Universal reference book for medicines
Product name: OMEPRAZOLE ZENTIVA (OMEPRAZOLE ZENTIVA)

Active substance: omeprazole

Type: H + -K + -ATPase inhibitor.
Antiulcer drug
Manufacturer: ZENTIVA (Czech Republic) manufactured by ZENTIVA (Slovak Republic)
Composition, form of production and packaging
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Capsules intestine -soluble hard gelatinous, size 3, with a casing of light brownish-yellow color and a lid of light orange color; the contents of capsules are spherical pellets from white to white with a light yellowish-brownish hue of color.
1 caps.

omeprazole 10 mg

Auxiliary substances: sugar grits - 83.96 mg (sucrose 80 - 91.5%, corn starch 8.5 - 20%, water purified - 1.5%), lactose anhydrous - 4.09 mg, hypromellose 2910/6 - 8.5 mg, giprolose - 3.065 mg, sodium lauryl sulfate - 0.255 mg, sodium hydrophosphate dodecahydrate 0.41 mg, triethyl citrate 2.865 mg, talc 12 mg, methacrylic acid and ethyl acrylate copolymer [1: 1] 24.855 mg.

The composition of the capsule shell: body: iron dye oxide black (E172) - 0.02%, iron dye red oxide (E172) - 0.04%, titanium dioxide (E171) - 4%, iron dye oxide yellow (E172) 0.22%, gelatin - up to 100%;
lid: iron dye oxide red (E172) - 0.06%, titanium dioxide (E171) - 1.33%, iron coloring oxide yellow (E172) - 0.65%, gelatin - up to 100%.
14 pcs.
- bottles of dark glass (1) - packs of cardboard.
28 pcs.
- bottles of dark glass (1) - packs of cardboard.
Intestine-soluble hard gelatin capsules, size 2, with a casing of light brownish-yellow color and a lid of light brown color;
the contents of capsules are spherical pellets from white to white with a light yellowish-brownish hue of color.
1 caps.

omeprazole 20 mg

Auxiliary substances: sugar grits - 167.92 mg (sucrose 80 - 91.5%, corn starch 8.5 - 20%, water purified - 1.5%), lactose anhydrous - 8.18 mg, hypromellose 2910/6 - 17 mg, giprolose - 6.13 mg, sodium lauryl sulfate - 0.51 mg, sodium hydrogen phosphate dodecahydrate - 0.82 mg, triethyl citrate - 5.73 mg, talc - 24 mg, methacrylic acid and ethyl acrylate copolymer [1: 1] - 49.71 mg.

The composition of the capsule shell: body: iron dye oxide black (E172) - 0.02%, iron dye red oxide (E172) - 0.04%, titanium dioxide (E171) - 4%, iron dye oxide yellow (E172) 0.22%, gelatin - up to 100%;
lid: iron dye red oxide (E172) - 0.47%, titanium dioxide (E171) - 1%, iron dye oxide yellow (E172) - 0.45%, gelatin - up to 100%.
14 pcs.
- bottles of dark glass (1) - packs of cardboard.
28 pcs.
- bottles of dark glass (1) - packs of cardboard.
90 pcs.
- bottles of dark glass (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Antiulcer drug.
H + -K + -ATPase inhibitor.
Omeprazole has a highly selective mechanism of action, which reduces the secretion of gastric juice.
It is a specific inhibitor of the proton pump of parietal cells of the stomach. The action of the drug occurs quickly and is mediated by reversible inhibition of the secretion of gastric juice. Omeprazole is a weak base. Concentrates in the acidic environment of the secretory tubules of parietal cells of the gastric mucosa, is activated and inhibits the proton pump - the enzyme H + -K + -ATP-ase. Effect of omeprazole on the last stage of the process of formation of hydrochloric acid in the stomach is dose-dependent and provides a highly effective inhibition of basal and stimulated secretion of hydrochloric acid regardless of the stimulating factor.
Omeprazole with daily oral administration provides rapid and effective inhibition of day and night secretion of hydrochloric acid.
The maximum effect is achieved within 4 days of treatment. In patients with duodenal ulcers, omeprazole at a dose of 20 mg causes a steady decrease in 24-hour gastric acidity by at least 80%. At the same time, the mean C max of hydrochloric acid is reduced after pentagastrin stimulation by 70% within 24 hours.
In patients with duodenal ulcers, omeprazole, when administered daily at a dose of 20 mg, maintains in the intragastric medium an acidity value of> 3 pH on average for 17 hours.

Inhibition of the secretion of hydrochloric acid depends on the AUC of omeprazole, and not on the concentration of the drug in the blood plasma at a given time.

Omeprazole has a bactericidal effect against Helicobacter pylori in vitro.
Eradication of Helicobacter pylori with omeprazole together with antibacterial agents is accompanied by rapid elimination of symptoms, high healing of defects in the gastrointestinal mucosa and long-term remission of peptic ulcer, which reduces the likelihood of complications such as bleeding, as effectively as constant maintenance therapy.
PHARMACOKINETICS

Suction

Omeprazole is rapidly absorbed from the gastrointestinal tract, C max in plasma is reached after 0.5-1 h. Omeprazole is absorbed in the small intestine, usually for 3-6 hours. Bioavailability after a single oral administration is approximately 30-40%, after a permanent application 1 time / day bioavailability increases to 60%.
Eating does not affect the bioavailability of omeprazole.
Distribution

The binding of omeprazole to plasma proteins is about 95%, V d is 0.3 l / kg.
Omeprazole does not have a cumulative effect.
Metabolism

Omeprazole is completely metabolized in the liver.
The main isoenzymes involved in the metabolic process are CYP2C19 and CYP3A4. Given the high degree of affinity of omeprazole to the isoenzyme CYP2C19, its competitive interaction with other drugs in the metabolism of which this isoenzyme participates is possible.Hydroxy-omeprazole is the main metabolite formed under the action of the isoenzyme CYP2C19. The resulting metabolites - sulfone and sulfide - do not have a significant effect on the secretion of hydrochloric acid.
Excretion

T 1/2 is about 40 minutes (30-90 minutes).
About 80% is excreted as metabolites by the kidneys, and the rest is through the intestine.
Pharmacokinetics in specific patient groups

In elderly patients there was a slight decrease in the metabolism of omeprazole.

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

In patients with impaired liver function, there is an increase in AUC.

INDICATIONS

For capsules 10 mg

- symptomatic treatment of reflux symptoms (heartburn, nausea, acidic eructation) associated with gastroesophageal reflux disease (GERD) in adults.

For capsules 20 mg

- stomach ulcer;

- peptic ulcer of the duodenum;

- NSAID-associated ulcers and erosion of the stomach and duodenum;

- eradication of Helicobacter pylori with peptic ulcer of the stomach and duodenum;

- reflux esophagitis;

- symptomatic gastro-oesophageal reflux disease;

- dyspepsia associated with increased acidity;

- Zollinger-Ellison syndrome.

DOSING MODE

The drug is taken orally, with a small amount of water (the contents of the capsule can not be chewed).
If you have difficulty swallowing the whole capsule, you can swallow its contents after opening or dissolving the capsule, and you can mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension for 30 minutes. Do not take with milk or soda at the same time.
For capsules 10 mg

The recommended dose is 1 caps.
1 time / day (preferably in the morning, on an empty stomach).
Reduction in the severity of symptoms is usually observed after 2-3 days of regular use of the drug.
In most patients, heartburn completely disappears within 7 days.After complete disappearance of the symptoms, treatment should be discontinued.
Treatment without medical supervision is carried out for 14 consecutive days.

For capsules 20 mg

Adults

Peptic ulcer disease of the duodenum

Patients with an active ulcer of the duodenum are recommended to take Omeprazole Zentiva 20 mg 1 time / day.
The drug provides a rapid elimination of symptoms.In most patients, healing of the ulcer occurs within 2 weeks. In those cases when the healing of the ulcer does not occur within 2 weeks, healing is achieved with a subsequent 2-week application of Omeprazole Zentiva.
Patients with a duodenal ulcer, weakly susceptible to treatment, are usually prescribed Omeprazole Zentiva 40 mg 1 time / day.
Healing of the ulcer usually occurs within 4 weeks.
To prevent relapse, patients with duodenal ulcers are recommended Omeprazole Zentiva 20 mg 1 time / day.
If necessary, the dose can be increased to 40 mg 1 time / day.
Stomach ulcer

The recommended dose of omeprazole Zentiva is 20 mg 1 time / day.
The drug provides a rapid elimination of symptoms. In most patients, the cure comes within 4 weeks. In those cases when, after the first course of the drug, complete healing does not occur, a four-week course of treatment is usually prescribed, during which healing is achieved.
Patients with a stomach ulcer, weakly susceptible to treatment, the drug is usually prescribed in a dose of 40 mg 1 time / day.
Healing is usually achieved within 8 weeks.
To prevent recurrence, a dose of 20 mg 1 time / day is recommended for patients with gastric ulcers.
If necessary, the dose can be increased to 40 mg 1 time / day.
NSAID-associated stomach ulcers or duodenal erosion

In the presence of NSAID-associated gastric ulcers, duodenal ulcers or gastroduodenal erosions in patients with continued therapy with NSAIDs or after its completion, the recommended dose of the drug is 20 mg 1 time / day.
The drug provides a rapid elimination of symptoms, the majority of patients cure occurs within 4 weeks. In those patients who have not had a cure during the initial therapy period, healing is usually achieved with a repeated 4-week use of the drug.
With duodenal ulcers, erosions and symptoms of dyspepsia associated with taking NSAIDs, a dose of 20 mg is recommended 1 time / day.

Eradication of Helicobacter pylori

The following combinations of the three-component treatment regimen are most often used:

- omeprazole 20 mg + amoxicillin 1000 mg + clarithromycin 500 mg twice a day, in the morning and in the evening;

- omeprazole 20 mg + metronidazole 400 mg + clarithromycin 250 mg twice a day, in the morning and in the evening;

- Omeprazole 20 mg + Metronidazole 400 mg + clarithromycin 500 mg twice a day, in the morning and in the evening;

- omeprazole 40 mg 1 time / day + amoxicillin 500 mg 3 times / day + metronidazole 400 mg 3 times / day.

The course of therapy is 7 days.

To conduct a 2-week course of dual therapy, the following combinations are used:

- omeprazole 20-40 mg + amoxicillin 750 mg 2 times / day;

- omeprazole 40 mg 1 time / day + clarithromycin 500 mg 3 times / day or amoxicillin 750-1500 mg 2 times / day;

In those cases when after the course of treatment the test for Helicobacter pylori remains positive, the course of treatment can be repeated.

Reflux-esophagitis

The recommended dose is 1 caps.
preparation Omeprazole Zentiva 20 mg 1 time / day. The drug provides a rapid elimination of symptoms. In most patients, the cure comes within 4 weeks. In those cases when, after the first course of the drug, there is no complete cure, a 4-week course of treatment is usually prescribed, during which a cure is achieved.
Patients with a severe form of reflux esophagitis are recommended Omeprazole Zentiva in a dose of 40 mg 1 time / day;
Cure usually occurs within 8 weeks.
Patients with reflux-esophagitis in remission are prescribed Omeprazole Zentiva 20 mg once a day in the form of long-term maintenance therapy.
If necessary, the dose can be increased to 40 mg.
Symptomatic gastroesophageal reflux disease

The recommended dose of omeprazole Zentiva is 20 mg 1 time / day.
The drug provides a rapid elimination of symptoms. Individual dose selection is not excluded. If after 4 weeks of treatment the symptoms do not disappear, an additional examination of the patient is recommended.
Dyspepsia associated with increased production of hydrochloric acid

To relieve pain and / or eliminate feelings of discomfort in the epigastric region, with heartburn or without heartburn, prescribe the drug Omeprazole Zentiva 20 mg 1 time / day.
If after 4 weeks of treatment the symptoms do not disappear, an additional examination of the patient is recommended.
Zollinger-Ellison Syndrome

Patients with Zollinger-Ellison syndrome the drug is prescribed in an individual dosage.
Treatment is continued according to clinical indications as long as necessary.The recommended initial dose of the drug is 60 mg daily. In patients with severe disease, and also when other therapeutic methods did not lead to the desired result, the use of the drug was effective in more than 90% of cases when administered at a dose of 20-120 mg daily. In those cases when the daily dose of the drug exceeds 80 mg, the dose should be divided into 2 parts and taken 2 times / day.
In children over 2 years of age and with a body weight> 20 kg, the recommended dose of the drug is 20 mg 1 time / day.
If necessary, the dose can be increased to 40 mg 1 time / day.
The duration of treatment with reflux-esophagitis is 4-8 weeks.

The duration of treatment with symptomatic therapy of heartburn and eructations is acidic for gastroesophageal reflux disease is 2-4 weeks.
If omeprazole is used for 2-4 weeks, the symptoms do not disappear, further examination is recommended.
In children over the age of 4 years and adolescents for the treatment of duodenal ulcers caused by H. pylori , when choosing an antibiotic for the appropriate combination therapy, it is necessary to take into account the individual tolerability of the drugs by the patient.
Drugs should be prescribed according to the nature of the resistance and treatment guidelines adopted in the country, at the regional level, and also at the local level, taking into account the duration of treatment (usually 7 days, sometimes 14 days) and the appropriate use of antibacterial drugs. Treatment should be carried out under the supervision of a specialist.
The following doses are recommended:

Body Weight Dosage

31-40 kg Combination with two antibiotics: 20 mg of omeprazole, 750 mg of amoxicillin and clarithromycin 7.5 mg / kg of body weight are applied simultaneously 2 times / day for one week.

> 40 kg Combination with two antibiotics: 20 mg of omeprazole, 1 g of amoxicillin and 500 mg of clarithromycin are applied simultaneously 2 times / day for one week.

Special patient groups

In patients with impaired renal function, dose adjustment is not required.

In patients with impaired liver function, a daily dose of 10-20 mg is usually sufficient.

In elderly patients (over 65 years of age), dose adjustment is not required.

SIDE EFFECT

The side effects of omeprazole are usually minor and reversible.
There may be the following side effects, which are divided into system-organ classes according to the classification of the Medical Dictionary of Regulatory Activities (MedDRA). The WHO classification was used to indicate the frequency of side effects: very often (? 10%), often (? 1% and <10%), infrequently (? 0.1% and <1%), rarely (? 0.01% and <0.1% ), very rarely (<0.01%), an unknown frequency (it is not possible to determine the incidence of side effects according to available data).
On the part of the hematopoiesis system: rarely - leukopenia, thrombocytopenia;
very rarely - agranulocytosis, pancytopenia.
On the part of the immune system: rarely - hypersensitivity reactions (eg, fever, angioedema, anaphylactic reaction / anaphylactic shock).

From the side of metabolism: rarely - hyponatremia;
unknown frequency - hypomagnesemia.
Mental disturbances: infrequently insomnia;
rarely - agitation, confusion, depression; very rarely - aggression, hallucinations.
From the nervous system: often - headache;
infrequently - dizziness, paresthesia, drowsiness; rarely - a taste disorder.
From the side of the organ of vision: rarely - blurred vision.

From the side of the organ of hearing and labyrinthine disturbances: infrequently - dizziness.

From the respiratory system: rarely - bronchospasm.

On the part of the digestive system: often - diarrhea, constipation, nausea, vomiting, flatulence, abdominal pain;
infrequently - increased activity of hepatic enzymes;rarely - dry mouth, stomatitis, candidiasis of the digestive tract, hepatitis (with jaundice or without); very rarely - liver failure, encephalopathy in patients with liver disease.
From the skin and subcutaneous tissues: infrequently - dermatitis, itching, rash, urticaria;
rarely - alopecia, photosensitization; very rarely - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the musculoskeletal system: infrequently - fractures of the thigh, bones of the wrist and vertebrae;
rarely - arthralgia, myalgia; very rarely - muscle weakness.
From the urinary system: rarely - interstitial nephritis.

From the genitals and the breast: very rarely - gynecomastia.

General violations and violations at the injection site: infrequently - malaise, peripheral edema;
rarely - excessive sweating.
There have been reports of the formation of gastric glandular cysts during long-term treatment with proton pump inhibitors (a consequence of the inhibition of hydrochloric acid secretion, is of a benign, reversible character).

CONTRAINDICATIONS

- simultaneous use with atazanavir and nelfinavir;

- deficiency of lactase, sucrose / isomaltase, lactose intolerance, fructose, glucose-galactose malabsorption;

- Children's age up to 2 years and body weight <20 kg (in the treatment of reflux-esophagitis, symptomatic treatment of heartburn and eructations with acidic in gastroesophageal reflux disease);

- Children under 4 years of age (with treatment of duodenal ulcers caused by H. pylori);

- Children and adolescence under 18 years (for capsules 10 mg);

- hypersensitivity to omeprazole, substituted benzimidazoles or other ingredients that make up the drug.

Caution should be applied to the drug in the presence of symptoms such as significant weight loss, frequent vomiting, dysphagia, vomiting with blood or melena;
in the presence of gastric ulcers (or suspicion of gastric ulcer) should exclude the presence of malignancy because treatment can lead to masking symptoms and, thus, delay the correct diagnosis.
PREGNANCY AND LACTATION

The results showed no side effects of omeprazole on the health of pregnant women, the fetus or newborn. Zentiva Omeprazole can be used during pregnancy.
Omeprazole is excreted in breast milk, but when it is used in therapeutic doses, effects on the baby are unlikely. Omeprazole Zentiva can be applied during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with impaired renal function dose adjustment is required.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In patients with impaired liver function usually sufficient application daily dose of 10-20 mg.
APPLICATION FOR CHILDREN

Not use this drug Omeprazole 20mg Zentiva in children under 2 years of age and with body weight <20 kg (for the treatment of reflux esophagitis, symptomatic treatment of heartburn and regurgitation with gastroesophageal reflux disease); Children aged up to 4 years (in the treatment of duodenal ulcer caused by H. pylori).
Do not use this drug Omeprazole Zentiva 10 mg in children and adolescents up to 18 years.
APPLICATION IN ELDERLY PATIENTS

In elderly patients (over 65 years) No dose adjustment is required.
SPECIAL INSTRUCTIONS

Before the start of therapy, it is necessary to exclude the presence of malignant process (especially with stomach ulcer), since
treatment, masking the symptoms, can delay the setting of the correct diagnosis. If after starting the drug Omeprazole Zentiva for 5 days no improvement status or heartburn intensifies, it is necessary to interrupt the treatment and consult a doctor.
Patients over the age of 45 years with symptoms of heartburn, emerged for the first time, can take the drug Omeprazole Zentiva only after consulting your doctor. The drug Omeprazole Zentiva should not be taken without medical supervision, if there is any of the following symptoms, or one of the states:
- weight loss for no apparent reason, and / or lack of appetite, fatigue;
- long-term pain in the abdomen;
- a stomach ulcer and / or duodenal ulcers in history;
- frequent vomiting;
- swallowing disorder / pain when swallowing;
- hematemesis / melena / rectal bleeding;
- heartburn stable (over three months);
- chronic cough, shortness of breath;
- jaundice;

- chest pain (particularly compression of the chest, or pain radiating to the neck, or upper limbs), combined with sweating, shortness of breath, or dizziness;
- an indication of the cancer of the stomach or esophagus in the history of the next of kin;
- liver failure;

- rare hereditary disorders, such as galactose intolerance, lactase deficiency lapp, fructose insufficiency, malabsorption of glucose-galactose or sucrase-isomaltase deficiency.
If you experience any of these symptoms / condition, the treatment should be under the supervision of a physician.
The risk of fractures of the hip, wrist bones and vertebrae
Proton pump inhibitors, especially when using the drug in high doses and long-term use (> 1 year), may moderately increase the risk of fractures of the hip, wrist bones and vertebrae, especially in elderly patients or in the presence of other risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%. Patients with risk of osteoporosis should be treated according to the latest clinical guidelines.
hypomagnesemia
In patients treated with omeprazole for at least 3 months of severe hypomagnesemia it was registered. There may be fatigue, delirium, seizures, dizziness and ventricular arrhythmia. In most patients, hypomagnesaemia was stopped after cancellation proton pump inhibitors and injection of magnesium preparations. In patients undergoing chronic treatment with omeprazole or assigned to digoxin or other drugs that can cause hypomagnesemia (eg diuretics) should evaluate the content of magnesium prior to initiating therapy and periodically monitor it during treatment.
Effects on absorption of vitamin B 12 (cyanocobalamin)
omeprazole, as with all drugs, reducing acidity, can lead to reduction of absorption of vitamin B 12(cyanocobalamin), because it causes hypo- or achlorhydria. This should be remembered in patients with a reduced margin of vitamin B 12 in the body, or with risk factors for malabsorption of vitamin B 12 during prolonged therapy.
Other effects associated with the inhibition of gastric acid secretion
in patients receiving drugs that reduce the secretion of gastric glands, over a long period of time, often marked the formation of glandular cysts in the stomach, which run independently on the background of continued therapy. These phenomena are caused by physiological changes as a result of inhibition of gastric acid secretion.
Reduced secretion of hydrochloric acid in the stomach by the action of proton pump inhibitors or other acid-inhibiting agent, increases the growth of normal intestinal microflora, which in turn may lead to a slight increase in risk of intestinal infections caused by bacteria of the genus Salmonella spp. and Campylobacter spp. as well as, perhaps, the bacterium Clostridium difficile in hospitalized patients.
Concentration chromogranin A (CgA) increases due to the reduction of acid secretion. Increasing CgA concentration can affect the results of examinations to detect neuroendocrine tumors. To prevent this influence it is necessary to temporarily suspend the use of omeprazole for 5 days prior to the survey CgA concentration.
Taking the drug simultaneously with food does not affect its effectiveness.

Impact on the ability to drive vehicles and manage mechanisms

There are no data on the effect of the drug on the ability to drive a motor vehicle or other machinery. However, due to the fact that during therapy may experience dizziness, blurred vision and drowsiness, use caution when driving or while working with machinery that requires high concentration and psychomotor speed reactions.
OVERDOSE

When omeprazole adults in a single dose of 560 mg moderate symptoms of intoxication were observed. A case of use of omeprazole in one dose of 2,400mg not cause any severe toxic symptoms. When increasing the dose rate of elimination did not change (first order kinetics), specific treatment is not required.
Symptoms: dizziness, confusion, lethargy, depression, headache, tachycardia, nausea, vomiting, flatulence, diarrhea,
Treatment: symptomatic therapy;
if necessary - gastric lavage, appointment of activated carbon.
DRUG INTERACTION

Absorption of certain drugs may change due to the reduced acidity of gastric medium.
As well as the use of other drugs suppressing the secretion of hydrochloric acid or antacid, omeprazole treatment may result in decreased absorption of posaconazole, erlotinib, ketoconazole or itraconazole, and also increase absorption of digoxin. The simultaneous use of omeprazole 20 mg 1 time / day and digoxin Digoxin increases bioavailability by 10%.
With simultaneous use of omeprazole with clopidogrel was decreased in the blood plasma of the active metabolite of clopidogrel is 46% on the first day and 42% on the fifth day of treatment, with the purpose of clopidogrel and omeprazole at different times does not exclude interaction of these drugs. Probably the observed effect is due to the inhibitory effect of omeprazole isoenzyme CYP2C19.
Not recommended simultaneous application of omeprazole with drugs such as nelfinavir and atazanavir, since their concentration in blood plasma decreases when combined with omeprazole.
While the use of omeprazole was reported to increase tacrolimus concentrations in blood plasma. Should be carefully monitoring of tacrolimus concentrations in blood plasma, as well as to monitor renal function (creatinine clearance), and to adjust the dose of tacrolimus, if necessary.
Revealed no interaction with food or antacids.
Since omeprazole is metabolized in the liver with isoenzyme CYP2C19, elimination of diazepam, warfarin (R-warfarin), Cilostazol, and phenytoin can be slowed down. We recommend monitoring the patients taking warfarin and phenytoin may require dose reduction aforementioned preparations. However, concomitant treatment with a daily dose of 20 mg did not affect the concentration of phenytoin in blood plasma of patients receiving long-term medication; concomitant treatment with omeprazole Zentiva in a daily dose of 20 mg did not lead to a change of coagulation time in patients receiving long-term warfarin.
Omeprazole does not affect the metabolism of drugs metabolized isoenzyme CYP3A4, such as cyclosporin, lidocaine, quinidine, estradiol, erythromycin and budesonide. Concentration of omeprazole and clarithromycin plasma increases while the use of these drugs.
Drugs that inhibit isozymes CYP2C19 and CYP3A4, such as voriconazole, while the use of omeprazole can lead to increased concentration of omeprazole in blood plasma due to the reduction of the drug metabolism rate. Patients with impaired liver function during long-term use of the drug may need Zentiva omeprazole dose reduction.
Medications which induce isozymes CYP2C19 and CYP3A4, such as, rifampicin and preparations Hypericum perforatum, while the use of omeprazole may lead to decrease in the concentration of omeprazole in blood plasma by accelerating the metabolism of omeprazole.
TERMS OF RELEASE FROM PHARMACY

Capsules of 10 mg are approved for use as a non-prescription medicines.
20 mg capsules dispensed by prescription.
TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 В° C.
Shelf life - 2 years.
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