FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
Nexium I.v. Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
NEXIUM I.V. for Injection is indicated for the short-term treatment of GERD with erosive esophagitis in adults and pediatric patients 1 month to 17 years, inclusively as an alternative to oral therapy when oral NEXIUM is not possible or appropriate.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in NEXIUM® I.V. (esomeprazole sodium) for Injection is (S)-5-methoxy-2[[(4-methoxy-3,5- dimethyl-2-pyridinyl)-methyl]sulfinyl]-1 H-benzimidazole sodium, a proton pump inhibitor that inhibits gastric acid secretion. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its empirical formula is C17H18N3O3SNa with molecular weight of 367.4 g/mol (sodium salt) and 345.4 g/mol (parent compound). Esomeprazole sodium is very soluble in water and freely soluble in ethanol (95%). The structural formula is:
NEXIUM I.V. for Injection is supplied as a sterile, freeze-dried, white to off-white, porous cake or powder in a 5 mL vial, intended for intravenous administration after reconstitution with 0.9% Sodium Chloride Injection, USP; Lactated Ringer’s Injection, USP or 5% Dextrose Injection, USP. NEXIUM I.V. for Injection contains esomeprazole sodium 21.3 mg or 42.5 mg equivalent to esomeprazole 20 mg or 40 mg, edetate disodium 1.5 mg and sodium hydroxide q.s. for pH adjustment. The pH of reconstituted solution of NEXIUM I.V. for Injection depends on the reconstitution volume and is in the pH range of 9 to 11. The stability of esomeprazole sodium in aqueous solution is strongly pH dependent. The rate of degradation increases with decreasing pH.
Sources
Nexium I.v. Manufacturers
-
Cardinal Health
Nexium I.v. | Cardinal Health
NEXIUM I.V. for Injection should not be administered concomitantly with any other medications through the same intravenous site and or tubing. The intravenous line should always be flushed with either 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP or 5% Dextrose Injection, USP both prior to and after administration of NEXIUM I.V. for Injection.
The admixture should be stored at room temperature up to 30°C (86°F) and should be administered within the designated time period as listed in the Table 1 below. No refrigeration is required.
Table 1
Diluent Administer within:0.9% Sodium Chloride Injection, USP
12 hours
Lactated Ringer’s Injection, USP
12 hours
5% Dextrose Injection, USP
6 hours
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
As soon as oral therapy is possible or appropriate, intravenous therapy with NEXIUM I.V. for Injection should be discontinued and the therapy should be continued orally.
Special Populations
Hepatic Insufficiency: No dosage adjustment is necessary in patients with mild to moderate liver impairment (Child Pugh Classes A and B). For patients with severe liver impairment (Child Pugh Class C), a dose of 20 mg of NEXIUM should not be exceeded [see Use in Specific Populations (8.6) and Clinical Pharmacology, Pharmacokinetics (12.3)].
2.1 GERD with Erosive EsophagitisAdults
The recommended adult dose is either 20 mg or 40 mg esomeprazole given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 minutes to 30 minutes).
Safety and efficacy of NEXIUM I.V. for Injection as a treatment of GERD patients with erosive esophagitis for more than 10 days have not been demonstrated.
Pediatric
The recommended doses for children ages 1 month to 17 years, inclusive, are provided below. Dose should be infused over 10 minutes to 30 minutes.
1 year to 17 years:
Body weight less than 55 kg: 10 mg
Body weight 55 kg or greater: 20 mg
1 month to less than 1 year of age: 0.5 mg/kg
2.2 Preparations for Use and AdministrationAdults
Intravenous Injection (20 mg or 40 mg vial) over no less than 3 minutes
The freeze-dried powder should be reconstituted with 5 mL of 0.9% Sodium Chloride Injection, USP. Withdraw 5 mL of the reconstituted solution and administer an intravenous injection over no less than 3 minutes.
Intravenous Infusion (20 mg or 40 mg) over 10 minutes to 30 minutes
A solution for intravenous infusion is prepared by first reconstituting the contents of one vial with 5 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP or 5% Dextrose Injection, USP and further diluting the resulting solution to a final volume of 50 mL. The solution (admixture) should be administered as an intravenous infusion over a period of 10 minutes to 30 minutes.
The reconstituted solution should be stored at room temperature up to 30°C (86°F) and administered within 12 hours after reconstitution. No refrigeration is required.
Pediatric Population
Intravenous Infusion over 10 minutes to 30 minutes (0.5 mg/kg) for patients ages 1 month to less than 1 year of age
A solution for intravenous infusion is prepared by first reconstituting the contents of one vial with 5 mL of 0.9% Sodium Chloride Injection, USP and further diluting the resulting solution to a final volume of 50 mL. The resultant concentration after diluting to a final volume of 50 mL is as follows:
40 mg vial: 0.8 mg/mL
20 mg vial: 0.4 mg/mL
Withdraw appropriate amount of volume for desired dose (0.5 mg/kg) and administer as an intravenous infusion over 10 minutes to 30 minutes
Intravenous Infusion (10 mg and 20 mg) over 10 minutes to 30 minutes for Pediatric Patients, ages 1 year to 17 years of age
40 mg vial
A solution for intravenous infusion is prepared by first reconstituting the contents of one vial with 5 mL of 0.9% Sodium Chloride Injection, USP and further diluting the resulting solution to a final volume of 50 ml. The resultant concentration after diluting to a final volume of 50 mL is 0.8 mg/mL.
20 mg dose: Withdraw 25 mL of the final solution and administer as an intravenous infusion over 10 minutes to 30 minutes
10 mg dose: Withdraw 12.5 mL of the final solution and administer as an intravenous infusion over 10 minutes to 30 minutes
20 mg vial
A solution for intravenous infusion is prepared by first reconstituting the contents of one vial with 5 mL of 0.9% Sodium Chloride Injection, USP and further diluting the resulting solution to a final volume of 50 mL The resultant concentration after diluting to a final volume of 50 mL is 0.4 mg/mL.
20 mg dose: Administer the final solution (50 mL) as an intravenous infusion over 10 minutes to 30 minutes
10 mg dose: Withdraw 25 mL of the final solution and administer as an intravenous infusion over 10 minutes to 30 minutes
-
Astrazeneca Lp
Nexium I.v. | Astrazeneca Lp
General Information
NEXIUM I.V. for Injection should not be administered concomitantly with any other medications through the same intravenous site and/or tubing. The intravenous line should always be flushed with either 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP or 5% Dextrose Injection, USP both prior to and after administration of NEXIUM I.V. for Injection.
The admixture should be stored at room temperature up to 30°C (86°F) and should be administered within the designated time period as listed in Table 1 below. No refrigeration is required.
Table 1 Storage Time for Final (diluted) Product Diluent Administer within:0.9% Sodium Chloride Injection, USP
12 hours
Lactated Ringer’s Injection, USP
12 hours
5% Dextrose Injection, USP
6 hours
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
As soon as oral therapy is possible or appropriate, intravenous therapy with NEXIUM I.V. for Injection should be discontinued and the therapy should be continued orally.
2.1 GERD with Erosive EsophagitisAdult Patients
The recommended adult dose is either 20 mg or 40 mg NEXIUM given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 minutes to 30 minutes). Safety and efficacy of NEXIUM I.V. for Injection as a treatment of GERD patients with erosive esophagitis for more than 10 days have not been demonstrated.
Dosage adjustment is not required in patients with mild to moderate liver impairment (Child Pugh Classes A and B). For patients with severe liver impairment (Child Pugh Class C), a maximum dose of 20 mg once daily of NEXIUM should not be exceeded [seeUse in Specific Populations (8.6), Clinical Pharmacology (12.3)].
Pediatric Patients
The recommended doses for children ages 1 month to 17 years, inclusive, are provided below. Dose should be infused over 10 minutes to 30 minutes.
1 year to 17 years:
Body weight less than 55 kg: 10 mg Body weight 55 kg or greater: 20 mg1 month to less than 1 year of age: 0.5 mg/kg
2.2 Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers following Therapeutic Endoscopy in AdultsAdult dose is 80 mg administered as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg/h for a total treatment duration of 72 hours (i.e., includes initial 30-minute dose plus 71.5 hours of continuous infusion). Intravenous therapy is aimed solely at the acute initial management of bleeding gastric or duodenal ulcers and does not constitute full treatment. Intravenous therapy should be followed by oral acid-suppressive therapy.
For patients with liver impairment, no dosage adjustment of the initial esomeprazole 80 mg infusion is necessary. For patients with mild to moderate liver impairment (Child Pugh Classes A and B), a maximum continuous infusion of esomeprazole 6 mg/h should not be exceeded. For patients with severe liver impairment (Child Pugh Class C), a maximum continuous infusion of 4 mg/h should not be exceeded [seeUse in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.3 Preparation and Administration InstructionsGeneral Information
The reconstituted solution of Nexium I.V. should be stored at room temperature up to 30°C (86°F) and administered within 12 hours after reconstitution. (Administer within 6 hours if 5% Dextrose Injection is used after reconstitution). No refrigeration is required [seeDosage and Administration (2), Table 1].
Gastroesophageal Reflux Disease (GERD) with Erosive Esophagitis
Preparation Instructions for Adult Patients
Intravenous Injection (20 mg or 40 mg vial) over no less than 3 minutes
The freeze-dried powder should be reconstituted with 5 mL of 0.9% Sodium Chloride Injection, USP. Withdraw 5 mL of the reconstituted solution and administer as an intravenous injection over no less than 3 minutes.Preparation Instructions for Pediatric Patients
Intravenous Infusion (20 mg or 40 mg) over 10 minutes to 30 minutes
A solution for intravenous infusion is prepared by first reconstituting the contents of one vial* with 5 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP or 5% Dextrose Injection, USP and further diluting the resulting solution to a final volume of 50 mL. The resultant concentration after diluting to a final volume of 50 mL is 0.8 mg/mL (for 40 mg vial) and 0.4 mg/mL (for 20 mg vial). The solution (admixture) should be administered as an intravenous infusion over a period of 10 minutes to 30 minutes. *For patients 1 month to less than 1 year of age, first calculate the dose (0.5 mg/kg) to determine the vial size needed.Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers in Adults
Preparation Instructions for Loading dose (80 mg) to be given over 30 minutes
The loading dose of 80 mg is prepared by reconstituting two 40 mg vials. Reconstitute each 40 mg vial with 5 mL of 0.9% Sodium Chloride Injection, USP. The contents of the two vials should be further diluted in 100 mL 0.9% Sodium Chloride Injection, USP for intravenous use. Administer over 30 minutes.
Preparation Instructions for Continuous Infusion to be given at 8 mg/hour for 71.5 hours
The continuous infusion is prepared by using two 40 mg vials. Reconstitute each 40 mg vial with 5 mL each of 0.9% Sodium Chloride Injection, USP. The contents of the two vials should be further diluted in 100 mL 0.9% Sodium Chloride Injection, USP for intravenous use. Administer at a rate of 8 mg/hour for 71.5 hours.
Login To Your Free Account