Usual Adult Dose for Duodenal Ulcer

ORAL:

• Treatment dose: 150 mg orally 2 times a day OR 300 mg orally once a day after the evening meal or at bedtime
• Maintenance dose: 150 mg orally once a day at bedtime
• Duration of therapy: 8 weeks (treatment); up to 1 year (maintenance)

• Usual dose: 50 mg IM or IV every 6 to 8 hours
• Maximum dose: 400 mg/day

• Usual rate: 6.25 mg/hour

• Patients may use antacids to treat pain.
• Both once or 2 times a day oral dosing regimens were shown to be effective in inhibiting gastric acid secretion.
• Injectable formulations do not require dilution when given as an IM injection.
• Intermittent IV bolus injections should be diluted up to 2.5 mg/mL and injected at a rate of up to 4 mL/min.
• Intermittent IV infusions should be diluted up to a concentration of 0.5 mg/mL and infused at a rate of up to 5 to 7 mL/min (approximately 15 to 20 minutes).
• Most patients receiving oral formulations heal within 4 weeks; there are no safety data for the treatment of uncomplicated duodenal ulcer beyond 8 weeks. Studies have not been conducted to assess safety in oral maintenance therapy longer than 1 year.

• Short-term treatment of active duodenal ulcer
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers
• Some hospitalized patients with intractable duodenal ulcers

Usual Adult Dose for Dyspepsia

ORAL (OVER-THE-COUNTER FORMULATIONS):

• Symptom relief: 75 to 150 mg orally with a glass of water
• Symptom prevention: 75 to 150 mg orally with a glass of water 30 to 60 minutes before a meal
• Maximum dose: 2 tablets/day
• Duration of therapy: Up to 14 days (self-treatment)

• Relief of heartburn associated with acid indigestion and sour stomach
• Relief of heartburn associated with acid indigestion and sour stomach brought on by eating/drinking certain foods and beverages

Usual Adult Dose for Erosive Esophagitis

ORAL:

• Treatment dose: 150 mg orally 4 times a day
• Maintenance dose: 150 mg orally 2 times a day
• Duration of therapy: Up to 48 weeks (maintenance)

• Symptomatic relief usually starts within 24 hours of starting oral treatment.
• Placebo-controlled studies included use of maintenance doses for up to 48 weeks.

• Treatment of endoscopically diagnosed erosive esophagitis

Usual Adult Dose for Zollinger-Ellison Syndrome

ORAL:

• Initial dose: 150 mg orally 2 times a day
• Maximum dose: Up to 6 g/day

• Initial rate: 1 mg/kg/hr
• Titration: After 4 hours, if gastric acid output is greater than 10 mEq/hr or the patient is symptomatic, the dose should be increased in 0.5 mg/kg/hr increments and acid levels should be re-measured
• Maximum dose: 2.5 mg/kg/hr
• Maximum rate: 220 mg/hr

• Continuous IV infusions should be diluted to a concentration of 2.5 mg/mL or less.

• Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, systemic mastocytosis)
• Alternative to oral formulations for short-term use in some hospitalized patients who are unable to take oral medications

Usual Adult Dose for Pathological Hypersecretory Conditions

ORAL:

• Initial dose: 150 mg orally 2 times a day
• Maximum dose: Up to 6 g/day

• Initial rate: 1 mg/kg/hr
• Titration: After 4 hours, if gastric acid output is greater than 10 mEq/hr or the patient is symptomatic, the dose should be increased in 0.5 mg/kg/hr increments and acid levels should be re-measured
• Maximum dose: 2.5 mg/kg/hr
• Maximum rate: 220 mg/hr

• Continuous IV infusions should be diluted to a concentration of 2.5 mg/mL or less.

• Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, systemic mastocytosis)
• Alternative to oral formulations for short-term use in some hospitalized patients who are unable to take oral medications

Usual Adult Dose for Gastroesophageal Reflux Disease

ORAL:

• Usual dose: 150 mg orally 2 times a day

• Symptomatic relief usually starts within 24 hours of starting oral treatment.

• Treatment of gastroesophageal reflux disease

Usual Adult Dose for Gastric Ulcer

ORAL:

• Treatment dose: 150 mg orally 2 times a day
• Maintenance dose: 150 mg orally once a day at bedtime

• Most patients heal within 6 weeks; there are no safety data for the treatment of uncomplicated, benign gastric ulcer beyond 6 weeks.

• Short-term treatment of active, benign gastric ulcer
• Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers

Usual Pediatric Dose for Duodenal Ulcer

Less than 1 month AND with Extracorporeal membrane oxygenation (ECMO):
PARENTERAL:

• 2 mg/kg IV every 12 to 24 hours OR as a continuous infusion

• Treatment dose: 2 to 4 mg/kg orally 2 times a day
• Maximum treatment dose: 300 mg/day
• Maintenance dose: 2 to 4 mg/kg orally once a day
• Maximum maintenance dose: 150 mg/day

• Usual dose: 2 to 4 mg/kg IV, divided and given every 6 to 8 hours OR as a continuous infusion
• Maximum dose: 50 mg/dose

• Treatment dose: 150 mg orally 2 times a day OR 300 mg orally once a day after the evening meal or at bedtime
• Maintenance dose: 150 mg orally once a day at bedtime
• Duration of therapy: 8 weeks (treatment); up to 1 year (maintenance)

• Usual dose: 50 mg IM or IV every 6 to 8 hours
• Maximum dose: 400 mg/day

• Usual rate: 6.25 mg/hour

• Patients younger than 1 month with ECMO who were given doses of 2 mg/kg had a gastric pH of greater than 4 for at least 15 hours.
• Placebo-controlled studies included use of maintenance doses for up to 48 weeks.
• Injectable formulations do not require dilution when given as an IM injection.
• Intermittent IV bolus injections should be diluted up to 2.5 mg/mL and injected at a rate of up to 4 mL/min.
• Intermittent IV infusions should be diluted up to a concentration of 0.5 mg/mL and infused at a rate of up to 5 to 7 mL/min (approximately 15 to 20 minutes).

• Alternative to oral formulations for short-term use in some hospitalized patients who are unable to take oral medications
• Short-term treatment of active duodenal ulcer
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers
• Some hospitalized patients with intractable duodenal ulcers

Usual Pediatric Dose for Gastric Ulcer

Less than 1 month AND with Extracorporeal membrane oxygenation (ECMO):
PARENTERAL:

• 2 mg/kg IV every 12 to 24 hours OR as a continuous infusion

• Treatment dose: 2 to 4 mg/kg orally 2 times a day
• Maximum treatment dose: 300 mg/day
• Maintenance dose: 2 to 4 mg/kg orally once a day
• Maximum maintenance dose: 150 mg/day

• Usual dose: 2 to 4 mg/kg IV, divided and given every 6 to 8 hours OR as a continuous infusion
• Maximum dose: 50 mg/dose

• Treatment dose: 150 mg orally 2 times a day OR 300 mg orally once a day after the evening meal or at bedtime
• Maintenance dose: 150 mg orally once a day at bedtime
• Duration of therapy: 8 weeks (treatment); up to 1 year (maintenance)

• Usual dose: 50 mg IM or IV every 6 to 8 hours
• Maximum dose: 400 mg/day

• Usual rate: 6.25 mg/hour

• Patients younger than 1 month with ECMO who were given doses of 2 mg/kg had a gastric pH of greater than 4 for at least 15 hours.
• Placebo-controlled studies included use of maintenance doses for up to 48 weeks.
• Injectable formulations do not require dilution when given as an IM injection.
• Intermittent IV bolus injections should be diluted up to 2.5 mg/mL and injected at a rate of up to 4 mL/min.
• Intermittent IV infusions should be diluted up to a concentration of 0.5 mg/mL and infused at a rate of up to 5 to 7 mL/min (approximately 15 to 20 minutes).

• Alternative to oral formulations for short-term use in some hospitalized patients who are unable to take oral medications
• Short-term treatment of active duodenal ulcer
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers
• Some hospitalized patients with intractable duodenal ulcers

Usual Pediatric Dose for Gastroesophageal Reflux Disease

1 month to 16 years:
ORAL:

• Usual dose: 5 to 10 mg/kg/day orally, given in 2 divided doses

• Usual dose: 150 mg orally 2 times a day

• Symptomatic relief usually starts within 24 hours of starting oral treatment.
• Placebo-controlled studies included use of maintenance doses for up to 48 weeks.

• Treatment of gastroesophageal reflux disease

Usual Pediatric Dose for Erosive Esophagitis

1 month to 16 years:
ORAL:

• Usual dose: 5 to 10 mg/kg/day, given in 2 divided doses

• Treatment dose: 150 mg orally 4 times a day
• Maintenance dose: 150 mg orally 2 times a day
• Duration of therapy: Up to 48 weeks (maintenance)

• Symptomatic relief usually starts within 24 hours of starting oral treatment.
• Placebo-controlled studies included use of maintenance doses for up to 48 weeks.

• Treatment of endoscopically diagnosed erosive esophagitis

Usual Pediatric Dose for Dyspepsia

12 years and older:
ORAL (OVER-THE-COUNTER FORMULATIONS):

• Symptom relief: 75 mg orally with a glass of water
• Symptom prevention: 75 mg orally with a glass of water 30 to 60 minutes before a meal
• Maximum dose: 150 mg/day
• Duration of therapy: Up to 14 days (self-treatment)

• Relieve heartburn associated with acid indigestion and sour stomach
• Relieve heartburn associated with acid indigestion and sour stomach brought on by eating/drinking certain foods and beverages

Renal Dose Adjustments

CrCl less than 50 mL/min:
Oral: 150 mg orally every 24 hours. The frequency of dosing may be increased with caution.
Parenteral:

• IM/IV: 50 mg IM/IV every 18 to 24 hours. The frequency of dosing may be increased to every 12 hours (or further) with caution.
• Continuous infusion: Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Elderly patients: Since elderly patients are more likely to have decreased renal function, dose selection should be made cautiously, and an increased frequency of renal function monitoring should be considered.

Precautions

This drug is not recommended for use in children when used to treat pathological hypersecretory conditions or to maintain healing of erosive esophagitis. In the treatment of other indications, safety and efficacy have not been established in patients younger than 1 month (prescription-only formulations) and 12 years (over-the-counter formulations).

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: The dosing schedule should be adjusted to coincide with the end of hemodialysis.
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

• Oral solution and syrup formulations may contain alcohol, which could have deleterious effects in younger patients.
• Effervescent tablets should be placed in a glass of water and allowed to dissolve completely before administration.

• The manufacturer product information should be consulted.

• The manufacturer product information should be consulted.

• The manufacturer product information should be consulted.

• Drug concentrations of approximately 36 to 94 ng/mL are needed to inhibit 50% of stimulated gastric acid secretion.
• Studies have demonstrated that duodenal ulcer treatment doses of 100 mg orally 2 times a day were equivalent in efficacy to 150 mg orally 2 times a day.
• This drug is not labeled to treat patients with complications associated with reflux esophagitis (e.g., esophageal stricture, Barrett's esophagus).
• Patients receiving long-term treatment should be reassessed periodically.

• ALT levels, especially in patients receiving high IV doses for at least 5 days
• Renal function, especially in elderly patients and/or those with renal dysfunction

• Patients should be instructed to contact their healthcare provider if symptoms do not improve or worsen during treatment.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.