Esomeprazole Sodium

ESOMEPRAZOLE SODIUM- esomeprazole sodium injection
Akorn

1 INDICATIONS AND USAGE

1.1 Treatment of Gastroesophageal Reflux Disease (GERD) with Erosive Esophagitis (EE)

Esomeprazole sodium for injection is indicated for the short-term treatment of GERD with EE in adults and pediatric patients 1 month to 17 years, inclusively as an alternative to oral therapy when oral esomeprazole is not possible or appropriate.

1.2 Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers following Therapeutic Endoscopy in Adults

Esomeprazole sodium for injection is indicated for risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers in adults.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for GERD with EE

Adult Patients

The recommended adult dosage is either 20 mg or 40 mg esomeprazole 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)].

Table 1: Recommended Pediatric Dosage Regimen for GERD with EE
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 esomeprazole sodium for injection for more than 10 days have not been demonstrated.
  • As soon as oral therapy is possible or appropriate, discontinue intravenous therapy with esomeprazole sodium for injection and continue with oral esomeprazole therapy.

2.2 Dosage for Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers following Therapeutic Endoscopy in Adults

The recommended adult dosage is 80 mg esomeprazole sodium for injection 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.

2.3 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)].

2.4 Preparation and Administration Instructions for GERD with EE

Do not administer esomeprazole sodium for injection concomitantly with any other medications through the same intravenous site and/or tubing.

Oral antacids may be used during treatment with esomeprazole sodium for injection.

Intravenous Injection Over At Least 3 Minutes in Adult Patients

  1. Reconstitute esomeprazole sodium for injection with 5 mL of 0.9% Sodium Chloride Injection, USP.
  2. Withdraw the desired dose of the reconstituted esomeprazole sodium for injection solution for a 20 mg or 40 mg dose.
  3. Discard any unused portion of esomeprazole sodium for injection solution remaining in the vial.
  4. Inspect the reconstituted esomeprazole sodium for injection 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 esomeprazole sodium for injection.

Intravenous Infusion Over 10 Minutes to 30 Minutes in Adult and Pediatric Patients

  1. Reconstitute the contents of one vial of esomeprazole sodium for injection 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 esomeprazole sodium for injection solution for an adult or pediatric dose.
  4. Discard any unused portion of esomeprazole sodium for injection solution remaining in the vial.
  5. Inspect the reconstituted esomeprazole sodium for injection 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 esomeprazole sodium for injection.

Storage

Store the final (diluted) esomeprazole sodium for injection solution at room temperature up to 30°C (86°F) and administer within the designated time period as listed in Table 2 below.

Table 2: Storage Time for Final (diluted) Esomeprazole Sodium for Injection
Diluent Administer within:
0.9% Sodium Chloride Injection, USP 12 hours
Lactated Ringer’s Injection, USP 12 hours
5% Dextrose Injection, USP 6 hours

2.5 Preparation and Administration Instructions for Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers in Adults

Do not administer esomeprazole sodium for injection concomitantly with any other medications through the same intravenous site and/or tubing.

Oral antacids may be used during treatment with esomeprazole sodium for injection.

Loading Dose (80 mg)

  1. Reconstitute each of two 40 mg vials of esomeprazole sodium for injection 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 esomeprazole sodium for injection 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 esomeprazole sodium for injection.

Continuous Infusion

  1. Reconstitute each of two 40 mg vials of esomeprazole sodium for injection with 5 mL of 0.9% Sodium Chloride Injection, USP.
  2. Further dilute the reconstituted esomeprazole sodium for injection solution in 100 mL 0.9% Sodium Chloride Injection, USP.
  3. Inspect the reconstituted esomeprazole sodium for injection 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 esomeprazole sodium for injection.

Storage

  • Store the final (diluted) esomeprazole sodium for injection solution at room temperature up to 30°C (86°F) and administer within 12 hours.

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