Can I take bismuth with omeprazole?
Release form, packaging and composition of the drug Omeprazole
Capsules | 1 capsules. |
omeprazole (as enteric pellets) | 20 mg |
Pellet composition: hyprolose, hypromellose, starch, colloidal silicon dioxide, magnesium carbonate, macrogol, methacrylic acid and ethyl acrylate copolymer [1:1] (contains sodium lauryl sulfate 0.7%, polysorbate-80 2.3%), sodium hydrogen phosphate, polysorbate-80, sugar semolina (sucrose, starch syrup), sucrose, talc, titanium dioxide.
10 pieces. – contour cell packaging (3) – cardboard packs.
Clinical and pharmacological group: H + -K + -ATPase inhibitor. Antiulcer drug
Pharmacotherapeutic group: Proton pump inhibitor
pharmachologic effect
H + -K + -ATPase inhibitor, is a weak base. 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. Plasma 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. T1/2 after IV administration is 40 minutes and does not change with long-term treatment.
In patients with chronic liver diseases, T1/2 increases to 3 hours. In patients with impaired liver function, there is an increase in the bioavailability of omeprazole and a significant decrease in plasma clearance.
Indications of the active substances of the drug Omeprazole
For oral administration
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.
Gastroesophageal reflux disease in children over 2 years of age, duodenal ulcer associated with Helicobacter pylori (as part of combination therapy) in children over 4 years of age.
For intravenous administration
Omeprazole for intravenous administration is indicated as an alternative to oral administration.
Peptic ulcer of the stomach and duodenum; erosive and ulcerative lesions of the stomach associated with taking NSAIDs; erosive and ulcerative lesions of the duodenum associated with taking NSAIDs; stress ulcers; symptomatic gastroesophageal reflux disease; reflux esophagitis; Zollinger-Ellison syndrome; prevention of aspiration of stomach contents into the respiratory tract during general anesthesia (Mendelssohn syndrome).
Code IKB-10 | Indication |
B98.0 | Helicobacter pylori as a cause of diseases classified elsewhere |
E16.4 | Impaired gastrin secretion (hypergastrinemia, Zollinger-Ellison syndrome) |
K21.0 | Gastroesophageal reflux with esophagitis |
K25 | Stomach ulcer |
K26 | Duodenal ulcer |
Y45 | Analgesic, antipyretic and anti-inflammatory drugs |
Dosing regimen
The method of administration and dosage regimen of a particular drug depend on its release form and other factors. The optimal dosage regimen is determined by the doctor. The compliance of the dosage form of a particular drug with the indications for use and dosage regimen should be strictly observed.
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.
Omeprazole can be administered intragastrically through a nasogastric tube in the appropriate dosage form according to the method described in the instructions for the drug used.
IV drip at a dose of 40-120 mg/day. The frequency of administration depends on the indications and the treatment regimen used.
Side effect
From the digestive system: often – diarrhea, constipation, abdominal pain, nausea, vomiting, flatulence; rarely – dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis. Cases of the formation of glandular cysts in the stomach have been reported in patients taking drugs that reduce the secretion of gastric glands for a long period of time; resolve on their own with continued therapy.
From the liver and biliary tract: infrequently – increased activity of liver enzymes; rarely – hepatitis (with or without jaundice), liver failure, encephalopathy in patients with liver disease.
From the hematopoietic system: rarely – leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypochromic microcytic anemia in children.
From the nervous system: often – headache; uncommon – vertigo, paresthesia, drowsiness; rarely – taste disturbance.
From the musculoskeletal system: infrequently – fractures of the hip, wrist bones and vertebrae; rarely – arthralgia, myalgia, muscle weakness.
From the skin and subcutaneous tissues: infrequently – dermatitis, rash, itching, urticaria; rarely – alopecia, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the immune system: rarely – hypersensitivity reactions (for example, angioedema, fever, anaphylactic reaction/anaphylactic shock).
Metabolic disorders: rarely – hyponatremia; very rarely – hypocalcemia due to severe hypomagnesemia, hypokalemia due to hypomagnesemia; unspecified frequency – hypomagnesemia.
From the mental side: infrequently – insomnia; rarely – agitation, aggression, confusion, hallucinations, depression.
From the side of the organ of vision: rarely – blurred vision.
From the respiratory system: rarely – bronchospasm.
From the kidneys and urinary tract: rarely – interstitial nephritis.
From the genital organs and breast: rarely – gynecomastia.
General reactions: infrequently – malaise; rarely – sweating, peripheral edema.
Contraindications for use
For oral administration
Hypersensitivity to omeprazole, substituted benzimidazoles; combined use with erlotinib, posaconazole, clarithromycin in patients with liver failure, St. John’s wort preparations; breastfeeding period.
Children under 18 years of age, with the exception of: gastroesophageal reflux disease in children over 2 years of age and weighing more than 20 kg; duodenal ulcer associated with Helicobacter pylori – in children over 4 years old and weighing more than 31 kg.
With caution: osteoporosis, significant spontaneous weight loss, frequent vomiting, dysphagia, vomiting with blood or melena, as well as in the presence of a gastric ulcer (or suspected gastric ulcer), pregnancy.
For intravenous administration
Hypersensitivity to omeprazole and other substituted benzimidazoles; children and adolescents up to 18 years of age; simultaneous use with erlotinib, posaconazole, nelfinavir, atazanavir and St. John’s wort preparations; simultaneous use with clarithromycin in patients with liver failure.
With caution: osteoporosis, liver failure, vitamin B12 deficiency, pregnancy, breastfeeding. Concomitant use with clopidogrel, itraconazole, warfarin, cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, clarithromycin, voriconazole, rifampicin. The presence of the following “alarming” symptoms; significant weight loss, repeated vomiting, vomiting blood (hematemesis), difficulty swallowing, change in stool color (tarry stool – melena)
Application in pregnancy and lactation
During pregnancy and breastfeeding, use is possible depending on the dosage form used.
Use for liver dysfunction
In patients with impaired liver function, there is an increase in the bioavailability of omeprazole and a significant decrease in plasma clearance.
Concomitant use with clarithromycin is contraindicated in patients with liver failure.
Use in children
Contraindicated for use in children and adolescents under 18 years of age, with the exception of: gastroesophageal reflux disease in children over 2 years of age and weighing more than 20 kg; duodenal ulcer associated with Helicobacter pylori – in children over 4 years old and weighing more than 31 kg.
Use in elderly patients
The rate of metabolism of omeprazole in elderly patients is slightly reduced, but no dose adjustment is required.
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.
Although a causal relationship between the use of omeprazole/esomeprazole and osteoporotic fractures has not been established, patients at risk of developing osteoporosis or having a fracture due to osteoporosis should be under appropriate clinical supervision.
Measurement of magnesium levels should be considered before starting proton pump inhibitor therapy and periodic monitoring during treatment
Impact on the ability to drive vehicles and operate machinery
Due to the fact that dizziness, blurred vision and drowsiness may occur during therapy, patients should be careful when driving or operating machinery that requires increased concentration and speed of psychomotor reactions.
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 concomitantly with bismuth tripotassium dicitrate, an undesirable increase in the absorption of bismuth may occur.
When used simultaneously with digoxin, a slight increase in the concentration of omeprazole in the blood plasma is possible. At a dose of omeprazole 20 mg/day, the bioavailability of digoxin increases by 10%.
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; with ketoconazole – decreased absorption of ketoconazole.
With prolonged simultaneous use with clarithromycin, the concentrations of omeprazole and clarithromycin in the blood plasma increase.
A decrease in the absorption of erlotinib was observed.
When used simultaneously with theophylline, a slight increase in the clearance of theophylline is possible.
Cases of increased concentrations of cyclosporine in blood plasma 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.
Omeprazole has been shown to interact with some antiretroviral drugs. The mechanisms and clinical significance of these interactions are not always known. An increase in pH during omeprazole therapy may affect the absorption of antiretroviral drugs. Interaction at the level of the CYP2C19 isoenzyme is also possible. When omeprazole is co-administered with certain antiretroviral drugs, such as atazanavir and nelfinavir, a decrease in their serum concentrations is observed during omeprazole therapy. In this regard, the combined use of omeprazole with antiretroviral drugs such as atazanavir and nelfinavir is not recommended.
Increased saquinavir serum concentrations were observed when omeprazole and saquinavir were administered concomitantly.
Concomitant use of omeprazole with other drugs metabolized by the CYP2C19 isoenzyme, such as diazepam, warfarin (R-warfarin) or other vitamin K antagonists, phenytoin and cilostozol, may lead to a slower metabolism of these drugs. Monitoring of patients taking phenytoin and omeprazole is recommended; a dose reduction of phenytoin may be required. However, concomitant treatment with omeprazole at a daily dose of 20 mg does not affect the concentration of phenytoin in the blood plasma in patients taking the drug for a long time. When using omeprazole in patients receiving warfarin or other vitamin K antagonists, INR monitoring is necessary; in some cases, it may be necessary to reduce the dose of warfarin or another vitamin K antagonist. At the same time, concomitant treatment with omeprazole at a daily dose of 20 mg does not lead to a change in coagulation time in patients taking warfarin for a long time. The use of omeprazole at a dose of 40 mg 1 time / day led to an increase in Cmax and AUC of cilostazol by 18% and 26%, respectively; for one of the active metabolites of cilostazol, the increase was 29% and 69%, respectively.
According to the results of the studies, a pharmacokinetic/pharmacodynamic interaction was noted between clopidogrel (loading dose of 300 mg and maintenance dose of 75 mg/day) and omeprazole (80 mg/day orally), which leads to a decrease in exposure to the active metabolite of clopidogrel by an average of 46% and a decrease in maximum inhibition of ADP-induced platelet aggregation by an average of 16%. The clinical significance of this interaction is unclear. Increased risk of cardiovascular complications with combined use of clopidogrel and proton pump inhibitors, incl. omeprazole has not been shown in randomized clinical trials. The results of a number of observational studies are contradictory and do not provide a clear answer about the presence or absence of an increased risk of thromboembolic cardiovascular complications during the combined use of clopidogrel and proton pump inhibitors.
With the simultaneous use of omeprazole and tacrolimus, an increase in the concentration of tacrolimus in the blood serum was noted.
Some patients have reported a slight increase in plasma concentrations of methotrexate when administered concomitantly with proton pump inhibitors. When using high doses of methotrexate, you should temporarily stop taking omeprazole.
The isoenzymes CYP2C19 and CYP3A4 are involved in the metabolism of omeprazole. Concomitant use of omeprazole and inhibitors of the CYP2C19 and CYP3A4 isoenzymes, such as clarithromycin, erythromycin and voriconazole, may lead to increased plasma concentrations of omeprazole by slowing down the metabolism of omeprazole. Concomitant use of omeprazole and voriconazole results in a more than twofold increase in the AUC of omeprazole. Due to the good tolerance of high doses of omeprazole, short-term joint use of these drugs does not require dose adjustment of omeprazole.
Drugs that induce the isoenzymes CYP2C19 and CYP3A4, such as rifampicin and St. John’s wort preparations, when used together with omeprazole, can lead to a decrease in its concentration in the blood plasma due to the acceleration of its metabolism.
Tested by medical expert Maria Sergeevna Yudintseva, Candidate of Medical Sciences, 38 years of experience
Omeprazole is a drug that specifically inhibits the proton pump of the parietal cells of the stomach and thereby reduces the acidity of gastric juice. The drug is used to treat patients with diseases and conditions associated with high acidity. An important point in clinical practice is that omeprazole indirectly affects all pathological conditions associated with stimulated secretion of gastric juice, for example, the secretion of pancreatic enzymes and contraction of the gallbladder.
How does omeprazole work?
Omeprazole is a mixture of two enantiomers that exhibit their pharmacological activity to the same extent. The target of action is the proton pump of the parietal cells of the stomach – an enzyme that provides the final stage of secretion of gastric acid. Moreover, the effect is dose-dependent, so the dose of omeprazole is selected depending on the patient’s condition. With regular use, both basal secretion of gastric juice (on an empty stomach) and stimulated secretion (in response to food intake) are suppressed.
Why is the drug omeprazole taken?
Omeprazole is used to treat patients with the following diseases and conditions:
- duodenal ulcer;
- prevention of relapses of duodenal ulcers;
- stomach ulcer;
- prevention of recurrence of stomach ulcers;
- in combination with antibacterial drugs for eradication Helicobacter pylori with peptic ulcer;
- gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs);
- reflux esophagitis;
- inactive reflux esophagitis;
- symptomatic gastroesophageal reflux disease;
- Zollinger-Ellison syndrome;
- reducing the severity of symptoms of acid-dependent dyspepsia.
How to take omeprazole correctly to treat peptic ulcers?
The usual dosage of the drug is 20 mg once a day, the course of treatment is 1 weeks. In case of insufficient effectiveness, the dose can be increased to 2 mg, and the course of treatment extended to 40 weeks.
How to take omeprazole correctly to prevent peptic ulcers?
The prophylactic dose, as well as the therapeutic dose, is 20–40 mg once a day. In some cases, a dose of 1 mg per day may be sufficient for prevention.
How to take omeprazole correctly for eradication H. pylori?
There are various schemes for eradication of Helicobacter pylori infection. In most cases, omeprazole is used in combination with two antibiotics, for example, omeprazole + clarithromycin + amoxicillin, omeprazole + clarithromycin + metronidazole, omeprazole + amoxicillin + metronidazole. Treatment usually lasts 7 days, but the optimal combination and duration of treatment is determined by the doctor.
How to take omeprazole correctly to prevent the appearance of ulcers and erosions of the gastric mucosa when taking NSAIDs?
To prevent the appearance of ulcers/erosions of the gastric mucosa or exacerbation of peptic ulcers, omeprazole should be taken at a dose of 20 mg 1 time per day during the entire course of taking NSAIDs.
How to take omeprazole correctly for gastritis?
For gastritis, omeprazole is usually taken at a dose of 10–20 mg per day for 2–4 weeks. If no significant improvement is achieved during this time, it is recommended to carefully examine the patient.
How to take omeprazole correctly for reflux esophagitis?
For the treatment of patients with reflux esophagitis, omeprazole is taken once a day at a dose of 1–20 mg for 40–4 weeks. It is further recommended to take 8 mg of omeprazole per day to maintain the therapeutic effect. The duration of the maintenance period varies depending on the patient’s condition, concomitant diseases and the use of other medications.
How to take omeprazole for children?
Children with a body weight of 10–20 kg are recommended to take 10 mg of omeprazole, and for children weighing >20 kg – 20 mg once a day. If a child cannot swallow an omeprazole capsule, you can open it and mix the contents with still water, fruit juice or applesauce.
How long does it take for omeprazole to take effect?
After taking 20 mg of omeprazole, suppression of gastric juice secretion develops within 1 hour.
When does the effect of omeprazole stop?
After a single dose of omeprazole, the acid-lowering effect stops after 24 hours, and after a course of treatment, the acidity of gastric juice returns to normal within 3-5 days.
When is it better to take omeprazole: before or after meals?
There are different forms of omeprazole for oral administration (capsules, gastro-resistant capsules, powder for oral suspension), so the regimen for taking a specific form of the drug should be checked with the doctor who prescribed the treatment. However, omeprazole is usually taken either before or during meals.
Is it possible to take omeprazole on an empty stomach?
It is possible, but when taken with food, the drug is absorbed faster.
How many times a day should you take omeprazole?
If omeprazole is prescribed in a dose of 10, 20 or 40 mg, then it is enough to take it once a day. Doses of 1 mg and above are usually divided into 80 doses.
How long can omeprazole be administered intravenously?
Omeprazole lyophilisate for the preparation of a solution for intravenous injection is usually prescribed when the patient cannot take the drug orally, for example, if the patient is in serious condition or has recently undergone surgery on the gastrointestinal tract. In general, the period of intravenous use of omeprazole is not limited, however, as the patient’s condition improves, a transfer to oral administration of the drug is recommended.
How long can you take omeprazole?
The course of treatment for patients with acute ulcers or acute gastritis is usually 7 days – 1 month. Then, depending on the patient’s condition, either the patient’s course of treatment is completed or a maintenance dose of omeprazole is prescribed. In some cases (for example, with Zollinger-Ellison syndrome), the drug can be taken continuously for a year or more.
Is it possible to take omeprazole every day?
Omeprazole can be taken continuously or in long courses. The drug is taken once a day, since the therapeutic effect from a single dose lasts 1 hours. If you take omeprazole less than once a day, the therapeutic effect will be insufficient and unpredictable.
What side effects are typical for omeprazole?
Use of omeprazole, especially in high doses and over a long period of time (>1 year), slightly increases the risk of hip, wrist and spine fractures, mainly in elderly patients or those with other risk factors. Studies have shown that omeprazole increases the risk of fractures by 10–40%. In some cases, this is due to the patient having other risk factors. Patients at risk of developing osteoporosis should be provided with appropriate treatment and adequate use of vitamin D and calcium.
When is omeprazole contraindicated?
- in case of individual intolerance to the active substance;
- during breastfeeding;
- when using antiviral drugs such as nelfinavir and atazanavir.
Can I take omeprazole at night?
It is recommended to use omeprazole at night when treating reflux esophagitis. This regimen of administration improves the effect of therapy, since it prevents the reflux of acidic gastric juice into the esophagus in a person who is in a horizontal position during sleep.
Does omeprazole affect liver function?
In most patients, omeprazole does not have any significant effect on the liver. However, if the patient has previously been diagnosed with liver disease, an increase in liver function tests (aspartate aminotransferase, alanine aminotransferase) may be observed when taking omeprazole.
Can I take omeprazole without a doctor’s prescription?
It is not recommended to take omeprazole without a doctor’s prescription, since the drug is rarely used as monotherapy, and a full medical examination is necessary to select complex treatment.
Can I take 2 omeprazole tablets?
This is not contraindicated, but it is not advisable. Omeprazole is not an anesthetic drug, and its therapeutic effect is manifested through a complex mechanism of reducing acidity and healing ulcerative defects of the mucous membrane. Therefore, a course of treatment with an adequately selected dose is more effective, and a one-time increase in dose will not significantly reduce the severity of stomach pain.
What is better to take: Vis-nol/De-nol or omeprazole?
Vis-nol and De-nol are drugs with an enveloping effect. Their main active ingredient, bismuth subcitrate, is used to protect the gastric mucosa from aggressive gastric juice and to stimulate the formation of mucus. It is often prescribed in combination with omeprazole. However, bismuth preparations are taken 4 times a day, and omeprazole – 1 time a day. It is recommended to take a break of 30 minutes between taking bismuth and omeprazole.