Nexium Dosage
Generic name: ESOMEPRAZOLE SODIUM 40mg in 5mL
Dosage form: injection
Drug class: Proton pump inhibitors
Medically reviewed by Drugs.com. Last updated on Jul 18, 2023.
Dosage for GERD with EE
Adult Patients
The recommended adult dosage is either 20 mg or 40 mg NEXIUM I.V. given once daily by intravenous injection (over at least 3 minutes) or intravenous infusion (10 minutes to 30 minutes) for up to 10 days [see Dosage and Administration (2.4)].
Pediatric Patients
The recommended dosage for pediatric patients is based on age and body weight as shown in Table 1 below. Administer as an intravenous infusion over 10 to 30 minutes once daily for up to 10 days [see Dosage and Administration (2.4)].
Age and Body Weight |
Dosage Regimen |
|
1 month to less than 1 year of age |
0.5 mg/kg once daily |
|
1 year to 17 years |
less than 55 kg |
10 mg once daily |
55 kg or greater |
20 mg once daily |
Completion of Treatment
- •
- The safety and effectiveness of NEXIUM I.V. for more than 10 days have not been demonstrated.
- •
- As soon as oral therapy is possible or appropriate, discontinue intravenous therapy with NEXIUM I.V. and continue with oral NEXIUM therapy.
Dosage for Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers following Therapeutic Endoscopy in Adults
The recommended adult dosage is 80 mg NEXIUM I.V. administered as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg/hour for a total treatment duration of 72 hours (i.e., includes initial 30-minute loading dose plus 71.5 hours of continuous infusion) [see Dosage and Administration (2.5)].
Intravenous therapy is aimed solely at the acute initial management of bleeding gastric or duodenal ulcers and does not constitute full treatment. Administer oral acid-suppressive therapy following intravenous therapy for a full course of treatment.
Dosage Adjustment for Hepatic Impairment
GERD with EE
For patients with severe hepatic impairment (Child-Pugh Class C), the maximum dosage is 20 mg once daily [see Use in Specific Populations (8.6)].
Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers following Therapeutic Endoscopy in Adults
For patients with mild to moderate hepatic impairment (Child-Pugh Classes A and B, respectively), administered 80 mg as an intravenous infusion over 30 minutes, followed by a continuous infusion of 6 mg/hour for 71.5 hours.
For patients with severe hepatic impairment (Child-Pugh Class C), administered 80 mg as an intravenous infusion over 30 minutes, followed by a continuous infusion of 4 mg/hour for 71.5 hours [see Use in Specific Populations (8.6)].
Preparation and Administration Instructions for GERD with EE
Do not administer NEXIUM I.V. concomitantly with any other medications through the same intravenous site and/or tubing.
Oral antacids may be used during treatment with NEXIUM I.V.
Intravenous Injection Over At Least 3 Minutes in Adult Patients
- 1.
- Reconstitute NEXIUM I.V. with 5 mL of 0.9% Sodium Chloride Injection, USP.
- 2.
- Withdraw the desired dose of the reconstituted NEXIUM I.V. solution for a 20 mg or 40 mg dose.
- 3.
- Discard any unused portion of NEXIUM I.V. solution remaining in the vial.
- 4.
- Inspect the reconstituted NEXIUM I.V. solution visually for particulate matter and discoloration prior to and during administration.
- 5.
- Administer as an intravenous injection over no less than 3 minutes.
- 6.
- Flush the intravenous line 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.
Intravenous Infusion Over 10 Minutes to 30 Minutes in Adult and Pediatric Patients
- 1.
- Reconstitute the contents of one vial of NEXIUM I.V. with 5 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP or 5% Dextrose Injection, USP.
- 2.
- Further dilute the resulting solution with 45 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP or 5% Dextrose Injection, USP to a final concentration of 0.8 mg/mL.
- 3.
- Withdraw the desired dose of the reconstituted NEXIUM I.V. solution for an adult or pediatric dose.
- 4.
- Discard any unused portion of NEXIUM I.V. solution remaining in the vial.
- 5.
- Inspect the reconstituted NEXIUM I.V. solution visually for particulate matter and discoloration prior to and during administration.
- 6.
- Administer intravenously over 10 minutes to 30 minutes.
- 7.
- Flush the intravenous line 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.
Storage
Store the final (diluted) NEXIUM I.V. solution at room temperature up to 30°C (86°F) and administer within the designated time period as listed in Table 2 below.
Diluent |
Administer within: |
0.9% Sodium Chloride Injection, USP |
12 hours |
Lactated Ringer’s Injection, USP |
12 hours |
5% Dextrose Injection, USP |
6 hours |
Preparation and Administration Instructions for Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers in Adults
Do not administer NEXIUM I.V. concomitantly with any other medications through the same intravenous site and/or tubing.
Oral antacids may be used during treatment with NEXIUM I.V.
Loading Dose (80 mg)
- 1.
- Reconstitute each of two 40 mg vials of NEXIUM I.V. with 5 mL of 0.9% Sodium Chloride Injection, USP.
- 2.
- Further dilute the resulting solution in 100 mL 0.9% Sodium Chloride Injection, USP.
- 3.
- Inspect the reconstituted NEXIUM I.V. solution visually for particulate matter and discoloration prior to and during administration.
- 4.
- Administer intravenously over 30 minutes.
- 5.
- Flush the intravenous line 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.
Continuous Infusion
- 1.
- Reconstitute each of two 40 mg vials of NEXIUM I.V. with 5 mL of 0.9% Sodium Chloride Injection, USP.
- 2.
- Further dilute the reconstituted NEXIUM I.V. solution in 100 mL 0.9% Sodium Chloride Injection, USP.
- 3.
- Inspect the reconstituted NEXIUM I.V. solution visually for particulate matter and discoloration prior to and during administration.
- 4.
- Administer intravenously as a continuous infusion at a rate of 8 mg/hour for 71.5 hours.
- 5.
- Flush the intravenous line 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.
Storage
- •
- Store the final (diluted) NEXIUM I.V. solution at room temperature up to 30°C (86°F) and administer within 12 hours.
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