PROTONIX® IV Dosage and Administration

(pantoprazole sodium for injection)

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for GERD Associated with a History of EE

Adult Patients

The recommended adult dosage of PROTONIX I.V. is 40 mg once daily by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes) for up to 10 days. Discontinue PROTONIX I.V. as soon as the patient is able to tolerate oral treatment. Switch to an appropriate oral medication within 10 days of starting PROTONIX I.V.

Pediatric Patients

•
The recommended dosage for pediatric patients 3 months of age and older is based on age and actual body weight as shown in Table 1 below.
•
Administer as an intravenous infusion over 15 minutes once daily.
Table 1: Recommended Pediatric Dosage Regimen for GERD and a History of EE
Age and Body WeightRecommended Dosage Regimen
(up to 7 days)

3 months to less than 1 year of age

Less than 12.5 kg

0.8 mg/kg once daily

12.5 kg and above

10 mg once daily

1 year to 17 years of age

Up to 15 kg

10 mg once daily

Greater than 15 kg

up to 40 kg

20 mg once daily

Greater than 40 kg

40 mg once daily

•
Discontinue PROTONIX I.V. as soon as the patient is able to tolerate oral treatment. Switch to an appropriate oral medication within 7 days of starting PROTONIX I.V.

2.2 Recommended Dosage for Pathological Hypersecretion Including Zollinger-Ellison Syndrome

     

•
The recommended adult dosage of PROTONIX I.V. is 80 mg every 12 hours by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes).
•
Adjust the frequency of dosing to individual patient needs based on acid output measurements. In those patients who need a higher dosage, 80 mg intravenously every 8 hours is expected to maintain acid output below 10 mEq/h.
•
When switching between intravenous to oral formulations of gastric acid inhibitors, consider the pharmacodynamic action of the drugs to ensure continuity of acid suppression.

2.3 Preparation and Administration Instructions for GERD Associated with a History of EE

15-Minute Intravenous Infusion for Pediatric or Adult Patients

1. Reconstitute each vial of PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection.

2. Dilute the resulting solution to a final concentration as described below:

•
Pediatric patients 3 months to less than 1 year of age: Dilute with 21 mL 0.9% Sodium Chloride Injection to a final concentration of approximately 1.3 mg/mL.
•
Pediatric patients 1 year to 17 years old and adult patients: Further dilute with 100 mL 5% Dextrose Injection or 0.9% Sodium Chloride Injection to a final concentration of approximately 0.4 mg/mL.

3. Inspect the diluted PROTONIX I.V. solution visually for particulate matter and discoloration prior to and during administration.

4. Withdraw the desired dose of the diluted PROTONIX I.V. solution for a pediatric or adult dose.

5. Discard any unused portion of the remaining PROTONIX I.V. solution.

6. Infuse intravenously over a period of approximately 15 minutes through a dedicated line or through a Y-site [see Dosage and Administration (2.5)].

7. Flush the intravenous line before and after administration of PROTONIX I.V. with either 5% Dextrose Injection or 0.9% Sodium Chloride Injection.

Storage

•
Store the reconstituted solution may be stored for up to 24 hours at room temperature up to 30°C (86°F) prior to intravenous infusion.
•
Do not freeze the reconstituted solution.

2-Minute Intravenous Injection for Adult Patients

1. Reconstitute each vial of PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection, to a final concentration of approximately 4 mg/mL.

2. Withdraw the dose of 40 mg of reconstituted PROTONIX I.V. solution.

3. Inspect the diluted PROTONIX I.V. solution visually for particulate matter and discoloration prior to and during administration.

4. Administer intravenously over a period of at least 2 minutes.

5. Flush the intravenous line before and after administration of PROTONIX I.V. with either 5% Dextrose Injection or 0.9% Sodium Chloride Injection.

Storage

•
Store the reconstituted solution may be up to 6 hours at room temperature up to 30°C (86°F) prior to further dilution.
•
Store the diluted solution at room temperature up to 30°C (86°F) and must be used within 24 hours from the time of initial reconstitution.
•
Do not freeze the reconstituted or diluted solution.

2.4 Preparation and Administration Instructions for Pathological Hypersecretion Including Zollinger-Ellison Syndrome

     

15-Minute Intravenous Infusion

1. Reconstitute each vial of PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection.

2. Combine the contents of the two vials and dilute with 80 mL of 5% Dextrose Injection or Sodium Chloride Injection to a total volume of 100 mL with a final concentration of approximately 0.8 mg/mL.

3. Inspect the diluted PROTONIX I.V. solution visually for particulate matter and discoloration prior to and during administration.

4. Administer intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.

5. Flush the intravenous line before and after administration of PROTONIX I.V. with either 5% Dextrose Injection or 0.9% Sodium Chloride Injection.

Storage

•
The reconstituted solution can be stored at room temperature up to 30°C (86°F) for up to 6 hours prior to further dilution.
•
Once further diluted, the diluted solution can be stored at room temperature up to 30°C (86°F) for up to 24 hours from the time of initial reconstitution.
•
Do not freeze the reconstituted or diluted solution.

2-Minute Intravenous Injection

1. Reconstitute each vial of PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection, per vial to a final concentration of approximately 4 mg/mL.

2. Inspect the diluted PROTONIX I.V. solution visually for particulate matter and discoloration prior to and during administration.

3. Administer the total volume from both vials intravenously over a period of at least 2 minutes.

4. Flush the intravenous line before and after administration of PROTONIX I.V. with either 5% Dextrose Injection or 0.9% Sodium Chloride Injection.

Storage

•
The reconstituted solution may be stored for up to 24 hours at room temperature.
•
Do not freeze the reconstituted solution.

2.5 Compatibility Information

•
Administer PROTONIX I.V. intravenously through a dedicated line or through a Y-site.
•
When administering through a Y-site, PROTONIX I.V. is compatible with the following solutions:
o
5% Dextrose Injection
o
0.9% Sodium Chloride Injection
•
Midazolam hydrochloride is incompatible with Y-site administration of PROTONIX I.V.
•
PROTONIX I.V. may not be compatible with products containing zinc [see Warnings and Precautions (5.3)].
•
Stop administering PROTONIX I.V. immediately through a Y-site if precipitation or discoloration occurs.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for GERD Associated with a History of EE

Adult Patients

The recommended adult dosage of PROTONIX I.V. is 40 mg once daily by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes) for up to 10 days. Discontinue PROTONIX I.V. as soon as the patient is able to tolerate oral treatment. Switch to an appropriate oral medication within 10 days of starting PROTONIX I.V.

Pediatric Patients

•
The recommended dosage for pediatric patients 3 months of age and older is based on age and actual body weight as shown in Table 1 below.
•
Administer as an intravenous infusion over 15 minutes once daily.
Table 1: Recommended Pediatric Dosage Regimen for GERD and a History of EE
Age and Body WeightRecommended Dosage Regimen
(up to 7 days)

3 months to less than 1 year of age

Less than 12.5 kg

0.8 mg/kg once daily

12.5 kg and above

10 mg once daily

1 year to 17 years of age

Up to 15 kg

10 mg once daily

Greater than 15 kg

up to 40 kg

20 mg once daily

Greater than 40 kg

40 mg once daily

•
Discontinue PROTONIX I.V. as soon as the patient is able to tolerate oral treatment. Switch to an appropriate oral medication within 7 days of starting PROTONIX I.V.

2.2 Recommended Dosage for Pathological Hypersecretion Including Zollinger-Ellison Syndrome

     

•
The recommended adult dosage of PROTONIX I.V. is 80 mg every 12 hours by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes).
•
Adjust the frequency of dosing to individual patient needs based on acid output measurements. In those patients who need a higher dosage, 80 mg intravenously every 8 hours is expected to maintain acid output below 10 mEq/h.
•
When switching between intravenous to oral formulations of gastric acid inhibitors, consider the pharmacodynamic action of the drugs to ensure continuity of acid suppression.

2.3 Preparation and Administration Instructions for GERD Associated with a History of EE

15-Minute Intravenous Infusion for Pediatric or Adult Patients

1. Reconstitute each vial of PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection.

2. Dilute the resulting solution to a final concentration as described below:

•
Pediatric patients 3 months to less than 1 year of age: Dilute with 21 mL 0.9% Sodium Chloride Injection to a final concentration of approximately 1.3 mg/mL.
•
Pediatric patients 1 year to 17 years old and adult patients: Further dilute with 100 mL 5% Dextrose Injection or 0.9% Sodium Chloride Injection to a final concentration of approximately 0.4 mg/mL.

3. Inspect the diluted PROTONIX I.V. solution visually for particulate matter and discoloration prior to and during administration.

4. Withdraw the desired dose of the diluted PROTONIX I.V. solution for a pediatric or adult dose.

5. Discard any unused portion of the remaining PROTONIX I.V. solution.

6. Infuse intravenously over a period of approximately 15 minutes through a dedicated line or through a Y-site [see Dosage and Administration (2.5)].

7. Flush the intravenous line before and after administration of PROTONIX I.V. with either 5% Dextrose Injection or 0.9% Sodium Chloride Injection.

Storage

•
Store the reconstituted solution may be stored for up to 24 hours at room temperature up to 30°C (86°F) prior to intravenous infusion.
•
Do not freeze the reconstituted solution.

2-Minute Intravenous Injection for Adult Patients

1. Reconstitute each vial of PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection, to a final concentration of approximately 4 mg/mL.

2. Withdraw the dose of 40 mg of reconstituted PROTONIX I.V. solution.

3. Inspect the diluted PROTONIX I.V. solution visually for particulate matter and discoloration prior to and during administration.

4. Administer intravenously over a period of at least 2 minutes.

5. Flush the intravenous line before and after administration of PROTONIX I.V. with either 5% Dextrose Injection or 0.9% Sodium Chloride Injection.

Storage

•
Store the reconstituted solution may be up to 6 hours at room temperature up to 30°C (86°F) prior to further dilution.
•
Store the diluted solution at room temperature up to 30°C (86°F) and must be used within 24 hours from the time of initial reconstitution.
•
Do not freeze the reconstituted or diluted solution.

2.4 Preparation and Administration Instructions for Pathological Hypersecretion Including Zollinger-Ellison Syndrome

     

15-Minute Intravenous Infusion

1. Reconstitute each vial of PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection.

2. Combine the contents of the two vials and dilute with 80 mL of 5% Dextrose Injection or Sodium Chloride Injection to a total volume of 100 mL with a final concentration of approximately 0.8 mg/mL.

3. Inspect the diluted PROTONIX I.V. solution visually for particulate matter and discoloration prior to and during administration.

4. Administer intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.

5. Flush the intravenous line before and after administration of PROTONIX I.V. with either 5% Dextrose Injection or 0.9% Sodium Chloride Injection.

Storage

•
The reconstituted solution can be stored at room temperature up to 30°C (86°F) for up to 6 hours prior to further dilution.
•
Once further diluted, the diluted solution can be stored at room temperature up to 30°C (86°F) for up to 24 hours from the time of initial reconstitution.
•
Do not freeze the reconstituted or diluted solution.

2-Minute Intravenous Injection

1. Reconstitute each vial of PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection, per vial to a final concentration of approximately 4 mg/mL.

2. Inspect the diluted PROTONIX I.V. solution visually for particulate matter and discoloration prior to and during administration.

3. Administer the total volume from both vials intravenously over a period of at least 2 minutes.

4. Flush the intravenous line before and after administration of PROTONIX I.V. with either 5% Dextrose Injection or 0.9% Sodium Chloride Injection.

Storage

•
The reconstituted solution may be stored for up to 24 hours at room temperature.
•
Do not freeze the reconstituted solution.

2.5 Compatibility Information

•
Administer PROTONIX I.V. intravenously through a dedicated line or through a Y-site.
•
When administering through a Y-site, PROTONIX I.V. is compatible with the following solutions:
o
5% Dextrose Injection
o
0.9% Sodium Chloride Injection
•
Midazolam hydrochloride is incompatible with Y-site administration of PROTONIX I.V.
•
PROTONIX I.V. may not be compatible with products containing zinc [see Warnings and Precautions (5.3)].
•
Stop administering PROTONIX I.V. immediately through a Y-site if precipitation or discoloration occurs.
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