Usual Adult Dose for Erosive Esophagitis

Treatment: 40 mg orally once a day

• Duration of therapy: 8 weeks

Maintenance: 40 mg orally once daily

Comments:

• If patients are not healed after 8 weeks or erosive esophagitis (EE) recurs with the oral formulation, treatment for another 8 weeks may be considered.
• Controlled studies using the oral formulation for maintenance did not extend beyond 12 months.

Uses:

• Short-term treatment in the healing and symptomatic relief of EE
• Maintenance of healing of EE

Usual Adult Dose for Gastroesophageal Reflux Disease

Oral: 40 mg orally once a day

• Duration of therapy: 8 weeks

Parenteral: 40 mg via IV infusion once a day, given over at least 2 minutes OR over 15 minutes

• Duration of therapy: 7 to 10 days

Comments:

• IV treatment should be discontinued once the patient is able to take an oral formulation.
• Use of the IV formulation has not been studied for longer than 10 days.
• Safety and efficacy for uses otherwise described (e.g., life-threatening gastrointestinal bleeds) are not available; however, use of this drug at 40 mg/day doses did not raise gastric pH to sufficient levels to contribute to the treatment of life-threatening conditions.
• If patients are not healed after 8 weeks with the oral formulation, treatment for another 8 weeks may be considered.

Uses:

• Short-term treatment of gastroesophageal reflux disease (GERD) in patients with a history of erosive esophagitis
• Reduction of relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD

Usual Adult Dose for Zollinger-Ellison Syndrome

Oral: 40 mg orally 2 times a day

• Maximum dose: 240 mg/day

Parenteral:

• Initial dose: 80 mg via IV infusion every 12 hours, given over at least 2 minutes OR over 15 minutes
• Maintenance dose: 80 mg via IV infusion every 8 to 12 hours, given over at least 2 minutes OR over 15 minutes
• Maximum dose: 240 mg/day
• Maximum duration of therapy: 6 days

Comments:

• IV treatment should be discontinued once the patient is able to take an oral formulation.
• Use of the IV formulation for longer than 6 days and/or with doses higher than 240 mg has not been adequately studied.
• Patients may be vulnerable to increased acid production despite a short period of loss of effective inhibition.
• Patients given the oral formulation should be continued on therapy for as long as clinically necessary.

Uses:

• Treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome
• Pathological hypersecretion conditions, including Zollinger-Ellison syndrome

Usual Adult Dose for Pathological Hypersecretory Conditions

Oral: 40 mg orally 2 times a day

• Maximum dose: 240 mg/day

Parenteral:

• Initial dose: 80 mg via IV infusion every 12 hours, given over at least 2 minutes OR over 15 minutes
• Maintenance dose: 80 mg via IV infusion every 8 to 12 hours, given over at least 2 minutes OR over 15 minutes
• Maximum dose: 240 mg/day
• Maximum duration of therapy: 6 days

Comments:

• IV treatment should be discontinued once the patient is able to take an oral formulation.
• Use of the IV formulation for longer than 6 days and/or with doses higher than 240 mg has not been adequately studied.
• Patients may be vulnerable to increased acid production despite a short period of loss of effective inhibition.
• Patients given the oral formulation should be continued on therapy for as long as clinically necessary.

Uses:

• Treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome
• Pathological hypersecretion conditions, including Zollinger-Ellison syndrome

Usual Pediatric Dose for Erosive Esophagitis

5 years and older:
15 to less than 40 kg: 20 mg orally once a day
40 kg and greater: 40 mg orally once a day
Duration of therapy: Up to 8 weeks

Comment: Safety has not been established in treatment beyond 8 weeks.

Uses:

• Short-term treatment in the healing and symptomatic relief of EE
• Short-term treatment of GERD in patients with a history of EE

Usual Pediatric Dose for Gastroesophageal Reflux Disease

5 years and older:
15 to less than 40 kg: 20 mg orally once a day
40 kg and greater: 40 mg orally once a day
Duration of therapy: Up to 8 weeks

Comment: Safety has not been established in treatment beyond 8 weeks.

Uses:

• Short-term treatment in the healing and symptomatic relief of EE
• Short-term treatment of GERD in patients with a history of EE

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

IV: Data not available

Oral: Doses over 40 mg/day have not been studied in patients with liver impairment. No adjustment recommended.

Dose Adjustments

CYP450 2C19 Poor Metabolizers:
Adults: No adjustment recommended.
Pediatric patients: Oral dose reductions should be considered.

Pathological Hypersecretion (including Zollinger-Ellison syndrome):

• Acid output target range: Less than 10 mEq/h

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component, substituted benzimidazoles, or any of the ingredients
• Patients receiving rilpivirine-containing products

Safety and efficacy of oral formulations have not been established in patients younger than 5 years. The IV formulation is not recommended for use in children.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Tablet formulations should be swallowed whole, without crushing/chewing; tablets may be taken with or without food.
• For patients unable to swallow a 40 mg tablet, two 20 mg tablets may be taken; however, the 40 mg oral suspension packet formulation should not be divided to create two-20 mg dosages.
• Oral suspension/granule formulations should be taken on an empty stomach, preferably 30 to 60 minutes before a meal.
• The granule formulation may be sprinkled into applesauce or mixed into a small volume of either apple juice or orange juice and swallowed immediately. This drug may be mixed with apple juice and administered via nasogastric tube.

Storage requirements: The manufacturer product information should be consulted.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

IV compatibility: The manufacturer product information should be consulted.

General:

• This drug may be used concomitantly with antacids without affecting the absorption.
• Reflux symptoms may take 2 to 3 days to improve after initiation.
• Rapid acid control may be achieved within an hour at an IV dose of 160 mg.

Monitoring:

• HEPATIC: Liver function tests, especially in patients with impaired liver function
• METABOLIC: Magnesium levels, especially in patients taking other drugs that could result in hypomagnesemia or those on long-term therapy; Vitamin B12 levels, especially in patients on long-term therapy
• MUSCULOSKELETAL: Bone fractures, especially in patients at high-risk for osteoporosis-related events
• RENAL: Renal function tests

Patient advice:

• Advise patients to avoid taking concomitant proton pump inhibitors and/or H2 antagonists during treatment.
• If using this drug to treat H pylori, tell patients that it is important to complete the full regimen.
• Instruct patients to seek medical attention if signs/symptoms of hypersensitivity, Clostridium difficile, or systemic cutaneous lupus erythematosus occur.
• Patients should be told that treatment may not provide immediate relief and that they should not take this drug for prophylaxis. Symptomatic relief may occur after 1 day of treatment, but patients should continue treatment for the full duration to achieve complete symptom control.
• Inform patients that this drug may cause dizziness or blurred vision, and they should avoid driving or operating machinery if these side effects occur.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

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