Ultop

526 5 minutes read

Active material: omeprazole
When ATH: A02BC01
CCF: Inhibitor N⁺-K⁺-ATPase. Anti-ulcer drug
ICD-10 codes (testimony): E16.8, K21.0, K25, K26, K27
When CSF: 11.01.03
Manufacturer: KRKA d.d. (Slovenia)

Pharmaceutical form, composition and packaging

Capsules bicolored: capsule body light pink, cover – white; contents of capsules – pellets from white to white with a slightly yellowish or white to slightly pinkish tint.

	1 caps.
omeprazole	10 mg

Excipients: sugar granules, sucrose, corn starch, hydroksypropyltsellyuloza (giproloza), magnesium carbonate heavy, sodium lauryl, methacrylic acid copolymer etilakrilovoy, talc, macrogol 6000, Titanium dioxide, Sodium hydroxide.

Ingredients of the capsule shell: Titanium dioxide (E171), iron oxide (E172), gelatin.

7 PC. – blisters (2) – packs cardboard.
7 PC. – blisters (4) – packs cardboard.
14 PC. – plastic pencil cases with polypropylene lid and the capsule gidrosorbenta (1) – packs cardboard.
28 PC. – plastic pencil cases with polypropylene lid and the capsule gidrosorbenta (1) – packs cardboard.

Capsules bicolored: capsule body light pink, cover – brown-pink; contents of capsules – pellets from white to slightly yellowish or slightly pinkish color.

	1 caps.
omeprazole	20 mg

Ingredients of the capsule shell: Titanium dioxide (E171), iron oxide (E172), gelatin.

Capsules bicolored: capsule body light pink, cover – brownish pink; contents of capsules – pellets from white to white with a slightly yellowish or white to slightly pinkish tint.

	1 caps.
omeprazole	40 mg

Ingredients of the capsule shell: Titanium dioxide (E171), iron oxide (E172), gelatin.

Pharmacological action

Anti-ulcer drug, inhibitor N⁺-K⁺-ATPase. Inhibits the activity of H⁺-K⁺ ATPase in the parietal cells of the stomach and thereby blocks the final phase of hydrochloric acid, that lowers the level of basal and stimulated secretion, regardless of the nature of the stimulus.

After a single oral dose of omeprazole effect occurs within the first hour and lasts for 24 no, the maximum effect is achieved through 2 no. After discontinuation secretory activity is completely restored by 3-5 d.

Pharmacokinetics

Absorption and distribution

After oral administration of omeprazole is rapidly absorbed from the gastrointestinal tract, C_max plasma achieved through 0.5-1 no.

Bioavailability is 30-40%. Plasma protein binding - 90%.

Metabolism and excretion

Omeprazole is almost completely biotransformed in the liver. Write mainly kidneys (70-80%) and the bile (20-30%).

Omeprazole is an inhibitor of isozyme CYPS19.

Pharmacokinetics in special clinical situations

In chronic renal insufficiency excretion is reduced in proportion to the decrease in creatinine clearance.

In the elderly elimination of omeprazole is reduced, increased bioavailability.

When liver failure bioavailability increases to 100%, T_1/2 – 3 no.

Testimony

- Gastric ulcer and duodenal ulcer (in the acute phase and anti-treatment), incl. associated with Helicobacter pylori (in a combination therapy);

- Reflux esophagitis;

- Erosive and ulcerative lesions of the stomach and duodenum, associated with taking NSAIDs, stress ulcers;

- Zollinger-Ellison.

Dosage regimen

At duodenal ulcer in the acute phase Ultop^® appoint 20 mg 1 times / day for 2-4 weeks. In resistant cases may increase the dose to 40 mg / day.

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

To eradication of Helicobacter pylori – by 20 mg 2 times / day for 7 or 14 days (depending on the applied treatment regimen) in combination with antibacterial agents.

To prevention of acute gastric ulcer and duodenal ulcer Ultop^® administered at a dose of 10-20 mg / day.

To prevention of acute reflux esophagitis – by 20 mg / day for a long time. You can receive the drug on demand.

At erosive and ulcerative lesions of the gastrointestinal tract, caused by NSAIDs, – by 20 mg / day for 4-8 weeks.

At Zollinger-Ellison syndrome Dose selected individually depending on the initial level of gastric secretion, typically starting with 60 mg / day. If necessary, increase the dose to 80-120 mg / day 2 admission.

In patients with severe liver failure daily dose should not exceed 20 mg.

The drug is taken orally, before meals, without chewing, with a little water.

Side effect

In rare cases, may occur following, usually reversible, Adverse Reactions:

From the digestive system: nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, dry mouth, taste disturbance, stomatitis, transient increase in liver enzymes in the blood plasma. In patients with severe liver disease previous – hepatitis (incl. with jaundice), abnormal liver function.

From the central and peripheral nervous system: headache, dizziness, excitation, drowsiness, insomnia, paresthesia, depression, hallucinations; in patients with severe concomitant somatic diseases, in patients with severe liver disease prior – encephalopathy.

On the part of the musculoskeletal system: muscular weakness, myalgia, arthralgia.

From the hematopoietic system: leukopenia, thrombocytopenia; in some cases – agranulocytosis, pancytopenia.

Dermatological reactions: skin rash, itch; in some cases - photosensitivity, erythema multiforme exudative, alopecia.

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

Other: blurred vision, peripheral edema, increased sweating, gynecomastia; rarely – the formation of gastric glandular cysts during long-term treatment (It results from the inhibition of gastric acid secretion and are benign and reversible).

Contraindications

- Children's age;

- Pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug.

FROM caution should be prescribed in patients with renal or hepatic insufficiency.

Pregnancy and lactation

It should not be used during pregnancy. If necessary, the appointment during lactation is necessary to resolve the issue of termination of breastfeeding.

Cautions

Before treatment to rule out malignancy (especially gastric ulcer), tk. treatment, maskyruya symptoms, may delay the correct diagnosis.

In special cases, If you have trouble swallowing whole capsules, You can swallow the contents after opening the capsules or resorption, and the contents of the capsule can be mixed with slightly acidified liquid (juice, yogurt) and use the resulting suspension for 30 m.

Effects on ability to drive vehicles and management mechanisms

In applying the drug in recommended doses is not marked effect on the ability to drive vehicles and management mechanisms.

Overdose

Symptoms: blurred vision, drowsiness, excitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.

Treatment: symptomatic therapy. There is no specific antidote.

Drug Interactions

Prolonged use of omeprazole dose 20 mg 1 time / day in combination with caffeine, theophylline, piroksikamom, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidokainom, quinidine and estradiol did not change their plasma concentration.

There was no interaction between omeprazole simultaneously take antacids.

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

As an inhibitor of cytochrome P450, omeprazole may increase concentration and reduce the excretion of diazepam, antykoahulyantov indirect actions, phenytoin, that in some cases may require reducing the dose of these drugs.

When concomitantly increases the absorption of omeprazole and clarithromycin.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be protected from moisture, inaccessible to children at temperature to 25 ° C. Shelf life - 2 year (when stored in the blister package); 3 year (when stored in a plastic box were).

Vladimir Andreevich Didenko

526 5 minutes read