Omeprazole capsules 20mg №14

Active substance

Omeprazole

Composition

Capsules

Active substance: Omeprazole 20.00 mg;

Excipients:sugar krupka [sucrose, starch 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 [1: 1] 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, dusk sunset yellow (E110) 0.468 mg red charming (E129) 0.096 mg, the dye brilliant blue (E133) 0.336 mg.

pharmachologic effect

H + -K + -ATP-ase inhibitor. Hinders the activity of H + -K + -ATP-ases in the parietal cells of the stomach and thereby blocks the final stage of the secretion of hydrochloric acid. This leads to a decrease in 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 simultaneous use of omeprazole and antibiotics allows you to quickly stop the symptoms of the disease,achieve a high degree of healing of the damaged mucous and resistant long-term remission and reduce the likelihood of bleeding from the gastrointestinal tract.

Pharmacokinetics

When ingestion is rapidly absorbed from the gastrointestinal tract. It penetrates into the parietal cells of the gastric mucosa. Plasma protein binding is about 95%, predominantly with albumin. Biotransforming in the liver. Excreted by the kidneys - 72-80%, with feces - about 20%. T1 / 2 0.5-1 h. In patients with chronic liver diseases, T1 / 2 increases to 3 h.

Indications

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

Contraindications

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

Side effects

From the blood and lymphatic system:rarely, hypochromic microcytic anemia in children; reversible thrombocytopenia, leukopenia, pancytopenia, agranulocytosis are very rare.
Immune system: very rarely - syt, fever, angioedema, narrowing of the bronchi, allergic vasculitis, fever, anaphylactic shock.
Nervous system: often - headache, dizziness, insomnia, drowsiness, lethargy (these side effects show a tendency to aggravate with prolonged therapy): rarely - paresthesia,confusion, hallucinations, especially in elderly patients or in severe illness; very rarely, anxiety, depression, especially in elderly patients or in severe cases of the disease.
Special senses: infrequently - visual disturbances, incl. reduction of visual fields, reduced sharpness and clarity of visual perception (usually disappear after cessation of therapy).
On the part of the organ of hearing and labyrinth disorders: infrequently, hearing impairment disorders, incl. "ringing in the ears" (usually disappear after cessation of therapy).
From the gastrointestinal tract: often - nausea, vomiting, flatulence, constipation, diarrhea, abdominal pain (in most cases, the severity of these phenomena increases with the continuation of therapy); infrequently - taste perversion (usually disappears after cessation of therapy); rarely, a change in the color of the tongue to brownish black and the appearance of benign cysts of the salivary glands while being used with Clarithromycin (phenomena are reversible after cessation of therapy); very rarely - dryness of the oral mucosa, stomatitis, candidiasis, pancreatitis.
Liver and biliary tract: infrequently, changes in liver enzymes (reversible); very rarely, hepatitis, jaundice, liver failure, encephalopathy, especially in patients with liver diseases.
Dermatological: infrequently rash, pruritus, alopecia, erythema multiforme, photosensitization,increased sweating; very rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the musculoskeletal and connective tissue: infrequently - fractures of the vertebrae, wrist bones, femoral head (see section "Special Instructions"); rarely - myalgia, arthralgia; very rarely - muscle weakness.
From the kidneys and urinary tract: rarely interstitial nephritis.
Other:infrequently-peripheral edema (usually disappear after cessation of therapy); rarely, hyponatremia; very rarely, hypomagnesemia (see section "Special Instructions"), gynecomastia.

Interaction

With simultaneous use with omeprazole, Ketoconazole absorption may be reduced.
When used simultaneously with omeprazole, the bioavailability of Digoxin increases by 10% due to an increase in pH.
Omeprazole can reduce the absorption of vitamin B12 with prolonged use.
Omeprazole should not be used simultaneously with the preparations of Hypericum because of the pronounced clinical significant interaction.
With the simultaneous use of omeprazole and clarithromycin, their plasma concentrations increase.
When applied simultaneously with omeprazole, the area of ​​atazanavir concentration-time mode modes is reduced by 75%, therefore their simultaneous use is contraindicated.
With simultaneous use with omeprazole may slow excretion of Warfarin, diazepam and phenytoin, as well as imipramine, clomipramine, citalopram, hexabarbital, disulfiram, because omeprazole biotransformed in the liver with the participation of the CYP2C19 isoenzyme.May require reduced doses of these drugs. When using omeprazole with caffeine, propranolol, theophylline, Metoprolol, Lidocaine, quinidine, Erythromycin, phenacetin, estradiol, Amoxicillin, Naproxen, Piroxicam and antacids, there is no clinically significant interaction.

How to take, the course of administration and dosage

Inside, in the morning before eating sludge during meals, washed down with a small amount of water; the contents of the capsule can not be chewed.
Adults
With exacerbation of gastric ulcer, duodenal ulcer and reflux esophagitis 
At 20 mg 1 time per day. The course of treatment is 4-8 weeks. In some cases, it is possible to increase the dose to 40 mg per day.
With maintenance tolerance, GERD for relapse prevention 
At 10-20 mg for 26-52 weeks, depending on the clinical effect, with severe esophagitis, for life. In the treatment of erosive and ulcerative lesions of the stomach and duodenum associated with the intake of NSAIDs (including for the prevention of recurrence)
At 10-20 mg per day.
With Zollinger-Ellison syndrome 
The dose is set individually. The recommended starting dose is 60 mg once a day. If necessary, increase the dose to 80-120 mg per day, in this case it should be divided into two doses.
Erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori 
At 20 mg 2 times a day in combination with antibacterial drugs for 7 days. In patients with gastric ulcer and / or duodenal ulcer in the acute stage, prolongation of monotherapy with omeprazole is possible.
Elderly patients dose adjustment is not required.
In patients with kidney failure, dose adjustment is not required.
In patients with liver failure, the maximum daily dose of 20 mg.
If you experience difficulty in swallowing a whole capsule, you can swallow its contents after opening or resorbing the capsule, and you can also mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension for 30 minutes.

Overdose

Symptoms:blurred vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.
Treatment: symptomatic therapy, hemodialysis is not effective enough. The specific antidote is not known.

Use during pregnancy

The use of omeprazole during pregnancy and breastfeeding is contraindicated due to insufficient data on the effectiveness and safety of this category of patients.

Special instructions

Before starting therapy, it is necessary to exclude the presence of a malignant process in the upper GI tract, since taking the drug Omeprazole-Teva may mask the symptoms and delay the formulation of the correct diagnosis.
Reducing gastric acidity, including when using proton pump blockers, increases the number of bacteria in the gastrointestinal tract, which increases the risk of gastrointestinal infections.
In patients with severe hepatic impairment, it is necessary to regularly monitor indicators of “liver” enzymes during therapy with Omeprazole-Teva.
Omeprazole-Teva contains sucrose and is therefore contraindicated in patients with congenital disorders of carbohydrate metabolism (fructose intolerance, sucrase deficiency / isomaltose, glucose-galactose malabsorption).
When treating erosive-ulcerative lesions associated with the use of NSAIDs, care should be taken to consider limiting or discontinuing NSAIDs to increase the effectiveness of anti-ulcer therapy.
The drug contains sodium, which should be taken into account in patients on a controlled sodium diet.
The ratio of risk and benefits of long-term (more than 1 year) maintenance therapy with Omeprazole-Teva should be regularly evaluated. There is evidence of an increased risk of vertebral fractures, carpal bones, and femoral head predominantly in elderly patients, as well as in the presence of predisposing factors. Patients at risk for osteoporosis should be given adequate intake of vitamin D and Calcium.
There are reports of the occurrence of severe hypomagnesemia in patients receiving therapy with proton pump inhibitors, including omeprazole, for more than 1 year.
A patient receiving therapy with omeprazole for a long time, especially in combination with digoxin or other drugs that reduce the content of Magnesium in the blood plasma (diuretics), requires regular monitoring of the content of magnesium.

Storage conditions

In the dark place at a temperature of no higher than 25 ° C.

Shelf life

2 years

Pharmacy sales terms

On prescription