Universal reference book for medicines
Product name: ULTOP ® (ULTOP)

Active substance: omeprazole

Type: H + -K + -ATPase inhibitor.
Antiulcer drug
Manufacturer: KRKA (Slovenia) packing and packing KRKA (Slovenia)
Composition, form of production and packaging
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Capsules two-color, the case of light pink color and a cover of white color; the contents of capsules - pellets from white to white with a yellowish or pinkish hue of color.
1 caps.

omeprazole 10 mg

Auxiliary substances: sugar grits (sucrose, molasses starch) - 40 mg, giprolose - 2.4 mg, magnesium hydroxycarbonate (magnesium carbonate, heavy) - 10 mg, sucrose - 16.1 mg, corn starch - 13.25 mg, sodium lauryl sulfate - 1.25 mg, copolymer methacrylic acid and ethyl acrylate (1: 1) 30% dispersion - 15.5 mg, talc - 3 mg, macrogol 6000 - 1.55 mg, titanium dioxide - 0.95 mg.

Composition of capsule capsule: gelatin - 14.896 mg, titanium dioxide (E171) - 0.304 mg, iron dye red oxide (E172).

The composition of the capsule body: gelatin - 22.0965 mg, titanium dioxide (E171) - 0.684 mg, iron oxide red (E172) - 0.0195 mg.

7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
14 pcs.
- polyethylene containers with a propylene lid and a capsule of a hydro-sorbent (1) - packs cardboard.
28 pcs.
- polyethylene containers with a propylene lid and a capsule of a hydro-sorbent (1) - packs cardboard.
Capsules two-color, the case of light pink color and a cover of a brownish-pink color;
the contents of the capsules are pellets from white to slightly yellowish or slightly pink in color.
1 caps.

omeprazole 20 mg

Auxiliary substances: sugar granules (sucrose, corn starch) - 80 mg, giprolase - 4.8 mg, magnesium hydroxycarbonate (magnesium carbonate, heavy) - 20 mg, sucrose - 32.2 mg, corn starch - 26.5 mg, sodium lauryl sulfate - 2.5 mg, copolymer methacrylic acid and ethyl acrylate (1: 1) 30% dispersion - 31 mg, talc - 6 mg, macrogol 6000 - 3.1 mg, titanium dioxide 1.9 mg, sodium hydroxide 0.21 mg.

Composition of capsule cap: iron oxide oxide red (E172) - 0.6153%, titanium dioxide (E171) - 2%, gelatin - up to 100%.

The composition of the capsule body: iron dye oxide red (E172) - 0.0875%, titanium dioxide (E171) - 3%, gelatin - up to 100%.

7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
14 pcs.
- polyethylene containers with a propylene lid and a capsule of a hydro-sorbent (1) - packs cardboard.
28 pcs.
- polyethylene containers with a propylene lid and a capsule of a hydro-sorbent (1) - packs cardboard.
The capsules are two-color, the case is brownish-pink and the cover is light pink in color;
the contents of capsules - pellets from white to white with a yellowish or pinkish hue of color.
1 caps.

omeprazole 40 mg

Auxiliary substances: sugar grits (sucrose, starch syrup) - 160 mg, giprolase - 9.6 mg, magnesium hydroxycarbonate (magnesium carbonate, heavy) - 40 mg, sucrose - 64.4 mg, corn starch - 53 mg, sodium lauryl sulfate - 5 mg, copolymer methacrylic acid and ethyl acrylate (1: 1) 30% dispersion - 62 mg, talc - 12 mg, macrogol 6000 - 6.2 mg, titanium dioxide - 3.8 mg.

Composition of capsule capsule: gelatin - 37.2151 mg, titanium dioxide (E171) - 1.152 mg, ferric oxide red oxide (E172) - 0.0329 mg.

The composition of the capsule body: gelatin - 56.0936 mg, titanium dioxide (E171) - 1.152 mg, iron oxide red (E172) - 0.3544 mg.

7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
14 pcs.
- polyethylene containers with a propylene lid and a capsule of a hydro-sorbent (1) - packs cardboard.
28 pcs.
- Polyethylene containers with propylene lid and 2 capsules of hydro-sorbent (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Antiulcer drug, inhibitor of H + -K + -ATPase.
It inhibits the activity of H + -K + -ATPase in the parietal cells of the stomach and blocks the final stage of 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 the action 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, the secretory activity is completely restored after 3-5 days.

PHARMACOKINETICS

Suction and distribution

After taking the drug inside, omeprazole is rapidly absorbed from the gastrointestinal tract, C max in the plasma is reached after 0.5-1 h.

Bioavailability is 30-40%.
Binding to plasma proteins is about 90-95%.
Metabolism and excretion

Omeprazole is almost completely biotransformed in the liver.
It is an inhibitor of the CYP 2C19 enzyme system.
It is excreted mainly by the kidneys (70-80%) and with bile (20-30%).
T 1/2 - 0.5-1 h.
Pharmacokinetics in special clinical cases

In chronic renal failure, excretion decreases in proportion to the decrease in QC.

In elderly people the excretion of omeprazole is reduced.

With liver failure T 1/2 - 2-3 hours.

INDICATIONS

Capsules enteric in solution 20 mg and 40 mg

- Stomach ulcer and duodenal ulcer (in the phase of exacerbation and anti-relapse treatment), incl.
Associated with Helicobacter pylori (as part of combination therapy);
- gastroesophageal reflux disease (GERD), incl.
reflux-esophagitis and non-erosive forms of reflux disease (NERD);
- erosive and ulcerative lesions of the stomach and duodenum associated with the administration of NSAIDs, stress ulcers;

- Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion.

Capsules, enteric, soluble 10 mg

- short-term therapy of non-ulcer dyspepsia;

- long-term maintenance therapy with the aim of preventing relapses of gastroesophageal reflux disease;

- Long-term maintenance therapy to prevent recurrences of gastric and duodenal ulcers.

DOSING MODE

The drug is taken orally, before meals (because eating slows the absorption of the drug), squeezed with a small amount of water (the contents of the capsule can not be chewed).

With duodenal ulcer in the phase of exacerbation Ultop ® is prescribed at 20 mg / day for 2-4 weeks.
In resistant cases it is possible to increase the dose to 40 mg / day.
With gastric ulcer in the acute phase and erosive-ulcerative esophagitis - 20-40 mg / day for 4-8 weeks.

With gastroesophageal reflux disease, patients with moderate inflammation of 1 caps.
20 mg 1 time / day in the morning, before breakfast for 4-8 weeks. To ensure the following dosing regimen, it is possible to take the drug at another registered dosage (Ultop®, enteric-soluble capsules 40 mg). The duration of the main course of treatment is usually 4-8 weeks. After healing of erosive esophagitis, supportive treatment for 26-52 weeks is shown, with severe esophagitis - for life. In cases of relapse of severe GERD or resistant GERD, the treatment can be extended up to 4-8 weeks.
With Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion, the dose is selected individually depending on the initial level of gastric secretion, usually starting at 60 mg / day.
If necessary, the dose is increased to 80-120 mg / day, in this case it is divided into 2-3 doses.
To eradicate Helicobacter pylori - 20 mg 2 times / day for 7 or 14 days (depending on the treatment regimen used) in combination with antibacterial drugs.

With non-ulcer dyspepsia, the usual dose is 10 mg to 20 mg 1 time / day for 2-4 weeks.
If after 4 weeks of taking the drug the condition does not improve, or the symptoms of dyspepsia appear again soon after stopping the intake, the diagnosis should be revised.
For the prevention of recurrences of peptic ulcer of the stomach and duodenum appoint
for 10-20 mg / day.
For the prevention of recurrences of gastroesophageal reflux disease - 20 mg / day for a long time.
The safety and efficacy of 12-month maintenance therapy have been proven. Application on demand is possible.
For patients with impaired renal function, dose adjustment is not required.

In patients with impaired liver function, the bioavailability and clearance of omeprazole is increased.
In this regard, the therapeutic dose should not exceed 10-20 mg / day.
For elderly patients , correction of the treatment regimen is not required.

SIDE EFFECT

In rare cases, the following, usually reversible, side reactions may occur.

On the part of the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, irritable bowel syndrome, heartburn, dry mouth, taste disorders, stomatitis, pancreatitis (including fulminant), loss of appetite, discoloration feces, candidiasis of the esophagus, atrophy of the mucous membrane of the tongue, transient increase in the activity of hepatic enzymes and bilirubin in plasma;
in patients with a previous severe liver disease - hepatitis (including jaundice), a violation of liver function or hepatic encephalopathy.
From the side of the nervous system: headache, dizziness, aggression, apathy, nervousness, agitation, drowsiness, insomnia, tremor, vertigo, paresthesia, depression, hallucinations, confusion;
in patients with severe concomitant somatic diseases, patients with previous severe liver disease - encephalopathy.
From the cardiovascular system: angina, tachycardia, bradycardia, palpitations, increased blood pressure, vasculitis, peripheral edema.

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

From the musculoskeletal system: muscle weakness, myalgia, arthralgia, ossalgia (pain in the bones), muscle cramps.

From the hemopoietic system: pancytopenia, agranulocytosis, anemia (including hemolytic anemia), neutropenia, thrombocytopenia, leukocytosis, and leukopenia.

From the skin: petechiae, itching, skin rash;
in some cases - photosensitivity, multiforme exudative erythema, hair loss, alopecia, dry skin, epidermal necrosis, Stevens-Johnson syndrome.
On the part of the respiratory system: a sore throat,
cough, copious nosebleeds.
On the part of the senses: ringing in the ears, unexpressed impairment of sight and hearing.

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

Laboratory indicators: hypoglycemia, hyponatremia.

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

- childhood;

- Pregnancy;

- lactation (breastfeeding);

- hereditary fructose intolerance, glucose-galactose malabsorption syndrome, sugarase / isomaltase deficiency;

- Hypersensitivity to the components of the drug.

With caution should prescribe the drug for renal or hepatic insufficiency.

PREGNANCY AND LACTATION

The safety of the use of Ultop ® in pregnancy and during lactation has not been studied.
Therefore, prescribe during pregnancy is not recommended. If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should prescribe the drug for kidney failure.

With caution, it is necessary to take Ultop ® in patients with impaired renal function.
In patients on dialysis, the pharmacokinetic parameters of omeprazole do not change.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should prescribe the drug for liver failure.

In patients with severe hepatic insufficiency, the daily dose of Ultop should not exceed 20 mg.

APPLICATION FOR CHILDREN

Contraindicated in childhood.

SPECIAL INSTRUCTIONS

Before the start of treatment, it is necessary to exclude the presence of malignant process (especially with gastric ulcer), because
treatment, masking the symptoms, can delay the setting of the correct diagnosis.
The intake of food slows the absorption of omeprazole, so the drug is taken before meals.

In special cases, if there are difficulties with swallowing the whole capsule, you can swallow its contents after opening or dissolving the capsule, and you can mix the contents of the capsule with a slightly acidic liquid (juice, yogurt) and use the resulting suspension for 30 minutes.

Caution is necessary to take Ultop ® in patients with cirrhosis of the liver;
the daily dose should not exceed 20 mg.
Also with caution, it is necessary to take Ultut® to patients with impaired renal function.
In patients on dialysis, the pharmacokinetic parameters of omeprazole do not change.
Ultop ® contains sucrose, so the drug is not recommended for patients with glucose malabsorption syndrome and / or galactose or sucrose / isomaltose deficiency.

Impact on the ability to drive vehicles and manage mechanisms

When using the drug in recommended doses does not affect the ability to drive vehicles and control mechanisms.

OVERDOSE

Patients tolerate the drug in a daily dose of up to 360 mg.

Symptoms: abdominal pain, drowsiness, headache, dizziness, dry mouth, tachycardia, arrhythmia, blurred vision, agitation, confusion, increased sweating, nausea;
in rare cases - convulsions, dyspnea, hypothermia.
Treatment: conduct symptomatic therapy.
There is no specific antidote. Hemodialysis is ineffective.
DRUG 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 change their plasma concentration.

No interaction of omeprazole with concomitant antacids was noted.

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

Being an inhibitor of cytochrome P450, omeprazole can increase the concentration and reduce the excretion of diazepam, an anticoagulant of indirect action, phenytoin, which in some cases may require a reduction in the doses of these drugs.

With simultaneous reception, the absorption of omeprazole and clarithromycin is increased.

TERMS OF RELEASE FROM PHARMACY

Capsules 10 mg are approved for use as an OTC product.

Capsules 20 and 40 mg are prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored in a place protected from moisture, inaccessible to children at a temperature of up to 25 ° C.
Shelf life of capsules 10 mg - 2 years (in blisters), 3 years (in pencil cases); capsules 20 mg and 40 mg - 3 years (in blisters and pencil cases).
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