythmia. Hypomagnesemia usually resolved after discontinuation of PPIs with the introduction of magnesium preparations. Patients who have to take omeprazole for a long time, or if omeprazole is prescribed in combination with digoxin or other drugs that can cause hypomagnesemia (including diuretics), it is required to determine the level of magnesium before starting the course and periodically during its course.

Omeprazole, as well as other drugs that suppress the production of hydrochloric acid, can reduce the absorption of vitamin B ₁₂ (cyanocobalamin), since the drug causes hypo- or achlorhydria. With long-term treatment, this fact must be taken into account in patients with a reduced supply of vitamin B ₁₂ or with risk factors for a decrease in its absorption.

In the case of prolonged use of Omitox, the formation of glandular cysts in the stomach is more often recorded, which pass independently against the background of ongoing therapy. This phenomenon is due to physiological changes due to inhibition of the production of hydrochloric acid.

A long-term decrease in the acidity of gastric juice causes an increase in the growth of normal intestinal microflora, which can also provoke a slight increase in the risk of developing intestinal infections caused by bacteria of the genus Campylobacter spp. and Salmonella spp. and, presumably, Clostridium difficile bacteria in hospitalized patients.

As a result of a decrease in the production of hydrochloric acid, the plasma level of chromogranin A (CgA) in the blood increases, which can cause false-positive test results for the detection of neuroendocrine tumors. To prevent this exposure, you must temporarily stop taking PPIs at least 5-14 days before the CgA level is established.

The simultaneous intake of Omitox with food does not affect its effectiveness.

Influence on the ability to drive vehicles and complex mechanisms

With the development of drowsiness, dizziness, visual impairment during therapy with Omitox, one should refrain from operating complex and potentially dangerous mechanisms, including driving vehicles.

Application during pregnancy and lactation

According to the results of the studies, omeprazole does not have a negative effect on the health of pregnant women, as well as on the fetus. At the same time, there is insufficient data confirming its complete safety for the fetus; therefore, it is not recommended to use Omitox during pregnancy.

Omeprazole passes into breast milk, but when used in therapeutic doses, it is unlikely to affect the infant. If it is necessary to take a course of the drug during lactation, it is recommended to resolve the issue of stopping breastfeeding.

Pediatric use

In children over 2 years of age and with a body weight of more than 10 kg, the use of Omitox is allowed only for the treatment of GERD, in children over 4 years of age or with a body weight of more than 15 kg - for the treatment of duodenal ulcer associated with Helicobacter pylori (as part of a complex treatment). For all other indications, taking the drug is contraindicated in patients under 18 years of age.

With impaired renal function

Patients with impaired renal function do not need individual dose selection.

For violations of liver function

In the presence of functional disorders of the liver, as a rule, the drug is prescribed in a daily dose of 10–20 mg.

The combined use of Omitox with clarithromycin is contraindicated in patients with hepatic insufficiency.

Use in the elderly

No dose adjustment is required for patients over 65 years of age.

Drug interactions

• ketoconazole, erlotinib, posaconazole, itraconazole, cyanocobalamin, iron preparations (drugs whose bioavailability depends on the acidity of the gastric juice): absorption of these drugs may increase or decrease;
• nelfinavir, atazanavir: a significant decrease in the level of these substances in plasma is possible; combinations are not recommended;
• warfarin (R-warfarin) and other vitamin K antagonists: a decrease in their doses may be required due to an increase in plasma concentration and T _½; it is required to monitor the International Normalized Ratio (INR); against the background of long-term treatment with warfarin, concomitant administration of omeprazole at a dose of 20 mg per day may lead to a change in the coagulation time;
• diazepam, phenytoin, as well as other drugs metabolized in the liver with the participation of the isoenzyme CYP2C19: an increase in plasma concentration and T _{½ of} these drugs may be required, which may require a decrease in their doses; however, when combining omeprazole at a dose of 20 mg with phenytoin, the plasma level of the latter in patients receiving the drug for a long time is not affected by omeprazole;
• digoxin: there is an increase in its bioavailability by 10% when combined with omeprazole at a dose of 20 mg; care should be taken to combine these funds in elderly patients;
• cilostazol: an increase in plasma concentration and T _{½ of} cilostazol is possible, which may require a decrease in its dose; while its combination with omeprazole in a daily dose of 40 mg fixed increase in the area under the curve (AUC) and C _max of cilostazol at 26 and 18%, respectively, and one of its active metabolite - by 69 and 29% respectively;
• methotrexate: against the background of the combined intake of this substance with PPI, its level in plasma may increase; when using methotrexate in high doses, it is necessary to decide on the temporary cancellation of omeprazole;
• tacrolimus: the plasma concentration of this substance increases, due to which dose adjustment may be necessary; when carrying out combination therapy, it is required to monitor the plasma level of tacrolimus and creatinine clearance;
• clopidogrel: when used simultaneously with omeprazole on the first day of treatment, the concentration of clopidogrel in plasma decreases by 46%, and on the fifth - by 42%; the simultaneous intake of these substances should be avoided, their intake at different times of the day also does not exclude the risk of interaction;
• voriconazole, clarithromycin and other inhibitors of the isoenzymes CYP2C19 and CYP3A4: the plasma concentration of omeprazole increases more than 2 times, which may require a change in the dose of the latter with prolonged use against the background of severe hepatic insufficiency; in the case of short-term combination therapy, dose adjustment is not required;
• metronidazole or amoxicillin: there is no change in the plasma concentration of omeprazole;
• rifampicin, preparations of St. John's wort (Hypericum perforatum) and other inducers of isoenzymes CYP2C19 and CYP3A4: there may be an increase in the metabolism of omeprazole, leading to a decrease in its concentration in plasma;
• theophylline, antacids, caffeine, piroxicam, S-warfarin, naproxen, diclofenac, lidocaine, metoprolol, quinidine, propranolol, ethanol: no clinically significant interaction was recorded.

Analogs

Omitox analogs are: Omez, Ultop, Promez, Cisagast, Otsid, Pleom-20, Gastrozole, Ortanol, Omeprazole, Omeprazole Stada, Romesek, Omizak, etc.

Terms and conditions of storage

Store in a place protected from moisture penetration and inaccessible to children, at a temperature not exceeding 25 ° C.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Omitoks

Reviews about Omitox are in most cases positive. Patients note the effectiveness of the drug in the treatment of gastric ulcer and duodenal ulcer, GERD, reflux esophagitis, NSAID gastropathy, Zollinger-Ellison syndrome. The antiulcer protects the stomach, relieves pain, and eliminates heartburn. With hyperacid gastritis, Omitox reduces the risk of inflammation of the gastric mucosa by reducing the content of hydrochloric acid in gastric juice. Also, the advantage of the drug, many patients consider its relatively low cost.

There are no complaints about the development of undesirable effects.

Price for Omitox in pharmacies

The price of Omitox is approximately 140 rubles per pack containing 30 tablets of 20 mg each.

Omitox: prices in online pharmacies

Drug name Price Pharmacy

Omitox capsules enteric solution. 20mg 30 pcs. 110 RUB Buy

Omitox 20 mg enteric capsules 30 pcs. 110 RUB Buy

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!