Omeprazol-Teva - instructions for use, dose, side effects, contraindications

1 capsule contains: active substance omeprazole 10.00 mg; Excipients: sugar crockery [sucrose, molasses starch] 43.49 mg, sodium carboxymethyl starch type A 2.55 mg, sodium lauryl sulfate 3.04 mg, povidone-KZO 4.83 mg, sodium phosphate dodecahydrate 0.33 mg, sodium hydroxide 0.07 mg, hypromellose 7.21 mg, methacrylic acid and ethyl acrylate copolymer [1: 1] 21.26 mg, triethyl citrate 3.08 mg, titanium dioxide (E 171) 1.65 mg, talc 0.10 mg. Gelatin capsule: cap: titanium dioxide (E 171) 0.0384-0.4 mg, water 2.9 mg, gelatin 16.7-18.816 mg; body: titanium dioxide (E 171) 0.576-0.6 mg, water 4.35 mg,gelatin 25.05-28.224 mg.

Dosage of 20 mg

1 capsule contains: active substance omeprazole 20.00 mg;

auxiliary substances: sugarcake [sucrose, molasses

starch] 86.98 mg, sodium carboxymethyl starch type A

5.10 mg, sodium lauryl sulfate 6.07 mg,povidone-KZO 9.66 mg, sodium phosphate

dodecahydrate 0.67 mg, sodium hydroxide 0.14 mg, hypromellose 14.42 mg,

methacrylic acid and ethyl acrylate copolymer [1: 1] 42.53 mg, triethyl citrate

6.17 mg, titanium dioxide (E 171) 3.31 mg,talc 0.19 mg.

Gelatin capsule: cap: titanium dioxide (E 171) 0.48-0.504 mg,

water 3.48-3,654 mg, gelatin 20.04-23.912 mg;

body:

titanium dioxide (E 171) 0.732-0.78 mg, water 5,481-5,655 mg, gelatin 31,563-35,868 mg.

The dosage of 40 mg

1 capsule contains: active substance omeprazole 40.00 mg;

auxiliary substances: sugarcake [sucrose, molasses starch] 173.97 mg,

sodium carboxymethyl starch type A 10.20 mg, sodium lauryl sulfate 12.15 mg,

povidone-KZO 19.31 mg, sodium phosphate dodecahydrate 1.34 mg, sodium hydroxide

0.29 mg, hypromellose 28.84 mg, methacrylic acid and ethyl acrylate

copolymer [1: 1] 85.05 mg, triethyl citrate 12.33 mg, titanium dioxide (E 171) 6.62 mg,

talc 0.38 mg.

Gelatin capsule: cap: titaniumdioxide (E 171) 0.74-0.784 mg,

water 5.36-5.684 mg, gelatin 30.89-37.632 mg;

body:

titanium dioxide (E 171) 1.152-1.18 mg, water 8,526-8,56 mg, gelatin 49,098-56,448 mg.

Black ink (for all doses):

Shellac 24-27%, ethanol * 23-26%,

isopropanol * 1-3%, propylene glycol 3-7 %,

Butanol * 1-3%, ammonia water 1-2 %,

potassium hydroxide 0.05-0.1%, water15-18 %,

dye iron oxide black (E 172) of 24-28%.

* Ethanol, isopropanol and butanol completely evaporate during the process of applying the inscriptions on the capsules and do not remain on the surface of the capsules.

Description

Dosage of 10 mg. White opaque hard gelatin capsules number 3.

Black ink on the cover "O", on the body - "10".

Dosage of 20 mg. White opaque hard gelatin capsules number 2.

Black ink on the cover "O", on the body - "20".

The dosage is 40 mg. White opaque hard gelatin capsules.

Black ink on the cover "O", on the case - "40".

Description:

Dosage of 10 mg. White opaque

hard gelatin capsules number 3.

Black ink on the cover

"O", on the body - "10".

Dosage of 20 mg. White opaque

hard gelatin capsules number 2.

Black ink on the cover

"O", on the body - "20".

The dosage is 40 mg. White opaque

hard gelatin capsules.

Black ink on the cover

"O", on the case - "40".

Pharmacotherapeutic group:glands of the stomach secretion-lowering agent - proton pump inhibitor

ATX: & nbsp

A.02.B.C.01 Omeprazole

Pharmacodynamics:

TOrmositis activity H⁺/TO⁺-ATPase in the parietal cells of the stomach and thereby block the final stage of hydrochloric acid secretion. The effect of omeprazole on the last stage of the formation of hydrochloric acid is dose-dependent and provides an effective inhibition of basal and stimulated secretion, regardless of the nature of the stimulating factor.

With daily intake omeprazole provides rapid and effective inhibition of day and night secretion of hydrochloric acid. The maximum effect is achieved within 4 days. In patients ulcerative disease of the duodenum, admission of 20 mg of omeprazole supports intragastric

acidity at pH above 3 for 17 hours.

The action of omeprazole together with antibacterial drugs leads to eradication Helicobacter pylori, which allows you to quickly stop the symptoms of the disease, achieve a high degree of healing of the damaged mucous membrane and a long-term remission and reduce the likelihood of bleeding from the gastrointestinal tract (GIT), and the need for a prolonged

antiulcer therapy.

Pharmacokinetics:

Absorption and distribution. After taking the drug inside omeprazole quickly absorbed from the small intestine,

maximum concentration in blood plasma

(FROMmah) is achieved after 0.5-3.5 hours. Bioavailability is 30-40%. with hepatic insufficiency - 100%.

Binding to blood plasma proteins (albumin and acid α1-glycoprotein) is about 90%.

Metabolism and excretion. Omeprazole

almost completely metabolized in the liver with the participation of the enzyme system CYP2C19 with formation of six pharmacologically inactive metabolites (hydroxyomeprazole, sulfide and sulphonic derivatives, etc.). Is an inhibitor of isoenzyme CYP2C19.

The half-life (T1/2) - 0.5-1 h, with hepatic insufficiency - 3 h. Clearance 300-600 ml / min.

It is excreted by the kidneys (70-80%) and through the intestine (20-30%) in the form of metabolites. Pharmacokinetics in special clinical cases. In chronic renal failure, excretion decreases in proportion to a decrease in creatinine clearance.

In elderly people omeprazole removal decreases, bioavailability increases.

Indications:

Adults

Peptic ulcer of the stomach and duodenum, incl. prevention of relapses.

Gastroesophageal reflux disease (GERD), reflux esophagitis, incl. prevention of relapses.

Erosive-ulcerative lesions stomach and duodenum, associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs).

Erosive-ulcerative lesions stomach and duodenum associated with Helicobacter pylori (as part of combination therapy).

Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion.

Children

Gastroesophageal reflux disease in children older than 2 years.

Duodenal ulcer associated with Helicobacter pylori (as part of combination therapy) in children older than 4 years.

Contraindications:

Hypersensitivity to omeprazole or any of the components of the drug; intolerance to fructose; deficiency of sugar / isomaltase; glucose-galactose malabsorption; simultaneous use with clarithromycin in patients with hepatic insufficiency; atazanavir, St. John's wort, erlotinib, posaconazole.

Children younger than 2 years old and with a body weight <20 kg (in the treatment of reflux-esophagitis, symptomatic treatment of heartburn and eructations in acidic gastroesophageal disease).

Children younger than 4 years (in the treatment of duodenal ulcers caused by H pylori).

Carefully:Lack of liver function; failure of kidney function;

osteoporosis; concurrent use with clarithromycin. simultaneous use with clopidogrel, itraconazole, warfarip, cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, voriconazole, rifampicin.

Pregnancy and lactation:The results of the studies indicate that there is no adverse effect on the course of pregnancy, the health of the fetus and the newborn baby. Omeprazole can be used during pregnancy. Omeprazole excreted in breast milk. However, when applied in therapeutic doses, the effect on the child is unlikely.

Dosing and Administration:

Inside, in the morning before a meal or during a meal, washing down with a small amount of water; the contents of the capsule can not be chewed. Adults

With exacerbation of stomach ulcer.

duodenal and reflux- esophagitis

20 mg once a 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 therapy GERD for the prevention of relapses

For 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 stomach and duodenum, associated with the intake of NSAIDs (including for prevention of relapses)

10-20 mg per day.

With Zollinger-Ellison syndrome The dose is set individually. The recommended initial dose is 60 mg once a day. If necessary, increase the dose to 80-120 mg per day, in which case it should be divided into two doses. Erosive-ulcerative lesions of the stomach and

duodenum.

associated with Helicobacter pylori Use in combination with 2 antibiotics:

- drug Omeprazol-Teva of 20 mg,

Amoxicillin 1000 mg and clarithromycin on 500 mg. All are applied simultaneously 2 times a day for 1 week.

- drug Omeprazol-Teva of 20 mg,

clarithromycin 250 mg (alternatively 500 mg), metronidazole 400 mg (or 500 mg or tinidazole on 500 mg). Each of the drugs is used 2 times a day for 1 week.

- a preparation of Omeprazol-Teva on 40 mg,

amoxicillin 500 mg and metronidazole 400 mg (or 500 mg or tinidazole on 500 mg). All are applied simultaneously 2 times a day for 1 week.

Application in combination with 1

antibiotic:

- a preparation of Omeprazol-Teva on 40 - 80 mg, amoxicillin 1500 mg daily (the dose should be divided into parts) within 2 weeks.

- a drug Omeprazole -Tev on 40 mg once a day, clarithromycin 500 mg 3 times a day for 2 weeks.

Children

Gastroesophageal reflux disease v

children over 2 years old (body weight over 20 kg)

20 mg once a day. If necessary, the dose can be increased to 40 mg once a day. Duration of treatment 4-8 weeks.

Peptic ulcer of the duodenum

gut associated with Helicobacter pylori (as part of combination therapy) in

children over 4 years old Children with a body weight of 15-30 kg Use in combination with 2 antibiotics: omeprazole-Teva 10 mg, amoxicillin at 25 mg / kg and clarithromycin at 7.5 mg / kg. All are applied simultaneously 2 times a day for 1 week.

In children with a body weight of 31-40 kg Use in combination with 2 antibiotics: omeprazole-Teva 20 mg, amoxicillin for 750 mg and clarithromycin at 7.5 mg / kg. All are applied simultaneously 2 times a day for 1 week.

Children with a body weight of more than 40 kg Use in combination with 2 antibiotics: omeprazole-Teva 20 mg, amoxicillin 1000 mg and clarithromycin on 500 mg. All are applied simultaneously 2 times a day for 1 week.

Have elderly patients (over 65 years of age) correction of the dose is not required.

In patients with renal insufficiency correction of the dose is not required.

Have patients from hepatic impairment the maximum daily dose of 20 mg.

If there are difficulties with 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.

Side effects:The frequency of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely (including isolated cases) - less than 0.01%. From the side of blood and lymphatic

diarrhea, abdominal pain (in most cases, the severity of these phenomena increases with the continuation of therapy); infrequently - (usually occurs after discontinuation of therapy); rarely - a violation of taste, a change in the color of the tongue to brown-black and the appearance of benign salivary gland cysts with simultaneous use with clarithromycin (phenomena are reversible after discontinuation of therapy), microscopic colitis; very rarely - the dryness of the oral mucosa, stomatitis, candidiasis, pancreatitis.

From the liver and bile ducts: infrequently - changes in the activity indices of "hepatic" enzymes (reversible character); very rarely - hepatitis, jaundice, liver failure, encephalopathy, especially in patients with liver disease.

From the skin and subcutaneous tissues: infrequently - hives, rash, itching, alopecia, erythema multiforme, photosensitization, increased sweating; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the side of the musculoskeletal and connective tissue: infrequently - fractures of the vertebrae, bones of the wrist, head of the femur (see section "Special instructions"); rarely - myalgia, arthralgia; very rarely - muscle weakness.

From the side of the kidneys and urinary tract: rarely interstitial nephritis.

General disorders and disorders at the site of administration: infrequently - peripheral edema (usually after the termination of therapy); rarely - hyponatremia; very rarely - gynecomastia; frequency is unknown - hypomagnetism (see section "Special instructions").

Overdose:

Symptoms: impaired 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.

Interaction:

With simultaneous application with omeprazole, absorption of ketoconazole may decrease.

Like other drugs that reduce the acidity of the gastric juice, treatment with omeprazole may lead to a reduction in absorption of ketoconazole, itraconazole, posaconazole and erlotinib, as well as an increase in the absorption of drugs such as digoxin. Joint reception of omeprazole at a dose of 20 mg once a day and digoxin increases the bioavailability of digoxin by 10% (bioavailability of digoxin was increased by up to 30% in 20% of patients). Omeprazole can reduce the absorption of vitamin B12 for prolonged use.

Omeprazole should not be used simultaneously with St. John's wort preparations due to the expressed clinically significant interaction.

When combined with omeprazole with clarithromycin or erythromycin, the concentration of omeprazole in the blood plasma is increased. When used simultaneously with omeprazole, the area under the "concentration-time" curve of atazanavir decreases by 75%, so their simultaneous use is contraindicated.

When used simultaneously with omeprazole, it is possible to slow the withdrawal of warfarin, diazepam and phenytoin, as well as imipramine, clomipramine, citalopram, hexabarbital, disulfiram, since omeprazole biotransformiruetsya in the liver with the participation of isoenzyme CYP2C19. It may be necessary to reduce the doses of these drugs.

With the simultaneous use of methotrexate with proton pump inhibitors, a slight increase in plasma methotrexate concentration was observed in some patients. When treating high doses of methotrexate, stop taking omeprazole temporarily. Simultaneous reception of omeprazole with amoxicillin or metronidazole does not affect the concentration of omeprazole in blood plasma.

With the joint use of omeprazole with caffeine, propranolol, theophylline, metoprolol, lidocaine, quinidine,phenacetin, estradiol, budesonide, diclofenac, naproxen, piroxicam, antacids and ethanol, there is no clinically significant interaction.

Special instructions:

Before the beginning of therapy it is necessary to exclude the presence of malignant process in the upper GI tract, tk. taking omeprazole-teva can mask the symptoms and delay the setting of the correct diagnosis. Reduction of gastric acidity, including when using blockers of the proton pump, increases the number of bacteria in the digestive tract, which increases the risk of developing gastrointestinal infections.

Increase in concentration CgA can influence the results of surveys to identify neuroendocrine tumors. To prevent of this influence It is necessary to temporarily stop taking omeprazole 5 days before the study concentration CgA.

In patients with severe deficiency of liver function, it is necessary to regularly monitor the indicators of "liver" enzymes during therapy with the drug Omeprazol-Teva. The drug Omeprazol-Teva contains sucrose and is therefore contraindicated patients with congenital disorders carbohydrate metabolism (intolerance fructose, insufficiency sugarase / isomaltase, glucose-galactose malabsorption). In the treatment of erosive-ulcerative lesions, associated with the intake of NSAIDs, should carefully consider restriction or termination of admission NSAIDs for increased efficacy antiulcer therapy. The drug contains sodium, which followstake into account in patients, on a controlled sodium diet.

The ratiothe

risk and benefit of long-term (more than 1 year)

maintenance therapy with the drug

Omeprazole-Teva. There are data on

increased risk of fractures

vertebrae, wrist bones, head

the femur mainly

elderly patients, and also in the presence of

predisposing factors. Patients with

risk of osteoporosis

ensure adequate consumption

vitamin A D and calcium.

There are reports of

pronounced hypomagnesemia in patients,

receiving therapy with inhibitors

proton pump, including omeprazole, for more than 1 year.

Patients. receiving therapy

omeprazole for a long time

time, especially in conjunction with

digoxin or other drugs,

reducing the magnesium content of the plasma

(diuretics), a regular

control of magnesium content.

Effect on the ability to drive transp. cf. and fur:

Given the possibility of undesirable effects from the central nervous system and the organ of vision, caution should be exercised during the treatment with omeprazole while driving vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Capsules enteric, 10 mg, 20 mg, 40 mg.

Packaging:

For 6, 7 or 10 capsules in an aluminum foil / PVC / PVDC juster and

polyamide film / aluminum

foil / PVC.

For 5 blisters for 6 capsules or 2 or 4 blisters for 7 capsules, or 3 blisters for 10 capsules together with instructions for use in a cardboard pack.

For 14, 28 or 30 capsules in a bottle of high-density polyethylene,

Capped with a lid of polypropylene with a desiccant (silica gel) and control of the first autopsy. 1 bottle with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 of the year.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001970

Date of registration:14.01.2013

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

TEVA PHARMA, S.L.U. Spain

Representation: & nbspTeva Teva Israel

Information update date: & nbsp18.07.2014

Illustrated instructions

Instructions

Omeprazole-Teva (Omeprazol-Teva)