Description
Latin name
Omeprazole
Release form
Capsules
packaging 28 pcs
Indications
Peptic ulcer of the stomach and duodenum, including relapse prevention
gastroesophageal reflux disease (GERD), reflux esophagitis, including prevention of recurrence of
erosive and ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs)
erosive and ulcerative lesions of the stomach and duodenum, associated with Helicobacter pylori (as part of combination therapy)
Zollinger-Ellison syndrome and other pathological conditions associated with permissible gastric secretion.
Contraindications
Hypersensitivity to omeprazole or any of the drug’s components fructose intolerance sucrose / isomaltose deficiency glucose-galactose malabsorption combined use with clarithromycin in patients with hepatic insufficiency, atazanavir, and maternal hyperthyroidism.
Precautions
Lack of liver function, renal failure, simultaneous use with clarithromycin.
Pregnancy and lactation
The use of omeprazole during pregnancy and breastfeeding is contraindicated due to insufficient data on efficacy and safety in this category of patients.
Composition
1 capsule contains: active substance omeprazole 20.00 mg
excipients: sugar grits [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, dye sun sunset yellow (E110) 0.468 mg dye red charming ( E129) 0.096 mg, brilliant blue dye (E133) 0.336 mg.
Dosage and administration
Inside, in the morning before eating, or while eating, with a small amount of water, do not chew the contents of the capsule.
Adults
With exacerbation of gastric ulcer, duodenum and reflux esophagitis
20 mg once a day. The course of treatment is 4-8 weeks. In some cases, a dose increase of up to 40 mg per day is possible.
With maintenance of GERD tolerance for the prevention of
recurrence, 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 NSAIDs (including for the prevention of relapse)
10-20 mg per day.
With Zollinger-Ellison Syndrome
Dose is set individually. The recommended starting dose is 60 mg once daily. If necessary, the dose is increased to 80-120 mg per day, then this case should be divided into two doses.
Erosive-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 peptic ulcer of the stomach and / or duodenum in the acute stage, prolongation of omeprazole monotherapy is possible.
In elderly patients, dose adjustment is not required.
Dose adjustment is not required in patients with impaired renal function.
In patients with liver failure, the maximum daily dose is 20 mg.
If you have difficulty swallowing an entire capsule, you can swallow its contents after opening or absorbing the capsule, 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 – at least 1%, but less than 10% infrequently – at least 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 blood and lymphatic system: rarely – hypochromic microcytic anemia in children is very rare – reversible thrombocytopenia, leukopenia, pancytopenia, agranulocytosis.
On the part of the immune system: very rarely – full, fever, angioedema, narrowing of the bronchi, allergic vasculitis, fever, anaphylactic shock.
From the nervous system: often – headache, dizziness, insomnia, drowsiness, lethargy (these side effects tend to worsen with prolonged therapy): rarely – paresthesia, confusion, hallucinations, especially in elderly patients or in severe cases of the disease rarely anxiety, depression, especially in elderly patients or in severe cases of the disease.
From the side of the organ of vision: infrequently – visual disturbances, incl. decreased visual fields, decreased visual acuity and clarity (usually disappear after discontinuation of therapy).
On the part of the organ of hearing and labyrinth disorders: infrequently, impaired auditory perception, incl. tinnitus (usually disappear after discontinuation of therapy).
From the gastrointestinal tract: often – nausea, vomiting, flatulence, constipation, diarrhea, abdominal pain (in most cases, the severity of these phenomena increases with continued therapy) infrequently – taste perversion (usually disappears after discontinuation of therapy) rarely – color change tongue to brown-black and the appearance of benign salivary gland cysts when used simultaneously with clarithromycin (phenomena are reversible after discontinuation of therapy) is very rare – dry mouth, stomatitis, candida of, pancreatitis.
From the liver and biliary tract: infrequently – changes in liver enzymes (reversible) are very rare – hepatitis, jaundice, liver failure, encephalopathy, especially in patients with liver diseases.
On the part of the skin and subcutaneous tissues: infrequently rash, itching, alopecia, erythema multiforme, photosensitivity, increased sweating very rarely – Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the side of musculoskeletal and connective tissue: infrequently – fractures of the vertebrae, bones of the wrist, femoral head (see section Special instructions) rarely – myalgia, arthralgia very rarely – muscle weakness.
From the kidneys and urinary tract: rarely interstitial nephritis.
General disorders and disorders at the injection site: infrequently – peripheral edema (usually disappears after discontinuation of therapy) rarely – hyponatremia very rarely – hypomagnesemia (see section Special instructions), gynecomastia.
Drug Interaction
When used with omeprazole, ketoconazole absorption may be reduced.
When co-administered with omeprazole, digoxin bioavailability is increased by 10% due to an increase in pH.
Omeprazole can reduce the absorption of vitamin B12 with prolonged use.
Omeprazole should not be used concomitantly with St. John’s wort preparations due to the pronounced clinically relevant interaction.
With concurrent administration of omeprazole and clarithromycin, their plasma concentrations increase.
When co-administered with omeprazole, the area of the concentration-time curve of atazanavir is reduced by 75%, so their simultaneous use is contraindicated.
When co-administered with omeprazole, the elimination of warfarin, diazepam and phenytoin, as well as imipramine, clomipramine, citalopram, hexabarbital, disulfiram, may be delayed. because omeprazole is biotransformed in the liver with the CYP2C19 isoenzyme. Doses of these drugs may be required.
There were no clinically relevant interactions with omeprazole with caffeine, propranolol, theophylline, metoprolol, lidocaine, quinidine, erythromycin, phenacetin, estradiol, amoxicillin, naproxen, piroxicam and antacids.
Overdose
Symptoms: impaired vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.
Treatment: carrying out symptomatic therapy, hemodialysis is not effective enough. The specific antidote is unknown.
Storage conditions
Store at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Expiration
2 Year
Active ingredient
Omeprazole
dosage form
dosage form
capsules
Teva Pharmaceutical Enterprise Co., Ltd., Israel
