2010/06/23

Ultop

Composition, structure and packing

Capsules two colors: body capsule pale pink cover - white; the contents of capsules - pellets from white to white with a slightly yellowish or until white with a slightly pinkish tint.
1 capsule.
omeprazole 10 mg



Excipients: granules of sugar, sucrose, corn starch, gidroksipropiltsellyuloza (giproloza), heavy magnesium carbonate, sodium lauryl sulphate, methacrylic acid copolymer and etakrilovoy, talc, macrogol 6000, titanium dioxide.

The composition of the shell capsules: titanium dioxide (E171), iron oxide (E172), gelatin.

7 pcs. - Blisters (2) - bundles of cardboard.

7 pcs. - Blisters (4) - bundle pasteboard.

14 pcs. - Plastic pencil cases with polypropylene lid and the capsule gidrosorbenta (1) - packs cardboard.

28 pieces. - Plastic pencil cases with polypropylene lid and the capsule gidrosorbenta (1) - packs cardboard.

Capsules two colors: body capsule pale pink cap - brown-pink color, the contents of capsules - pellets from white to slightly yellowish or slightly pink color.
1 capsule.
omeprazole 20 mg


Excipients: granules of sugar, sucrose, corn starch, gidroksipropiltsellyuloza (giproloza), heavy magnesium carbonate, sodium lauryl sulfate, methacrylic acid copolymer and etakrilovoy, talc, macrogol 6000 and titanium dioxide.

The composition of the shell capsules: titanium dioxide (E171), iron oxide (E172), gelatin.

7 pcs. - Blisters (2) - bundles of cardboard.

7 pcs. - Blisters (4) - bundle pasteboard.

14 pcs. - Plastic pencil cases with polypropylene lid and the capsule gidrosorbenta (1) - packs cardboard.

28 pieces. - Plastic pencil cases with polypropylene lid and the capsule gidrosorbenta (1) - packs cardboard.

Capsules two colors: body capsule pale pink color, cover - a brownish-pink color, the contents of capsules - pellets from white to white with a slightly yellowish or white up with a slightly pinkish tint.
A capsule.
omeprazole 40 mg



Excipients: granules of sugar, sucrose, corn starch, gidroksipropiltsellyuloza (giproloza), heavy magnesium carbonate, sodium lauryl sulfate, methacrylic acid copolymer and etakrilovoy, talc, macrogol 6000, titanium dioxide.

The composition of the shell capsules: titanium dioxide (E171), iron oxide (E172), gelatin.

7 pcs. - Blisters (2) - bundles of cardboard.

7 pcs. - Blisters (4) - bundle pasteboard.

14 pcs. - Plastic pencil cases with polypropylene lid and the capsule gidrosorbenta (1) - packs cardboard.

28 pieces. - Plastic pencil cases with polypropylene lid and the capsule gidrosorbenta (1) - packs cardboard.

Clinico-pharmacological group: an inhibitor of H +-K +-ATPase. Antiulcer drug

Registration № №:
cps. 20 mg: 14 or 28 pieces. - P № 014514/01, 22.10.08
cps. 10 mg: 14 or 28 pieces. - LS-000 695, 31.08.07
cps. 40 mg: 14 or 28 pieces. - LS-000 695, 31.08.07

Pharmacological action

Antiulcer drug, an inhibitor of H +-K +-ATPase. Inhibits the activity of H +-K + ATPase in gastric parietal cells and thus blocks the final stage of formation of hydrochloric acid, which lowers the level of basal and stimulated secretion, irrespective of the nature of the stimulus.

After a single dose of the drug into the effect of omeprazole occurs within the first hour and continues for 24 h, the maximum effect is achieved within 2 hours after stopping the secretory activity was fully restored within 3-5 days.

Pharmacokinetics

Absorption and distribution

After taking the drug inside omeprazole is rapidly absorbed from the gastrointestinal tract, Cmax in the plasma is achieved through 0.5-1 hours

Bioavailability is 30-40%. Binding to plasma proteins - 90%.

Metabolism and excretion

Omeprazole virtually biotransformiruetsya in the liver with the formation of six pharmacologically inactive metabolites (gidroksiomeprazol, sulfide and sulfonic derivatives). Write mainly by the kidneys (70-80%) and bile (20-30%).

Omeprazole is an inhibitor of isoenzyme CYPS19.

Pharmacokinetics in special clinical situations

In chronic renal failure, excretion decreased proportionally reduced creatinine clearance.

In the elderly excretion of omeprazole decreases bioavailability increases.

When liver failure bioavailability increases to 100%, T 1 / 2 - 3 hours

Statement
stomach ulcer and duodenal ulcer (in the exacerbation and anti-treatment), including associated with Helicobacter pylori (in the combined therapy)
reflux esophagitis
erosive and ulcerative lesions of the stomach and duodenal ulcers associated with NSAID intake, stress ulcer
Zollinger-Ellison syndrome

Dosage regimen

In duodenal ulcer in acute Ultop prescribe 20 mg 1 time / day for 2-4 weeks. In resistant cases, may increase the dose to 40 mg / day.

In gastric ulcer in acute and erosive-ulcerative esophagitis - from 20-40 mg / day for 4-8 weeks.

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

To prevent worsening of gastric ulcer and duodenal ulcer Ultop administered in doses of 10-20 mg / day.

In order to prevent aggravation of reflux esophagitis - 20 mg / day for a long time. Chance of receiving the drug on demand.

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

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

In patients with severe hepatic insufficiency Ultopa daily dose should not exceed 20 mg.

The drug, taken orally, before eating, not liquid, squeezed a small amount of water.

Side effect

In rare cases, may experience the following, usually reversible adverse reactions:

On the part of the digestive system: nausea, diarrhea, constipation, abdominal pain, flatulence, dry mouth, breach of taste, stomatitis, transient increase in liver enzymes in blood plasma. Patients with previous severe liver disease - hepatitis (including those with jaundice), abnormal liver function.

From the side of the central nervous system and peripheral nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations, blurred vision, patients with severe concomitant somatic diseases, patients with prior severe liver disease - encephalopathy.

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

On the part of the hemopoietic system: leucopenia, thrombocytopenia, and in certain cases - agranulocytosis, pancytopenia.

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

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

Other: peripheral edema, increased sweating, gynaecomastia, rarely - the formation of gastric glandulyarnyh cysts during long-term treatment (result from the inhibition of secretion of hydrochloric acid and are benign and reversible).

Contraindications
childhood
pregnancy
lactation (breastfeeding)
Hypersensitivity to the drug's components

Precautions should be prescribed the drug in renal or hepatic insufficiency.

Application of pregnancy and breastfeeding

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

Application for violations of liver function

Precautions should be prescribed the drug for hepatic failure.

In patients with severe hepatic insufficiency Ultopa daily dose should not exceed 20 mg.

Application for violations of renal function

Precautions should be prescribed the drug in renal failure.

Cautions

Before treatment is necessary to exclude the presence of malignant process in the upper GI tract (since treatment can mask symptoms and complicate diagnosis).

Under special circumstances, if you have trouble swallowing the whole capsule can be swallowed its contents after opening or dissolving the capsule, and you can mix the contents of a capsule with slightly acidified liquid (juice, yogurt), and use the suspension for 30 min.

Overdose

Symptoms: visual disturbances, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.

Treatment: perform symptomatically. Specific antidote exists.

Drug Interactions

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

There was no interaction with omeprazole simultaneously take antacids.

Omeprazole can decrease 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 may increase concentration and reduce the excretion of diazepam, indirect anticoagulants, phenytoin, in some cases may require a reduction of doses of these medicines.

At the same time receiving increased absorption of omeprazole and clarithromycin.

To the top

Drug prescription.

Terms and Conditions of storage

List B. The drug should be stored protected from moisture away from children at a temperature of 25 ° C. Shelf life - 2 years (when stored in a blister pack), 3 years (when stored in a plastic pencil box).