Ulkozol - instructions for use, dose, side effects, contraindications

Excipients: sugar spheres, sodium lauryl sulfate, sodium hydrophosphate, lactose monohydrate, hypromellose, giprolose, hypromellose phthalate, diethyl phthalate, gelatin, titanium dioxide, iron oxide ferric oxide black.

Each vial with lyophilizate for the preparation of a solution for intravenous administration / complete with a solvent contains:

Vial with active substance: omeprazole (in the form of omeprazole sodium) - 40 mg Ampoule with solvent: Macrogol 400, citric acid, water for injection q.s. 10 ml.

Description:

Capsules: hard gelatin capsules, size 2, body - white, cap - gray, containing pellets from white to yellowish color.

Lyophilizate for solution for intravenous administration: white or almost white color lyophilized mass.

Solvent: clear, colorless liquid.

Description of the reconstituted solution (finished product): a clear solution slightly yellowish in color.

Pharmacotherapeutic group:antiulcer - proton pump inhibitor.

ATX: & nbsp

A.02.B.C.01 Omeprazole

Pharmacodynamics:

Omeprazole inhibits the enzyme H + .K + -ATP-asu ("proton pump") in parietal cells of the stomach and blocks the final stage of the synthesis of hydrochloric acid. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. After a single intake of the drug, omeprazole acts within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains an intragastric pH> 3.0 for 17 hours. After discontinuation of the drug secretory activity is completely restored after 3-5 days.

Pharmacokinetics:

Ingestion omeprazole quickly absorbed from the gastrointestinal tract, the peak concentration in the plasma is achieved after 0.5-1 hour. Bioavailability is 30-40%. The connection with plasma proteins is about 90%. Omeprazole almost completely metabolized in the liver. Half-life is 0.5-1 hour. It is excreted by the kidneys (70-80%) and with bile (20-30%). In chronic renal failure, excretion decreases in proportion to a decrease in creatinine clearance.In elderly patients excretion decreases, bioavailability increases. With hepatic failure, bioavailability is 100%, the half-life increases to 3 hours.

Indications:

Stomach ulcer and duodenal ulcer.

Reflux esophagitis.

Erosive-ulcerative lesions of the stomach and duodenum,

associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), stress ulcers.

Erosive-ulcerative lesions of the stomach and duodenum,

associated with Helicobacter pylori (as part of complex therapy). Zollinger-Ellison syndrome.

Prevention of ingestion of acidic stomach contents in the respiratory tract during general anesthesia (Mendelssohn syndrome).

Contraindications:

Hypersensitivity to the drug, a child's age, pregnancy, lactation.

Carefully: renal and/ or liver failure.

Pregnancy and lactation:contraindicated

Dosing and Administration:

Capsules.

Inside. Capsules should be taken without chewing, squeezed a small amount of liquid, regardless of food intake (usually recommended in the morning before meals or during meals).In case of necessity of 2-fold reception, the evening dose should be taken before dinner.

Peptic ulcer of duodenum in the phase of exacerbation - 20 mg per day for 2-4 weeks (in resistant cases, up to 40 mg per day).

Stomach ulcer in the phase of exacerbation and erosive-ulcerative esophagitis - 20-40 mg per day for 4-8 weeks.

Erosive-ulcerative lesions of the gastrointestinal tract caused by the intake of NSAIDs by 20 mg per day for 4-8 weeks.

Eradication Helicobacter pylori - 20 mg twice a day for 7 days in combination with antibacterial agents.

Anti-relapse treatment of peptic ulcer of stomach and duodenum - 20 mg per day.

Anti-relapse treatment of reflux esophagitis - 20 mg per day for a long time (up to 6 months).

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

Lyophilizate for the preparation of a solution for intravenous administration.

The drug is administered intravenously once a day in cases where oral administration of the drug is difficult.

The lyophilizate is dissolved in 10 ml of the applied solvent (1 ampoule).Do not use any other solvents!

The prepared solution should be used within 4 hours.

Enter the solution intravenously slowly over a period of at least 2.5 minutes at a rate not exceeding 4 ml / min.

If necessary, the infusion of omeprazole, the lyophilizate is dissolved in the applied solvent and then added to 100 ml of physiological saline or 5% dextrose and infused (intravenously dropwise for 20-30 minutes). The prepared solution can be stored at room temperature for no more than 12 hours.

In the prevention of Mendelssohn syndrome, 40 mg of the drug is administered 1 hour before the operation. In the case of an operation for more than 2 hours, the dose of the drug should be re-entered.

Side effects:

On the part of 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 the plasma; in patients with a previous severe liver disease - hepatitis (including jaundice), a violation of liver function.

From the nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations (in patients with

severe concomitant somatic diseases), patients with previous severe liver disease - encephalopathy.

From the musculoskeletal system: muscle weakness, myalgia, arthralgia.

On the part of the hematopoiesis system: leukopenia, thrombocytopenia; at

In some cases - agranulocytosis, pancytopenia.

From the skin: itching; rarely - skin rash, in some cases - photosensitivity, multiforme exudative erythema, alopecia.

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

Other: impaired vision, peripheral edema, increased sweating, fever, gynecomastia; rarely - the formation of gastric glandular cysts during long-term treatment (the consequence of inhibition of the secretion of hydrochloric acid, is benign, reversible).

Overdose:

Symptoms: visual impairment, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia. There is no specific antidote.

Treatment - symptomatic. Hemodialysis is not effective enough.

Interaction:

Long-term use of omeprazole 20 mg once daily in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not change their plasma concentration.

No interaction with concomitant antacids was noted.

It can reduce the absorption of esters of penicillin, iron salts, itraconazole and ketoconazole (omeprazole increases the pH of the stomach). Being an inhibitor of cytochrome P450, it can increase the concentration and reduce the excretion of diazepam, anticoagulants of indirect action, phenytoin (drugs that are metabolized in the liver via cytochrome

CYP2C19), which in some cases may require a reduction in the doses of these drugs. Increases the inhibitory effect on the hemopoietic system of other drugs.

Special instructions:

Before the start of therapy, it is necessary to exclude the presence of malignant process (especially with gastric ulcer), because treatment, masking the symptoms, can delay the establishment of the correct diagnosis.

Admission simultaneously with food does not affect the effectiveness of omeprazole.

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

Form release / dosage:

Capsules 20 mg.

Packaging:

7 capsules in a blister of aluminum. For 1, 2 or 4 blisters in a cardboard box with instructions for use.

Liofilizate for the preparation of a solution for intravenous administration of 40 mg / complete with a solvent. For 40 mg in bottles of dark glass, type 1 FSU with a glued label, sealed with a rubber stopper and rolled up with an aluminum cap. 10 ml of solvent into neutral glass ampoules. The vial with lyophilizate and ampoule with solvent are placed in a cardboard box with instructions for use.

Storage conditions:

List B. In a dry, protected from light and inaccessible to children place, at a temperature of no higher than 25 ° C,

Shelf life:2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001960/07

Date of registration:07.08.2007

The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia

Manufacturer: & nbsp

Laboratorios BAGO, S.A. Argentina

Representation: & nbspVALEANT LLC VALEANT LLC Russia

Information update date: & nbsp24.01.2014

Illustrated instructions

Instructions

Ulcozol® (Ulcozol®)