Ultop capsules 10mg №14

Dosage form

Capsules

Composition

1 capsule contains: Omeprazole 10 mg.
Excipients: sugar granules, sucrose, corn starch, hydroxypropylcellulose (hyprolose), heavy Magnesium carbonate, sodium lauryl sulfate, methacrylic and ethacrylic acid copolymer, talc, macrogol 6000, titanium dioxide.
The composition of the shell of capsules: titanium dioxide (E171), iron oxide (E172), gelatin.

Packing

In the package of 14 capsules.

Mechanism of action

Ultop is an anti-ulcer drug, H + -K + -ATP-ase inhibitor.
Inhibits the activity of H + -K + ATP-ase in the parietal cells of the stomach and thereby blocks the final stage of the formation of hydrochloric acid, which leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus.
After a single dose of the drug inside omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is reached after 2 hours. After stopping the drug, secretory activity is fully restored in 3-5 days.

Indications and usage

- Peptic ulcer of the stomach and duodenum (in the acute phase and anti-relapse treatment), including associated with Helicobacter pylori (as part of combination therapy).
- Reflux esophagitis.
- Erosive and ulcerative lesions of the stomach and duodenum associated with the intake of NSAIDs, stressful ulcers.
- Zollinger-Ellison syndrome.

Contraindications

- Childhood.
- Pregnancy.
- Lactation (breastfeeding).
- Hypersensitivity to the drug.
Precautions should be prescribed the drug for renal or hepatic failure.

Pregnancy and Breastfeeding

Do not use Ultop during pregnancy. If necessary, the appointment of the drug during lactation is necessary to solve the issue of termination of breastfeeding.

Dosage and administration

The drug is taken orally, before eating, without chewing, with a small amount of water.
With duodenal ulcer in the acute phase - Ultop designate 20 mg 1 time / day for 2-4 weeks. In resistant cases, it is possible to increase the dose to 40 mg / day.
In case of gastric ulcer in the acute phase and erosive-ulcerative esophagitis - at 20-40 mg / day for 4-8 weeks.
When erosive and ulcerative lesions of the gastrointestinal tract caused by the intake of NSAIDs - at 20 mg / day for 4-8 weeks.
With Zollinger-Ellison syndrome - The dose is selected individually depending on the initial level of gastric secretion, usually starting at 60 mg / day. If necessary, increase the dose to 80-120 mg / day in 2 divided doses.
For eradication of Helicobacter pylori - 20 mg 2 times / day for 7 or 14 days (depending on the regimen used) in combination with antibacterial drugs.
For the prevention of acute gastric ulcer and duodenal ulcer - Ultop prescribed in a dose of 10-20 mg / day.
For the prevention of exacerbation of reflux esophagitis - at 20 mg / day for a long time. It is possible to take the drug on demand.
Use in patients with severe liver failure - daily dose of Ultopa should not exceed 20 mg.

Adverse reactions

In rare cases, the following, usually reversible, side reactions may occur:
Gastrointestinal: nausea, diarrhea, constipation, abdominal pain, flatulence, dry mouth, taste disturbance, stomatitis, transient increase in liver enzymes in plasma. In patients with previous severe liver diseases - hepatitis (including jaundice), impaired liver function.
Nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesias, depression, hallucinations, blurred vision; in patients with severe concomitant somatic diseases, patients with previous severe liver disease - encephalopathy.
Musculoskeletal system: muscle weakness, myalgia, arthralgia.
Hemic and lymphatic: leukopenia, thrombocytopenia; in some cases - agranulocytosis, pancytopenia.
Dermatologic: skin rash, itching; in some cases - photosensitization, erythema multiforme exudative, alopecia.
Allergic reactions: urticaria, angioedema, bronchospasm, interstitial nephritis, anaphylactic shock, fever.
Other: peripheral edema, increased sweating, gynecomastia; rarely, the formation of gastric glandular cysts during long-term treatment (resulting from the inhibition of the secretion of hydrochloric acid and are benign and reversible).

Special notes

Before starting treatment, it is necessary to exclude the presence of a malignant process in the upper GI tract (since treatment may mask symptoms and make diagnosis more difficult).
In special cases, if you have difficulty in swallowing a whole capsule, you can swallow its contents after opening or resorbing 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.

Drug Interactions

Prolonged use of omeprazole in 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 concentration.
No interaction of omeprazole with concomitant antacids was observed.
Omeprazole can reduce the absorption of ampicillin esters, iron salts, itraconazole and Ketoconazole (because omeprazole increases the pH of the stomach).
As an inhibitor of cytochrome P450, omeprazole can increase the concentration and reduce the excretion of diazepam, indirect anticoagulants, phenytoin, which in some cases may require a reduction in doses of these drugs.
With simultaneous reception increases the absorption of omeprazole and Clarithromycin.

Overdosage

Symptoms: blurred vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.
Treatment: conduct symptomatic therapy. There is no specific antidote.

Storage conditions

Store in a dry place at temperatures up to 25 ° C.

2 years