PROTONIX® IV Dosage and Administration

(pantoprazole sodium for injection)

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis

The recommended adult dosage of PROTONIX I.V. is 40 mg given once daily by intravenous infusion for 7 to 10 days.

Discontinue treatment with PROTONIX I.V. as soon as the patient is able to receive treatment with PROTONIX Delayed-Release Tablets or Oral Suspension.

Data on the safe and effective dosing for conditions other than those described [see Indications and Usage (1)] such as life-threatening upper gastrointestinal bleeds, are not available. PROTONIX I.V. 40 mg once daily does not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions.

2.2 Preparation and Administration Instructions for Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis

Only for intravenous infusion; other parenteral routes of administration are not recommended.

Fifteen Minute Infusion

1.
Reconstitute PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection, USP.
2.
Further dilute with 100 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a final concentration of approximately 0.4 mg/mL.
3.
Inspect the diluted PROTONIX I.V. solution visually for particular 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.

Storage

The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The admixed solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the admixed solution do not need to be protected from light.

Do not freeze the reconstituted solution.

Two Minute Infusion

1.
Reconstitute PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection, USP, to a final concentration of approximately 4 mg/mL.
2.
Inspect the diluted PROTONIX I.V. solution visually for particular matter and discoloration prior to and during administration.
3.
Administer intravenously over a period of at least 2 minutes.

Storage

The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light.

Do not freeze the reconstituted solution.

2.3 Dosage for Pathological Hypersecretion Including Zollinger-Ellison Syndrome

The recommended adult dosage of PROTONIX I.V. is 80 mg intravenously every 12 hours. The frequency of dosing can be adjusted 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. Daily doses higher than 240 mg or administered for more than 6 days have not been studied [see Clinical Studies (14)]. Transition from oral to intravenous and from intravenous to oral formulations of gastric acid inhibitors should be performed in such a manner to ensure continuity of effect of suppression of acid secretion. Patients with ZE Syndrome may be vulnerable to serious clinical complications of increased acid production even after a short period of loss of effective inhibition.

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

Only for intravenous infusion; other parenteral routes of administration are not recommended.

Fifteen Minute Infusion

1.
Reconstitute each vial of PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection, USP.
2.
Combine the contents of the two vials and further dilute with 80 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, 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 particular 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.

Storage

The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The admixed solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the admixed solution do not need to be protected from light.

Do not freeze the reconstituted solution.

Two Minute Infusion

1.
Reconstitute PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg/mL.
2.
Inspect the diluted PROTONIX I.V. solution visually for particular 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.

Storage

The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light.

Do not freeze the reconstituted solution.

2.5 Compatibility Information

•
Administer PROTONIX I.V. intravenously through a dedicated line or through a Y-site.
•
Flush the intravenous line before and after administration of PROTONIX I.V. with either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP.
•
When administered through a Y-site, PROTONIX I.V. is compatible with the following solutions: 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP.
•
Midazolam HCl has been shown to be 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)].
•
When PROTONIX I.V. is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis

The recommended adult dosage of PROTONIX I.V. is 40 mg given once daily by intravenous infusion for 7 to 10 days.

Discontinue treatment with PROTONIX I.V. as soon as the patient is able to receive treatment with PROTONIX Delayed-Release Tablets or Oral Suspension.

Data on the safe and effective dosing for conditions other than those described [see Indications and Usage (1)] such as life-threatening upper gastrointestinal bleeds, are not available. PROTONIX I.V. 40 mg once daily does not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions.

2.2 Preparation and Administration Instructions for Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis

Only for intravenous infusion; other parenteral routes of administration are not recommended.

Fifteen Minute Infusion

1.
Reconstitute PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection, USP.
2.
Further dilute with 100 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a final concentration of approximately 0.4 mg/mL.
3.
Inspect the diluted PROTONIX I.V. solution visually for particular 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.

Storage

The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The admixed solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the admixed solution do not need to be protected from light.

Do not freeze the reconstituted solution.

Two Minute Infusion

1.
Reconstitute PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection, USP, to a final concentration of approximately 4 mg/mL.
2.
Inspect the diluted PROTONIX I.V. solution visually for particular matter and discoloration prior to and during administration.
3.
Administer intravenously over a period of at least 2 minutes.

Storage

The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light.

Do not freeze the reconstituted solution.

2.3 Dosage for Pathological Hypersecretion Including Zollinger-Ellison Syndrome

The recommended adult dosage of PROTONIX I.V. is 80 mg intravenously every 12 hours. The frequency of dosing can be adjusted 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. Daily doses higher than 240 mg or administered for more than 6 days have not been studied [see Clinical Studies (14)]. Transition from oral to intravenous and from intravenous to oral formulations of gastric acid inhibitors should be performed in such a manner to ensure continuity of effect of suppression of acid secretion. Patients with ZE Syndrome may be vulnerable to serious clinical complications of increased acid production even after a short period of loss of effective inhibition.

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

Only for intravenous infusion; other parenteral routes of administration are not recommended.

Fifteen Minute Infusion

1.
Reconstitute each vial of PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection, USP.
2.
Combine the contents of the two vials and further dilute with 80 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, 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 particular 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.

Storage

The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The admixed solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the admixed solution do not need to be protected from light.

Do not freeze the reconstituted solution.

Two Minute Infusion

1.
Reconstitute PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg/mL.
2.
Inspect the diluted PROTONIX I.V. solution visually for particular 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.

Storage

The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light.

Do not freeze the reconstituted solution.

2.5 Compatibility Information

•
Administer PROTONIX I.V. intravenously through a dedicated line or through a Y-site.
•
Flush the intravenous line before and after administration of PROTONIX I.V. with either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP.
•
When administered through a Y-site, PROTONIX I.V. is compatible with the following solutions: 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP.
•
Midazolam HCl has been shown to be 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)].
•
When PROTONIX I.V. is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.
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