Dosage & Administration

NEXIUM Delayed-Release Capsules and NEXIUM for Delayed-Release Oral Suspension¹

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NEXIUM for Pediatric Patients

Dosage and administration of NEXIUM in pediatric patients 1 to 17 years old¹

Administration of NEXIUM Delayed-Release Capsules and NEXIUM Delayed Release Oral Suspension

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NEXIUM I.V. for Injection²

NEXIUM I.V. is a proton pump inhibitor indicated for the short-term treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis in adults and pediatric patients greater than one month of age, when oral therapy is not possible or appropriate.

Please click here for the full Prescribing Information (PDF – 72 KB) for NEXIUM I.V.

NEXIUM I.V. for Injection for Adult Patients

Prepare and administer in 2 steps—no filter needed.²

3-minute intravenous injection (20 mg or 40 mg) following reconstitution²

To reconstitute: Draw up 5 mL of 0.9% Sodium Chloride Injection, USP, into a syringe and inject solution into a 20-mg or 40-mg vial of NEXIUM I.V. Mix thoroughly. Use within 12 hours of reconstitution.

To administer: Withdraw the reconstituted solution (5 mL) into a syringe and inject through an I.V. port over no less than 3 minutes.

10- to 30-minute intravenous infusion (20 mg or 40 mg) following reconstitution²

To reconstitute: Draw up 5 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer Injection, USP, or 5% Dextrose Injection, USP, from a 50-mL bag into a syringe and inject into the vial of NEXIUM I.V. Mix thoroughly.

To administer: Withdraw the reconstituted solution (5 mL) into a syringe and inject back into the 50-mL bag. Administer as an I.V. infusion over 10 to 30 minutes. Stability times: NSS/12 hours, LR/12 hours, and D5W/6 hours.

 

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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Store unopened vials away from light. Unopened vials may be stored at 77°F with excursions permitted from 59°F to 86°F.

NEXIUM IV for Injection for Pediatric Patients

Patients ages 1 month to 17 years of age, inclusive (dose should be infused over 10 minutes to 30 minutes):

• 1 month to less than 1 year of age: 0.5 mg/kg
• 1 year to 17 years
  • Body weight less than 55 kg: 10 mg
  • Body weight 55 kg or greater: 20 mg

To reconstitute: For patients 1 month to 1 year of age,draw up 5 mL of 0.9% Sodium Chloride Injection, USP, further diluting to a final volume of 50mL. Resultant concentration after dilution is:

• 40 mg vial: 0.8 mg/mL
• 20 mg vial: 0.4 mg/mL

To administer: For patients 1month to 1 year of age, withdraw appropriate amount of volume for desired dose (0.5 mg/kg) and administer as an IV infusion over 10 minutes to 30 minutes.

To reconstitute: For patients 1 year to 17 years of age, for the 40 mg vial: draw up 5 mL of 0.9% Sodium Chloride Injection, USP, further diluting to a final volume of 50 mL. Resultant concentration after dilution

• 50 mL: 0.8 mg/mL

To administer: For patients 1 year to 17 years of age, for the 20 mg dose, withdraw 25 mL of the final solution and administer as an IV infusion over 10 minutes to 30 minutes. For the 10 mg dose, withdraw 12.5 mL of the final solution and administer as an IV infusion over 10 minutes to 30 minutes.

To reconstitute: For patients 1 year to 17 years of age, for the 20 mg vial: draw up 5 mL of 0.9% Sodium Chloride Injection, USP, further diluting to a final volume of 50 mL. Resultant concentration after dilution

• 50 mL: 0.4 mg/mL

To administer: For patients 1 year to 17 years of age, for the 20 mg dose, withdraw 50 mL of the final solution and administer as an IV infusion over 10 minutes to 30 minutes. For the 10 mL dose, withdraw 25 mL of the final solution and administer as an IV infusion over 10 minutes to 30 minutes.

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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Store unopened vials away from light. Unopened vials may be stored at 77°F with excursions permitted from 59°F to 86°F.

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