Compound

Each sustained release capsule contains:

active ingredient: Omeprazole 20mg

excipients: mannitol, sodium lauryl sulfate, sodium hydrogen orthophosphate, calcium carbonate, sucrose, polyvinylpyridone K-30, hypromellose (HPMC E-5), hypromellose phthalate (HPMCP HP-55), cetyl alcohol, titanium dioxide.

The composition of the capsule shell: gelatin, purified water, methylparaben, propylparaben, carmoisine E122, sodium lauryl sulfate.

Description

Pink/white transparent hard gelatin capsules, size #2.

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pharmachologic effect

Omeprazole inhibits the enzyme H7K + -ATPase, which is responsible for the secretion of hydrochloric acid by the acidic cells of the stomach. Due to this selective intracellular action, independent of membrane receptors, omeprazole belongs to an independent class of hydrochloric acid secretion inhibitors that block the final phase of the secretory process. Due to its mechanism of action, omeprazole reduces not only basal acid secretion, but also that secretion that can be stimulated, regardless of the type of stimulant; it raises the pH value and reduces the secretory volume.

The antisecretory effect after taking 20 mg occurs within the first hour, maximum after 2 hours. Inhibition of 50% of maximum secretion lasts 24 hours. disappearing by the end of 3-4 days after the end of the reception. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains an intragastric pH of 3 for 17 hours.

Pharmacokinetics

Absorption and distribution

Omeprazole is acid-labile and is taken orally as enteric-coated granules in capsules. Completely absorbed from the small intestine, usually within 3-6 hours. The systemic bioavailability of omeprazole with a single dose of omeprazole capsules is about 35%. After repeated use of the drug once a day, bioavailability increases to approximately 60%. Concomitant food intake does not affect bioavailability. The binding of omeprazole to plasma proteins is about 95%.

Excretion and metabolism

The mean half-life of the terminal phase of the plasma concentration-versus-time curve is about 40 minutes. There are no changes in the half-life during treatment with the drug. Inhibition of acid secretion correlates with the area under the plasma concentration/time curve (AUC), but not with the actual plasma concentration at a given time.

Omeprazole is completely metabolized, mainly in the liver. The metabolites identified in plasma are sulfone-, sulfide- and hydroxy-omeprazole. These metabolites do not significantly affect acid secretion. About 80% of the metabolites are excreted in the urine and the rest in the faeces. The two main urinary metabolites are hydroxyomeprazole and the corresponding carboxylic acid.

The systemic bioavailability of omeprazole does not change significantly in patients with reduced renal function. The area under the plasma concentration/time curve increases in patients with impaired liver function, but no tendency to accumulation of omeprazole was observed.

Indications for use

Peptic ulcer of the stomach and duodenum 12 (including prevention of recurrence),

Reflux esophagitis,

Hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis).

Prevention of aspiration of acidic stomach contents in Airways during general anesthesia(Mendelssohn's syndrome).

NSAID gastropathy.

Eradication of Helicobacter pylori in infected patients with gastric ulcer and duodenal ulcer (as part of combination therapy).

Pregnancy and lactation

Pregnancy

An analysis of the results of three epidemiological studies did not reveal evidence confirming the occurrence of adverse events with the use of omeprazole that would affect the course of pregnancy or the health of the fetus or newborn child. Omeprazole should only be used during pregnancy if it is really needed.

The period of breastfeeding is contraindicated.

Dosage and administration

Inside, the capsules are usually taken in the morning, the capsules should not be chewed with a small amount of water (just before a meal or during a meal).

adults

Gastroesophageal reflux disease, including reflux esophagitis.

The usual dosage is 20 mg once a day. Most patients recover after 4 weeks. In patients who do not fully recover after the initial course, recovery usually occurs within the next 4-8 weeks of treatment.

Omeprazole has also been used at a dose of 40 mg once daily in patients with reflux esophagitis resistant to other therapies. Recovery usually occurred within 8 weeks.

Treatment of patients can be continued at a dose of 20 mg once a day.

acid reflux disease

Ulcer duodenum and benign gastric ulcer

The usual dose is 20 mg once a day. Most patients with duodenal ulcers recover after 4 weeks. Most patients with benign gastric ulcers recover within 8 weeks. In severe or recurrent cases, the dose may be increased to 40 mg per day. Long-term treatment of patients with a history of recurrent duodenal ulcer is recommended at a dose of 20 once daily.

To prevent recurrence in patients with duodenal ulcer, the recommended dose is 10 mg once a day, with the possibility of increasing it to 20 mg once a day when symptoms recur.

The following populations are at risk for recurrent ulcer recurrence: patients with Helicobacter pylori infection, patients less than 60 years of age, patients with symptoms that persist for more than one year, and patients who smoke. In the case of such patients, a long initial course of treatment with omeprazole 20 mg once a day is required, with the possibility of reducing the dose to 10 mg once a day if necessary.

Treatment regimens for diseases associated with Helicobacter Pylori (HP):

Triple therapy regimens for peptic ulcer duodenum:

Omeprazole and the following combinations of antimicrobials:

Amoxicillin 1 g and Clarithromycin 500 mg twice daily. The course of treatment is 7-14 days.

Dual therapy regimens for duodenal ulcer:

Omeprazole at the standard dose and Amoxicillin 750 mg to 1 g twice a day for two weeks.

Omeprazole at the standard dose and Clarithromycin 500 mg three times a day for two weeks. Dual therapy regimens for gastric ulcer:

Omeprazole and amoxicillin 750 mg to 1 g twice a day for two weeks.

In each regimen, in the case of recurrence of symptoms and / ^-positive patients, therapy can be repeated, or one of the alternative regimens can be used; in the case of Hp-negative patients, follow the dosage instructions for acid-dependent reflux disease.

To ensure recovery in patients with active duodenal ulcer, see dosage recommendations for duodenal ulcer and benign gastric ulcer.

Prevention of acid aspiration

In patients at risk of aspiration of gastric contents during general anesthesia, the recommended dose is 40 mg of omeprazole the evening before surgery and 40 mg 2-6 hours before surgery.

Zollinger-Ellison Syndrome

The recommended starting dose is 60 mg once daily. The dosage is adjusted exclusively individually, and the duration of treatment depends on the clinical indications. More than 90% of patients with severe disease and inadequate response to other therapies were effectively controlled at doses of 20-120 mg per day. At daily doses above 80 mg, the dose should be divided and the drug should be taken twice a day.

For the treatment of NSAID-associated gastric, duodenal, or gastroduodenal erosions

The recommended dose is 20 mg once a day. Resolution of symptoms is rapid and most patients recover within 4 weeks. In patients who do not fully recover after the initial course, recovery usually occurs within the next 4 weeks of treatment.

For the prevention of NSAID-associated gastric and duodenal ulcers, gastroduodenal erosions and symptoms of dyspeptic phenomena in patients with a previous history of erosive and ulcerative gastroduodenal lesions who require further treatment NSAIDs

Pathological hypersecretory conditions

The dosage of omeprazole in patients with pathological hypersecretory conditions depends on the individual patient. The recommended starting dose for adults is 60 mg once daily. The dose should be adjusted according to the individual characteristics of the patient, therapy is continued for as long as necessary. May be required daily dose up to 120mg. A dose above 80 mg per day should be divided into several doses.

Elderly patients Dose adjustment is not required.

Impaired kidney function

Dose adjustment is not required in patients with impaired renal function.

Impaired liver function

Because bioavailability and half-life may increase in patients with impaired liver function, dose adjustment is required at maximum sue

Use in patients who cannot swallow omeprazole capsules

Capsules can be opened and swallowed directly with half a glass of water, or diluted in 10 ml of still water, any fruit juice with a pH less than 5, such as apple, orange, pineapple, applesauce or yogurt and swallowed immediately after mixing or within 30 minutes . Stir only before use and swallow with half a glass of water. In addition, the capsules can be sucked and then swallowed with half a glass of water. There is no evidence to support the use of sodium bicarbonate buffer as a delivery form. It must be ensured that the contents of the capsule have not been damaged or chewed.

Side effect

Omeprazole capsules are well tolerated and adverse events are generally mild and reversible. During clinical trials or as a result of daily use of the drug, the following adverse events were observed, although in many cases a causal relationship with the use of omeprazole has not been established.

Are used the following definitions frequency of occurrence of adverse events:

Often > 1/100

Uncommon > 1/1000 and< 1 /100

Rarely< 1 /1000

From the digestive system:

Often: diarrhea or constipation, abdominal pain, nausea, vomiting, flatulence.

Rarely: taste disturbances, dryness of the oral mucosa, stomatitis, increased activity of "liver" enzymes.

Pancreatitis, sometimes fatal, anorexia, acute liver failure, sometimes fatal, liver necrosis, sometimes fatal, hepatic encephalopathy.

In patients with previous serious illness liver - hepatitis (including with jaundice), impaired liver function.

From the side of the cardiovascular system:

Pain in chest, angina pectoris, tachycardia, palpitations, increased blood pressure.

From the side of the hematopoietic organs:

Rarely: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.

From the side nervous system:

Often: headache.

In patients with severe concomitant somatic diseases - dizziness, headache, irritability, depression, in patients with previous severe liver disease - encephalopathy.

Mental disorders:

Uncommon: sleep disturbances.

Rare: agitation, depression, hallucinations.

From the musculoskeletal system:

Rare: arthralgia, myasthenia gravis, myalgia.

Bone fractures.

From the side of the skin:

Uncommon: skin rash and/or itching.

Rare: photosensitivity, erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia.

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

Reproductive system:

Rare: gynecomastia.

Respiratory system:

Rare: bronchospasm.

From the side of the kidneys and urinary system:

Interstitial nephritis Other:

Uncommon: malaise, vertigo.

Rare: hyponatremia, visual disturbances, peripheral edema, increased sweating, formation of gastric glandular cysts during long-term treatment (due to inhibition of HC1 secretion; is benign, reversible). Contraindications

Known hypersensitivity to omeprazole or to any of the excipients of the drug.

Childhood. There is no experience in treating children; therefore Omeprazole is contraindicated in children.

lactation period.

Omeprazole, as well as other proton pump inhibitors, should not be co-administered with atazanavir and nelfinavir.

Overdose

Symptoms: Overdose symptoms are variable and include the following: confusion, drowsiness, visual disturbances, tachycardia, nausea, vomiting, sweating, flushing, headache, dry mouth and other adverse reactions similar to those seen in normal clinical practice. High single (up to 160 mg) and daily (up to 360 mg) doses of omeprazole were tolerated without side effects.

Treatment: In addition to monitoring breathing and circulatory status according to general rules treatment of intoxication, there are no special recommendations regarding therapeutic measures.

Interaction with other drugs

Due to reduced intragastric acidity, the absorption of ketoconazole or itraconazole may be reduced during treatment with omeprazole, as well as during concomitant treatment with other inhibitors of acid secretion.

Since omeprazole is metabolized in the liver by the cytochrome P450 system, the drug can increase the elimination period of diazepam, phenytoin, warfarin and other vitamin K antagonists, which are a weak substrate for this enzyme. It is recommended to monitor patients receiving phenytoin, with the possible need to reduce the dose of the latter. When treating patients receiving warfarin or other vitamin K antagonists, it is recommended to monitor the INR and, if necessary, reduce the dose of warfarin (or other vitamin K antagonists).

Omeprazole is an inhibitor of the CYP2C19 enzyme. Clopidogrel is metabolized to the active metabolite in part by CYP2C19. The simultaneous use of omeprazole 80 mg leads to a decrease in the plasma concentration of the active metabolite of clopidogrel and a decrease in platelet inhibition by clopidogrel.

The concentration of omeprazole and clarithromycin in plasma increases with the concomitant use of drugs. This interaction is considered favorable in the eradication of Helicobacter Pylori. Omeprazole does not interact with metronidazole or amoxicillin. These antimicrobials are used in combination with omeprazole to eradicate Helicobacter pylori.

There is no evidence to support drug interactions with phenacetin, theophylline, caffeine, propranolol, metoprolol, cyclosporine, lidocaine, quinidine, estradiol, or antacids.

Alcohol or food does not affect the absorption of omeprazole.

There is no evidence to support drug interactions with piroxicam, diclofenac, or naproxen.

Continued treatment with the aforementioned drugs is considered appropriate.

The concomitant use of omeprazole with digoxin in healthy patients leads to an increase in the bioavailability of the latter by 10%, as a result of an increase in intragastric pH.

Concomitant use of omeprazole (40 mg once daily) with atazanavir 300 mg, ritonavir 100 mg in healthy volunteers resulted in a significant reduction in atazanavir exposure (decrease in AUC, C max and C m j n by approximately 75%). Increasing the dose of atazanavir to 400 mg did not compensate for the effect of omeprazole on exposure.

Concomitant use of omeprazole with tacrolimus may increase the serum concentration of the latter.

Concomitant use of omeprazole with the CYP2C19 and CYP3A4 inhibitor voriconazole more than doubled omeprazole exposure. Omeprazole (40 mg once daily) increased the Cmax and AUC of voriconazole (CYP2C19 substrate) by 15% and 41%, respectively. Usually no dose adjustment of omeprazole is required in any of these cases. However, dose adjustment should be considered in patients with severe hepatic impairment and if prolonged treatment is required.

Application features

Omeprazole should not be used for minor gastrointestinal complaints such as "irritable stomach syndrome".

If a gastric ulcer is suspected, the possibility of a malignant development of the disease must be ruled out before starting therapy with Omeprazole Capsules, since treatment can relieve symptoms and make the diagnosis more difficult.

In patients with a stomach or duodenal ulcer, it is necessary to establish the status of Helicobacter pylori. For Helicobacter pylori-positive patients, treatment may be focused on killing the bacterium whenever possible.

In seriously ill patients, especially those with an unstable circulatory state, severe, irreversible visual impairment up to blindness and hearing loss up to its complete loss have been reported in isolated cases when omeprazole was used as a bolus injection. To date, the relationship of such cases has not been established.

However, Special attention strict adherence to approved indications and recommended doses in the treatment of critically ill patients should also be considered when omeprazole is taken orally. As far as possible, the functions of vision and hearing, as well as the fundus of the eye, should be monitored in such patients before and during the administration of the drug. Omeprazole must be canceled immediately after the establishment of any changes or violations.

Several observational studies have shown that proton pump inhibitor therapy may be associated with an increased risk of hip, wrist, or spine fractures. The risk of fractures was increased in patients receiving high doses and long-term therapy with proton pump inhibitors (a year or more). Patients should use low doses and a minimum duration of therapy sufficient to treat the conditions for which omeprazole was prescribed. Patients at risk of fracture should be monitored according to available guidelines.

Impact on ability to drive vehicles and other mechanisms.

Due to the fact that dizziness and drowsiness may occur during therapy with Omeprazole, care should be taken when driving vehicles and other mechanisms.

"Omeprazole" is used for the treatment of peptic ulcer in various manifestations. In particular, the drug is used to treat gastric ulcer, duodenal ulcer, peptic ulcer caused by Helicobacter pylori, reflux esophagitis. The drug is also prescribed for benign tumor pancreas in combination with a stomach ulcer (Zollinger-Ellison syndrome).

The drug "Omeprazole" is available in the form of capsules with a dosage of 10, 20 and 40 mg.

Instructions for use "Omeprazole"

With reflux, the daily dosage is 20 mg of Omeprazole, the course of treatment lasts 4 weeks; in severe cases, take 40 mg of the drug for 8 weeks. In the treatment of peptic ulcers, 20-40 mg of the drug "Omeprazole" is prescribed twice a day for 2-4 weeks. With Zollinger-Ellison syndrome, the dosage is determined at 60 mg of Omeprazole 1 time per day, in severe cases, 40-60 mg 2 times per day.

"Omeprazole" is taken before meals.

Contraindications and warnings

Before starting therapy with this drug, it is necessary to exclude the presence of malignant tumors in the patient, since taking Omeprazole can mask the signs of the disease and thus delay its timely diagnosis.

Side effects

The drug Omeprazole instructions for use defines it as an antiulcer agent, a hydrogen pump blocker. The drug is produced in Russia, Hungary, Israel and Ukraine. Doctors prescribe this drug for the treatment of heartburn, gastritis, peptic ulcer of the stomach and duodenum.

What Omeprazole helps with, the prices of tablets and capsules 10 mg, 20 mg, 40 mg, injections in pharmacies, real reviews of doctors and patients, as well as analogues for replacement will be presented in the annotation.

Forms of release and composition

Omeprazole is produced by various manufacturers (Teva, Stada (Stada), Gedeon Richter, Zentiva, Lekpharm, ProMed, Farmex, Vokate, Darnitsa, KMP, Akrikhin, Zdorovye, Ozone, Farmak, Astrapharm) in the following forms:

• Transparent capsules filled with white granules. The package contains official instruction, as well as a different number of capsules for internal use - 10, 30, 60, 100 or 120.
• Powders for dilution and production of sterile solutions for injections. Each original package contains 1 bottle and instructions for use in Russian.

The main component that is part of the medical product is the chemical compound Omeprazole (with international name omeprazole). One dose may contain a different amount of active active substances, depending on the form of release:

• 10, 20 or 40 mg capsules;
• 40 mg powder for injection.

Indications for use

What do omeprazole capsules help with? The medicine is prescribed for the following diseases:

• Zolinger-Elinson syndrome;
• NSAID-gastropathy (ulcerative process, which is a consequence of the potentiated intake of non-steroidal anti-inflammatory drugs);
• Systemic mastocytosis;
• Stress ulcers of the digestive tract;
• Erosive and ulcerative esophagitis;
• Ulcer of the stomach and 12 duodenal ulcer;
• Polyendocrine adenomatosis;
• Recurrent peptic ulcers of the stomach and intestines.

Instructions for use of Omeprazole: dosages and rules of administration

Omeprazole is taken orally with a small amount of water. The capsule cannot be chewed. Simultaneous intake with food does not affect the effectiveness of the drug.

• Destruction of Helicobacter pylori (eradication of Helicobacter pylori): daily dose - 40 mg (in 2 doses), course duration - 7 days in combination with antibacterial drugs;
• Pancreatic adenoma ulcerogenic: the dose is selected based on the initial level of gastric secretion; the average initial daily dose is 60 mg, later it is increased to 80-120 mg (in 2 divided doses);
• Defeats gastrointestinal tract erosive and ulcerative nature associated with the use of non-steroidal anti-inflammatory drugs: daily dose - 20 mg, course duration - 1-2 months;
• Reflux esophagitis (with anti-relapse purpose): daily dose - 20 mg, course duration - up to six months;
• Peptic ulcer of the stomach and duodenum (for anti-relapse purposes): daily dose - 20 mg;
• Erosive and ulcerative esophagitis and exacerbation of gastric ulcer: daily dose - 20-40 mg, course duration - 1-2 months;
• Exacerbation of duodenal ulcer: daily dose - 20 mg (if necessary, in resistant cases - up to 40 mg), course duration - 14-28 days;

Methods of application of injection forms

The drug is administered intravenously by performing slow infusions. The contents of the vial should be shaken beforehand and diluted first in 5 ml, then in 100 ml of Na chloride (0.9%) or Glucose (5%).

The recommended dosage for one administration per day is 40 mg of Omeprazole (1 vial). In some pathologies, a large dose is required, which can be 60-80 mg per day. In such cases, 2 infusions are recommended. The duration of therapy is determined by the doctor.

How to drink the drug: before or after meals

Omeprazole, which has other names (omez, ultop, gastrosol), is a capsule in a soluble shell. They must be swallowed whole, without chewing, so it is allowed to drink the medicine with a sufficient amount of liquid.

Omeprazole: what treats, how long to take? Before or after a meal?

According to the manufacturer's instructions - this should be done before meals, preferably half an hour. No matter what reason could have been missed another reception medications, doubling the next dose taken is strongly discouraged.

Pharmacokinetics and pharmacodynamics

Omeprazole is an antiulcer drug, an inhibitor of the enzyme H+/K+-adenosine triphosphate (ATP)-phase.

The active component of the drug is a specific proton pump inhibitor that inhibits the activity of H, K and ATPase ions in the parietal cells of the stomach. This substance reduces the production of hydrochloric acid, blocking the final stage of its secretion, regardless of the nature of the stimulating factor. Inhibition of maximum acid secretion by 50% continues throughout the day.

Side effects

Side effects of the drug appear as:

• Digestive system disorders (abdominal pain, stool disorders, nausea, vomiting, increased activity liver enzymes, flatulence, taste disturbance, stomatitis, dry mouth, liver dysfunction, patients with previous severe liver disease may develop hepatitis).
• Violations by skin(photosensitivity, skin rashes, pruritus, alopecia, erythema multiforme exudative).
• Hypersensitivity reactions: bronchospasm, fever, angioedema, urticaria, anaphylactic shock, interstitial nephritis.
• Gynecomastia, general malaise, peripheral edema, visual impairment, hyperhidrosis, the formation of benign glandular (glandular) cysts in the stomach (the pathology develops with prolonged use of the drug as a result of suppression of HCl secretion and is reversible).
• Violations of the function of the hematopoietic organs, the symptoms of which are leuko-, pancyto-, thrombocytopenia, agranulocytosis.
• Violations of the function of the musculoskeletal system (myalgia, arthralgia, myasthenia gravis).
• Dysfunction of the NS: in patients with concomitant severe somatic pathologies, dizziness, headaches, depression or agitation are possible; in patients with previous severe liver disease - encephalopathy.

Contraindications

According to the annotation to Omeprazole, the use of the drug is contraindicated in:

• pregnancy;
• Hypersensitivity to the ingredients of the drug;
• The period of breastfeeding.

The intravenous form of the drug is not prescribed for children under 18 years old, capsules up to 2 years old, and children weighing up to 20 kg. It is not recommended to treat PUD caused by Helicobacter pylori in children under 4 years of age. It should not be taken if you are allergic to the components of the drug or in case of its acute intolerance.

Children, during pregnancy and lactation

Omeprazole is prescribed during pregnancy in case of urgent need, taking into account the excess of benefits and effectiveness over the likely risks. There are no research results that indicate a negative effect of the drug on the body of the expectant mother and fetus.

Omeprazole has the ability to penetrate into breast milk. There is no precise data on the safety of the drug in breastfeeding(GV) of the child during lactation in the mother.

For kids

Capsules in pediatrics are prescribed for children over 5 years old with a weight of at least 20 kg.

The standard dose for a child is 20 mg / day. If necessary, it can be doubled. Treatment, depending on the diagnosis, lasts from 2 to 8 weeks.

H. pylori eradication therapy in children over 5 years of age should be carried out with extreme caution and under constant medical supervision. The course of treatment is 1 week, if necessary - 2 weeks.

If the weight of the child is from 30 to 40 kg, he is given Omeprazole (0.02 g), (0.75 g) and Clarithromycin (7.5 mg / kg) twice a day. If the child's weight is more than 40 kg, a single dose of Amoxicillin is 1 g, Clarithromycin is 0.5 g. The treatment regimen is the same.

Experience with the use of omeprazole for intravenous administration in pediatrics is limited.

Drug Interactions

Omeprazole is able to enhance the inhibitory effect of drugs that affect the hematopoietic system.

Increases concentration and reduces the excretion of indirect anticoagulants, diazepam and phenytoin.

Omeprazole is able to reduce the absorption of ketoconazole and itraconazole, iron salts and ampicillin.

Does not interact with amoxicillin, metronidazole, diclofenac, theophylline, lidocaine, cyclosporine, estradiol, caffeine, propranol, quinidine and concomitantly used antacids.

Application features

Before carrying out therapy with the use of omeprazole, it is necessary to exclude the presence of malignant processes in the patient, since the drug can mask the symptoms of oncological diseases, thereby preventing the diagnosis.

Dose adjustment is not required for elderly patients or those who suffer from impaired renal function.

For patients with severe liver damage, the drug is prescribed per day at a dosage of not more than 20 mg.

Prices in pharmacies

For reference: the average price of Omeprazole in Moscow:

• capsules 20 mg No. 14 cost from 22 rubles;
• 40 mg No. 28 - from 153 rubles;
• powder 40 mg No. 1 - from 182 rubles. for domestic and from 556 rubles. - foreign.

Vacation and storage conditions

The drug belongs to group B, it must be stored in places inaccessible to the child, no more than 3 years from the date of issue. The storage location must be protected from direct sunlight. The maximum temperature at which Omeprazole retains therapeutic qualities is + 25 ° C. Released by prescription.

Similar funds

Complete analogues of Omeprazole:

1. Gastrozole;
2. Demeprazole;
3. Zhelkizol;
4. Zerocide;
5. Zolsser;
6. Vero-omeprazole;
7. Crismel;
8. Losek;
9. Losek Maps;
10. Omez Insta;
11. Omezol;
12. Omecaps;
13. Omeprus;
14. Omephez;
15. Omizak;
16. Omipiks;
17. Omitox;

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Catad_pgroup Antisecretory, proton pump inhibitors

Omeprazole-Teva - instructions for use

Registration number:

LP-001970

Trade name: Omeprazole-Teva

international generic name(INN): omeprazole

Dosage form:

Compound
Dosage 10 mg
1 capsule contains:
active substance omeprazole 10.00 mg;
Excipients: grain sugar [sucrose, starch syrup] 48.00 mg, sodium carboxymethyl starch type A 2.10 mg, sodium lauryl sulfate 2.99 mg, povidone 4.75 mg, potassium oleate 0.644 mg, oleic acid 0.107 mg, hypromellose 3.00 mg, methacrylic acid and ethyl acrylate copolymer 20.455 mg. triethyl citrate 2.345 mg, titanium dioxide (E171) 0.75 mg talc 0.095 mg.
Cellulose capsule: carrageenan 0.15 mg, potassium chloride 0.2 mg, titanium dioxide (E171) 3.1912 mg, hypromellose 39.96 mg, water 2.30 mg, sunset yellow dye (E110) 0.3588 mg, iron oxide dye red (E172) 0.5888 mg, charming red dye (E129) 0.276 mg.
Dosage 20 mg
1 capsule contains: active substance omeprazole 20.00 mg;
Excipients: grain sugar [sucrose, glucose syrup] 96.00 mg, sodium carboxymethyl starch type A 4.20 mg, sodium lauryl sulfate 5.98 mg, povidone 9.50 mg, potassium oleate 1.287 mg, oleic acid 0.214 mg, hypromellose 6.00 mg , melacrylic acid and ethyl acrylate copolymer 40.91 mg, triethyl citrate 4.69 mg, titanium dioxide (E171) 1.50 mg, talc 0.19 mg.
Cellulose capsule: carrageenan 0.185 mg, potassium chloride 0.265 mg, titanium dioxide (E171) 3.60 mg, hypromellose 52.05 mg, water 3.00 mg, sunset yellow dye (E110) 0.468 mg charming red dye (E129) 0.096 mg , dye brilliant blue (E133) 0.336 mg.
Dosage 40 mg
1 capsule contains: active substance omeprazole 40.00 mg:
excipients: grain sugar [sucrose, starch syrup] 1912.00 mg, sodium carboxymethyl starch type A 8.40 mg, 9-sodium lauryl sulfate 11.96 mg, povidone 19.00 mg, potassium oleate 2.576 mg, oleic acid 0.428 mg, hypromellose 12.00 mg , methacrylic acid and ethyl acrylate copolymer 81.82 mg triethyl citrate 9.38 mg, titanium dioxide (E171) 3.00 mg, talc 0.38 mg.
Cellulose capsule: carrageenan 0.283 mg, potassium chloride 0.397 mg, titanium dioxide (E171) 5.40 mg, hypromellose 78.07 mg, water 4.50 mg, sunset yellow dye (E110) 0.702 mg, charming red dye (E129) 0.144 mg, dye brilliant blue (E133) 0.504 mg.
The composition of the white ink used to print the inscriptions on the capsules (for all dosages): shellac 11-13%, ethanol 15-18%, isopropanol 15-18%, propylene glycol 1-3%, butanol 4-7%, povidone 10-13%, sodium hydroxide 0.m5-0.1%, titanium dioxide- (E 7) -32-36-%.

Description
Dosage 10 mg. No. 3 hard, opaque cellulose capsules with orange body and red cap. White ink on the cover "O", on the body - "10".
Dosage 20 mg. Hard opaque cellulose capsules No. 2 with an orange body and a blue cap. White ink on the cover "O", on the body - "20".
Dosage 40 mg. No. 0 opaque cellulose hard capsules with orange body and blue cap. White ink on the cover "O", on the body - "40".
The contents of the capsules are micropellets from white to white with a yellowish or pinkish tint.

Pharmacotherapeutic group:

ATX code: A02BC01

Pharmacological properties
Pharmacodynamics. It inhibits the activity of H + /K + -ATPase in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid secretion. The effect of omeprazole on last stage the formation of hydrochloric acid is dose-dependent and provides effective inhibition of basal and stimulated secretion, regardless of the nature of the stimulating factor.
When taken daily, omeprazole provides rapid and effective inhibition of daytime and nighttime secretion of hydrochloric acid. The maximum effect is achieved within 4 days. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains intragastric acidity at a pH level of more than 3 for 17 hours.
The action of omeprazole together with antibacterial drugs leads to the eradication of Helicobacter pylori, which allows you to quickly stop the symptoms of the disease, achieve high degree healing of the damaged mucous membrane and stable long-term remission and reduce the likelihood of bleeding from the gastrointestinal tract (GIT), and the need for long-term antiulcer therapy disappears.

Pharmacokinetics
Suction and distribution. After taking the drug inside, omeprazole is rapidly absorbed from the small intestine, the maximum plasma concentration (Cmax) is reached after 0.5-3.5 hours.
Bioavailability is 30-40%, with liver failure - 100%. Binding to plasma proteins (albumin and acid aα1-glycoprotein) - about 90%.
Metabolism and excretion. (omeprazole is almost completely metabolized in the liver with the participation of the CYP2C19 enzyme system with the formation of six pharmacologically inactive metabolites (hydroxyomeprazole, sulfide and sulfone derivatives, etc.). It is an inhibitor of the CYP2C19 isoenzyme.
The half-life (T 1 / 2) - 0.5-1 h, with liver failure -3 hours. Clearance 300-600 ml / min.
It is excreted by the kidneys (70-80%) and through the intestines (20-30%) as metabolites.
Pharmacokinetics in special clinical situations. In chronic renal failure, excretion decreases in proportion to the decrease in creatinine clearance.
In the elderly, the excretion of omeprazole decreases, the bioavailability increases.

Indications for use

Omeprazole is a popular drug from the group of organotropic gastrointestinal drugs used in the treatment of inflammatory and destructive diseases of the digestive system.

It has an active inhibitory effect on the production of hydrochloric acid in terminal stage its synthesis. Omeprazole is included in the standard regimen complex treatment peptic ulcer.

In this article, we will consider why doctors prescribe Omeprazole, including instructions for use, analogues and prices for this drug in pharmacies. If you have already used Omeprazole, leave feedback in the comments.

Composition and form of release

Clinical and pharmacological group: H+-K+-ATPase inhibitor. Antiulcer drug.

The composition of one capsule includes 20 mg of pellets in terms of omeprazole. Pellets are spherical microgranules. Auxiliary components of pellets: additives E421, E217, E171, E219, E170; dodecyl sulfate and sodium hydrogen phosphate, dodecahydrate, cetyl alcohol, sucrose, hypromelose.

The drug begins to act within the first 60 minutes after administration. The effect persists for the next 24 hours, while it reaches a peak 2 hours after ingestion.

Why is Omeprazole prescribed?

According to the instructions for Omeprazole, the medication is prescribed in such cases:

1. Zollinger-Ellison syndrome;
2. Multiple endocrine adenomatosis;
3. Systemic mast cell leukemia;
4. Prevention of acid aspiration pneumonitis (Mendelssohn's syndrome);
5. Stress ulcers of the gastrointestinal tract;
6. Reflux esophagitis (including erosive);
7. Ulcerative lesions of the stomach and duodenum - during the period of exacerbations, in the prevention of relapses, as well as in the association of these diseases with Helicobacter pylori infection (with complex therapy, including antibacterial drugs).

Also, the drug is prescribed for gastropathy (erosive and ulcerative defects) provoked by the use of non-steroidal anti-inflammatory drugs.

pharmachologic effect

Suppresses the secretion of hydrochloric acid in the stomach, being an inhibitor (suppresses the function) of the “proton pump” (the process of exchanging hydrogen ions). The mechanism of antisecretory action is associated with inhibition (suppression of activity) of the enzyme H-K-ATPase (an enzyme that accelerates the exchange of hydrogen ions) in the membranes of the cells of the gastric mucosa, which leads to blocking the final stage of the formation of hydrochloric acid.

As a result, the level of basal (own) and stimulated secretion (secretion of digestive juices) decreases, regardless of the nature of the stimulus. The action of the drug occurs quickly and depends on the dose. After a single dose of 0.02 g of omeprazole, the effect lasts for 24 hours.

Instructions for use

Taking the drug for adults and children over 12 years of age, as a rule, is prescribed in such doses:

1. With exacerbation of peptic ulcer, reflux esophagitis and gastropathy caused by taking NSAIDs - 20 mg 1 time per day. For patients with severe reflux esophagitis, the dose is increased to 40 mg 1 time per day. The course of treatment for duodenal ulcer - 2-4 weeks, if necessary - 4-5 weeks; with gastric ulcer, with reflux esophagitis, with erosive and ulcerative lesions of the gastrointestinal tract caused by taking NSAIDs - within 4-8 weeks.
2. Patients resistant to treatment with other antiulcer drugs are prescribed 40 mg per day. The course of treatment for duodenal ulcer - 4 weeks, for gastric ulcer and reflux esophagitis - 8 weeks.
3. Zollinger-Ellison syndrome: the initial (daily) dose of Omeprazole, applied once in the morning - 60 mg; if necessary, the daily dose is increased to 80-120 mg. The dose must be selected individually, taking into account the reaction of the body. If the daily dose exceeds 80 mg, it must be divided into 2-3 doses.
4. For the prevention of recurrence of peptic ulcer - 10 mg 1 time per day.
5. For the eradication of Helicobacter pylori, "triple" therapy is used (for 1 week: omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg - 2 times a day; or omeprazole 20 mg, clarithromycin 250 mg, metronidazole 400 mg - 2 times a day day; either omeprazole 40 mg 1 time per day, amoxicillin 500 mg and metronidazole 400 mg - 3 times a day) or "double" therapy (for 2 weeks: omeprazole 20-40 mg and amoxicillin 750 mg - 2 times a day day or omeprazole 40 mg - 1 time per day and clarithromycin 500 mg - 3 times a day or amoxicillin 0.75-1.5 g - 2 times a day).

Dose adjustment of omeprazole in the elderly is not required. Dose adjustment of omeprazole in patients with impaired renal function is not required. In case of impaired liver function, the maximum daily dose of omeprazole is 20 mg.

Contraindications

Among the unconditional contraindications for the use of omeprazole is hypersensitivity to the drug, benzimidazole derivatives (for example, esomeprazole, lansoprazole), or any other component of the pharmacological agent.

Other contraindications to omeprazole may include:

• atrophic gastritis: long-term therapy aggravates the patient's condition;
• oncological tumors - in the chord of the study, a tendency was revealed to increase the size of neoplasms during omeprazole therapy;
• osteoporosis and frequent bone fractures (in some cases, omeprazole may be taken with additional vitamin D intake);
  low levels of magnesium in the blood plasma, the use of omeprazole can provoke a washout of this element.

Before prescribing omeprazole it is necessary to make sure that the patient does not have the following conditions:

• malignant tumors of the stomach: relief of symptoms does not exclude the presence malignant neoplasm stomach;
• gastrointestinal infections (eg Salmonella, Campylobacter): the use of inhibitors may increase the risk of developing these infections;
• hepatic insufficiency: an increase in bioavailability may be observed in patients with impaired liver function; dose reduction should be considered, especially for the treatment of erosive esophagitis.

In the elderly, the bioavailability of omeprazole can be dramatically increased. This requires careful calculation of the daily and single dose of the drug on an individual basis, taking into account the patient's body weight and his general condition.

Pregnancy and lactation

Contraindicated during pregnancy and lactation.

Application in childhood

Contraindicated in children.

Side effects

When using Omeprazole, violations are possible:

• from the gastrointestinal tract: often - diarrhea, constipation, abdominal pain, nausea, vomiting, flatulence; rarely - dry mouth, stomatitis, candidiasis of the gastrointestinal tract, lack of appetite;
• from the musculoskeletal system: rarely - arthralgia, muscle weakness, myalgia;
• on the part of the skin and its derivatives: infrequently - rash (including bullous) and / or itching, dermatitis, urticaria; rarely - photosensitivity, erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia;
• from the liver and biliary system: infrequently - a violation of taste, an increase in the activity of "liver" enzymes; rarely - in patients with previous severe liver disease - hepatitis (including with jaundice), encephalopathy, severe liver dysfunction (including liver failure);
• from the hemopoietic system: rarely - anemia, leukopenia, pancytopenia, thrombocytopenia, agranulocytosis, eosinophilia;
• from the side of the central and peripheral nervous system: often - headache; infrequently - dizziness, loss of consciousness, general weakness, insomnia, drowsiness, anxiety, paresthesia; rarely - agitation, reversible confusion, aggressiveness, depression and hallucinations;
• allergic reactions: rarely - angioedema, fever, bronchospasm, anaphylactic shock;
• others: infrequently - malaise; rarely - interstitial nephritis, gynecomastia, visual impairment, peripheral edema, increased sweating, impotence, hyponatremia.

Criteria for assessing the incidence of adverse reactions medicinal product: often (≥ 1/100); infrequently (≥ 1/1000 and< 1/100); редко (< 1/1000).

Overdose

In case of an overdose, the following symptoms may occur:

• nausea;
• drowsiness;
• blurred vision;
• arrhythmia;
• headache;
• dry mouth;
• confusion;
• tachycardia.

Treatment is symptomatic. Hemodialysis is ineffective. there is no specific antidote.

special instructions

Before starting therapy with omeprazole, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), because. treatment, by masking symptoms, may delay the correct diagnosis.
Taking it with food does not affect its effectiveness.

Analogues

Omeprazole analogues with the same active substance: Omeprazole-Acre, Omeprazole-Teva, Gastrozole, Omeprazole-STADA, Zerocid, Omez, Omipiks, Omitox, Omizak, Omeprazole-Richter, Promez, Ultop, Helicid.

Prices

The average price of OMEPRAZOL in pharmacies (Moscow) is 25 rubles.

Terms and conditions of storage

Store in a dark, dry place out of the reach of children at temperatures up to 25 °C. Shelf life - 2 years.