Pantoprazole (Lexi-Drugs)

Drug Shortages

One or more forms of this drug may be in short supply or unavailable. Refer to the following for additional information:

ASHP: http://www.ashp.org/menu/DrugShortages

Pronunciation

(pan TOE pra zole)

Brand Names: US

Protonix

Brand Names: Canada

Abbott-Pantoprazole [DSC]; ACT Pantoprazole [DSC]; AG-Pantoprazole; AG-Pantoprazole Sodium; APO-Pantoprazole; Auro-Pantoprazole; BIO-Pantoprazole; DOM-Pantoprazole; JAMP-Pantoprazole; M-Pantoprazole; Mar-Pantoprazole; MINT-Pantoprazole; MYLAN-Pantoprazole T; MYLAN-Pantoprazole [DSC]; NRA-Pantoprazole; Panto IV [DSC]; Pantoloc; Pantoprazole; Pantoprazole T; Pantoprazole-20; Pantoprazole-40; PMS-Pantoprazole; Priva-Pantoprazole; Q-Pantoprazole [DSC]; RAN-Pantoprazole; RATIO-Pantoprazole [DSC]; RIVA-Pantoprazole; SANDOZ Pantoprazole; Tecta; TEVA-Pantoprazole; TEVA-Pantoprazole Magnesium; VAN-Pantoprazole

Dosing: Adult

Dyspepsia (off-label use): Oral: 20 to 40 mg once daily for 4 weeks (Jung 2016, Pinto-Sanchez 2017, van Rensburg 2008)

Erosive esophagitis associated with GERD:

Oral:

Treatment: 40 mg once daily for up to 8 weeks; an additional 8 weeks may be used in patients who have not healed after an 8-week course. Lower doses (20 mg once daily) have been used successfully in mild GERD treatment (Dettmer 1998).

Maintenance of healing: 40 mg once daily; 20 mg once daily has been used successfully in maintenance of healing (Escourrou 1999). Note: Has not been studied beyond 12 months.

IV: 40 mg once daily for 7 to 10 days

Pathological hypersecretory conditions, including Zollinger-Ellison syndrome:

Oral: Initial: 40 mg twice daily; adjust dose based on patient needs; doses up to 240 mg daily have been administered

IV: 80 mg every 12 hours; adjust dose based on acid output measurements; 160 to 240 mg daily in divided doses has been used for a limited period (up to 7 days)

Prevention of rebleeding in peptic ulcer bleed (off-label use):

IV:

Continuous infusion: Loading dose of 80 mg, followed by 8 mg/hour infusion for 72 hours (Barkun 2010; Zargar 2006).

Intermittent dosing: Loading dose of 80 mg followed by either 40 mg every 12 hours for 72 hours (Hung 2007; Yamada 2012) or 40 mg every 6 hours for 72 hours (Hsu 2009). May also administer 40 mg every 12 hours for 72 hours without a loading dose (Yuksel 2008).

Note: After completion, continue therapy with a single daily-dose oral PPI for a duration dictated by the underlying etiology (Barkun 2010; Laine 2012).

Oral: 40 mg once daily for 2 to 4 weeks (treatment of duodenal ulcer) or 4 to 8 weeks (treatment of gastric ulcer) (Pantoloc Canadian product labeling)

Helicobacter pylori eradication (off-label use): Oral: American College of Gastroenterology guidelines (Chey 2007; Chey 2017):

Clarithromycin triple regimen: 40 to 80 mg twice daily in combination with clarithromycin 500 mg twice daily and either amoxicillin 1 g twice daily or metronidazole 500 mg 3 times per day; continue regimen for 14 days. Note: Avoid use of clarithromycin triple therapy in patients with risk factors for macrolide resistance (eg, prior macrolide exposure, local clarithromycin resistance rates ≥15%, eradication rates with clarithromycin-based regimens ≤85%) (ACG [Chey 2017]; Fallone 2016).

Bismuth quadruple regimen: 40 mg twice daily in combination with tetracycline 500 mg 4 times per day, metronidazole 250 mg 4 times per day or 500 mg 3 or 4 times per day, and either bismuth subcitrate 120 to 300 mg 4 times per day or bismuth subsalicylate 300 mg 4 times per day; continue regimen for 10 to 14 days.

Concomitant regimen: 40 mg twice daily in combination with amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and either metronidazole or tinidazole 500 mg twice daily; continue regimen for 10 to 14 days.

Sequential regimen: 40 mg twice daily plus amoxicillin 1 g twice daily for 5 to 7 days; then continue pantoprazole along with clarithromycin 500 mg twice daily, and either metronidazole or tinidazole 500 mg twice daily for 5 to 7 days.

Hybrid regimen: 40 mg twice daily plus amoxicillin 1 g twice daily for 7 days; then continue pantoprazole and amoxicillin along with clarithromycin 500 mg twice daily, and either metronidazole or tinidazole 500 mg twice daily for 7 days.

Levofloxacin triple regimen: 40 mg twice daily in combination with amoxicillin 1 g twice daily and levofloxacin 500 mg once daily; continue regimen for 10 to 14 days.

Prevention of NSAID-induced ulcers (off-label): Oral: 20 to 40 mg once daily (Bianchi Prollo 2000; Lanza 2009; Regula 2006)

Discontinuation of therapy: Oral: Some experts recommend a step-down approach in order to avoid worsening or rebound symptoms. One strategy is to decrease the dose by 50% over 2 to 4 weeks. If the patient is already on the lowest possible dose, alternate day therapy may be considered. If symptoms worsen during treatment or after discontinuation, patient should be re-evaluated (Kim 2018).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

No dosage adjustment necessary; pantoprazole is not removed by hemodialysis.

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary; doses >40 mg daily have not been evaluated.

Dosing: Pediatric

Note: Parenteral therapy should be discontinued as soon as the patient tolerates oral therapy.

GERD, symptomatic: Limited data available:

Infants and Children <5 years: Oral: 1.2 mg/kg/day once daily for 4 weeks was shown to reduce GERD symptoms but was not significantly different from placebo (n=128; age range: 1 to 11 months) (Winter 2010); a pharmacokinetic trial showed this dose produced similar serum concentrations as adults receiving 40 mg in infants 1 to 11 months (mean age: 6.3 months) and slightly lower concentrations in children 1 to <6 years (mean age: 3.2 years) (Tammara 2011)

Children 5 to 11 years: Oral: 20 or 40 mg once daily have been shown to reduce severity and frequency of symptoms within 1 week based on the GERD Assessment of Symptoms in Pediatric Patients Questionnaire (n=53, age range: 5 to 11 years); results also showed that while a lower dose of 10 mg improved symptoms, it took longer (3 weeks) for results (Tolia 2006); a pharmacokinetic trial in patients 6 to 11 years old (n=24) showed that 40 mg once daily produced similar systemic exposure as adults receiving 40 mg; however, the authors suggested that 20 mg once daily may be appropriate for small children (Ward 2011)

Children and Adolescents 12 to 16 years: Oral: 20 or 40 mg once daily was shown to reduce symptoms in patients with confirmed or clinically suspected diagnosis of GERD (n=136) based on the GERD Assessment of Symptoms in Pediatric Patients Questionnaire (Tsou 2011); a pharmacokinetic trial showed that a 40 mg dose produced similar systemic exposure as adults receiving 40 mg; however, suggested that 20 mg once daily may be appropriate for smaller adolescents (<40 kg) (Ward 2011)

Erosive esophagitis associated with GERD:

Children 1 to 5 years: Limited data available: Oral: 0.3, 0.6, or 1.2 mg/kg/day once daily for 8 weeks was used in a dose-finding study of 60 patients with histologic or erosive esophagitis. High-dose treatment (1.2 mg/kg/day) was administered as a fixed dose of either: 15 mg for 1-year-olds or 20 mg for 2- to 5-year-olds. Patients with erosive esophagitis (n=4) received either 0.6 or 1.2 mg/kg/day. All patients had symptomatic improvement and patients with erosive esophagitis were healed by week 8; no dose response relationship was demonstrated (Baker 2010)

Children ≥5 years and Adolescents: Oral:

≥15 to <40 kg: 20 mg once daily for up to 8 weeks

≥40 kg: 40 mg once daily for up to 8 weeks

Gastric acid suppression; oral therapy not appropriate or tolerated: Limited data available; dosing regimens variable: Infants, Children, and Adolescents: IV: Dosing based on pharmacokinetic data from 39 pediatric patients (age range: 10 days to 16 years) which has shown doses within this range produce similar AUC as adult patients with comparable dosing; efficacy was not evaluated in either trial (Kearns 2008; Petersen 2009).

Weight-based dosing: Children ≥2 years and Adolescents: IV: 0.8 or 1.6 mg/kg once daily; maximum single dose: 80 mg; dosing from a single dose pharmacokinetic study in 18 patients (age range: 2 to 14 years) (Kearns 2008). In the BSA-based dosing trial (Petersen 2009), the final median dose when standardized to weight was 1.1 mg/kg/day (range: 0.5 to 4.6 mg/kg/day). (Note: The 4.6 mg/kg/day dose was a prescription error; however, the patient experienced no adverse consequences due to high dose). Additionally, some clinicians have used 1 to 2 mg/kg/day in single or divided doses. Note: In a very small trial (n=8), a median dose of 1.1 mg/kg (0.9 to 2.5 mg/kg) produced similar AUC values as adults, but only produced a definable response (gastric pH >4) in one patient; in the remaining seven patients the mean percentage of time with intragastric pH ≥4 was 7.4 % (Petersen 2005); the pharmacodynamic profile needs further defined (Petersen 2009)

Body surface area (BSA)-based dosing: Infants, Children, and Adolescents: IV: 40 mg/1.73 m2/day; if inadequate response (eg, continued symptoms or target gastric pH not achieved) may titrate up to a maximum dose of 80 mg/1.73 m2/day; dosing based on multidose pharmacokinetic analysis; in the final analysis, the median reported dose was 41.8 mg/1.73 m2/day (range: 19.9-140.6 mg/1.73 m2/day) (Note: The 140.6 mg/1.73 m2/day dose was a prescription error; however, the patient experienced no adverse consequences due to high dose) (Petersen 2009).

Dosing: Renal Impairment: Pediatric

Infants, Children and Adolescents: There are no pediatric specific recommendations; based on experience in adult patients, no dosage adjustment needed and not appreciably removed by hemodialysis

Dosing: Hepatic Impairment: Pediatric

Infants, Children and Adolescents: There are no pediatric specific recommendations; based on experience in adult patients, dosing adjustment suggested in some cases

Use: Labeled Indications

Oral:

Erosive esophagitis associated with gastroesophageal reflux disease: Short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis in adults and pediatric patients 5 years and older.

Maintenance of healing of erosive esophagitis: Maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gastroesophageal reflux disease (GERD).

Pathological hypersecretory conditions, including Zollinger-Ellison syndrome: Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

IV:

Gastroesophageal reflux disease associated with a history of erosive esophagitis: Short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis.

Pathological hypersecretory conditions, including Zollinger-Ellison: Treatment of adult patients with pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Use: Off-Label: Adult

  DyspepsiaLevel of Evidence [A, G]

Data from a multicenter, double-blinded, placebo-controlled trial as well as from a double-blinded non-inferiority trial support the use of pantoprazole for the treatment of dyspepsia Ref. In addition, data from a systematic review support the use of pantoprazole for the treatment of patients with ulcer and reflux-like functional dyspepsia Ref.

Based on the American College of Gastroenterology (ACG) and Canadian Association of Gastroenterology (CAG) guidelines for the management of dyspepsia, the use of pantoprazole is effective and recommended treatment for dyspepsia and functional dyspepsia in patients <60 years of age who are H. pylori negative or who remain symptomatic after H. pylori eradication therapy Ref.

  Helicobacter pylori eradicationLevel of Evidence [G]

Based on the American College of Gastroenterology Clinical Guideline for Treatment of Helicobacter pylori infection, the use of proton pump inhibitors is effective and recommended in the treatment of H. pylori infection Ref.

  Prevention of NSAID-induced ulcersLevel of Evidence [B, G]

According to the American College of Gastroenterology 2009 Guidelines for Prevention of NSAID-Related Ulcer Complications, proton pump inhibitors (including pantoprazole) are effective and recommended in the prophylaxis of gastric and duodenal ulcers in patients receiving NSAID therapy Ref.

Data from a randomized, double-blind, multicenter, parallel-group study and from a limited number of patients in a placebo-controlled, double-blind, parallel-group study, support the use of pantoprazole in the prevention of NSAID-induced ulcers Ref.

  Prevention of rebleeding in peptic ulcer bleedLevel of Evidence [A, G]

Data from multiple randomized clinical trials including both open-label and double-blinded, randomized trials in patients with active peptic ulcer bleed treated with either continuous infusion or intermittent pantoprazole after endoscopic hemostasis support the use of either continuous infusion or intermittent pantoprazole for the treatment of this condition Ref.

Based on the International Consensus Recommendations on the Management of Patients With Nonvariceal Upper Gastrointestinal Bleeding, the use of an intravenous bolus followed by continuous infusion PPI therapy should be used to decrease rebleeding and mortality in patients with high-risk stigmata who have undergone successful endoscopic therapy Ref. A meta-analysis concluded that the use of intermittent proton pump inhibitors (PPIs) was comparable to the use of continuous infusion PPIs in patients with high-risk endoscopic findings Ref. The use of intermittent infusions may be preferable considering the lower cost and resource utilization associated with the use of intermittent PPI therapy. However, intermittent dosing may still be preferred for the patient with low risk of recurrent bleeding (eg, clean ulcer base [Forrest type III]) Ref. The American College of Gastroenterology Guidelines for Management of Patients with Ulcer Bleeding recommends oral PPI therapy for long term prophylaxis of recurrent bleeding ulcers; standard PPI therapy is recommended for ulcers with a flat pigmented spot or clean base Ref.

  Stress ulcer prophylaxis in critically ill patientsLevel of Evidence [C, G]

Dosing for this indication has not been established; however, data from one study demonstrated that intermittent IV pantoprazole using multiple dosing regimens (ie, 40 mg every 24 hours, 40 mg every 12 hours, 80 mg every 24 hours, 80 mg every 12 hours, or 80 mg every 8 hours) effectively controls gastric pH (ie, maintains pH ≥4) compared to cimetidine (300 mg bolus followed by 50 mg/hour) Ref. Additional data is necessary to further define the role of pantoprazole in this setting.

Based on the Surviving Sepsis Campaign International Guidelines for the Management of Severe Sepsis and Septic Shock, stress ulcer prophylaxis using a PPI or a histamine H2-receptor antagonist is recommended in sepsis or septic shock patients who have GI bleeding risk factors.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Barrett Esophagus:

ACG, “Diagnosis and Management of Barrett’s Esophagus,” January 2016

Critical Care:

“Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016,” March 2017

Drug-Induced Liver Injury:

American College of Gastroenterology (ACG), “2014 ACG Guideline for Idiosyncratic Drug-induced Liver Injury,” July 2014

Dyspepsia:

ACG/CAG “Guidelines for the Management of Dyspepsia,” June 2017

Gastroesophageal Reflux Disease:

ACG, “Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease,” March 2013

AGA, “Medical Position Statement on the Management of Gastroesophageal Reflux Disease,” October 2008

Helicobacter pylori Infection:

“ACG Guideline on the Management of Helicobacter pylori Infection,” August 2007

“ACG Guideline on the Treatment of Helicobacter pylori Infection,” February 2017

NSAID-Related Ulcers:

“ACG Guidelines for Prevention of NSAID-Related Ulcer Complications,” February 2009

Proton Pump Inhibitors & Thienopyridines:

“2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention,” November 2011

“ACCF/ACG/AHA 2010 Expert Consensus Document on the Concomitant Use of Proton Pump Inhibitors and Thienopyridines,” December 2010

“The Use of Antiplatelet Therapy in the Outpatient Setting: Canadian Cardiovascular Society Guidelines,” 2011

Upper Gastrointestinal Bleeding:

“International Consensus Recommendations on the Management of Patients with Nonvariceal Upper Gastrointestinal Bleeding,” 2010

Usual Infusion Concentrations: Adult

IV infusion: 80 mg in 100 mL (concentration: 0.8 mg/mL) of D5W or NS

Administration: IV

Flush IV line before and after administration with D5W, NS, or LR. In-line filter not required.

2-minute infusion: The volume of reconstituted solution (4 mg/mL) to be injected may be administered intravenously over at least 2 minutes.

15-minute infusion: Infuse over ~15 minutes at a rate of ~7 mL/minute (3 mg/minute).

Continuous infusion: May also be administered as a continuous infusion for the prevention of rebleeding with in peptic ulcer bleed (off-label use).

Administration: Oral

Tablet: Should be swallowed whole, do not split, crush, or chew. May administer with or without food; concomitant administration of antacids does not affect absorption.

Delayed-release oral suspension: Should only be administered in apple juice or applesauce and taken ~30 minutes before a meal; do not chew or crush granules. Do not administer with any other liquid (eg, water) or foods.

Oral administration in applesauce: Sprinkle intact granules on 1 teaspoon of applesauce and swallow within 10 minutes of preparation.

Oral administration in apple juice: Empty intact granules into 5 mL of apple juice, stir for 5 seconds (granules will not dissolve), and swallow immediately after preparation. Rinse container once or twice with apple juice and swallow immediately.

Nasogastric tube administration: Separate the plunger from the barrel of a 60 mL catheter tip syringe and connect to a ≥16 French nasogastric tube. Holding the syringe attached to the tubing as high as possible, empty the contents of the packet into barrel of the syringe, add 10 mL of apple juice and gently tap/shake the barrel of the syringe to help empty the syringe. Add an additional 10 mL of apple juice and gently tap/shake the barrel to help rinse. Repeat rinse at least twice with 10 mL aliquots of apple juice. No granules should remain in the syringe.

Administration: Pediatric

Parenteral: IV: Not for IM or SubQ use. Flush IV line with NS, D5W, or LR before and after administration.

IV push: Administer over 2 minutes at a concentration of 4 mg/mL

Intermittent IV infusion: Using a 0.4 to 0.8 mg/mL solution, infuse over 15 minutes at a rate not to exceed 7 mL/minute

Oral:

Tablet: Should be swallowed whole; do not chew or crush. May be taken without regard to meals; however, best if taken 30 minutes before a meal (Lightdale 2013); may be administered with antacids.

Delayed release oral suspension: Should only be administered in apple juice or applesauce and administered 30 minutes before a meal. Do not administer in water, other liquids, or foods. Per manufacturer’s labeling, do not divide the 40 mg delayed release oral suspension packet to create a 20 mg dosage for pediatric patients who are unable to take the tablet formulation.

Oral administration in apple juice: Empty intact granules into 5 mL of apple juice, stir for 5 seconds, and swallow immediately. Rinse container once or twice with apple juice and swallow immediately.

Oral administration in applesauce: Sprinkle intact granules on 1 teaspoonful of applesauce; swallow within 10 minutes of preparation.

Nasogastric tube administration: Separate the plunger from the barrel of a 60 mL catheter tip syringe and connect to a ≥16 French nasogastric tube. Holding the syringe attached to the tubing as high as possible, empty granules into barrel of syringe, add 10 mL of apple juice, and gently tap/shake the barrel of the syringe to help empty the syringe. Add an additional 10 mL of apple juice and gently tap/shake the barrel to help rinse. Repeat rinse with at least 2 to 10 mL aliquots of apple juice. No granules should remain in the syringe.

Oral administration in syringe: In neonatal trials, fixed dosage packets of 2.5 mg pantoprazole were mixed with grape flavoring and 2.5 mL of water and administered immediately (Ward 2010).

Dietary Considerations

IV: Due to EDTA in preparation, zinc supplementation may be needed in patients prone to zinc deficiency.

Storage/Stability

Oral: Store tablet and oral suspension at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

IV: Prior to reconstitution, store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze. Protect from light prior to reconstitution; upon reconstitution, protection from light is not required. Do not freeze reconstituted solution. Per manufacturer’s labeling, reconstituted solution is stable at room temperature for up to 6 hours; further diluted (admixed) solution in D5W, LR, or NS should be stored at room temperature and used within 24 hours from the time of initial reconstitution. However, studies have shown that reconstituted solution (4 mg/mL) in polypropylene syringes is stable up to 96 hours at room temperature (Johnson 2005). Upon further dilution, the admixed solution should be used within 96 hours from the time of initial reconstitution. The preparation should be stored at 3°C to 5°C (37°F to 41°F) if it is stored beyond 48 hours to minimize discoloration.

Preparation for Administration: Adult

15-minute infusion:

40 mg dose: Reconstitute 1 vial with 10 mL of NS; further dilute with 100 mL of D5W, NS, or LR to a final concentration of ~0.4 mg/mL.

80 mg dose: Reconstitute 2 vials each with 10 mL of NS; combine the content of both vials and further dilute with 80 mL of D5W, NS, or LR to a final concentration of ~0.8 mg/mL.

2-minute infusion: Reconstitute with 10 mL of NS to a final concentration of ~4 mg/mL.

Preparation for Administration: Pediatric

IV:

IV push: Reconstitute powder for injection with 10 mL NS; final concentration: 4 mg/mL

Intermittent IV infusion: After reconstitution, further dilute in NS, D5W, or LR to a final concentration of 0.4 to 0.8 mg/mL

Compatibility

See Trissel’s IV Compatibility Database

Extemporaneously Prepared

A 2 mg/mL pantoprazole oral suspension may be made with pantoprazole tablets, sterile water, and sodium bicarbonate powder. Remove the Protonix® imprint from twenty 40 mg tablets with a paper towel dampened with ethanol (improves the look of product). Let tablets air dry. Crush the tablets in a mortar and reduce to a fine powder. Transfer to a 600 mL beaker, and add 340 mL sterile water. Place beaker on a magnetic stirrer. Add 16.8 g of sodium bicarbonate powder and stir for about 20 minutes until the tablet remnants have disintegrated. While stirring, add another 16.8 g of sodium bicarbonate powder and stir for about 5 minutes until powder has dissolved. Add enough sterile water for irrigation to bring the final volume to 400 mL. Mix well. Transfer to amber-colored bottle. Label “shake well” and “refrigerate”. Stable for 62 days refrigerated.

Dentinger PJ, Swenson CF, and Anaizi NH, “Stability of Pantoprazole in an Extemporaneously Compounded Oral Liquid,” Am J Health Syst Pharm, 2002, 59(10):953-6.[PubMed 12040734]

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, diarrhea, nausea, vomiting, flatulence, common cold symptoms, or joint pain. Have patient report immediately to prescriber signs of low magnesium (mood changes; muscle pain or weakness; muscle cramps or spasms; seizures; tremors; lack of appetite; severe nausea or vomiting; or an abnormal heartbeat), signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, angina or shortness of breath, or swelling in the arms or legs), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), severe dizziness, passing out, severe abdominal pain, bone pain, chills, pharyngitis, excessive weight loss, injection site irritation, signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Administration issues:
  Geriatric Patients: High-Risk Medication:
  International issues:
Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Protonix granules for oral suspension, delayed release tablets: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s053,022020s015lbl.pdf#page=30

Contraindications

Hypersensitivity (eg, anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria) to pantoprazole, other substituted benzimidazole proton pump inhibitors, or any component of the formulation; in combination with rilpivirine-containing products.

Canadian labeling: Additional contraindications (not in US labeling): Concomitant use with rilpivirine

Warnings/Precautions

Concerns related to adverse effects:

• Carcinoma: Benign and malignant neoplasia has been observed in long-term (2-year) rodent studies; while not reported in humans, the relevance of these findings in regards to tumorigenicity in humans is not known.

• Clostridioides (formerly Clostridiumdifficile-associated diarrhea (CDAD): Use of proton pump inhibitors (PPIs) may increase risk of CDAD, especially in hospitalized patients; consider CDAD diagnosis in patients with persistent diarrhea that does not improve. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.

• Cutaneous and systemic lupus erythematosus: Has been reported as new onset or exacerbation of existing autoimmune disease; most cases were cutaneous lupus erythematosus (CLE), most commonly, subacute CLE (occurring within weeks to years after continuous therapy). Systemic lupus erythematosus (SLE) is less common (typically occurs within days to years after initiating treatment) and occurred primarily in young adults up to elderly patients. Discontinue therapy if signs or symptoms of CLE or SLE occur and refer to specialist for evaluation; most patients improve 4 to 12 weeks after discontinuation of pantoprazole.

• Fractures: Increased incidence of osteoporosis-related bone fractures of the hip, spine, or wrist may occur with PPI therapy. Patients on high-dose or long-term therapy (≥1 year) should be monitored. Use the lowest effective dose for the shortest duration of time, use vitamin D and calcium supplementation, and follow appropriate guidelines to reduce risk of fractures in patients at risk.

• Fundic gland polyps: Use of PPIs increases risk of fundic gland polyps, especially with long-term use >1 year. May occur without symptoms, but nausea, vomiting, or abdominal pain may occur; GI bleeding and/or anemia may occur with ulcerated polyps. Diagnosis of polyps may also increase risk for small intestinal blockage. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.

• GI infection (eg, Salmonella, Campylobacter): Use of PPIs may increase risk of these infections.

• Hepatic effects: Mild, transient transaminase elevations have been observed.

• Hypomagnesemia: Reported rarely, usually with prolonged PPI use of ≥3 months (most cases >1 year of therapy). May be symptomatic or asymptomatic; severe cases may cause tetany, seizures, and cardiac arrhythmias. Consider obtaining serum magnesium concentrations prior to beginning long-term therapy, especially if taking concomitant digoxin, diuretics, or other drugs known to cause hypomagnesemia; and periodically thereafter. Hypomagnesemia may be corrected by magnesium supplementation, although discontinuation of pantoprazole may be necessary; magnesium levels typically return to normal within 2 weeks of stopping.

• Infusion-related reactions: Thrombophlebitis and serious hypersensitivity reactions, including anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported with IV administration.

• Interstitial nephritis: Acute interstitial nephritis has been observed in patients taking PPIs; may occur at any time during therapy and is generally due to an idiopathic hypersensitivity reaction. Discontinue if acute interstitial nephritis develops.

• Vitamin B12 deficiency: Prolonged treatment (≥2 years) may lead to vitamin B12 malabsorption and subsequent vitamin B12 deficiency. The magnitude of the deficiency is dose-related and the association is stronger in females and those younger in age (<30 years of age); prevalence is decreased after discontinuation of therapy (Lam 2013).

Disease-related concerns:

• Gastric malignancy: Relief of symptoms does not preclude the presence of a gastric malignancy.

Concurrent drug therapy issues:

• Clopidogrel: PPIs may diminish the therapeutic effect of clopidogrel, thought to be due to reduced formation of the active metabolite of clopidogrel. The manufacturer of clopidogrel recommends either avoidance of both omeprazole (even when scheduled 12 hours apart) and esomeprazole or use of a PPI with comparatively less effect on the active metabolite of clopidogrel. Of the PPIs, pantoprazole has the lowest degree of CYP2C19 inhibition in vitro (Li 2004) and has been shown to have less effect on conversion of clopidogrel to its active metabolite compared to omeprazole (Angiolillo 2011). In contrast to these warnings, others have recommended the continued use of PPIs, regardless of the degree of inhibition, in patients with a history of GI bleeding or multiple risk factors for GI bleeding who are also receiving clopidogrel since no evidence has established clinically meaningful differences in outcome; however, a clinically significant interaction cannot be excluded in those who are poor metabolizers of clopidogrel (Abraham 2010; Levine 2011).

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Edetate sodium (EDTA): Some dosage forms may contain edetate sodium; use caution in patients who are at risk for zinc deficiency if other EDTA-containing solutions are coadministered.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Appropriate use: Helicobacter pylori eradication: Short-term combination therapy (≤7 days) has been associated with a higher incidence of treatment failure. The American College of Gastroenterology recommends 10 to 14 days of therapy (triple or quadruple) for eradication of H. pylori (Chey 2017).

• Laboratory test interference: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acid; may cause false-positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop pantoprazole treatment at least 14 days before CgA test; if CgA level is high, repeat test to confirm. Use same commercial laboratory for testing to prevent variable results.

Geriatric Considerations

Dosage adjustment not required.

Use has been associated with C. difficile infection, bone loss and fractures, and hypomagnesemia. Refer to Medication Safety Issues for Beers Criteria information.

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies.

Recommendations for the treatment of GERD in pregnancy are available. As in nonpregnant patients, lifestyle modifications followed by other medications are the initial treatments (Body 2016; Huerta-Iga 2016; Katz 2013; van der Woude 2014). Based on available data, PPIs may be used when clinically indicated (Body 2016; Matok 2012; Pasternak 2010; van der Woude 2014).

Breast-Feeding Considerations

Pantoprazole is present in breast milk (Plante 2004).

The relative infant dose (RID) of pantoprazole was determined to be 0.14% when calculated using the highest breast milk concentration located and compared to a weight-adjusted maternal dose of 40 mg/day.

In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).

The RID of pantoprazole was calculated using a milk concentration of 0.036 mg/L, providing an estimated infant dose via breast milk of 7.3 mcg; the authors calculated the estimated infant dose by assuming 200 mL of breast milk would be ingested around the time of the peak breast milk concentration. This milk concentration was obtained following administration of a single maternal dose of oral pantoprazole 40 mg. Peak concentrations appeared in the breast milk 2 hours after the dose; pantoprazole was undetectable in breast milk by 5 hours postadministration. No adverse events were reported in the mother or infant for the 2 weeks following administration (Plante 2004).

The manufacturer recommends that a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother. However, the acidic content of a breastfed infant’s stomach may potentially inactivate any pantoprazole ingested via breast milk (Plante 2004).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Incidences are associated with adults unless otherwise specified.

>10%: Central nervous system: Headache (adults 12%; children & adolescents: >4%)

1% to 10%:

Cardiovascular: Facial edema (children, adolescents, & adults: ≤4%), edema (≤2%), thrombophlebitis (IV: ≤2%)

Central nervous system: Dizziness (children, adolescents, & adults: ≤4%), vertigo (children, adolescents, & adults: ≤4%), depression (≤2%)

Dermatologic: Skin rash (adults: ≤2%; children & adolescents: >4%), urticaria (children, adolescents, & adults: ≤4%), pruritus (≤2%), skin photosensitivity (≤2%)

Endocrine & metabolic: Increased serum triglycerides (children, adolescents, & adults: ≤4%)

Gastrointestinal: Diarrhea (children, adolescents, & adults: 4% to 9%), abdominal pain (children & adolescents: >4%), vomiting (children, adolescents, & adults: ≥4%), constipation (children, adolescents, & adults: ≤4%), flatulence (children & adolescents: ≤4%), nausea (children & adolescents: ≤4%), xerostomia (≤2%)

Hematologic & oncologic: Leukopenia (≤2%), thrombocytopenia (≤2%)

Hepatic: Increased liver enzymes (children, adolescents, & adults: ≤4%), hepatitis (≤2%)

Hypersensitivity: Hypersensitivity reaction (children, adolescents, & adults: ≤4%)

Neuromuscular & skeletal: Arthralgia (children, adolescents, & adults: ≤4%), increased creatine phosphokinase (children, adolescents, & adults: ≤4%), myalgia (children, adolescents, & adults: ≤4%)

Ophthalmic: Blurred vision (≤2%)

Respiratory: Upper respiratory tract infection (children & adolescents: >4%)

Miscellaneous: Fever (adults: ≤2%; children & adolescents: >4%)

<1%, postmarketing, and/or case reports: Acute interstitial nephritis, ageusia, agranulocytosis, anaphylactic shock, anaphylaxis, angioedema, asthenia, bone fracture, Clostridioides(formerly Clostridiumdifficile-associated diarrhea, confusion, cutaneous lupus erythematous, drowsiness, dysgeusia, erythema multiforme, fatigue, gastric polyp (fundic gland), hallucination, hepatic failure, hepatotoxicity, hypomagnesemia, hyponatremia, insomnia, jaundice, laboratory test abnormality (false-positive for THC), malaise, pancytopenia, pneumonia (Eom 2011), renal disease (chronic; Lazarus 2016), rhabdomyolysis, severe dermatological reaction, Stevens-Johnson syndrome, systemic lupus erythematosus, toxic epidermal necrolysis, weight changes

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP2C19 (major), CYP2D6 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Acalabrutinib: Proton Pump Inhibitors may decrease the serum concentration of Acalabrutinib. Risk X: Avoid combination

Amphetamine: Proton Pump Inhibitors may increase the absorption of Amphetamine. Risk C: Monitor therapy

Atazanavir: Proton Pump Inhibitors may decrease the serum concentration of Atazanavir. Management: See full drug interaction monograph for details. Risk D: Consider therapy modification

Bisphosphonate Derivatives: Proton Pump Inhibitors may diminish the therapeutic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy

Bosutinib: Proton Pump Inhibitors may decrease the serum concentration of Bosutinib. Management: Consider alternatives to proton pump inhibitors, such as antacids or H2 receptor antagonists. Administer alternative agents more than 2 hours before or after bosutinib. Risk D: Consider therapy modification

Capecitabine: Proton Pump Inhibitors may diminish the therapeutic effect of Capecitabine. Risk C: Monitor therapy

Cefditoren: Proton Pump Inhibitors may decrease the serum concentration of Cefditoren. Management: If possible, avoid use of cefditoren with proton pump inhibitors (PPIs). Consider alternative methods to minimize/control acid reflux (eg, diet modification) or alternative antimicrobial therapy if use of PPIs can not be avoided. Risk D: Consider therapy modification

Cefpodoxime: Proton Pump Inhibitors may decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy

Cefuroxime: Proton Pump Inhibitors may decrease the absorption of Cefuroxime. Risk X: Avoid combination

Clopidogrel: Pantoprazole may decrease serum concentrations of the active metabolite(s) of Clopidogrel. Management: Due to the possible risk for impaired clopidogrel effectiveness, clinicians should carefully consider the need for proton pump inhibitor therapy in patients receiving clopidogrel. Other acid-lowering therapies do not appear to share this interaction.Risk C: Monitor therapy

CYP2C19 Inducers (Moderate): May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP2C19 Inducers (Strong): May increase the metabolism of CYP2C19 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

Cysteamine (Systemic): Proton Pump Inhibitors may diminish the therapeutic effect of Cysteamine (Systemic). Risk C: Monitor therapy

Dabrafenib: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP2C19 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dacomitinib: Proton Pump Inhibitors may decrease the serum concentration of Dacomitinib. Management: Avoid concurrent use of dacomitinib with proton pump inhibitors. Antacids may be used. Histamine H2-receptor antagonists (HR2A) may be used if dacomitinib is given at least 6 hours before or 10 hours after the H2RA. Risk X: Avoid combination

Dasatinib: Proton Pump Inhibitors may decrease the serum concentration of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of the proton pump inhibitor if some acid-reducing therapy is needed. Risk X: Avoid combination

Delavirdine: Proton Pump Inhibitors may decrease the serum concentration of Delavirdine. Management: Chronic therapy with proton pump inhibitors (PPIs) should be avoided in patients treated with delavirdine. The clinical significance of short-term PPI therapy with delavirdine is uncertain, but such therapy should be undertaken with caution. Risk X: Avoid combination

Dexmethylphenidate: Proton Pump Inhibitors may increase the absorption of Dexmethylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy

Dextroamphetamine: Proton Pump Inhibitors may increase the absorption of Dextroamphetamine. Specifically, the dextroamphetamine absorption rate from mixed amphetamine salt extended release (XR) capsules may be increased in the first hours after dosing. Risk C: Monitor therapy

Doxycycline: Proton Pump Inhibitors may decrease the bioavailability of Doxycycline. Risk C: Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Conversely, concentrations of active metabolites may be increased for those drugs activated by CYP2C19. Management: Concurrent use of enzalutamide with CYP2C19 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C19 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Erlotinib: Proton Pump Inhibitors may decrease the serum concentration of Erlotinib. Risk X: Avoid combination

Fluconazole: May increase the serum concentration of Proton Pump Inhibitors. Risk C: Monitor therapy

Gefitinib: Proton Pump Inhibitors may decrease the serum concentration of Gefitinib. Management: Avoid use of proton pump inhibitors (PPIs) with gefitinib when possible. If required, administer gefitinib 12 hours after administration of the PPI or 12 hours before the next dose of the PPI. Risk D: Consider therapy modification

Indinavir: Proton Pump Inhibitors may decrease the serum concentration of Indinavir. Risk C: Monitor therapy

Iron Salts: Proton Pump Inhibitors may decrease the absorption of Iron Salts. Exceptions: Ferric Carboxymaltose; Ferric Citrate; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Isomaltoside; Iron Sucrose. Risk C: Monitor therapy

Itraconazole: Proton Pump Inhibitors may increase the serum concentration of Itraconazole. Proton Pump Inhibitors may decrease the serum concentration of Itraconazole. Management: Administer Sporanox brand itraconazole at least 2 hours before or 2 hours after administration of any proton pump inhibitors (PPIs). Exposure to Tolsura brand itraconazole may be increased by PPIs; consider itraconazole dose reduction. Risk D: Consider therapy modification

Ketoconazole (Systemic): Proton Pump Inhibitors may decrease the serum concentration of Ketoconazole (Systemic). Ketoconazole (Systemic) may increase the serum concentration of Proton Pump Inhibitors. Risk D: Consider therapy modification

Ledipasvir: Proton Pump Inhibitors may decrease the serum concentration of Ledipasvir. Management: PPI doses equivalent to omeprazole 20 mg or lower may be given with ledipasvir under fasted conditions. Administration with higher doses of PPIs, 2 hours after a PPI, or in combination with food and PPIs may reduce ledipasvir bioavailability. Risk D: Consider therapy modification

Lumacaftor: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Risk C: Monitor therapy

Mesalamine: Proton Pump Inhibitors may diminish the therapeutic effect of Mesalamine. Proton pump inhibitor-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Consider avoiding concurrent administration of high-dose proton pump inhibitors (PPIs) with sustained-release mesalamine products. Risk D: Consider therapy modification

Methotrexate: Proton Pump Inhibitors may increase the serum concentration of Methotrexate. Risk C: Monitor therapy

Methylphenidate: Proton Pump Inhibitors may increase the absorption of Methylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): Proton Pump Inhibitors may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, the absorption of iron may be decreased. Risk C: Monitor therapy

Mycophenolate: Proton Pump Inhibitors may decrease the serum concentration of Mycophenolate. Specifically, concentrations of the active mycophenolic acid may be reduced. Risk C: Monitor therapy

Nelfinavir: Proton Pump Inhibitors may decrease serum concentrations of the active metabolite(s) of Nelfinavir. Proton Pump Inhibitors may decrease the serum concentration of Nelfinavir. Risk X: Avoid combination

Neratinib: Proton Pump Inhibitors may decrease the serum concentration of Neratinib. Specifically, proton pump inhibitors may reduce neratinib absorption. Risk X: Avoid combination

Nilotinib: Proton Pump Inhibitors may decrease the serum concentration of Nilotinib. Management: Avoid this combination when possible since separation of doses is not likely to be an adequate method of minimizing the interaction. Risk D: Consider therapy modification

PAZOPanib: Proton Pump Inhibitors may decrease the serum concentration of PAZOPanib. Risk X: Avoid combination

Posaconazole: Proton Pump Inhibitors may decrease the serum concentration of Posaconazole. Risk D: Consider therapy modification

Raltegravir: Proton Pump Inhibitors may increase the serum concentration of Raltegravir. Risk C: Monitor therapy

Rilpivirine: Proton Pump Inhibitors may decrease the serum concentration of Rilpivirine. Risk X: Avoid combination

Riociguat: Proton Pump Inhibitors may decrease the serum concentration of Riociguat. Risk C: Monitor therapy

Risedronate: Proton Pump Inhibitors may diminish the therapeutic effect of Risedronate. Proton Pump Inhibitors may increase the serum concentration of Risedronate. This applies specifically to use of delayed-release risedronate. Risk X: Avoid combination

Saquinavir: Proton Pump Inhibitors may increase the serum concentration of Saquinavir. Risk C: Monitor therapy

Secretin: Proton Pump Inhibitors may diminish the diagnostic effect of Secretin. Specifically, use of PPIs may cause a hyperresponse in gastrin secretion in response to secretin stimulation testing, falsely suggesting gastrinoma. Management: Avoid concomitant use of proton pump inhibitors (PPIs) and secretin, and discontinue PPIs several weeks prior to secretin administration, with the duration of separation determined by the specific PPI. See full monograph for details. Risk D: Consider therapy modification

Tipranavir: May decrease the serum concentration of Proton Pump Inhibitors. These data are derived from studies with Ritonavir-boosted Tipranavir. Risk C: Monitor therapy

Velpatasvir: Proton Pump Inhibitors may decrease the serum concentration of Velpatasvir. Risk X: Avoid combination

Voriconazole: May increase the serum concentration of Proton Pump Inhibitors. Proton Pump Inhibitors may increase the serum concentration of Voriconazole. Management: In patients receiving omeprazole 40 mg/day or greater, reduce omeprazole dose by half when initiating voriconazole. Risk C: Monitor therapy

Food Interactions

Prolonged treatment (≥2 years) may lead to malabsorption of dietary vitamin B12 and subsequent vitamin B12 deficiency (Lam, 2013).

Test Interactions

Chromogranin A (CgA) levels: Proton pump inhibitors (PPIs), including pantoprazole, may increase CgA levels, which may interfere with neuroendocrine tumor detection. To avoid interference, stop PPI therapy 14 days prior to CgA measurements.

Tetrahydrocannabinol (THC) urine screening tests: PPIs, including pantoprazole, may cause false-positive urine THC tests. Alternative confirmatory methods should be considered to verify positive results.

Genes of Interest
Monitoring Parameters

Bone loss and fractures, CDAD, magnesium (baseline and periodically thereafter), and serum gastrin levels

Hypersecretory disorders: Acid output measurements, target level <10 mEq/hour (<5 mEq/hour if prior gastric acid-reducing surgery)

Advanced Practitioners Physical Assessment/Monitoring

Assess other medications for effectiveness and interactions (cytochrome P450 enzyme substrate), especially those drugs in which absorption is determined by an acidic gastric pH.

Nursing Physical Assessment/Monitoring

Monitor for rebleeding.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Packet, Oral:

Protonix: 40 mg (1 ea, 30 ea) [contains polysorbate 80]

Solution Reconstituted, Intravenous:

Generic: 40 mg (1 ea)

Solution Reconstituted, Intravenous [preservative free]:

Protonix: 40 mg (1 ea) [contains edetate disodium]

Tablet Delayed Release, Oral:

Protonix: 20 mg, 40 mg

Generic: 20 mg, 40 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Intravenous:

Panto IV: 40 mg (1ea[DSC]) [contains EDETATE DISODIUM DIHYDRATE, SODIUM HYDROXIDE]

Generic: 40 mg (1ea)

Tablet Delayed Release, Oral:

Pantoloc: 20 mg, 40 mg [contains POLYSORBATE 80]

Tecta: 40 mg

Generic: 20 mg, 40 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • A02BC02
Generic Available (US)

May be product dependent

Pricing: US

Pack (Protonix Oral)

40 mg (per each): $18.07

Solution (reconstituted) (Pantoprazole Sodium Intravenous)

40 mg (per each): $4.08 – $8.50

Solution (reconstituted) (Protonix Intravenous)

40 mg (per each): $6.00

Tablet, EC (Pantoprazole Sodium Oral)

20 mg (per each): $0.43 – $10.79

40 mg (per each): $0.43 – $10.79

Tablet, EC (Protonix Oral)

20 mg (per each): $18.08

40 mg (per each): $18.08

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Proton pump inhibitor, suppresses gastric acid secretion by inhibiting the parietal cell H+/K+ ATP pump

Pharmacodynamics/Kinetics

Note: Pediatric patients who have the poor metabolizer genotype of CYP2C19 (CYP2C19 *2/*2) exhibited greater than a 6-fold increase in AUC compared with pediatric extensive (CYP2C19 *1/*1) and intermediate (CYP2C19 *1/*x) metabolizers. Poor metabolizers exhibited approximately 10-fold lower apparent oral clearance compared with extensive metabolizers.

Onset of action: Acid secretion: Oral: 2.5 hours; IV: 15 to 30 minutes

Maximum effect: IV: 2 hours

Absorption: Rapid, well absorbed

Duration: Oral, IV: 24 hours

Distribution: Vd:

Children and Adolescents (Kearns 2008): IV (2 to 16 years of age): 0.22 ± 0.14 L/kg; Oral (5 to 16 years of age): 0.24 ± 0.09 L/kg

Adults: 11 to 23.6 L

Protein binding: 98%, primarily to albumin

Metabolism: Extensively hepatic; CYP2C19 (demethylation), CYP3A4; no evidence that metabolites have pharmacologic activity

Bioavailability: ~77%

Half-life elimination:

Neonates (PMA: 37 to 44 weeks): ~3 hours (Ward 2010)

Children and Adolescents (Kearns 2008): IV (2 to 16 years of age): 1.22 ± 0.68 hours; Oral (5 to 16 years of age): 1.27 ± 1.29 hours

Adults: 1 hour; increased to 3.5 to 10 hours with CYP2C19 deficiency

Time to peak:

Children and Adolescents (Kearns 2008): IV (2 to 16 years of age): 0.34 ± 0.12 hours; Oral (5 to 16 years of age): 2.54 ± 0.72 hours

Adults: Oral: 2.5 hours

Excretion: Urine (71% as metabolites); feces (18%); pantoprazole clearance increased with weight and age (Pettersen 2009)

Pharmacodynamics/Kinetics: Additional Considerations

Hepatic function impairment: Increase in serum elimination half-life to 7 to 9 hours; AUC increases by 5- to 7-fold.

Geriatric: Moderate increase in AUC (43%) and Cmax (26%) after oral administration.

Gender: A modest increase in AUC and Cmax in women.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Pantoprazole Magnesium; Pantoprazole Sodium

FDA Approval Date
February 02, 2000
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Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012;107(3):345-360. doi: 10.1038/ajg.2011.480.[PubMed 22310222]

Lam JR, Schneider JL, Zhao W, Corley DA. Proton pump inhibitor and histamine 2 receptor antagonist use and vitamin B12 deficiency. JAMA. 2013;310(22):2435-2422.[PubMed 24327038]

Lanza FL, Chan FK, Quigley EM; Practice Parameters Committee of the American College of Gastroenterology. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol. 2009;104(3):728-738. doi: 10.1038/ajg.2009.115.[PubMed 19240698]

Lau JY, Barkun A, Fan DM; Kuipers EJ, Yang YS, Chan FK. Challenges in the management of acute peptic ulcer bleeding. Lancet. 2013;381:2033-2043.[PubMed 23746903]

Lau JY, Leung WK, Wu JC, et al, “Omeprazole Before Endoscopy in Patients With Gastrointestinal Bleeding,” N Engl J Med, 2007, 356(16):1631-40.[PubMed 17442905]

Lau JY, Sung JJ, Lee KK, et al, “Effect of Intravenous Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers,” N Engl J Med, 2000, 343(5):310-6.[PubMed 10922420]

Lazarus B, Chen Y, Wilson FP, et al. Proton pump inhibitor use and the risk of chronic kidney disease. JAMA Intern Med. 2016:238-246.

Levine GN, Bates ER, Blankenship JC, et al, “2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions,” Circulation, 2011, 124(23):e574-651.[PubMed 22064601]

Lew EA, Pisegna JR, Starr JA, et al, “Intravenous Pantoprazole Rapidly Controls Gastric Acid Hypersecretion in Patients With Zollinger-Ellison Syndrome,” Gastroenterology, 2000, 118(4):696-704.[PubMed 10734021]

Lin HJ, Lo WC, Lee FY, et al, “A Prospective Randomized Comparative Trial Showing That Omeprazole Prevents Rebleeding in Patients With Bleeding Peptic Ulcer After Successful Endoscopic Therapy,” Arch Intern Med, 1998, 158(1):54-8.[PubMed 9437379]

Li X-Q, Anderson TB, Ahlstrom M, et al, “Comparison of Inhibitory Effects of the Proton Pump-Inhibiting Drugs Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, and Rabeprazole on Human Cytochrome P450 Activities,” Drug Metab Disp, 2004, 32(8):821-7.

Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172.[PubMed 10985636]

Madrazo-de la Garza A, Dibildox M, Vargas A, et al, “Efficacy and Safety of Oral Pantoprazole 20 mg Given Once Daily for Reflux Esophagitis in Children,” J Pediatr Gastroenterol Nutr, 2003, 36(2):261-5.[PubMed 12548064]

Matok I, Levy A, Wiznitzer A, et al, “The Safety of Fetal Exposure to Proton-Pump Inhibitors During Pregnancy,” Dig Dis Sci, 2012, 57(3):699-705.[PubMed 22038541]

Moayyedi PM, Lacy BE, Andrews CN, Enns RA, Howden CW, Vakil N. ACG and CAG clinical guideline: management of dyspepsia. Am J Gastroenterol. 2017;112(7):988-1013. doi: 10.1038/ajg.2017.154.[PubMed 28631728]

Morgan D, “Intravenous Proton-Pump Inhibitors in the Critical Care Setting,” Crit Care Med, 2002, 30(6 Suppl):369-72.[PubMed 12072664]

Natsch S, Vinks MH, Voogt AK, et al, “Anaphylactic Reactions to Proton-Pump Inhibitors,” Ann Pharmacother, 2000, 34(4):474-6.[PubMed 10772433]

Panto IV (pantoprazole) [product monograph]. Oakville, Ontario, Canada: Takeda Canada Inc; August 2017.

Pantoloc (pantoprazole) [product monograph]. Oakville, Ontario, Canada: Takeda Canada Inc.; March 2018.

Paoluzi P, Iacopini F, Crispino P, et al, “2-Week Triple Therapy for Helicobacter pylori Infection is Better Than 1-Week in Clinical Practice: a Large Prospective Single-Center Randomized Study,” Helicobacter, 2006, 11(6):562-8.[PubMed 17083378]

Pasternak B and Hviid A, “Use of Proton-Pump Inhibitors in Early Pregnancy and the Risk of Birth Defects,” N Engl J Med, 2010, 363(22):2114-23.[PubMed 21105793]

Perri F, Festa V, Clemente R, et al, “Randomized Study of Two “Rescue” Therapies for Helicobacter pylori-infected Patients After Failure of Standard Triple Therapies,” Am J Gastroenterol, 2001, 96(1):58-62.[PubMed 11197288]

Pettersen G, Mouksassi MS, Theoret Y, et al. Population pharmacokinetics of intravenous pantoprazole in paediatric intensive care patients. Br J Clin Pharmacol. 2009;67(2):216-227.[PubMed 19173681]

Pinto-Sanchez MI, Yuan Y, Bercik P, et al. Proton pump inhibitors for functional dyspepsia. Cochrane Database Syst Rev. 2017;3:CD011194. doi: 10.1002/14651858.CD011194.pub2.[PubMed 28271513]

Plante L, Ferron GM, Unruh M, et al, “Excretion of Pantoprazole in Human Breast,” J Reprod Med, 2004, 49(10):825-7.[PubMed 15568407]

Poole P, “Pantoprazole,” Am J Health-Syst Pharm, 2001, 58:999-1008.[PubMed 11402494]

Protonix Oral (pantoprazole) [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; June 2018.

Protonix I.V. (pantoprazole) [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; May 2018.

Regula J, Butruk E, Dekkers CP, et al. Prevention of NSAID-associated gastrointestinal lesions: a comparison study pantoprazole versus omeprazole. Am J Gastroenterol. 2006;101(8):1747-1755.[PubMed 16817839]

Rhodes A, Evans LE, Alhazzani W, et al. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock: 2016. Intensive Care Med. 2017;43(3):304-377. doi: 10.1007/s00134-017-4683-6.[PubMed 28101605]

Sachar H, Vaidya K, Laine L. Intermittent vs continuous proton pump inhibitor therapy for high-risk bleeding ulcers: a systematic review and meta-analysis. JAMA Intern Med. 2014;174(11):1755-1762.[PubMed 25201154]

Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313.[PubMed 7746084]

Somberg L, Morris J, Fantus R, et al, “Intermittent Intravenous Pantoprazole and Continuous Cimetidine Infusion: Effect on Gastric pH Control in Critically Ill Patients at Risk of Developing Stress-Related Mucosal Disease,” J Trauma, 2008, 64(5):1202-10.[PubMed 1846964]

Sung JJ, Barkun A, Kuipers EJ, et al, “Intravenous Esomeprazole for Prevention of Recurrent Peptic Ulcer Bleeding: A Randomized Trial,” Ann Intern Med, 2009, 150(7):455-64.[PubMed 19221370]

Talley NJ and Vakil N, “Practice Parameters Committee of the American College of Gastroenterology. Guidelines for the Management of Dyspepsia,” Am J Gastroenterol, 2005, 100(10):2324-37.[PubMed 16181387]

Tecta (pantoprazole) [product monograph]. Oakville, Ontario, Canada: Takeda Canada Inc; March 2018.

Tolia V, Bishop PR, Tsou VM, et al, “Multicenter, Randomized, Double-Blind Study Comparing 10, 20 and 40 mg Pantoprazole in Children (5-11 Years) With Symptomatic Gastroesophageal Reflux Disease,” J Pediatr Gastroenterol Nutr, 2006, 42(4):384-91.[PubMed 16641576]

Tsou VM, Baker R, Book L, et al, “Multicenter, Randomized, Double-Blind Study Comparing 20 and 40 mg of Pantoprazole for Symptom Relief in Adolescents (12 to 16 Years of Age) With Gastroesophageal Reflux Disease (GERD),” Clin Pediatr, 2006, 45(8):741-9.[PubMed 16968960]

van der Woude CJ, Metselaar HJ, Danese S. Management of gastrointestinal and liver diseases during pregnancy. Gut. 2014;63(6):1014-1023.[PubMed 24429582]

van Rensburg C, Berghofer P, Enns R, et al. Efficacy and safety of pantoprazole 20 mg once daily treatment in patients with ulcer-like functional dyspepsia. Curr Med Res Opin.2008;24(7):2009-2018. doi: 10.1185/03007990802184545.[PubMed 18534050]

Vcev A, Stimac D, Ivandic A, et al, “Pantoprazole, Amoxycillin, and Either Azithromycin or Clarithromycin for Eradication of Helicobacter pylori in Duodenal Ulcer,” Aliment Pharmacol Ther, 2000, 14(1):69-72.[PubMed 10632647]

Ward RM, Tammara B, Sullivan SE, et al. Single-dose, multiple-dose, and population pharmacokinetics of pantroprazole in neonates and preterm infants with a clinical diagnosis of gastroesophageal reflux disease (GERD). Eur J Clin Pharmacol. 2010;66:555-561.[PubMed 20306184]

Wolfe MM and Sachs G, “Acid Suppression: Optimizing Therapy for Gastroduodenal Ulcer Healing, Gastroesophageal Reflux Disease, and Stress-Related Erosive Syndrome,” Gastroenterology, 2000,118(2 Suppl 1):9-31.[PubMed 10868896]

Yamada S,Wongwanakul P. Randomized controlled trial of high dose bolus versus continuous intravenous infusion pantoprazole as an adjunct therapy to therapeutic endoscopy in massive bleeding peptic ulcer. J Med Assoc Thai. 2012;95(3):349-357.[PubMed 22550833]

Yüksel I, Ataseven H, Köklü S, et al. Intermittent versus continuous pantoprazole infusion in peptic ulcer bleeding: a prospective randomized study. Digestion. 2008;78(1):39-43.[PubMed 18824852]

Zargar SA, Javid G, Khan BA, et al. Pantoprazole infusion as adjuvant therapy to endoscopic treatment in patients with peptic ulcer bleeding: prospective randomized controlled trial. J Gastroenterol Hepatol. 2006;21(4):716-721.[PubMed 16677158]

Brand Names: International

Acernix (PH); Acipan (HR, SI); Alapanzol (ES); Alpanzole (SG); Altana (PH); Anagastra (ES); Antopral (EG); Anxel (EE); Apton (PT); Axepron (PH); Azatol (RO); Azidex (AT); Bio-Panto (VN); Branzol (UY); Ciproton (MX); Conpanzole (MY); Controloc (BG, CZ, EE, EG, HR, HU, IL, IR, JO, LT, LV, MT, MY, PK, PL, RO, RU, SE, SG, SI, SK, TH, UA, ZA); Duonazole (SG); Eumac (IN); Eupantol (FR); Fozole (IN); Futapan (EG); Gastenz (AU); Gastroloc (TW); Gastromax (AR); Gastropan (LB); Inipomp (FR); Ipraalox (LU, LV); Kaiji (CN); Kuppam (MX); Leminter (MX); Luganor (LB); Luoxu (CN); Mefogin (VN); Nelpaza (UA); Nixpan (BD); Noacid (BG); Nocid (PH); Nolpaza (EE, LV, SK); Ottozol (ID); Ozpan (AU); Panfred (LK); Panloc (ID); Panoz (BD); Panprax (CH); Panrazol (HK); Pantasan (UA); Pantazol (PH); Pantec (IN); Pantecta (CR, DO, ES, GT, HN, IT, MT, NI, NL, PA, SV); Panteon (KR); Pantex (BD); Pantin (SG, ZW); Panto (TR); Panto-Byk (LU); Pantoavenir IV (IL); Pantoc (PT); Pantocar (LK, PH); Pantocid (NZ, TH, ZA); Pantodac (IN); Pantodar (AE, CY, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Pantokem (PH); Pantol (LV); Pantoline (KR); Pantoloc (AT, CN, DK, EG, ES, FR, HK, JO, KR, LT, PH, QA, SE, TW, TZ, VN); Pantoloc Control (HK); Pantomax (BH, QA); Pantomed (KR); Pantop (AR, PK, VE); Pantopan (IN, IT); Pantoprix (PH); Pantoprol (TH); Pantopump (ID); Pantor (BH, PH); Pantostac (KR); Pantostad (HK); Pantover (BH, QA); Pantoz (LK); Pantozol (AE, AT, BE, BH, CH, CY, DE, EG, ID, IQ, IR, JO, KW, LU, LY, MT, MX, NL, OM, PH, QA, SA, SE, SY, YE); Pantul (EE); Panwin (PH); Panzol (BD); Panzole (MY, SG); Panzor (FI); Pauly (MX); Pentowin (HK); Peptazol (AR, MY, SG); Peptazole (HK); Pepticus (PY); Peucetol (MX); Pozola (TW); Prompin (LK); Propanzol (ID); Protium (GB, IE); Protocid (BD); Proton (QA); Protopan (PY); Prozolan (MX); Pulcet (BG, UA); Razon (LB, QA); Regad (MX); Rifun 40 (DE); Salpraz (AU); Segregam (CO); Somac (AU, CZ, FI, NO, NZ); Sozol (AU, VN); Stripole (TH); Sunpraz (RU); Tecta (CO, CR, DO, EC, GT, HN, MX, NI, PA, SV); Tonval (PE); Topazol (ID); Toprazol (KR); Toprazole (BH, ET, MY, QA); Topzole (ZW); Trupan (LK); Ulcan (ID); Ulcemex (CL, PY); Ulceron (IL); Ulcoreks (ET); Ulprix (BG); Unigastrozol (MX); Vencid (MY); Vomizole (ID); Xotepic (PL); Zolpra (MX); Zoltum (CR, DO, EC, GT, HN, NI, PA, PE, SV); Zurcal (AT, BR, CH, CL, CO, EC, MX, PE, PT); Zurcazol (GR)

Pantoprazole (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(pan TOE pra zole)

Brand Names: US

Protonix

Brand Names: Canada

Panto I.V.; Pantoloc; Tecta

What is this drug used for?
  • It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
  • It is used to treat syndromes caused by lots of stomach acid.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to pantoprazole or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Atazanavir, nelfinavir, or rilpivirine.
  • If you are breast-feeding or plan to breast-feed.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • Call your doctor if you have throat pain, chest pain, very bad belly pain, trouble swallowing, or signs of a bleeding ulcer like black, tarry, or bloody stools, throwing up blood, or throw up that looks like coffee grounds. These may be signs of a worse health problem.
  • This drug may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if you take this drug in high doses or for longer than a year, or if you are older than 50 years old. Talk with your doctor.
  • Use care if you have risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your doctor about your risks of osteoporosis.
  • Low magnesium levels have rarely happened in people taking drugs like this one for at least 3 months. Most of the time, this has happened after 1 year of care. You will need to have your blood work checked if you will be taking this drug for a long time or if you take certain other drugs like digoxin or water pills. Talk with your doctor.
  • Long-term treatment (for instance longer than 3 years) with drugs like this one has rarely caused low vitamin B-12 levels. Talk with the doctor.
  • Lupus has happened with this drug, as well as lupus that has gotten worse in people who already have it. Tell your doctor if you have lupus. Call your doctor right away if you have signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
  • Injection:
  • You may need to take zinc while you take this drug. Talk with your doctor.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Very bad dizziness or passing out.
  • Very bad belly pain.
  • Bone pain.
  • Fever or chills.
  • Sore throat.
  • A big weight loss.
  • This drug may raise the chance of a severe form of diarrhea called C diff-associated diarrhea (CDAD). Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with your doctor.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Injection:
  • Irritation where the shot is given.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Headache.
  • Diarrhea.
  • Belly pain.
  • Upset stomach or throwing up.
  • Gas.
  • Dizziness.
  • Joint pain.
  • Signs of a common cold.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Tablets:
  • Take with or without food.
  • Swallow whole. Do not chew, break, or crush.
  • If you have trouble swallowing, talk with your doctor.
  • Granules:
  • Take 30 minutes before a meal.
  • Mix granules with 1 teaspoon of applesauce or 1 teaspoon (5 mL) of apple juice and drink it right away.
  • Do not mix with any other foods or liquids.
  • Do not chew or crush.
  • Those who have feeding tubes may use this drug. Use as you have been told. Flush the feeding tube after this drug is given.
  • Injection:
  • This drug is given as a shot into a vein or into a vein nonstop for a period of time.
What do I do if I miss a dose?
  • Tablets and granules:
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Injection:
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • Tablets and granules:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Injection:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Pantoprazole (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(pan TOE pra zole)

Brand Names: US

Protonix

Brand Names: Canada

Panto I.V.; Pantoloc; Tecta

What is this drug used for?
  • It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
  • It is used to treat syndromes caused by lots of stomach acid.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is taking any of these drugs: Atazanavir, nelfinavir, or rilpivirine.
  • If your child is breast-feeding a baby:
  • Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • Call the doctor if your child has throat pain, chest pain, very bad belly pain, trouble swallowing, or signs of a bleeding ulcer like black, tarry, or bloody stools, throwing up blood, or throw up that looks like coffee grounds. These may be signs of a worse health problem.
  • This drug may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if this drug is taken in high doses or for longer than a year. Talk with the doctor.
  • Use care if your child has risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your child’s doctor about your child’s risks of osteoporosis.
  • Low magnesium levels have rarely happened in people taking drugs like this one for at least 3 months. Most of the time, this has happened after 1 year of care. Your child will need to have their blood work checked if they will be taking this drug for a long time or if they take certain other drugs like digoxin or water pills. Talk with the doctor.
  • Long-term treatment (for instance longer than 3 years) with drugs like this one has rarely caused low vitamin B-12 levels. Talk with the doctor.
  • Lupus has happened with this drug, as well as lupus that has gotten worse in people who already have it. Tell your child’s doctor if your child has lupus. Call your child’s doctor right away if your child has signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
  • Injection:
  • You may need to give your child zinc while your child takes this drug. Talk with your child’s doctor.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Very bad dizziness or passing out.
  • Very bad belly pain.
  • Bone pain.
  • Fever or chills.
  • Sore throat.
  • A big weight loss.
  • This drug may raise the chance of a severe form of diarrhea called C diff-associated diarrhea (CDAD). Call your child’s doctor right away if your child has stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with your child’s doctor.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
  • Injection:
  • Irritation where the shot is given.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Diarrhea.
  • Belly pain.
  • Upset stomach or throwing up.
  • Gas.
  • Dizziness.
  • Joint pain.
  • Signs of a common cold.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Tablets:
  • Give this drug with or without food.
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • If your child has trouble swallowing, talk with the doctor.
  • Granules:
  • Give 30 minutes before a meal.
  • Mix granules with 1 teaspoon of applesauce or 1 teaspoon (5 mL) of apple juice and have your child drink it right away.
  • Do not mix with any other foods or liquids.
  • Do not let your child chew or crush.
  • Those who have feeding tubes may use this drug. Use as you have been told. Flush the feeding tube after this drug is given.
  • Injection:
  • This drug is given as a shot into a vein or into a vein nonstop for a period of time.
What do I do if my child misses a dose?
  • Tablets and granules:
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Injection:
  • Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
  • Tablets and granules:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Injection:
  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.