Omeprazole Teva capsules kish-sol. 20 mg N28

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Active ingredients

Omeprazole

Release form

Capsules

Composition

1 capsule contains: Active substance: omeprazole 20 mg. Adjuvants: sugar crumb 96 mg, sodium carboxymethyl starch (type A) 4.2 mg, sodium lauryl sulfate 5.98 mg, povidone 9.5 mg, potassium oleate 1.287 mg, oleic acid 0.214 mg, hypromellose 6 mg , methacrylic acid and ethyl acrylate copolymer [1: 1] 40.91 mg, triethyl acetate 4.69 mg, titanium dioxide (E171) 1.5 mg, talc 0.19 mg. Composition of cellulose capsule: carrageenan 0.185 mg, potassium chloride 0.265 mg, titanium dioxide (E 171) 3.6 mg, hypromellose 52.05 mg, water 3 mg, sunset sunflower yellow (E 110) 0.468 mg, red dye enchanting (E 129) 0.096 mg, dye brilliant blue (E 133) 0.336 mg. Ink composition: shellac 11-13%, ethanol 15-18%, isopropanol 15-18%, propylene glycol 1-3%, butanol 4-7% , povidone 10-13%, sodium hydroxide 0.05-0.1%, titanium dioxide (E 171) 32-36%.

Pharmacological 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 arrest the symptoms of the disease, achieve a high degree of healing of the damaged mucous and persistent 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, incl. relapse prevention, gastroesophageal reflux disease (GERD), reflux esophagitis, incl. prevention of recurrence; erosive-ulcerous lesion of gastric and duodenal ulcers associated with nonsteroidal antiinflammatory drugs (NSAIDs); erosive-ulcerous lesion of gastric and duodenal ulcers associated with Helicobacter pylori (in combination therapy); Zollinger-Ellison syndrome, and other pathological conditions associated with gallstone secretion.

Contraindications

Hypersensitivity to omeprazole or any of the components of the drug; fructose intolerance; sucrose / isomaltose deficiency; glucose-galactose malabsorption; combined use with clarithromycin in patients with liver failure, atazanavir, and hunters; pregnancy, breastfeeding period; age up to 18 years.

Precautionary measures

Do not exceed recommended doses.

Use during pregnancy and lactation

Due to the lack of clinical experience, omeprazole is not recommended for use during pregnancy. If necessary, use during lactation should decide on the termination of breastfeeding.

Dosage and administration

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. By 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 patience GERD for the prevention of relapse 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 relapse) 10-20 mg per day. In 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. 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 do not need dose adjustment. 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.

Side effects

The frequency of side effects is classified in accordance with the recommendations of the World Health Organization: very often - at least 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 system: rarely -hypochromic microcytic anemia in children; very rare - reversible thrombocytopenia, leukopenia, pancytopenia, agranulocytosis. From the immune system: very rarely - syt, body temperature, angioedema, bronchial contraction, allergic vasculitis, fever, anaphylactic shock. dizziness, insomnia, drowsiness, lethargy (these side effects show a tendency to aggravate with prolonged therapy): rarely - paresthesia, confusion, hallucinations, especially in elderly patients or with severe the course of the disease; very rarely, anxiety, depression, especially in elderly patients or in severe cases of the disease. On the part of the organ of vision: infrequently - visual disturbances, incl. reduction of visual fields, decrease in sharpness and clarity of visual perception (usually disappear after cessation of therapy). On the part of the organ of hearing, and labyrinth disorders: infrequently, impairment of hearing, including tinnitus (usually disappear after stopping 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. On the part of the liver and biliary tract: infrequently, changes in liver enzymes (reversible); very rarely, hepatitis, jaundice, liver failure, encephalopathy, especially in patients with liver diseases. On the part of the skin and subcutaneous tissues: infrequent rash, itching, alopecia, erythema multiforme, photosensitization, increased sweating; very rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis.On the part of the musculoskeletal and connective tissues: infrequently - fractures of the vertebrae, wrist bones, femoral head (see section Special Instructions); rarely - myalgia, arthralgia; very rarely - muscle weakness. On the part of the kidneys and urinary tract: rarely interstitial nephritis. General disorders and disorders at the injection site: infrequently-peripheral edema (usually disappear after cessation of therapy); rarely, hyponatremia; very rarely, hypomagnesemia (see section Special Instructions), gynecomastia.

Overdose

Data on drug overdose is not provided.

Interaction with other drugs

With simultaneous use, cases of the development of symptoms of the toxic effect of benzodiazepines are described, which is associated with inhibition of the activity of CYP3A isoenzymes and, apparently, CYP2C9. With simultaneous use with digoxin, a slight increase in the concentration of omeprazole in the blood plasma is possible. With simultaneous use with disulfiram described the case of impaired consciousness and catatonia; with indinavir - decrease in plasma indinavir concentration is possible; with ketoconazole - decrease in ketoconazole absorption. With prolonged simultaneous use with clarithromycin, concentrations of omeprazole and clarithromycin in the blood plasma increase. There are cases of reduced clearance of methotrexate from patients receiving omeprazole. with the simultaneous use of omeprazole in high doses and phenytoin, it is possible to increase the concentration of phenytoin in the blood plasma. the solution at a concentration of cyclosporin plasma while the use of simultaneous application tsiklosporinom.Pri with erythromycin described upconcentration case of omeprazole in blood plasma, the decreased efficiency of omeprazole.

special instructions

Before starting therapy, it is necessary to exclude the possibility of the presence of a malignant process (especially in case of a stomach ulcer), sincetreatment with omeprazole may mask the symptoms and delay the correct diagnosis. Against the background of the use of omeprazole, the results of laboratory studies of liver function and indicators of gastrin concentration in plasma may be distorted.

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