PROTONIX® IV Highlights

(pantoprazole sodium for injection)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PROTONIX I.V. safely and effectively. See full prescribing information for PROTONIX I.V.

PROTONIX I.V. (pantoprazole sodium) for injection, for intravenous use
Initial U.S. approval: 2000

RECENT MAJOR CHANGES

Indications and Usage (1)

8/2024

Dosage and Administration (2.1, 2.3)

8/2024

Warnings and Precautions (5.2, 5.5)

8/2024

INDICATIONS AND USAGE

PROTONIX I.V. is a proton pump inhibitor (PPI) indicated for treatment of:

•
gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric patients 3 months and older. (1)
•
pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. (1)

Limitations of Use

The safety and effectiveness of PROTONIX I.V. for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. (1)

DOSAGE AND ADMINISTRATION

GERD and a History of EE

Adults:

•
The recommended dosage is 40 mg once daily by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes) for up to 10 days. (2.1)
•
Discontinue as soon as the patient is able to receive oral treatment. Switch to an appropriate oral medication within 10 days of starting PROTONIX I.V. (2.1)

Pediatrics 3 Months of Age and Older:

•
The recommended dosage for pediatric patients 3 months of age and older is based on age and actual body weight as shown in the table. (2.1)
•
Administer as an intravenous infusion over 15 minutes once daily. (2.1)

Age and Body Weight

Recommended 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. (2.1)

Pathological Hypersecretion Conditions, Including ZE Syndrome

•
The recommended adult dosage is 80 mg every 12 hours by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes). (2.2)
•
For information on how to adjust dosing for individual patient needs, see the full prescribing information. (2.2)
•
When switching between intravenous to oral formulations of gastric acid inhibitors, consider the pharmacodynamic action of the drugs to ensure continuity of acid suppression. (2.2)

Preparation and Administration Instructions

•
See full prescribing information for preparation and administration instructions by indication. (2.3, 2.4)

DOSAGE FORMS AND STRENGTHS

For Injection: 40 mg pantoprazole freeze-dried powder in a single-dose vial for reconstitution or dilution. (3)

CONTRAINDICATIONS

•
Known hypersensitivity to any component of the formulation or to substituted benzimidazoles. (4)
•
Patients receiving rilpivirine-containing products. (4, 7)

WARNINGS AND PRECAUTIONS

•
Gastric Malignancy: In adults, symptomatic response to therapy with PROTONIX I.V. does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1)
•
Injection Site Reactions: Thrombophlebitis is associated with the administration of PROTONIX I.V. Assess the patient and remove the catheter if clinically indicated. (5.2)
•
Potential Exacerbation of Zinc Deficiency: Consider zinc supplementation in patients who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously. (5.3)
•
Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. (5.4)
•
Clostridioides difficile-Associated Diarrhea: PPI therapy may be associated with increased risk. (5.5)
•
Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. (5.6)
•
Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. (5.7)
•
Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue treatment and refer to specialist for evaluation. (5.8)
•
Hepatic Effects: Elevations of transaminases observed. (5.9)
•
Hypomagnesemia and Mineral Metabolism: Reported rarely with prolonged treatment with PPIs. (5.10)
•
Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. (5.11)

ADVERSE REACTIONS

Most common adverse reactions (> 2%) are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

See the full prescribing information for a list of clinically important drug interactions. (7)

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, may cause fetal harm. (8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2024

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PROTONIX I.V. safely and effectively. See full prescribing information for PROTONIX I.V.

PROTONIX I.V. (pantoprazole sodium) for injection, for intravenous use
Initial U.S. approval: 2000

RECENT MAJOR CHANGES

Indications and Usage (1)

8/2024

Dosage and Administration (2.1, 2.3)

8/2024

Warnings and Precautions (5.2, 5.5)

8/2024

INDICATIONS AND USAGE

PROTONIX I.V. is a proton pump inhibitor (PPI) indicated for treatment of:

•
gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric patients 3 months and older. (1)
•
pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. (1)

Limitations of Use

The safety and effectiveness of PROTONIX I.V. for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. (1)

DOSAGE AND ADMINISTRATION

GERD and a History of EE

Adults:

•
The recommended dosage is 40 mg once daily by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes) for up to 10 days. (2.1)
•
Discontinue as soon as the patient is able to receive oral treatment. Switch to an appropriate oral medication within 10 days of starting PROTONIX I.V. (2.1)

Pediatrics 3 Months of Age and Older:

•
The recommended dosage for pediatric patients 3 months of age and older is based on age and actual body weight as shown in the table. (2.1)
•
Administer as an intravenous infusion over 15 minutes once daily. (2.1)

Age and Body Weight

Recommended 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. (2.1)

Pathological Hypersecretion Conditions, Including ZE Syndrome

•
The recommended adult dosage is 80 mg every 12 hours by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes). (2.2)
•
For information on how to adjust dosing for individual patient needs, see the full prescribing information. (2.2)
•
When switching between intravenous to oral formulations of gastric acid inhibitors, consider the pharmacodynamic action of the drugs to ensure continuity of acid suppression. (2.2)

Preparation and Administration Instructions

•
See full prescribing information for preparation and administration instructions by indication. (2.3, 2.4)

DOSAGE FORMS AND STRENGTHS

For Injection: 40 mg pantoprazole freeze-dried powder in a single-dose vial for reconstitution or dilution. (3)

CONTRAINDICATIONS

•
Known hypersensitivity to any component of the formulation or to substituted benzimidazoles. (4)
•
Patients receiving rilpivirine-containing products. (4, 7)

WARNINGS AND PRECAUTIONS

•
Gastric Malignancy: In adults, symptomatic response to therapy with PROTONIX I.V. does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1)
•
Injection Site Reactions: Thrombophlebitis is associated with the administration of PROTONIX I.V. Assess the patient and remove the catheter if clinically indicated. (5.2)
•
Potential Exacerbation of Zinc Deficiency: Consider zinc supplementation in patients who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously. (5.3)
•
Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. (5.4)
•
Clostridioides difficile-Associated Diarrhea: PPI therapy may be associated with increased risk. (5.5)
•
Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. (5.6)
•
Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. (5.7)
•
Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue treatment and refer to specialist for evaluation. (5.8)
•
Hepatic Effects: Elevations of transaminases observed. (5.9)
•
Hypomagnesemia and Mineral Metabolism: Reported rarely with prolonged treatment with PPIs. (5.10)
•
Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. (5.11)

ADVERSE REACTIONS

Most common adverse reactions (> 2%) are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

See the full prescribing information for a list of clinically important drug interactions. (7)

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, may cause fetal harm. (8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2024
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