Protonix I.V. 40 mg/10mL
pantoprazole sodium · INJECTION, POWDER, FOR SOLUTION · Cardinal Health 107, LLC
Protonix I.V. is a proton pump inhibitor injection used to reduce stomach acid in patients who cannot take medication by mouth, often for conditions like gastroesophageal reflux disease or peptic ulcers. It is administered intravenously by a healthcare provider.
Key Facts
- Brand Name
- Protonix I.V.
- Generic Name
- pantoprazole sodium
- NDC Code (Product)
55154-4225- Manufacturer
- Cardinal Health 107, LLC
- Strength
- 40 mg/10mL
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA020988
- Marketing Start
- 05/01/2001
Recall History
Pfizer Inc.
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE PROTONIX I.V. is 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. • pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. 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. 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 & Administration
2 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 …
Contraindications
4 CONTRAINDICATIONS • PROTONIX I.V. 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) and Adverse Reactions (6) ] . • Proton pump inhibitors (PPIs), including PROTONIX I.V., are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7) ] . • Known hypersensitivity to any component of the formulation or to substituted benzimidazoles. ( 4 ) • Patients receiving rilpivirine-containing products. ( 4 , 7 )
Drug Interactions
7 DRUG INTERACTIONS Table 3 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PROTONIX I.V. and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 3: Clinically Relevant Interactions Affecting Drugs Co-Administered with PROTONIX I.V. and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with pantoprazole may reduce antiviral effect and promote the development of drug resistance. • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with pantoprazole may increase toxicity of the antiretroviral drugs . • There are other antiretroviral drugs which do not result in clinically relevant interactions with pantoprazole. Intervention: Rilpivirine-containing products: Concomitant use with PRO…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: • Injection Site Reactions [see Warnings and Precautions (5.2) ] • Potential for Exacerbation of Zinc Deficiency [see Warnings and Precautions (5.3) ] • Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.4) ] • Clostridioides difficile- Associated Diarrhea [see Warnings and Precautions (5.5) ] • Bone Fracture [see Warnings and Precautions (5.6) ] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.7) ] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.8) ] • Hepatic Effects [see Warnings and Precautions (5.9) ] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.10) ] • Fundic Gland Polyps [see Warnings and Precautions (5.11) ] 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 . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, …
Frequently Asked Questions
What is Protonix I.V. used for?
Protonix I.V. is a proton pump inhibitor injection used to reduce stomach acid in patients who cannot take medication by mouth, often for conditions like gastroesophageal reflux disease or peptic ulcers. It is administered intravenously by a healthcare provider.
Is Protonix I.V. a controlled substance?
Protonix I.V. is not classified as a controlled substance by the DEA.
What is the generic name for Protonix I.V.?
The generic name for Protonix I.V. is pantoprazole sodium. There are 12 other brand versions of pantoprazole sodium.
What is the NDC code for Protonix I.V. 40 mg/10mL?
The NDC (National Drug Code) for Protonix I.V. 40 mg/10mL is 55154-4225, listed by Cardinal Health 107, LLC.
Other Pantoprazole Brands
See all →- Pantoprazole Sodium40 mg/176420-806
- Pantoprazole Sodium DR20 mg/180425-0278
- Pantoprazole Sodium40 mg/10143-9284
- Pantoprazole Sodium40 mg/155154-4382
- Pantoprazole sodium40 mg/10mL70095-024
- Pantoprazole sodium delayed-release20 mg/170756-018
- Pantoprazole Sodium40 mg/10mL73043-020
- Pantoprazole Sodium20 mg/176420-805
- Pantoprazole Sodium DR40 mg/180425-0162
- Pantoprazole sodium40 mg/127241-256
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)