Omeprazole | Ultop lyophilisate for solution for infusion vial 40 mg 1 pc.

Release form

Lyophilisate for preparation infusion

Pharmacological action

Ultop - proton inhibitory pump.

Pharmacodynamics

Inhibits the enzyme H + -K + -ATPase (proton pump) in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid synthesis. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. After a single oral administration of the drug, the action of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours.

After stopping the drug, secretory activity is fully restored after 3-5 days. Basal gastric secretion is reduced to 94% after taking 40 mg of omeprazole. The acidity of gastric juice within 24 hours decreases by 80–97% when taking 20 mg of omeprazole and by 92–94% when taking 40 mg. Inhibition of 50% of maximum secretion lasts 24 hours.

Pharmacokinetics

Omeprazole is rapidly absorbed from the gastrointestinal tract, Cmax in plasma is reached after 0.5–1 hours. Bioavailability is 30–40%. Bioavailability is slightly increased in elderly patients and patients with impaired liver function, and to a large extent in patients with chronic liver failure (can reach 100%). Plasma protein binding is about 90–95%. Omeprazole is almost completely metabolized in the liver with the formation of 6 pharmacologically inactive metabolites. It is an inhibitor of the CYP2C19 enzyme system. T1 / 2 - 0.5–1 hours. Excretion by the kidneys - 70–80% and with bile - 20–30%. In case of impaired renal function, omeprazole excretion decreases in proportion to a decrease in creatinine clearance. In cases of impaired liver function, T1 / 2 is 2-3 hours. The total clearance is 500-600 ml / min.

Indications

peptic ulcer of the stomach and duodenum

reflux esophagitis

erosive-ulcerative lesions of the stomach and duodenum associated with the use of NSAIDs, stress ulcers of the sardlcericobacteri as part of complex therapy)

Zollinger-Ellison syndrome

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

Contraindications

hypersensitivity to omeprazole or other components of the

preparation childhood

pregnancy

lactation period

hereditary fructose intolerance

glucose galactose malabsorption syndrome srdlzp deficiency.

Precautions: renal and / or liver failure.

Pregnancy and lactation

Ultop should not be used during pregnancy. If it is necessary to prescribe the drug during lactation, it is necessary to decide on the termination of breastfeeding.

Composition of

1 vial contains:

Active ingredient: laronidase 500 PIECES (excess of filling - 30 PIECES)

Excipients: sodium sodium chloride phosphate monosubstituted sodium monohydrate phosphate disubstituted heptahydrate polysorbate 80fl sfff79 water 1 for injection Active ingredient: omeprazole 40 mg

Excipients: sodium hydroxide solution 1N - 0.132 ml disodium edetate - 1 mg.

Dosage and administration of

If oral therapy is not possible, patients with a stomach ulcer and duodenal ulcer or reflux esophagitis are recommended to be given iv administration of Ultop® at a dose of 40 mg once a day.

In patients with Zollinger-Ellison syndrome, the introduction of Ultopa® in the initial dose of 60 mg / day is recommended. Doses are selected individually, sometimes a higher dose is required. If the daily dose exceeds 60 mg, then it should be divided into 2 introductions.

Ultop® infusion solution is administered iv in a drip over a period of 20-30 minutes.

It is recommended that the infusion solution be administered immediately after preparation.

Patients with impaired renal function. There is no need for dose adjustment.

Patients with impaired liver function. It is recommended that the daily dose be reduced to 10–20 mg, as T1 / 2 omeprazole in this category of patients is more prolonged.

Elderly patients do not require dose adjustment.

Preparation of the

infusion solution Dissolve the lyophilized omeprazole powder in 100 ml of a 5% dextrose (glucose) infusion solution or in 100 ml of physiological saline. An infusion solution of 5% dextrose should be used for 6 hours on saline solution - for 12 hours.

Side effects of

From the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disturbances, stomatitis, transient increase in plasma liver enzymes in patients with previous severe liver disease - hepatitis ( including jaundice), impaired liver function.

From the nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations in patients with severe concomitant somatic diseases, patients with a previous severe liver disease - encephalopathy.

From the CCC side: angina pectoris, tachycardia, bradycardia, palpitations, increased blood pressure, vasculitis, peripheral edema.

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

From the musculoskeletal system: muscle weakness, myalgia, arthralgia, bone pain, muscle cramps.

From the hemopoietic system: pancytopenia, agranulocytosis, anemia, neutropenia, thrombocytopenia, leukocytosis, leukopenia.

From the skin: petechiae, itching, skin rash in some cases - photosensitivity, erythema multiforme, hair loss, alopecia, dry skin, epidermal toxic necrolysis, Stevens-Johnson syndrome.

On the part of the respiratory system: sore throat, cough, profuse nosebleeds.

From the sensory organs: ringing in the ears, unexpressed visual and hearing impairment.

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 prolonged treatment (due to inhibition of hydrochloric acid secretion, is benign, reversible), general fatigue, general weakness, weight gain, fever.

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, cyclosporin .

There has been no interaction of omeprazole with concurrent antacids.

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

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

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

Overdose

Symptoms: abdominal pain, drowsiness, headache, dizziness, sweating, dry mouth, palpitations, impaired vision. Convulsions, shortness of breath and a decrease in body temperature are possible. There is no specific antidote.

Treatment: symptomatic. Hemodialysis is not effective enough.

Storage conditions

Store in a dry place at temperatures up to 25 РC.

Expiration

2 Year

Deystvuyuschee substance omeprazole



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dosage form

infusion solution

KRKA d.d. Novo mesto AO, Slovenia