Pantoprazole intravenous
Other products: Pantoprazole
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Dosing in kidney impairment
Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia).
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Preparation and administration
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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 ] . 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.
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.
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 ].
Stop administering PROTONIX I.V. immediately through a Y-site if precipitation or discoloration occurs.
Drug interactions
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- Pantoprazole intravenous
Label text (8 paragraphs)
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 PROTONIX I.V. is contraindicated [see Contraindications (4) ] . See prescribing information.
Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with PROTONIX I.V. See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir and monitor for potential saquinavir toxicities. Other antiretrovirals: See prescribing information. Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range.
See prescribing information for warfarin. Clopidogrel Clinical Impact: Concomitant administration of pantoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition [see Clinical Pharmacology (12.3) ]. Intervention: No dose adjustment of clopidogrel is necessary when administered with an approved dose of PROTONIX I.V. Methotrexate Clinical Impact: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities.
No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warnings and Precautions (5.14) ] . Intervention: A temporary withdrawal of PROTONIX I.V. may be considered in some patients receiving high-dose methotrexate. Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
Intervention: Mycophenolate mofetil (MMF): Co-administration of pantoprazole sodium in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH [see Clinical Pharmacology (12.3) ] . The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving PROTONIX I.V. and MMF. Use PROTONIX I.V. with caution in transplant patients receiving MMF. See the prescribing information for other drugs dependent on gastric pH for absorption.
Interactions with Investigations of Neuroendocrine Tumors Clinical Impact: CgA levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors [see Warnings and Precautions (5.12) and Clinical Pharmacology (12.2) ] . Intervention: Temporarily stop PROTONIX I.V. treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.
False Positive Urine Tests for THC Clinical Impact: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs [see Warnings and Precautions (5.13) ] . Intervention: An alternative confirmatory method should be considered to verify positive results. See the full prescribing information for a list of clinically important drug interactions. ( 7 )
Supplement interactions
Dietary supplement interactions
3 noted- Gastric acid inhibitors include proton pump inhibitors, such as omeprazole (Prilosec) and lansoprazole (Prevacid), and histamine 2-receptor antagonists, such as cimetidine (Tagamet) and ranitidine (Zantac). They can interfere with vitamin B12 absorption from food by slowing the release of gastric acid into the stomach and thereby lead to vitamin B12 deficiency.
- Prescription proton pump inhibitor (PPI) drugs, such as esomeprazole magnesium (Nexium) and lansoprazole (Prevacid), can cause hypomagnesemia when taken for prolonged periods (typically more than a year). In the cases that FDA reviewed, magnesium supplements often raised the low serum magnesium levels caused by PPIs.
- Gastric acid plays an important role in the absorption of nonheme iron from the diet. Because proton pump inhibitors, such as lansoprazole (Prevacid) and omeprazole (Prilosec), reduce the acidity of stomach contents, they can reduce iron absorption.
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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
CLikelihood score C: Probable rare cause of clinically apparent liver injury.
Pantoprazole is a proton pump inhibitor (PPI) and a potent inhibitor of gastric acidity which is widely used in the therapy of gastroesophageal reflux and peptic ulcer disease. Pantoprazole therapy is associated with a low rate of transient and asymptomatic serum aminotransferase elevations and is a rare cause of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole sodium. Reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose) with administration of pantoprazole during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to pantoprazole in this study (see Data ) .
A pre-and post-natal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. Oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. Changes in bone morphology were observed in pups exposed to pantoprazole in utero and through milk during the period of lactation as well as by oral dosing from postnatal day (PND) 4 through PND 21 [see Use in Specific Populations (8.4) ] . There were no drug-related findings in maternal animals .
Advise pregnant women of the potential risk of fetal harm. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and pantoprazole use.
Methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. In a prospective study by the European Network of Teratology Information Services, outcomes from a group of 53 pregnant women administered median daily doses of 40 mg pantoprazole were compared to a control group of 868 pregnant women who did not take any proton pump inhibitors (PPIs). There was no difference in the rate of major malformations between women exposed to PPIs and the control group, corresponding to a Relative Risk (RR)=0.55, [95% Confidence Interval (CI) 0.08–3.95].…
Breastfeeding (LactMed)
Maternal pantoprazole doses of 40 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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