Protonix Iv

— THERAPEUTIC CATEGORIES —
  • Hyperacidity, GERD, and ulcers
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Protonix Iv Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Pantoprazole (as sodium) 40mg; per vial; pwd for IV infusion after reconstitution and dilution; contains edetate disodium.

    Pharmacological Class

    Proton pump inhibitor.

    See Also

    How Supplied

    Tabs—90; Susp—30 packets; Vials—1, 10, 25

    How Supplied

    Protonix IV

    • Supplied in a single-dose vial as a white to off-white freeze-dried powder for reconstitution containing 40 mg of pantoprazole.  

    • Available as 40mg/vial in the following package sizes: single vial; 10- and 25-count vials.

    Storage

    • Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light.

    • 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.

    Manufacturer

    Pfizer Inc.

    Generic Availability

    YES

    Mechanism of Action

    Pantoprazole suppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell.

    Protonix Iv Indications

    Indications

    Short-term treatment (7–10 days) of GERD associated with a history of erosive esophagitis. Pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome).

    Protonix Iv Dosage and Administration

    Adult

    Give by IV infusion over 2mins or 15mins (see full labeling). ≥18yrs: GERD: 40mg once daily for 7–10 days; switch to tabs or oral suspension as soon as possible. Hypersecretory conditions: 80mg every 8–12hrs; usual max 240mg/day or 6 days' treatment.

    Children

    <18yrs: not established.

    Administration

    Give by IV infusion. Admixed solution: give IV over 15 minutes at a rate of 7mL/min. Reconstituted solution: give IV over a period of at least 2 minutes.

    Nursing Considerations

    Give by IV infusion. Admixed solution: give IV over 15 minutes at a rate of 7mL/min. Reconstituted solution: give IV over a period of at least 2 minutes.

    Protonix Iv Contraindications

    Contraindications

    Concomitant rilpivirine-containing products.

    Protonix Iv Boxed Warnings

    Not Applicable

    Protonix Iv Warnings/Precautions

    Warnings/Precautions

    Symptomatic response does not preclude gastric malignancy. Discontinue and evaluate if acute tubulointerstitial nephritis, severe cutaneous adverse reactions, or cutaneous/systemic lupus erythematosus occurs. Long-term therapy (eg, >3yrs) may lead to malabsorption/deficiency of Vit. B12. Monitor magnesium levels during prolonged therapy. Consider monitoring magnesium, calcium levels in those with preexisting risk of hypocalcemia (eg, hypoparathyroidism). Increased risk of fundic gland polyps with long-term use (esp. >1yr) or osteoporosis-related fractures (hip, wrist or spine) with long-term (>1yr) and multiple daily dose PPI therapy. Use lowest dose for shortest duration appropriate to condition. Reevaluate periodically. IV: consider zinc supplementation in those prone to zinc deficiency. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Presence of Gastric Malignancy

    • Symptomatic response does not preclude gastric malignancy. Consider additional follow-up and diagnostic testing in adults with suboptimal response or an early symptomatic relapse after completing treatment.

    • Consider endoscopy in older patients.

    Injection Site Reactions

    • Thrombophlebitis was associated with administration.

    Potential for Exacerbation of Zinc Deficiency

    • Protonix IV contains edetate disodium, a chelator of metal irons including zinc.

    • Consider zinc supplementation in patients who are prone to zinc deficiency.

    • Use caution when other EDTA containing products are coadministered intravenously.

    Acute Tubulointerstitial Nephritis

    • Acute tubulointerstitial nephritis (TIN) may occur at any point during PPI therapy.

    • Signs and symptoms may vary from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function.

    • Discontinue and evaluate patients with suspected acute TIN.

    Clostridium difficile-Associated Diarrhea 

    • Protonix may be associated with a greater risk of Clostridium difficile associated diarrhea, especially in hospitalized patients.

    • Consider diagnosis of Clostridium difficile for diarrhea does not improve.

    • Use the lowest dose of Protonix and for the shortest duration of PPI therapy appropriate to the condition.

    Bone Fracture

    • PPI therapy may be associated with a greater risk of osteoporosis-related fractures of the hip, wrist, or spine.

    • Higher risk in patients who receive high-dose (multiply daily doses) and long-term PPI therapy (1 year or longer).

    • Use the lowest dose of Protonix and for the shortest duration of PPI therapy appropriate to the condition.

    Severe Cutaneous Adverse Reactions

    • PPI therapy have been associated with severe cutaneous adverse reactions (SCARs), including erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).

    • Discontinue at the first sign or symptoms of SCARs or other signs of hypersensitivity and consider further evaluation.

    Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)

    • Cutaneous and systemic lupus erythematosus have been reported with PPI therapy; a majority of cases were CLE.

    • The most common form of CLE was subacute.

    • Avoid administering PPI therapy for longer than medically indicated.

    • Discontinue Protonix and refer to a specialist for evaluation if signs or symptoms consistent with CLE or SLE are observed. Most patients improved after discontinuing PPI in 4 to 12 weeks.

    Hepatic Effects

    • Mild transient transaminase elevations may occur, but the clinical significance of this finding is unknown.

    Hypomagnesemia and Mineral Metabolism

    • Consider monitoring magnesium levels prior to initiation and periodically during treatment in patients expected to be on prolonged treatment, in patients who take concomitant medications (eg, digoxin) that may cause hypomagnesemia, and in patients with a preexisting risk of hypocalcemia (eg, hypoparathyroidism). 

    • Patients with preexisting risk of hypocalcemia will need magnesium and/or calcium supplementation. Consider discontinuing PPI therapy if hypocalcemia is refractory to treatment.

    Fundic Gland Polyps 

    • Increased risk of fundic gland polyps which increases with long-term use (especially beyond 1 year).

    • Patients were mostly asymptomatic and the fundic gland polyps were identified incidentally on endoscopy.

    • Use the shortest duration of PPI therapy.

    Interference with Investigations for Neuroendocrine Tumors 

    • Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity.

    • May cause false (+) results in diagnostic investigations for neuroendocrine tumors. 

    • Temporarily discontinue Protonix at least 14 days prior to CgA level assessment and consider repeating the test if initial CgA levels are high.

    Interference with Urine Screen for THC 

    • May cause false (+) urine THC test.

    Concomitant Use of Protonix with Methotrexate 

    • Concomitant use of PPI with high-dose methotrexate may potentiate serum levels of methotrexate and/or its metabolites and lead to toxicities.

    • Consider temporarily withdrawing the PPI therapy in patients receiving high-dose methotrexate.

    Pregnancy Considerations

    Risk Summary

    • Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole.

    Nursing Mother Considerations

    Risk Summary

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Protonix and any potential adverse effects on the breastfed child or from the underlying maternal condition.

    Pediatric Considerations

    • The safety and effectiveness of Protonix IV have not been established in pediatric patients. 

    Geriatric Considerations

    • The incidence rates of adverse reactions and laboratory abnormalities in patients aged 65 years and older were similar to those associated with patients younger than 65 years of age.

    Protonix Iv Pharmacokinetics

    Absorption

    • In CYP2C19 extensive metabolizers with normal liver function receiving a 40 mg dose of Protonix IV by constant rate over 15 minutes, the peak concentration (Cmax) is 5.52 ±1.42 mcg/mL and the total area under the plasma concentration versus time curve (AUC) is 5.4 ±1.5 mcg hr/mL.

    Distribution

    • Apparent volume of distribution is approximately 11 to 23.6 L, mainly distributed in extracellular fluid.

    • ~98% serum protein bound, primarily to albumin.

    Metabolism

    • Extensively metabolized in the liver via CYP system.

    • Main metabolic pathway is demethylation by CYP2C19 with subsequent sulfation. Other metabolic pathways include oxidation by CYP3A4.

    Elimination

    • Renal (71%), fecal (18%).

    • Total clearance is 7.6 to 14 L/h. 

    • Following the administration of Protonix IV, the serum concentration of pantoprazole declines biexponentially with a terminal elimination half-life of approximately 1 hour.

    Protonix Iv Interactions

    Interactions

    See Contraindications. May antagonize atazanavir, nelfinavir (avoid). May potentiate saquinavir, methotrexate (at high doses, consider temporary withdrawal of the PPI); monitor. May alter absorption of gastric pH-dependent drugs (eg, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole). Caution with digoxin or drugs that may cause hypomagnesemia (eg, diuretics); monitor. Monitor warfarin. May cause false (+) results in diagnostic investigations for neuroendocrine tumors; discontinue pantoprazole 14 days prior to CgA level assessment. May cause false (+) urine THC test. IV: caution with concomitant other EDTA-containing products.

    Protonix Iv Adverse Reactions

    Adverse Reactions

    Headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, arthralgia; possible C. difficile-associated diarrhea, inj site reactions (IV); rare: hypomagnesemia and mineral metabolism. Also children: URI, fever, rash.

    Protonix Iv Clinical Trials

    Clinical Trials

    Gastroesophageal Reflux Disease (GERD) Associated with a History of Erosive Esophagitis

    Multicenter, double-blind, two-period placebo-controlled study

    • The study evaluated the ability of Protonix IV to maintain gastric acid suppression in patients switched from Protonix Delayed-Release Tablets to Protonix IV.

    • GERD patients with a history of EE were randomly assigned to receive either oral pantoprazole 20 mg or 40 mg once daily for 10 days (period 1), then were switched in period 2 to either daily Protonix IV or placebo for 7 days.

    • Maximum acid output (MAO) and basal acid output (BAO) were evaluated 24 hours following the last day of oral medication, the first day of IV administration and the last day of IV administration (day 7).

    • Results showed that the oral and IV dosage forms were similar in their ability to suppress MAO and BAO in patients with GERD and a history of EE.

    Protonix IV as an initial treatment to suppress gastric acid secretion – Study 1

    • The study evaluated the pharmacodynamic effects of Protonix IV and Protonix Delayed-Release Tablets in patients with GERD and a history of EE.

    • Patients were randomly assigned to receive either Protonix 40 mg IV, Protonix Delayed-Release Tablets 40 mg, or placebo once daily for 7 days. MAO and BAO were evaluated 24 hours after the last day of study medication.

    • Patients treated with Protonix IV had significantly lower MAO and BAO vs placebo (P <.001), and were comparable to those patients who received Protonix Delayed-Release Tablets.

    Protonix IV as an initial treatment to suppress gastric acid secretion – Study 2

    • The study evaluated the clinical effects of Protonix IV and Protonix Delayed-Release Tablets. 

    • Patients with acute endoscopically proven reflux esophagitis with at least 1 of 3 symptoms typical for reflux esophagitis (acid eructation, heartburn, or pain on swallowing) were randomized to receive either Protonix IV 40 mg or Protonix Delayed-Release Tablets 40 mg once daily for 5 days.

    • There was no significant difference in symptom relief between IV and tablet formulations within the first 5 days. 

     

    Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome 

    • 2 studies evaluated the pharmacodynamic effects of 6 day treatment with Protonix IV in patients with ZE Syndrome.

    • In one study, an initial treatment with Protonix IV reduced acid output to the target level of 10 mEq/h or less and significantly reduced H+ concentration and the volume of gastric secretions.

    • In the other study, patients who switched from oral PPI to Protonix IV had maintained or improved control of gastric acid secretion.

    • Both studies showed that Protonix IV maintained basal acid secretion below target levels in all patients. Once gastric acid secretion was controlled, there was no evidence of tolerance. Basal acid secretion was maintained below target levels for at least 24 hours in all patients and through the end of treatment.

    Protonix Iv Note

    Not Applicable

    Protonix Iv Patient Counseling

    Patient Counseling

    Adverse Reactions 

    • Report any signs or symptoms consistent with: injection site reactions, potential for exacerbation of zinc deficiency, acute tubulointerstitial nephritis, C.diff-associated diarrhea, bone fracture, severe cutaneous adverse reactions, CLE and SLE, hepatic effects, hypomagnesemia and mineral metabolism.

    Drug Interactions 

    • Inform healthcare provider of any other medications if you are currently taking, including rilpivirine-containing products, digoxin and high dose methotrexate. 

    Pregnancy 

    • Advise a pregnant woman of the potential risk to a fetus. Inform healthcare provider of a known or suspected pregnancy.

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