Pantoprazole (oral)

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Pantoprazole (oral)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
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Overview

Pantoprazole (oral) is an proton pump inhibitor that is FDA approved for the treatment of short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD), maintenance of healing of erosive esophagitis, pathological hypersecretory conditions including Zollinger-Ellison Syndrome.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, arthralgia, URI, fever, and rash.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
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Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Pantoprazole (oral) in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pantoprazole (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Pantoprazole (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Pantoprazole (oral) in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pantoprazole (oral) in pediatric patients.

Contraindications

Pantoprazole sodium is contraindicated in patients with known hypersensitivity to any component of the formulation [see Description (11) ] or any substituted benzimidazole.

Warnings

Title
See full prescribing information for complete Boxed Warning.
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  • 5.1 Concurrent Gastric Malignancy

Symptomatic response to therapy with pantoprazole does not preclude the presence of gastric malignancy.

5.2 Atrophic Gastritis

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with pantoprazole, particularly in patients who were H. pylori positive.

5.3 Cyanocobalamin (Vitamin B-12) Deficiency

Generally, daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (Vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.

5.4 Clostridium difficile associated diarrhea

Published observational studies suggest that PPI therapy like pantoprazole may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve.

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

5.5 Bone Fracture

Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.

5.6 Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.

5.7 Tumorigenicity

Due to the chronic nature of GERD, there may be a potential for prolonged administration of pantoprazole. In long-term rodent studies, pantoprazole was carcinogenic and caused rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown.

5.8 Interference with Urine Screen for THC

See Drug Interactions.

5.9 Concomitant use of Pantoprazole with Methotrexate

Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Pantoprazole (oral) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Pantoprazole (oral) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pantoprazole (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Pantoprazole (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Pantoprazole (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Pantoprazole (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Pantoprazole (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Pantoprazole (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Pantoprazole (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Pantoprazole (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Pantoprazole (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Pantoprazole (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Pantoprazole (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Pantoprazole (oral) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Pantoprazole (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Pantoprazole (oral) in the drug label.

Pharmacology

There is limited information regarding Pantoprazole (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Pantoprazole (oral)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Pantoprazole (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Pantoprazole (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Pantoprazole (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Pantoprazole (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Pantoprazole (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Pantoprazole (oral) in the drug label.

Precautions with Alcohol

  • Alcohol-Pantoprazole (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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  2. ↑ "http://www.ismp.org". External link in |title= (help)

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