International nonproprietary name. Interaction with other drugs

Ultop is another fairly well-known brand of the anti-ulcer drug omeprazole from the respected Slovenian pharmaceutical company KRKA. The drug penetrates the parietal cells of the gastric mucosa and interferes with the work of the so-called proton pump (or H+-K+-ATPase), and therefore the secretion of hydrogen ions into the stomach cavity stops. Thus, under conditions of deficiency of hydrogen ions, the formation of hydrochloric acid does not occur (the final stage of this process is blocked). The action of ultop is dose-dependent, i.e. the decrease in the level of basal (independent of external factors) and stimulated secretion depends on the amount of the drug taken. The secretion of the gastric digestive enzyme pepsin under the influence of ultratop is also reduced. The drug effectively inhibits the production of hydrochloric acid both during the day and at night. The effect of the drug can be fully felt 1 hour after administration. One taken capsule of Ultop retains its effect for 24 hours, with its maximum occurring in the first 2 hours from the moment of administration. Inhibition of gastric secretion is naturally reversible: this process returns to physiological norm 3-5 days after discontinuation of the drug. Good news for patients suffering from Helicobacter pylori: Ultop has a bactericidal effect against Helicobacter pylori.

And now - some specific therapeutic and statistical calculations: with daily use of Ultop in the amount of 20 mg (traditionally recommended dose), the average healing rate of duodenal ulcer in the first 14 days is 68%, after 30 days - 93%. A stomach ulcer heals over the same period of time - 30 days - in 77% of cases, and after 60 days - in 96%. However, recurrence of peptic ulcers occurs in only 41% of cases.

Ultop is available in two dosage forms, which differ fundamentally in the way they are administered into the body: enteric capsules and lyophilisate for preparing a solution for infusion. The second dosage form is used, as a rule, in a hospital setting in severe cases and when it is impossible to take the drug orally. As for the capsules, they should be taken before meals, accompanied by a small amount of liquid (attention: the capsule must not be chewed!). Before the therapeutic course, it is recommended to undergo an oncological examination to exclude the possibility of a malignant neoplasm in the stomach, which can also serve as a source of pain.

Pharmacology

Antiulcer drug, H + -K + -ATPase inhibitor. Inhibits the activity of H + -K + -ATPase in the parietal cells of the stomach and thereby blocks the final stage of the formation of hydrochloric acid, which leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus.

After a single oral dose of the drug, the effect of omeprazole occurs within the first hour and continues for 24 hours, the maximum effect is achieved after 2 hours. After stopping the drug, secretory activity is completely restored after 3-5 days.

Pharmacokinetics

Suction and distribution

After taking the drug orally, omeprazole is quickly absorbed from the gastrointestinal tract, Cmax in plasma is reached after 0.5-1 hour.

Bioavailability is 30-40%. Plasma protein binding is about 90-95%.

Metabolism and excretion

Omeprazole is almost completely biotransformed in the liver. It is an inhibitor of the CYP 2C19 enzyme system.

It is excreted mainly by the kidneys (70-80%) and bile (20-30%). T 1/2 - 0.5-1 hours.

Pharmacokinetics in special clinical situations

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

In elderly people, the excretion of omeprazole is reduced.

For liver failure T1/2 - 2-3 hours.

Release form

The capsules are two-color: the capsule body is light pink, the lid is brown-pink; the contents of the capsules are pellets from white to slightly yellowish or slightly pinkish in color.

Excipients: sugar granules (sucrose, corn starch) - 80 mg, hyprolose - 4.8 mg, magnesium hydroxycarbonate (magnesium carbonate, heavy) - 20 mg, sucrose - 32.2 mg, corn starch - 26.5 mg, sodium lauryl sulfate - 2.5 mg, copolymer methacrylic acid and ethyl acrylate (1:1) 30% dispersion - 31 mg, talc - 6 mg, macrogol 6000 - 3.1 mg, titanium dioxide - 1.9 mg, sodium hydroxide - 0.21 mg.

Composition of the capsule cap: red iron oxide dye (E172) - 0.6153%, titanium dioxide (E171) - 2%, gelatin - up to 100%.
Composition of the capsule body: red iron oxide dye (E172) - 0.0875%, titanium dioxide (E171) - 3%, gelatin - up to 100%.

7 pcs. - blisters (2) - cardboard packs.
7 pcs. - blisters (4) - cardboard packs.
14 pcs. - polyethylene pencil cases with a propylene lid and a hydrosorbent capsule (1) - cardboard packs.
28 pcs. - polyethylene pencil cases with a propylene lid and a hydrosorbent capsule (1) - cardboard packs.

Dosage

The drug is taken orally, before meals (since food intake slows down the absorption of the drug), with a small amount of water (the contents of the capsule must not be chewed).

For duodenal ulcers in the acute phase, Ultop ® is prescribed at a dose of 20 mg/day for 2-4 weeks. In resistant cases, the dose may be increased to 40 mg/day.

For gastric ulcers in the acute phase and erosive-ulcerative esophagitis - 20-40 mg/day for 4-8 weeks.

For gastroesophageal reflux disease, patients with moderate inflammation: 1 caps. 20 mg 1 time/day in the morning, before breakfast for 4-8 weeks. To ensure the dosage regimen below, it is possible to take the drug in another registered dosage (Ultop ®, enteric capsules 40 mg). The duration of the main course of treatment is usually 4-8 weeks. After healing of erosive esophagitis, maintenance treatment is indicated for 26-52 weeks, for severe esophagitis - for life. In cases of relapse of severe GERD or resistant GERD disease, treatment can be extended to 4-8 weeks.

For Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion, the dose is selected individually depending on the initial level of gastric secretion, usually starting from 60 mg/day. If necessary, the dose is increased to 80-120 mg/day, in which case it is divided into 2-3 doses.

For eradication of Helicobacter pylori - 20 mg 2 times a day for 7 or 14 days (depending on the treatment regimen used) in combination with antibacterial drugs.

For non-ulcer dyspepsia, the usual dose is from 10 mg to 20 mg 1 time / day for 2-4 weeks. If after 4 weeks of taking the drug the condition does not improve, or symptoms of dyspepsia reappear shortly after stopping use, the diagnosis should be reconsidered.

To prevent relapses of gastric and duodenal ulcers, 10-20 mg/day is prescribed.

To prevent relapses of gastroesophageal reflux disease - 20 mg/day for a long time. The safety and effectiveness of 12 months of maintenance therapy have been proven. Can be used upon request.

For patients with impaired renal function, no dose adjustment is required.

In patients with impaired liver function, the bioavailability and clearance of omeprazole is increased. In this regard, the therapeutic dose should not exceed 10-20 mg/day.

For elderly patients, no adjustment of the treatment regimen is required.

Overdose

Patients tolerate the drug well in a daily dose of up to 360 mg.

Symptoms: abdominal pain, drowsiness, headache, dizziness, dry mouth, tachycardia, arrhythmia, blurred vision, agitation, confusion, increased sweating, nausea; in rare cases - convulsions, shortness of breath, hypothermia.

Treatment: carry out symptomatic therapy. There is no specific antidote. Hemodialysis is ineffective.

Interaction

Long-term use of omeprazole at a dose of 20 mg 1 time / day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not lead to a change in their plasma concentrations.

There was no interaction between omeprazole and concomitantly taken antacids.

Omeprazole may reduce the absorption of ampicillin esters, iron salts, itraconazole and ketoconazole (because omeprazole increases gastric pH).

Being an inhibitor of cytochrome P450, omeprazole can increase the concentration and reduce the excretion of diazepam, indirect anticoagulants, phenytoin, which in some cases may require a reduction in the doses of these drugs.

When taken simultaneously, the absorption of omeprazole and clarithromycin is enhanced.

Side effects

In rare cases, the following, usually reversible, side effects may occur.

From the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, irritable bowel syndrome, heartburn, dry mouth, taste disturbances, stomatitis, pancreatitis (including fulminant pancreatitis), loss of appetite, discoloration feces, candidiasis of the esophagus, atrophy of the mucous membrane of the tongue, transient increase in the activity of liver enzymes and bilirubin in plasma; in patients with pre-existing severe liver disease - hepatitis (including jaundice), impaired liver function or hepatic encephalopathy.

From the nervous system: headache, dizziness, aggressiveness, apathy, nervousness, agitation, drowsiness, insomnia, tremor, vertigo, paresthesia, depression, hallucinations, confusion; in patients with severe concomitant somatic diseases, patients with previous severe liver disease - encephalopathy.

From the cardiovascular system: angina pectoris, tachycardia, bradycardia, palpitations, increased blood pressure, vasculitis, peripheral edema.

From the genitourinary system: interstitial nephritis, urinary tract infections, microscopic pyuria, proteinuria, hematuria, glucosuria, increased serum creatinine concentration, gynecomastia, testicular pain.

From the musculoskeletal system: muscle weakness, myalgia, arthralgia, ossalgia (bone pain), muscle cramps.

From the hematopoietic system: pancytopenia, agranulocytosis, anemia (including hemolytic anemia), neutropenia, thrombocytopenia, leukocytosis, leukopenia.

From the skin: petechiae, skin itching, skin rash; in some cases - photosensitivity, exudative erythema multiforme, hair loss, alopecia, dry skin, epidermal necrosis, Stevens-Johnson syndrome.

From the respiratory system: sore throat, cough, profuse nosebleeds.

From the senses: ringing in the ears, mild visual and hearing impairment.

Allergic reactions: urticaria, angioedema, bronchospasm, interstitial nephritis, anaphylactic shock, fever.

Laboratory indicators: hypoglycemia, hyponatremia.

Other: back pain, increased sweating; rarely - the formation of gastric glandular cysts during long-term treatment (a consequence of inhibition of hydrochloric acid secretion, is benign, reversible), general fatigue, general weakness, weight gain, fever.

Indications

Enteric capsules 20 mg and 40 mg

  • peptic ulcer of the stomach and duodenum (in the acute phase and anti-relapse treatment), incl. associated with Helicobacter pylori (as part of combination therapy);
  • gastroesophageal reflux disease (GERD), incl. reflux esophagitis and non-erosive forms of reflux disease (NERD);
  • erosive and ulcerative lesions of the stomach and duodenum associated with taking NSAIDs, stress ulcers;
  • Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion.

Enteric capsules 10 mg

  • short-term therapy of non-ulcer dyspepsia;
  • long-term maintenance therapy to prevent relapses of gastroesophageal reflux disease;
  • long-term maintenance therapy to prevent relapses of gastric and duodenal ulcers.

Contraindications

  • childhood;
  • pregnancy;
  • lactation (breastfeeding);
  • hereditary fructose intolerance, glucose-galactose malabsorption syndrome, sucrase/isomaltase deficiency;
  • hypersensitivity to the components of the drug.

The drug should be prescribed with caution in case of renal or liver failure.

Features of application

Use during pregnancy and breastfeeding

The safety of using Ultop ® during pregnancy and lactation has not been studied. Therefore, it is not recommended to prescribe during pregnancy. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Use for liver dysfunction

The drug should be prescribed with caution in case of liver failure.

In patients with severe liver failure, the daily dose of Ultop should not exceed 20 mg.

Use for renal impairment

The drug should be prescribed with caution in case of renal failure.

Ultop ® should be taken with caution in patients with impaired renal function. In patients on dialysis, the pharmacokinetic parameters of omeprazole do not change.

Use in children

Contraindicated in children.

special instructions

Before starting treatment, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), because Treatment, masking symptoms, can delay the correct diagnosis.

Eating slows down the absorption of omeprazole, so the drug is taken before meals.

In special cases, if you have difficulty swallowing a whole capsule, you can swallow its contents after opening or dissolving the capsule, and you can also mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension for 30 minutes.

Ultop ® should be taken with caution in patients with liver cirrhosis; the daily dose should not exceed 20 mg.

It is also necessary to take the drug Ultop ® with caution in patients with impaired renal function. In patients on dialysis, the pharmacokinetic parameters of omeprazole do not change.

Ultop ® contains sucrose, so the drug is not recommended for use in patients with glucose and/or galactose malabsorption syndrome or sucrose/isomaltose deficiency.

Impact on the ability to drive vehicles and operate machinery

Composition and release form of the drug

Capsules two-color: the capsule body is light pink, the lid is brown-pink; the contents of the capsules are pellets from white to slightly yellowish or slightly pinkish in color.

Excipients: (sucrose, corn starch) - 80 mg, hyprolose - 4.8 mg, magnesium hydroxycarbonate (magnesium carbonate, heavy) - 20 mg, sucrose - 32.2 mg, corn starch - 26.5 mg, sodium lauryl sulfate - 2.5 mg, methacrylic acid copolymer and ethyl acrylate (1:1) 30% dispersion - 31 mg, talc - 6 mg, macrogol 6000 - 3.1 mg, titanium dioxide - 1.9 mg, sodium hydroxide - 0.21 mg.

Composition of the capsule cap: red iron oxide dye (E172) - 0.6153%, titanium dioxide (E171) - 2%, gelatin - up to 100%.
Composition of the capsule body: red iron oxide dye (E172) - 0.0875%, titanium dioxide (E171) - 3%, gelatin - up to 100%.

7 pcs. - blisters (2) - cardboard packs.
7 pcs. - blisters (4) - cardboard packs.
14 pcs. - polyethylene pencil cases with a propylene lid and a hydrosorbent capsule (1) - cardboard packs.
28 pcs. - polyethylene pencil cases with a propylene lid and a hydrosorbent capsule (1) - cardboard packs.

pharmachologic effect

H+-K+-ATPase inhibitor. Inhibits the activity of H + -K + -ATPase in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid secretion. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. Due to a decrease in acid secretion, it reduces or normalizes the effect of acid on the esophagus in patients with reflux esophagitis.

Omeprazole has a bactericidal effect on Helicobacter pylori. Eradication of H. pylori with the simultaneous use of omeprazole and antibiotics allows you to quickly relieve the symptoms of the disease, achieve a high degree of healing of damaged mucosa and stable long-term remission and reduce the likelihood of bleeding from the gastrointestinal tract.

Pharmacokinetics

When taken orally, it is quickly absorbed from the gastrointestinal tract. Penetrates the parietal cells of the gastric mucosa. Protein binding is about 95%, mainly with albumin. Biotransformed in the liver. Excreted by the kidneys - 72-80%, with feces - about 20%. T1/2 0.5-1 hour. In patients with chronic liver diseases, T1/2 increases to 3 hours.

Indications

Peptic ulcer of the stomach and duodenum in the acute phase (including those associated with Helicobacter pylori), reflux esophagitis, Zollinger-Ellison syndrome, erosive and ulcerative lesions of the stomach and duodenum associated with taking NSAIDs.

Contraindications

Chronic liver diseases (including a history), childhood, hypersensitivity to omeprazole.

Dosage

Individual. When taken orally, a single dose is 20-40 mg. Daily dose - 20-80 mg; frequency of use - 1-2 times/day. Duration of treatment is 2-8 weeks.

Side effects

From the digestive system: rarely - nausea, diarrhea, constipation, abdominal pain, flatulence.

From the side of the central nervous system: rarely - headache, dizziness, weakness.

From the hematopoietic system: in some cases - anemia, eosinopenia, neutropenia, thrombocytopenia.

From the urinary system: in some cases - hematuria, proteinuria.

From the musculoskeletal system: in some cases - arthralgia, muscle weakness, myalgia.

Allergic reactions: rarely - skin rash.

Drug interactions

With simultaneous use, cases of the development of symptoms of the toxic effects of benzodiazepines have been described, which is associated with inhibition of the activity of CYP3A isoenzymes and, apparently, CYP2C9.

When used simultaneously with atracurium besylate, the effects of atracurium besylate are prolonged.

When used simultaneously with a possible undesirable increase in the absorption of bismuth.

When used simultaneously with digoxin, a slight increase in the concentration of omeprazole in the blood plasma is possible.

When used simultaneously with disulfiram, a case of impaired consciousness and catatonia has been described; with indinavir - a decrease in the concentration of indinavir in the blood plasma is possible; c - decreased absorption of ketoconazole.

With prolonged simultaneous use with clarithromycin, the concentrations of omeprazole and clarithromycin in the blood plasma increase.

Cases of decreased excretion from the body have been described in patients receiving omeprazole.

When used simultaneously with theophylline, a slight increase in the clearance of theophylline is possible.

It is believed that with the simultaneous use of omeprazole in high doses and phenytoin, an increase in the concentration of phenytoin in the blood plasma is possible.

Cases of increased plasma concentrations have been described when used simultaneously with cyclosporine.

When used simultaneously with erythromycin, a case of increased concentration of omeprazole in the blood plasma was described, while the effectiveness of omeprazole decreased.

special instructions

Before starting therapy, it is necessary to exclude the possibility of a malignant process (especially with a stomach ulcer), because Treatment with omeprazole may mask symptoms and delay correct diagnosis.

The use of omeprazole may distort the results of laboratory tests of liver function and gastrin concentrations in the blood plasma.

Pregnancy and lactation

Due to the lack of clinical experience, omeprazole is not recommended for use during pregnancy. If it is necessary to use it during lactation, the issue of stopping breastfeeding should be decided.

Use in childhood

Due to the lack of experience in clinical use, omeprazole is not recommended for use in children.

For liver dysfunction

Contraindicated in chronic liver diseases (including a history).

When treating gastric ulcers, doctors prescribe the drug Ultop, which, when taken in daily dosages, inhibits the production of gastric juice and reduces the concentration of basal and stimulated secretion. Being an antiulcer agent, this medication is characterized by a local effect in the body. Self-medication is contraindicated.

Composition and release form

The drug belongs to the pharmacological group of proton pump inhibitors, reduces the secretion of gastric glands. Ultop is produced in two dosage forms:

  1. Enteric capsules are pale pink in color with white pellets inside. The medicine is packaged in blisters of 7 pcs., a cardboard pack contains 2 or 4 pcs. In addition, Ultop is sold in a polyethylene case of 14 or 28 pcs. Instructions for use are included.
  2. Lyophilisate for the preparation of solution for infusion. A homogeneous white powder is scattered into 40 mg bottles. The package contains 1 bottle, instructions for use.

The active component, omeprazole, with cytoprotective properties, inhibits acid formation in the stomach. Features of the chemical composition of Ultop:

Release form

Active ingredient

Auxiliary components

Composition of the gelatin shell

capsules, 1 pc.

omeprazole

(10, 20 or 40 mg)

corn starch;

granulated sugar;

sucrose;

sodium lauryl sulfate;

hyprolose;

magnesium hydroxycarbonate;

titanium dioxide;

macrogol 6,000;

ethyl acrylate;

30% dispersion of methacrylic acid and ethyl acrylate copolymer (1:1).

iron oxide red dye;

titanium dioxide

lyophilisate, 1 bottle

omeprazole

water for injections

sodium hydroxide solution;

disodium edetate.

Properties of the drug

The medicine Ultop acts locally in the body. The active component omeprazole inhibits the intense production of gastric juice, but does not have a stimulating effect on the nervous system or histamine receptors. The active substance blocks the enzyme H+-K+-ATPase, which reduces the concentration of hydrochloric acid in the stomach and ensures remission of the underlying disease.

The medication begins to act 1 hour after oral administration of a single dose. Ultop reaches its maximum concentration in blood plasma after 2 hours. The bioavailability rate is 30–40%, the degree of binding to plasma proteins is up to 90%. Omeprazole is quickly absorbed from the digestive tract and metabolized in the liver. Ultop is excreted in urine by 70-80% and in bile by 20%. The instructions for use say that after stopping the course, the concentration of gastric juice is restored after 3-5 days.

Indications for use of Ultop

The drug is prescribed for stomach and duodenal ulcers. The instructions for use of Ultop provide a list of medical indications:

  • erosive and ulcerative esophagitis;
  • recurrent gastritis;
  • non-ulcer dyspepsia;
  • duodenitis;
  • Zollinger-Ellison syndrome;
  • eradication of Helicobacter pylorus;
  • gastroesophageal reflux;
  • stress and peptic ulcers.

According to the instructions, Ultop is prescribed as a prophylaxis for ulcers and erosions during long-term use of non-steroidal anti-inflammatory drugs (NSAIDs), with severe signs of dyspepsia, for example, in the event of heartburn. Such pharmaceutical prescription is primary or auxiliary and is carried out exclusively by a gastroenterologist.

Directions for use and dosage

Ultop tablets are intended for oral use. The course of treatment is determined individually. The medicine must be swallowed whole, washed down with a moderate amount of liquid. The medication must be taken before breakfast, in 2 approaches. Daily doses depend on the disease and are described in the instructions for use:

Diseases

Daily doses

Note

relapse of peptic ulcer

gastroesophageal reflux

In case of complicated disease, increase to 40 mg.

erosion after taking NSAIDs

dosage is adjusted individually

Helicobacter pylori eradication

treatment: 20 mg twice a day;

prophylaxis: 10 mg

The drug is prescribed simultaneously with antibacterial agents.

Zollinger-Ellison syndrome

initial dose – 60 mg/day

Gradually increase to 120 mg.

esophagitis, stomach ulcer

If it is not possible to take the medicine orally, the patient is prescribed Ultop lyophilisate. The solution is intended for intravenous drip administration with an infusion duration of 30 minutes. It is recommended to prepare the lyophilisate immediately before use. The powder is dissolved in 100 ml of 5% dextrose (glucose) solution or saline infusion solution. Daily doses are described in the instructions for use:

  • stomach ulcer, reflux esophagitis: 40 mg once;
  • Zollinger-Ellison syndrome: initial dose – 60 mg once, gradually increased;
  • for liver failure: no more than 10–20 mg per day.

special instructions

The drug Ultop is recommended to be taken on an empty stomach, since food intake slows down the absorption of active substances from the digestive tract. The capsule should be swallowed whole. If this is not possible, you need to dissolve the contents in water and take orally as a suspension. The instructions for use also contain other instructions that are valuable for patients:

  1. Before starting drug therapy, it is necessary to examine and determine the main cause of the increase in gastric acidity. If a malignant tumor of the stomach develops, the use of Ultop masks the symptoms and aggravates the clinical picture. Prescribing the drug is prohibited.
  2. When treating patients with liver cirrhosis, constant monitoring by a specialist is important, with the maximum dosage being up to 20 mg/day, no more.
  3. In case of glucose or galactose malabsorption syndrome, sucrase deficiency, isomaltase deficiency, such pharmaceutical prescription is contraindicated.
  4. Ultop does not inhibit the functions of the nervous system and does not inhibit the body’s psychomotor reactions. During treatment, it is allowed to drive vehicles and power mechanisms, and engage in types of work that require increased concentration.
  5. During pregnancy and lactation, Ultop capsules are not prescribed, since the effect of omeprazole in the body of these categories of patients has not been clinically studied.

Ultop and alcohol

This medication is not recommended to be combined with drinking alcoholic beverages, otherwise the therapeutic effect weakens and side effects (symptoms of intoxication of the body) develop. Drinking alcohol is allowed 18–24 hours before taking a single dose of Ultop or 8–14 hours after.

Drug interactions

The drug Ultop is involved in a complex treatment regimen. The doctor selects drug therapy taking into account information about drug interactions described in the instructions for use:

  1. Simultaneous use with drugs for the treatment of iron deficiency anemia is prohibited (the therapeutic effect of the latter is reduced).
  2. Omeprazole increases the concentration of Diazepam, Neodicoumarin, Syncumar, Phenilin, so individual dosage adjustment is necessary.
  3. When combined with indirect anticoagulants, the risk of side effects from the blood and liver increases.
  4. The drug Ultop significantly slows down the absorption of ampicillin, ketoconazole, and iron salts.
  5. When used simultaneously with clarithromycin, the blood concentrations of both medications increase.

Side effects of Ultop

During treatment, side effects cannot be ruled out. In such clinical cases, discontinuation of the medication or individual adjustment of daily dosages is required. Side effects:

  • digestive system: signs of dyspepsia, diarrhea or constipation, stomatitis, nausea, vomiting, flatulence, increased liver enzymes, dry mouth;
  • nervous system: depression, weakness, dizziness, migraine attacks, insomnia, emotional agitation, encephalopathy, hallucinations;
  • cardiovascular system: peripheral edema, tachycardia, angina pectoris, increased blood pressure;
  • musculoskeletal system: arthralgia, myalgia, convulsions;
  • hematopoietic organs: agranulocytosis, thrombocytopenia, anemia, leukopenia, neutropenia;
  • urinary system, kidneys: interstitial nephritis, sugar, red blood cells and protein in the urine, increased creatinine in the blood;
  • allergic reactions: skin itching and rash, urticaria, swelling and hyperemia of the epidermis, dry dermis;
  • others: alopecia, pain in the testicular area in men, nosebleeds, dry cough, ringing in the ears, loss of visual acuity, weight gain, general weakness, increased sweating, gynecomastia.

Overdose

If the recommended dosage of Ultop is exceeded, the patient's condition worsens. Doctors do not exclude the formation of benign cysts in the stomach, fever, convulsions, hypothermia and chills, cardiac arrhythmia and tachycardia develop. Treatment is symptomatic and includes oral administration of intestinal sorbents.

Contraindications

The use of Ultop is not permitted for all patients. The instructions contain a list of medical contraindications, the violation of which worsens the patient’s well-being:

  • pregnancy, lactation;
  • age up to 12 years;
  • hypersensitivity of the body to active substances;
  • lactase deficiency;
  • caution in case of renal or liver failure.

Terms of sale and storage

Ultop is a prescription drug sold at pharmacies. The medicine should be stored at temperatures up to 25 degrees, in a dry and cool place, out of reach of small children. Shelf life – 3 years.

Analogs

If treatment is not suitable, the doctor individually adjusts the prescribed drug therapy regimen. Analogues of Ultop and their characteristics:

  1. Gastrozol. These are capsules that are effective for reflux esophagitis, stomach ulcers, pain syndrome of the gastrointestinal tract, and non-steroidal gastropathy. According to the instructions, the patient is prescribed 1–2 pcs. twice a day.
  2. Losek. A prescription drug in the form of tablets, effective against infectious lesions of the gastric mucosa Helicobacter Pylori and more. According to the instructions, you should take 1 tablet. 20 mg 1 time per day.
  3. Omeprazole. These are gelatin capsules with a pronounced antiulcer effect. The drug is prescribed to patients over 12 years of age. Daily doses depend on the disease and are described in the instructions for use.
  4. Omez. A complete analogue of the above-described medication in the form of enteric capsules. The medicine is prescribed to patients over 18 years of age for recurrent stomach pain. The course of treatment and dose depend on the nature of the pathological process.
  5. Ulcazole. This is a lyophilisate in ampoules. The prepared solution is administered intravenously slowly, dropwise. The medication is an emergency aid for exacerbation of the above diseases.
  6. Bioprazole. These are capsules for oral use and powder for suspension. According to the instructions, the patient is prescribed 20–40 mg of medication once a day. The course of treatment depends on the diagnosed disease.
  7. Ornatol. This is an effective remedy for heartburn, heaviness in the stomach, and stomach pain. The medicine is produced in the form of capsules. The therapeutic effect is maintained for 24 hours after using a single dose.

Internet pharmacy "Yug"

Description and instructions: to " ULTOP, caps 40 mg No. 14*"

Pharmachologic effect.
Antiulcer drug, H+-K+-ATPase inhibitor. It inhibits the activity of H+-K+ ATPase in the parietal cells of the stomach and thereby blocks the final stage of the formation of hydrochloric acid, which leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus.
After a single oral dose of the drug, the effect of omeprazole occurs within the first hour and continues for 24 hours, the maximum effect is achieved after 2 hours. After stopping the drug, secretory activity is completely restored after 3-5 days.
Pharmacokinetics.
Absorption and distribution.
After taking the drug orally, omeprazole is quickly absorbed from the gastrointestinal tract, Cmax in plasma is reached after 0.5-1 hour.
Bioavailability is 30-40%. Plasma protein binding – 90-95%.
Metabolism and excretion.
Omeprazole is almost completely biotransformed in the liver with the formation of 6 pharmacologically inactive metabolites (hydroxyomeprazole, sulfide and sulfone derivatives). It is excreted mainly by the kidneys (70-80%) and bile (20-30%).
Pharmacokinetics in special clinical situations.
In chronic renal failure, excretion decreases in proportion to the decrease in creatinine clearance.
In elderly people, the excretion of omeprazole decreases and bioavailability increases.
In case of liver failure, bioavailability increases to 100%, T1/2 - 2-3 hours.
Indications:
– peptic ulcer of the stomach and duodenum;
– reflux esophagitis;
– erosive and ulcerative lesions of the stomach and duodenum associated with taking NSAIDs;
– Zollinger-Ellison syndrome.
Dosage regimen.
For duodenal ulcers in the acute phase, Ultop is prescribed 20 mg 1 time/day for 2-4 weeks. In resistant cases, the dose may be increased to 40 mg/day.
For gastric ulcers in the acute phase and erosive-ulcerative esophagitis - 20-40 mg/day for 4-8 weeks.
To eradicate Helicobacter pylori - 20 mg 2 times a day for 7 days in combination with antibacterial drugs.
To prevent exacerbation of gastric and duodenal ulcers, Ultop is prescribed at a dose of 20 mg/day.
To prevent exacerbation of reflux esophagitis - 20 mg/day for a long time (up to 6 months).
For erosive and ulcerative lesions of the gastrointestinal tract caused by taking NSAIDs - 20 mg/day. within 4-8 weeks.
For Zollinger-Ellison syndrome, the dose is selected individually depending on the initial level of gastric secretion, usually starting from 60 mg/day. If necessary, the dose is increased to 80-120 mg/day in 2 doses.
In patients with severe liver failure, the daily dose of Ultop should not exceed 20 mg.
Ultop is taken in the morning, on an empty stomach. The capsules are not chewed, washed down with a small amount of water, or taken immediately before or during meals.
Side effect.
From the digestive system: nausea, diarrhea, constipation, abdominal pain, flatulence, dry mouth, taste disturbance, stomatitis, transient increase in the activity of liver enzymes in the blood plasma. In patients with pre-existing severe liver disease, hepatic encephalopathy may develop.
From the central nervous system and peripheral nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations; rarely – visual impairment.
From the musculoskeletal system: muscle weakness, myalgia, arthralgia.
From the hematopoietic system: in some cases - leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.
Dermatological reactions: urticaria, itching; in some cases - photosensitivity, erythema multiforme, alopecia.
Other: rarely - peripheral edema, increased sweating, fever, gynecomastia, formation of glandular cysts during long-term treatment (arise as a result of inhibition of hydrochloric acid secretion and are benign and reversible).
As a rule, side effects occur rarely and are reversible.
Contraindications:
- childhood;
– pregnancy;
– lactation (breastfeeding);
– hypersensitivity to the components of the drug.
Pregnancy and lactation.

It is not recommended to use Ultop during pregnancy. If it is necessary to prescribe the drug during lactation, it is necessary to decide on stopping breastfeeding.
Special instructions.

Before starting treatment, it is necessary to exclude the presence of a malignant process in the upper gastrointestinal tract (since taking Ultop can mask symptoms and complicate diagnosis).
Use in pediatrics
It is not recommended to use Ultop in pediatric practice.
Overdose.
Symptoms: blurred vision, drowsiness, agitation, headache, increased sweating, dry mouth, nausea, tachycardia.
Treatment: carry out symptomatic therapy. There is no specific antidote.
Drug interactions.
When used simultaneously with the drug Ultop, it is possible to lengthen the elimination period of warfarin, diazepam, indirect anticoagulants and phenytoin, since omeprazole is biotransformed in the liver with the participation of enzymes of the cytochrome P450 system.
When used simultaneously with Ultop, the absorption of ketoconazole, ampicillin, and iron supplements may be reduced.
When used together, the absorption of omeprazole and clarithromycin increases.
Storage conditions and periods.
The drug should be stored in a dry place, out of reach of children, at temperatures up to 25°C. Shelf life – 2 years (when stored in blister packs); 3 years (when stored in a plastic case).
Conditions for dispensing from pharmacies.
The drug is available with a prescription.
  • - Descriptions and photographs in product cards may differ from what is presented in the pharmacy. Please check information with operators before placing an order.
  • - This product cannot be exchanged or returned on the basis of Resolution 55 of January 19, 1998.