Pantoprazole Sodium (Northstar Rx LLC): FDA Package Insert (2024)

PANTOPRAZOLE SODIUM- pantoprazole sodium injection, powder, for solution
Northstar Rx LLC

1 INDICATIONS AND USAGE

1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis

Pantoprazole Sodium for Injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE).

Safety and efficacy of Pantoprazole Sodium for Injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated.

1.2 Pathological Hypersecretion Including Zollinger-Ellison Syndrome

Pantoprazole Sodium for Injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.

2 DOSAGE AND ADMINISTRATION

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

The recommended adult dosage of pantoprazole sodium for injection is 40 mg given once daily by intravenous infusion for 7 to 10 days.

Discontinue treatment with pantoprazole sodium for injection as soon as the patient is able to receive treatment with pantoprazole sodium 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. Pantoprazole sodium for injection 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 pantoprazole sodium for injection 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 per mL.
3. Inspect the diluted pantoprazole sodium for injection 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 pantoprazole sodium for injection with 10 mL of 0.9% Sodium Chloride Injection, USP, to a final concentration of approximately 4 mg per mL.
2. Inspect the diluted pantoprazole sodium for injection 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 pantoprazole sodium for injection 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 pantoprazole sodium for injection 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 per mL.
3. Inspect the diluted pantoprazole sodium for injection 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 pantoprazole sodium for injection with 10 mL of 0.9% Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg per mL.
2. Inspect the diluted pantoprazole sodium for injection 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 pantoprazole sodium for injection intravenously through a dedicated line or through a Y-site.
• Flush the intravenous line before and after administration of pantoprazole sodium for injection with either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer’s Injection, USP.
• When administered through a Y-site, pantoprazole sodium for injection 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 pantoprazole sodium for injection
• Pantoprazole sodium for injection may not be compatible with products containing zinc [see Warnings and Precautions (5.3)].
• When pantoprazole sodium for injection is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.

3 DOSAGE FORMS AND STRENGTHS

For Injection: 40 mg of pantoprazole white to off-white freeze-dried powder in a single-dose vial for reconstitution.

4 CONTRAINDICATIONS

• Pantoprazole sodium is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2, 5.4), Adverse Reactions (6)].
• Proton pump inhibitors (PPIs), including pantoprazole sodium, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)].

5 WARNINGS AND PRECAUTIONS

5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with pantoprazole sodium does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.