Omzol powder for solution for infusion 40mg 10 vials — Made in Portugal — Free Delivery

Brand: Sofarimex Industria Quimica e Farmaceutica Lda
Product Code: Omzol
Availability: In Stock

$78.47

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Description

Product description

Powder for solution for infusion "Omzol" is used for the following indications:

treatment of duodenal ulcers;
prevention of recurrence of duodenal ulcers;
treatment of stomach ulcers;
prevention of recurrence of stomach ulcers;
in combination with appropriate antibiotics, for the eradication of Helicobacter pylori (H. pylori), which is associated with peptic ulcer disease;
treatment of stomach and duodenal ulcers associated with the use of non-steroidal anti-inflammatory preparations (NSAIDs);
prevention of gastric and duodenal ulcers associated with the use of NSAIDs in predisposed patients at risk;
reflux esophagitis treatment;
maintenance therapy in patients after reflux esophagitis treatment;
symptomatic treatment of gastroesophageal reflux disease (GERD);
treatment of Zollinger-Ellison syndrome.

Compound

The active ingredient is omeprazole (1 bottle contains 42.6 mg sodium omeprazole, equivalent to 40 mg omeprazole).

Excipients: sodium hydroxide, disodium edetate (Trilon B).

Contraindications

Hypersensitivity to omeprazole, to other substituted benzimidazoles or to any of the excipients of the preparation.

Omzol, like other PPIs, should not be used concomitantly with nelfinavir or atazanavir.

Mode of application

Dosage

Alternative to oral therapy. For patients for whom the oral form of the preparation is unacceptable, it is recommended to use omeprazole 40 mg once a day. For patients with Zollinger-Ellison syndrome, the recommended starting dose of the preparation, which is administered intravenously, is 60 mg per day. There may be a need for higher daily doses, so the dose should be selected individually. If the dose exceeds 60 mg, it should be divided into two equal parts and administered 2 times a day. The preparation should be used intravenously only, it cannot be administered in any other way. The solution must be used immediately after preparation, but no later than 3 hours later. Do not store the diluted omeprazole solution in the refrigerator. Dispose of unused solution.

Instructions for reconstitution of the preparation before administration

For intravenous infusions, the contents of each vial of omeprazole, which contains 40 mg of omeprazole, are reconstituted in 10 ml and brought to 100 ml with 0.9% sodium chloride solution or 5% glucose solution. The stability of omeprazole depends on the pH of the infusion solution, so other solvents or other amounts should be used for dilution.

The preparation is administered in the form of an infusion over a period of 20-30 minutes.

For intravenous injections, the contents of one vial of omeprazole, which contains 40 mg of omeprazole, are dissolved in 10 ml of water for injection. The preparation in the form of intravenous injection should be administered slowly (within 5 minutes).

The solution must be used immediately after preparation, but no later than 3 hours later. Do not store the diluted omeprazole solution in the refrigerator.

Dispose of any unused product or waste in accordance with local regulations.

Special categories of patients

No dose adjustment is required in patients with impaired renal function.

For patients with impaired liver function, a daily dose of 10-20 mg may be sufficient.

No dose adjustment is required in elderly patients (> 65 years).

Application features

Pregnant

Research results indicate no undesirable effects of omeprazole on pregnancy or fetal / newborn health. Omeprazole can be used during pregnancy.

Omeprazole is excreted in breast milk, but is unlikely to affect the baby when used in therapeutic doses.

Children

The experience of using the preparation for intravenous administration in pediatric practice is limited, therefore, this category of patients should not be prescribed.

Drivers

It is unlikely that the preparation affects the ability to drive or operate other machinery. Considering that in sensitive patients, when using the preparation, side reactions (dizziness, drowsiness, hallucinations, reversible confusion) may occur, such patients should refrain from driving vehicles and working with mechanisms that require concentration of attention during the period of taking the preparation.

Overdose

There is limited information on the effects of an overdose of omeprazole in humans. Cases of the use of the preparation at a dose of up to 560 mg have been described; there were also isolated reports of oral administration of single doses of omeprazole, which reached 2400 mg (120 times the usual recommended clinical dose). Cases of nausea, vomiting, dizziness, abdominal pain, diarrhea and headache have been reported. Apathy, depression, and confusion have also been reported on rare occasions. The symptoms described were transient and no serious effects were reported. The preparation excretion rate did not change (first-order kinetics) with increasing doses of the preparation.

If necessary, symptomatic treatment should be carried out. When conducting clinical studies, intravenous administration of the preparation was used at a dose of up to 270 mg for one day and up to 650 mg for three days, which did not lead to the appearance of any dose-dependent adverse reactions.

Side effects

The most common side effects are headache, abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting.

Storage conditions

Keep the bottle in an outer box at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Shelf life after preparation of the solution: the stability of the chemical and physical properties of the prepared solution was demonstrated within 12 hours at 25 ° C after dissolution with 0.9% sodium chloride solution and within 6 hours after dissolution with 5% glucose solution. From a microbiological point of view, the resulting solution should be used immediately, unless the recovery of the preparation occurs under controlled and aseptic conditions, confirmed by validation methods.

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