Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, United Kingdom
Nexium for injection and infusion is indicated in adults for:
Nexium for injection and infusion is indicated in children and adolescents aged 1-18 years for:
Patients who cannot take oral medication may be treated parenterally with 20–40 mg once daily. Patients with reflux esophagitis should be treated with 40 mg once daily. Patients treated symptomatically for reflux disease should be treated with 20 mg once daily.
For healing of gastric ulcers associated with NSAID therapy the usual dose is 20 mg once daily. For prevention of gastric and duodenal ulcers associated with NSAID therapy, patients at risk should be treated with 20 mg once daily.
Usually the intravenous treatment duration is short and transfer to oral treatment should be made as soon as possible.
Following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers, 80 mg should be administered as a bolus infusion over 30 minutes, followed by a continuous intravenous infusion of 8 mg/h given over 3 days (72 hours).
The parenteral treatment period should be followed by oral acid-suppression therapy.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
5 ml of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes.
2.5 ml or half of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes. Any unused solution should be discarded.
The reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes.
Half of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. Any unused solution should be discarded.
The reconstituted solution should be given as a continuous intravenous infusion over 30 minutes.
The reconstituted solution should be given as a continuous intravenous infusion over a period of 71.5 hours (calculated rate of infusion of 8 mg/h. See section 6.3 for shelf-life of the reconstituted solution).
Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution (see section 5.2).
GERD: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum daily dose of 20 mg Nexium I.V. should not be exceeded (see section 5.2).
Bleeding ulcers: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, following an initial bolus dose of 80 mg Nexium for infusion, a continuous intravenous infusion dose of 4 mg/h for 71.5 hours may be sufficient (see section 5.2).
Dose adjustment is not required in the elderly.
Children and adolescents aged 1-18 years:
Gastric antisecretory treatment when the oral route is not possible.
Patients who cannot take oral medication may be treated parenterally once daily, as a part of a full treatment period for GERD (see doses in table below).
Usually the intravenous treatment duration should be short and transfer to oral treatment should be made as soon as possible.
Recommended intravenous doses of esomeprazole:
| Age group | Treatment of erosive reflux esophagitis | Symptomatic treatment of GERD |
|---|---|---|
| 1-11 Years | Weight <20 kg: 10 mg once daily | 10 mg once daily |
| Weight ≥20 kg: 10 mg or 20 mg once daily | ||
| 12-18 Years | 40 mg once daily | 20 mg once daily |
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
ml of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes.
2.5 ml or half of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes. Any unused solution should be discarded.
1.25 ml of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes. Any unused solution should be discarded.
The reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes.
Half of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. Any unused solution should be discarded.
A quarter of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. Any unused solution should be discarded.
There is very limited experience to date with deliberate overdose. The symptoms described in connection with an oral dose of 280 mg were gastrointestinal symptoms and weakness. Single oral doses of 80 mg esomeprazole and intravenous doses of 308 mg esomeprazole over 24 hours were uneventful. No specific antidote is known. Esomeprazole is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.
2 years in all climate zones.
Shelf-life after reconstitution: Chemical and physical in-use stability has been demonstrated for 12 hours at 30°C. From a microbiological point of view, the product should be used immediately.
Store in the original package, in order to protect from light. Vials can however, be stored exposed to normal indoor light outside the box for up to 24 hours. Do not store above 30°C.
5ml vial made of colourless borosilicate glass, type I. Stopper made of bromobutyl latex-free rubber, cap made of aluminium and a plastic flip-off seal.
Pack sizes: 1 vial, 10 vials.
Not all pack sizes may be marketed.
The reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration. Only clear solution should be used. For single use only.
If the entire reconstituted content of the vial is not required, any unused solution should be disposed of in accordance with local requirements.
A solution for injection (8 mg/ml) is prepared by adding 5ml of 0.9% sodium chloride for intravenous use to the esomeprazole 40 mg vial.
The reconstituted solution for injection is clear and colourless to very slightly yellow.
A solution for infusion is prepared by dissolving the content of one vial with esomeprazole 40°mg in up to 100 ml of 0.9% sodium chloride for intravenous use.
A solution for infusion is prepared by dissolving the contents of two vials of esomeprazole 40 mg in up to 100 ml of 0.9% sodium chloride for intravenous use.
The reconstituted solution for infusion is clear and colourless to very slightly yellow.
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