Omeprazol-Teva

General characteristics. Structure:

Dosage of 10 mg
Contains in 1 capsule:
active agent омепразол 10,00 mg;
excipients: sugar krupka [sucrose, starch syrup] of 48,00 mg, sodium carboxymethylstarch type A of 2,10 mg, sodium lauryl sulfate of 2,99 mg, povidone of 4,75 mg, potassium oleate of 0,644 mg, olein kislota0,107 mg, gipromelloza of 3,00 mg, methacrylic acid and ethyl acrylate mg copolymer [1:1] 20,455. triethyl citrate of 2,345 mg, titanium dioxide (E171) of 0,75 mg talc of 0,095 mg.
Cellulose capsule: каррагинан 0,15 mg, potassium chloride of 0,2 mg, titanium dioxide (E171) of 3,1912 mg, gipromelloza of 39,96 mg, water of 2,30 mg, dye solar decline yellow (E110) of 0,3588 mg, dye ferrous oxide red (E172) of 0,5888 mg, dye red charming (E129) of 0,276 mg.
Dosage of 20 mg
Contains in 1 capsule: active agent омепразол 20,00 mg;
excipients: sugar krupka [sucrose, starch syrup] of 96,00 mg, sodium carboxymethylstarch type A of 4,20 mg, sodium lauryl sulfate of 5,98 mg, povidone of 9,50 mg, potassium oleate of 1,287 mg, oleic acid of 0,214 mg, gipromelloza of 6,00 mg, melakrilovy acid and ethyl acrylate mg copolymer [1:1] 40,91, triethyl citrate of 4,69 mg, titanium dioxide (E171) of 1,50 mg, talc of 0,19 mg.
Cellulose capsule: каррагинан 0, 185 mg, potassium chloride of 0,265 mg, titanium dioxide (E171) of 3,60 mg, gipromelloza of 52,05 mg, water of 3,00 mg, dye sunset yellow (E110) of 0,468 mg dye red charming (E129) of 0,096 mg, dye diamond blue (E133) of 0,336 mg.
Dosage of 40 mg
Contains in 1 capsule: active agent омепразол 40,00 mg:
auxiliary substances: sugar krupka [sucrose, treacle krakhmalimy] 1912,00 mg, sodium carboxymethylstarch type A 8,40 mg, 9 atriums lauryl sulfate of 11,96 mg, povidone of 19,00 mg, potassium oleate of 2,576 mg, oleic acid of 0,428 mg, gipromelloza of 12,00 mg, methacrylic acid and ethyl acrylate mg copolymer [1:1] 81,82 triethyl citrate of 9,38 mg, titanium dioxide (E171) of 3,00 mg, talc of 0,38 mg.
Cellulose capsule: каррагинан 0,283 mg, potassium chloride of 0,397 mg, titanium dioxide (E171) of 5,40 mg, gipromelloza of 78,07 mg, water of 4,50 mg, dye sunset yellow (E110) of 0,702 mg, dye red charming (E129) of 0,144 mg, dye diamond blue (E133) of 0,504 mg.
Composition of the white ink used for drawing texts on capsules (for all dosages): shellac of 11-13%, ethanol of 15-18%, isopropanol of 15-18%, propylene glycol of 1-3%, butanol of 4-7%, povidone of 10-13%, sodium hydroxide 0, m5-0,1%, titanium dioxide - (Е 7)-32-36%.

Description
Dosage of 10 mg. Solid opaque cellulose capsules No. 3 with the orange case and a red lid. Are put with white ink on a cover "About", on the case - "10".
Dosage of 20 mg. Solid opaque cellulose capsules No. 2 with the orange case and a blue lid. Are put with white ink on a cover "About", on the case - "20".
Dosage of 40 mg. Solid opaque cellulose capsules No. of 0 C orange case and blue lid. Are put with white ink on a cover "About", on the case - "40".
Contents of capsules - micropellets from color, white to white with a yellowish or pinkish shade.

Pharmacological properties:

Pharmacodynamics. Brakes activity of H+/K +-ATF-azy in parietal cells of a stomach and blocks thereby a final stage of secretion of hydrochloric acid. Influence of an omeprazol on the last stage of process of formation of hydrochloric acid is dozozavisimy and provides effective inhibition of basal and stimulated secretion, irrespective of the nature of the stimulating factor.
At daily reception омепразол provides bystry and effective inhibition of day and night secretion of hydrochloric acid. The maximum effect is reached within 4 days. At patients with a peptic ulcer of a duodenum reception of 20 mg of an omeprazol maintains intragastric acidity at the level of pH more than 3 within 17 hours.
Action of an omeprazol together with antibacterial drugs leads to Helicobacter pylori eradikation that allows to stop quickly disease symptoms, to reach high extent of healing of the injured mucous membrane and permanent long remission and to reduce probability of development of bleeding from the digestive tract (DT), and also need of performing long antiulcerous therapy disappears.

Pharmacokinetics. Absorption and distribution. After administration of drug inside омепразол it is quickly absorbed from a small intestine, the maximum concentration in a blood plasma (Cmax), is reached in 0,5-3,5 h.
Bioavailability makes 30-40%, at a liver failure - 100%. Linkng with proteins of a blood plasma (albumine and acid аα1-гликопротеин) - about 90%.
Metabolism and removal. (омепразол it is almost completely metabolized in a liver with participation of the fermental CYP2C19 system with formation of six pharmacological inactive metabolites (гидроксиомепразол, sulphidic and sulfonic derivatives, etc.). Is CYP2C19 isoenzyme inhibitor.
Elimination half-life (T1/2) - 0,5-1 h, at a liver failure of-3 h. Clearance of 300-600 ml/min.
It is removed by kidneys (70-80%) and through intestines (20-30%) in the form of metabolites.
Pharmacokinetics in special clinical cases. At a chronic renal failure removal decreases in proportion to decrease in clearance of creatinine.
At elderly people removal of an omeprazol decreases, bioavailability increases.

Indications to use:

• peptic ulcer of a stomach and duodenum, including prevention of a recurrence;
• gastroesophageal reflux disease (GERB), reflux esophagitis, including prevention of a recurrence;
• the erosive cankers of a stomach and duodenum connected with reception of non-steroidal anti-inflammatory drugs (NPVP);
• the erosive cankers of a stomach and duodenum associated with Helicobacter pylori (as a part of a combination therapy);
• Zollingera-Ellison's syndrome and other morbid conditions connected with the settled gastric secretion.

Route of administration and doses:

Inside, in the morning before food silt during food, washing down with a small amount of water; contents of the capsule cannot be chewed.
Adults
At an aggravation of a peptic ulcer of a stomach, duodenum and reflux esophagitis
On 20 mg of 1 times a day. Course of treatment of 4-8 weeks. Increase in a dose up to 40 mg a day is in certain cases possible.
At supporting GERB terpiya for prevention of a recurrence
On 10-20 mg for 26-52 weeks depending on clinical effect, at a heavy esophagitis - for life. At treatment of the erosive cankers of a stomach and duodenum connected with reception of NPVP (including for prevention of a recurrence)
On 10-20 mg a day.
At Zollingera-Ellison's syndrome
The dose is established individually. The recommended initial dose - 60 mg once a day. If necessary the dose is increased to 80-120 mg е days, the t this case should divide it into two receptions.
The erosive cankers of a stomach and duodenum associated with Helicobacter pylori
On 20 mg 2 times a day in combination with antibacterial drugs within 7 days. At patients with a peptic ulcer of a stomach and/or duodenum in a stage of an aggravation monotherapy extension omeprazoly is possible.
It is not required from patients of advanced age of dose adjustment.
With insufficiency of function of kidneys of dose adjustment it is not required from patients.
Patients with insufficiency have functions of a liver the maximum daily dose of 20 mg.
At emergence of difficulties with a proglatyvaniye of the whole capsule it is possible to swallow its contents after opening or a rassasyvaniye of the capsule, and also it is possible to mix capsule contents with slightly acidified liquid (juice, yogurt) and to use the received suspension within 30 min.

Features of use:

Before therapy it is necessary to exclude existence of malignant process in upper parts of a GIT since administration of drug of Omeprazol-Tev can mask symptomatology and delay statement of the correct diagnosis.
Decrease in gastric acidity including when using blockers of a proton pomp increases number of bacteria in a GIT that increases risk of developing of gastrointestinal infections.
At patients with the expressed insufficiency of function of a liver it is regularly necessary to control indicators of "hepatic" enzymes during therapy by the drug Omeprazol-of Tev.
Omeprazol-Tev's drug contain sucrose and therefore it is contraindicated to patients with inborn disturbances of carbohydrate metabolism (intolerance of fructose, insufficiency of invertase/isomaltose, glyukozo-galaktozny malabsorption).
At therapy of the erosive cankers connected with reception of NPVP it is necessary to consider carefully the possibility of restriction or termination of reception of NPVP for increase in efficiency of antiulcerous therapy.
Drug contains sodium that it is necessary to take into account at the patients who are on a controlled sodium diet.
It is regularly necessary to estimate a ratio of risk and benefit long (more than 1 year) a maintenance therapy Omeprazol-Tev's drug. There are data on increase in risk of developing of fractures of vertebras, bones of a wrist, heads of a femur is preferential at elderly patients, and also in the presence of the contributing factors. Patients with risk of development of osteoporosis should provide adequate consumption of vitamin D and calcium.
The patients receiving therapy by inhibitors of the proton pump, including omeprazoly, over 1 year have messages on emergence of the expressed hypomagnesiemia.
By the patient receiving therapy omeprazoly for a long time especially in combination with the digoxin or other drugs reducing the content of magnesium in a blood plasma (diuretics) regular control of content of magnesium is required.

Influence on ability to management of transport and work with the equipment
Considering a possibility of emergence of undesirable effects from the central nervous system and an organ of sight, during treatment omeprazoly it is necessary to be careful, during the driving of motor transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

Frequency of side effects is classified according to recommendations of 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%; seldom - not less than 0,01%, but less than 0,1%; very seldom (including isolated cases) - less than 0,01%.
From blood and lymphatic system: seldom - hypochromia microcytic anemia at children; are very rare - reversible thrombocytopenia, a leukopenia, a pancytopenia, an agranulocytosis.
From immune system: very seldom - it is full, fervescence, a Quincke's disease, narrowing of bronchial tubes, an allergic vasculitis, fever, an acute anaphylaxis.
From a nervous system: often - a headache, dizziness, sleeplessness, drowsiness, slackness (the listed side effects find a tendency to aggravation at long therapy): seldom - paresthesias, confusion of consciousness, a hallucination, especially at elderly patients or at a severe disease; very seldom - concern, a depression, especially at elderly patients or at a severe disease.
From an organ of sight: infrequently - visual disturbances, including reduction of fields of vision, decrease in sharpness and clearness of visual perception (usually pass after the therapy termination).
From an acoustic organ and labyrinth disturbances: infrequently - disturbances of acoustical perception, including "a ring in ears" (usually pass after the therapy termination).
From digestive tract: often - nausea, vomiting, a meteorism, a lock, diarrhea, an abdominal pain (in most cases expressiveness of the listed phenomena increases with therapy continuation); infrequently - a food faddism (usually passes after the therapy termination); seldom - language discoloration to brown-black and emergence of benign cysts of sialadens at simultaneous use with klaritromitsiny (the phenomena have reversible character after the therapy termination); very seldom - a xerostomia, stomatitis, candidiasis, pancreatitis.
From a liver and biliary tract: infrequently - changes of indicators of "hepatic" enzymes (reversible character); very seldom - hepatitis, jaundice, a liver failure, encephalopathy, especially at patients with liver diseases.
From skin and hypodermic fabrics: infrequently - rash, an itch, an alopecia, a multiformny erythema, a photosensitization, the increased sweating; very seldom - Stephens-Johnson's syndrome, a toxic epidermal necrolysis.
From skeletal and muscular and connecting fabric: infrequently - fractures of vertebras, bones of a wrist, a femur head (see the section "Special Instructions"); seldom - a mialgiya, an arthralgia; very seldom - muscular weakness.
From kidneys and urinary tract: seldom - intersticial nephrite.
The general frustration and disturbances in an injection site: infrequently - peripheral hypostases (usually pass after the therapy termination); seldom - a hyponatremia; very seldom - a hypomagnesiemia (see the section "Special Instructions"), a gynecomastia.

Interaction with other medicines:

At simultaneous use with omeprazoly absorption of a ketokonazol can decrease.
At simultaneous use with omeprazoly bioavailability of digoxin owing to increase in pH increases by 10%.
Omeprazol can reduce absorption of B12 vitamin at prolonged use.
Omeprazol it is not necessary to apply at the same time with St. John's Wort drugs in view of the expressed clinical significant interaction.
At simultaneous use of an omeprazol and klaritromitsin of their concentration increase in a blood plasma.
At a simultaneous prpmineniye with omeprazoly the area of fashion of a curve "concentration time" of an atazanavir therefore their simultaneous use is contraindicated decreases by 75%.
At simultaneous use with omeprazoly delay of removal of warfarin, diazepam and Phenytoinum, and also Imipraminum, klomipramin, tsitalopram, hexabarbital, Disulfiramum as омепразол it biotransformirutsya in a liver with participation of an isoenzyme of CYP2C19 is possible. Decrease in doses of these drugs can be required. At use of an omeprazol with caffeine, propranolol, theophylline, metoprololy, lidocaine, quinidine, erythromycin, acetphenetidiene, oestradiol, amoxicillin, Naproxenum, piroxicam and antacids of clinically significant interaction it is not established.

Contraindications:

Hypersensitivity to an omeprazol or any of drug components; intolerance of fructose; deficit of sucrose/isomaltose; glyukozo-galaktozny malabsorption; combined use with klaritromitsiny at patients with a liver failure, atazanaviry, a St. John's Wort; pregnancy, breastfeeding period; age up to 18 years.

With care
Insufficiency of function of a liver; insufficiency of function of kidneys; simultaneous use with klaritromitsiny.

Use at pregnancy and during breastfeeding
Use of an omeprazol at pregnancy and breastfeeding is contraindicated owing to insufficient data by efficiency and safety at this category of patients.

Overdose:

Symptoms: a vision disorder, drowsiness, excitement, confusion of consciousness, a headache, increase in sweating, dryness in a mouth, nausea, arrhythmia.
Treatment: performing symptomatic therapy, a hemodialysis it is insufficiently effective. The specific antidote is not known.

Storage conditions:

Period of validity 2 years. Not to apply after the period of validity specified on packaging. To store at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

capsules kishechnorastvorimy 10 mg, 20 mg, 40 mg.
On 6 or 7 capsules in the blister from an aluminum foil / PVC / PVDH and a polyamide film / an aluminum foil / PVC.
On 5 blisters on 6 capsules or пи 2 or 4 blisters on 7 capsules together with the application instruction in a cardboard pack.