OMEPRAZOLE Powder for solution for infusion Ref.[7024] Active ingredients: Omeprazole

Posology

Alternative to oral therapy

In patients where the use of oral medicinal products is inappropriate, Omeprazole IV 40 mg once daily is recommended. In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided and given twice daily.

Omeprazole is to be administered in an intravenous infusion for 20-30 minutes.

For instructions on reconstitution of the product before administration, see section 6.6.

Special populations

Impaired renal function

Dose adjustment is not needed in patients with impaired renal function (see section 5.2).

Impaired hepatic function

In patients with impaired hepatic function a daily dose of 10-20 mg may be sufficient (see section 5.2).

Elderly (>65 years old)

Dose adjustment is not needed in the elderly (see section 5.2).

Paediatric patients

There is limited experience with Omeprazole for intravenous use in children.

Method of administration

Omeprazole for intravenous is to be administered in an intravenous infusion for 20-30 minutes. After reconstitution the solution is colourless, clear, practically free from visible particles.

There is limited information available on the effects of overdoses of omeprazole in humans. In the literature, doses of up to 560 mg have been described, and occasional reports have been received when single oral doses have reached up to 2,400 mg omeprazole (120 times the usual recommended clinical dose). Nausea, vomiting, dizziness, abdominal pain, diarrhoea and headache have been reported. Also apathy, depression and confusion have been described in single cases.

The symptoms described have been transient, and no serious outcome has been reported. The rate of elimination was unchanged (first order kinetics) with increased doses. Treatment, if needed, is symptomatic.

Intravenous doses of up to 270 mg on a single day and up to 650 mg over a three-day period have been given in clinical trials without any dose-related adverse reactions.

Shelf life

Powder for solution for infusion: 2 years.

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 12 hours when dissolved in NaCl 0.9% solution and for 6 hours in 5% glucose when reconstituted under controlled aseptic conditions and stored below 25°C.

Chemical and physical in-use stability has also been demonstrated for 24 hours at 2-8°C in both NaCl 0.9% solution and 5% glucose.

From a microbiological point of view, the product should be used immediately.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and aseptic conditions.

Powder for solution for infusion: do not store above 25°C. Keep vials in the outer carton in order to protect from light.

For storage conditions of the reconstituted medicinal product, see section 6.3.

10 ml colourless glass vial Type I with a red bromobutyl rubber stopper, and an aluminium cramping cap with polypropylene cap.

Pack sizes: 1, 5, 10 or 20 vials.

Not all pack sizes may be marketed.

The entire contents of each vial is to be dissolved in approximately 5 ml and then immediately diluted to 100 ml. Sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion must be used. The stability of omeprazole is influenced by the pH of the solution for infusion, which is why no other solvent or quantities should be used for dilution.

Preparation:

1. With a syringe draw 5 ml of infusion solution from the 100 ml infusion bottle or bag.
2. Add this volume to the vial with the freeze-dried omeprazole, mix thoroughly making sure all omeprazole is dissolved.
3. Draw the omeprazole solution back into the syringe.
4. Transfer the solution into the infusion bag or bottle.
5. Repeat steps 1-4 to make sure all omeprazole is transferred from the vial into the infusion bag or bottle.

Alternative preparation for infusions in flexible containers:

1. Use a double-ended transfer needle and attach to the injection membrane of the infusion bag. Connect the other needle-end from the vial with freeze-dried omeprazole.
2. Dissolve the omeprazole substance by pumping the infusion solution back and forward between the infusion bag and the vial.
3. Make sure all omeprazole is dissolved.

The solution for infusion is to be administered in an intravenous infusion for 20-30 minutes. After reconstitution the solution is colourless, clear, practically free from visible particles.

Any unused product or waste material should be disposed of in accordance with local requirements.