Ultop, enteric-soluble 20mg capsules, 28pcs

Composition

of 1 capsule:

– omeprazole 10 mg,20 mg or 40 mg

Auxiliary substances:

sugar granules,

sucrose,

corn starch,

hydroxypropylcellulose (hyprolose),

heavy magnesium carbonate,

sodium lauryl sulfate,

methacrylic and ethylacrylic acid copolymer,

talc,

macrogol 6000,

titanium dioxide,

sodium hydroxide.

Capsule shell composition:

titanium dioxide (e171), iron oxide (e172), gelatin.

Pharmacological action

Ultop is a proton pump inhibitor.

Pharmacodynamics

Inhibits the enzyme H+ – K+ – ATPASE (proton pump) in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid synthesis. This leads to a decrease in basal and stimulated secretion, regardless of the nature of the stimulus. After a single oral dose, the effect of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours.

After discontinuation of the drug, secretory activity is fully restored in 3-5 days. Basal gastric secretion decreases to 94% after taking 40 mg of omeprazole. The acidity of gastric juice within 24 hours decreases by 80-97% when taking 20 mg of omeprazole and by 92-94% when taking 40 mg. Inhibition of 50% of the maximum secretion lasts 24 hours

. Pharmacokinetics

Omeprazole is rapidly absorbed from the gastrointestinal tract, Cmax in plasma is reached after 0.5-1 h. Bioavailability is 30-40%. Bioavailability is slightly increased in elderly patients and patients with impaired liver function, and to a significant extent-in patients with chronic liver failure (can reach 100%). Binding to plasma proteins is about 90-95%. Omeprazole is almost completely metabolized in the liver with the formation of 6 pharmacologically inactive metabolites. It is an inhibitor of the CYP2C19. T1 enzyme system/2 — 0,5–1 h. Excretion by the kidneys — 70-80% and with bile-20-30%. In patients with impaired renal function, omeprazole excretion decreases in proportion to the decrease in creatinine clearance. With impaired liver function, T1 / 2 is 2-3 hours. The total clearance is 500-600 ml / min.

Indications

• gastric ulcer and duodenal ulcer (acute phase and anti-treatment), including associated with Helicobacter pylori (in combination therapy);
• gastroesophageal reflux disease (GERD), including reflux esophagitis and non-erosive forms reflux disease (NERD);
• erosive and ulcerative lesions of gastric and duodenal ulcers associated with taking NSAIDs, stress ulcers;
• zollingerellison syndrome and other pathological conditions associated with increased gastric secretion.

Use during pregnancy and lactation

Do not use Ultop during pregnancy.

If it is necessary to prescribe the drug during lactation, it is necessary to decide whether to stop breastfeeding.

Contraindications

• hypersensitivity to omeprazole or other components of the drug;
• childhood;
• pregnancy;
• lactation;
• hereditary fructose intolerance;
• glucose-galactose malabsorption syndrome;
• sucrose/isomaltase deficiency.

With caution:  renal and / or hepatic insufficiency.

Side effects

From the digestive system:  diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disorders, stomatitis, transient increase in the activity of liver enzymes in plasma; in patients with previous severe liver disease-hepatitis (including jaundice), impaired liver function.

Nervous system disorders:  headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations; in patients with severe concomitant somatic diseases, patients with previous severe liver disease — encephalopathy.

From the CCC side:  angina pectoris, tachycardia, bradycardia, palpitations, increased blood pressure Blood pressure, vasculitis, peripheral edema.

From the genitourinary system:  interstitial nephritis, urinary tract infections, microscopic pyuria, proteinuria, hematuria, glucosuria, increased serum creatinine, gynecomastia, testicular pain.

From the musculoskeletal system:  muscle weakness, myalgia, arthralgia, bone pain, muscle cramps.

From the hematopoietic system:  pancytopenia, agranulocytosis, anemia, neutropenia, thrombocytopenia, leukocytosis, leukopenia.

From the side of the skin:  petechiae, pruritus, skin rash; in some cases — photosensitization, erythema multiforme, hair loss, alopecia, dry skin, epidermal toxic necrolysis, Stevens-Johnson syndrome.

Respiratory system disorders:  sore throat, cough, heavy nosebleeds.

From the side of the senses:  tinnitus, mild visual and hearing impairments.

Allergic reactions:  urticaria, angioedema, bronchospasm, interstitial nephritis, anaphylactic shock, fever.

Laboratory parameters:  hypoglycemia, hyponatremia.

Other services:  back pain, increased sweating; rarely – formation of gastric glandular cysts during long-term treatment (due to inhibition of hydrochloric acid secretion, is benign, reversible), general fatigue, general weakness, weight gain, fever.

Interaction

Long-term use of omeprazole at a dose of 20 mg 1 time / day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not lead to a change in their plasma concentrations.

There was no interaction of omeprazole with concomitant antacids.

Omeprazole may reduce the absorption of ampicillin esters, iron salts, itraconazole and ketoconazole (because omeprazole increases the pH of the stomach).

Being a cytochrome P450 inhibitor, omeprazole can increase the concentration and decrease the excretion of diazepam, indirect anticoagulants, and phenytoin, which in some cases may require a reduction in the doses of these drugs. Simultaneous use increases the absorption of omeprazole and clarithromycin.

How to take, course of use and dosage

Inside, before meals, with a small amount of water (the contents of the capsule can not be chewed).

Duodenal ulcer in the acute phase — 20 mg / day for 2-4 weeks (in resistant cases-up to 40 mg/day).

Gastric ulcer in the acute phase and erosive-ulcerative esophagitis-20-40 mg / day for 4-8 weeks.

Gastroesophageal reflux disease (GERD):  patients with moderate inflammation — 1 capsule (20 mg) 1 time a day in the morning, before breakfast, for 4-8 weeks. To ensure the following dosage regimen, it is possible to take the drug in a different registered dosage (Ultop ® capsules 40 mg). Patients with a severe course of GERD, resistant to conventional therapy-40 mg 1 time a day, before breakfast. The duration of the main course is usually 4-8 weeks. After healing of erosive esophagitis, maintenance treatment is indicated for 26-52 weeks, with severe esophagitis — for life.

Erosive and ulcerative lesions of the gastrointestinal tract caused by NSAIDs — 20 mg / day for 4-8 weeks.

Eradication of Helicobacter pylori — 20 mg 2 times a day for 7 or 14 days (depending on the treatment regimen used) in combination with antibacterial agents.

Anti-relapse treatment of peptic ulcer of the stomach and duodenum — 10-20 mg / day.

Anti-relapse treatment of reflux esophagitis — 20 mg / day for a long time. Reception is possible on demand.

Zollinger-Ellison syndrome-the dose is selected individually depending on the initial level of gastric secretion, usually starting from 60 mg / day. If necessary, the dose is increased to 80-120 mg / day, in this case it is divided into 2 doses.

Non-ulcer dyspepsia-the usual dose is 10 mg to 20 mg once a day for 2-4 weeks. If after 4 weeks of taking the drug, the condition does not improve, or the symptoms of dyspepsia reappear shortly after discontinuation of the drug, the diagnosis should be reviewed.

Impaired renal function. No dose adjustment is required for patients with impaired renal function.

Impaired liver function. In patients with impaired liver function, the bioavailability and clearance of omeprazole increases. In this regard, the therapeutic dose should not exceed 10-20 mg per day.

Advanced age. For elderly patients, no adjustment of the treatment regimen is required.

Overdose

Symptoms:  abdominal pain, drowsiness, headache, dizziness, dry mouth, tachycardia, arrhythmia, blurred vision, agitation, confusion, increased sweating, nausea; in rare cases — convulsions, shortness of breath, hypothermia.

There is no specific antidote.

Treatment:  symptomatic.

Special instructions

Before starting treatment, it is necessary to exclude the presence of a malignant process in the upper gastrointestinal tract (since treatment can mask the symptoms and make diagnosis difficult).

In special cases, if you have difficulty swallowing a whole capsule, you can swallow its contents after opening or resorbing the capsule, or you can mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension for 30 minutes.

Form of production

Ultop capsules are two-color, the body is light pink and the lid is white; the contents of the capsules are pellets from white to white with a yellowish or pinkish tinge of color.

Storage conditions

In a dry place, at temperatures below 25 °C

Shelf life

3 years

Active ingredient

Omeprazole

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

For adults as directed by your doctor

Indications

Heartburn, Stomach and Duodenal ulcers, GI infections caused by Helicobacter Pylori, Reflux Esophagitis