Usual Adult Dose for Duodenal Ulcer

Oral:

• Usual dose: 40 mg orally once a day at bedtime OR 20 mg orally 2 times a day
• Maintenance dose: 20 mg orally once a day at bedtime
• Duration of therapy: 4 weeks

• Usual dose: 20 mg IV every 12 hours

• Most patients who received oral formulations healed within 4 weeks, with few patients requiring treatment for 6 to 8 weeks; there are no safety data for the treatment of uncomplicated active duodenal ulcer beyond 8 weeks. Studies have not been conducted in patients receiving oral maintenance therapy for longer than 1 year.
• Parenteral treatment should be limited to patients who cannot tolerate oral formulations.

• Short-term treatment of active duodenal ulcer
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer
• Hospitalized patients with intractable ulcers, or as an alternative to the oral dosage forms for short-term use in patients who are unable to take oral medication for active duodenal ulcers
• Alternative to the oral dosage forms for short-term use in specific hospitalized patients who are unable to take oral medication for duodenal ulcer maintenance therapy

Usual Adult Dose for Peptic Ulcer

Oral:

• Usual dose: 40 mg orally once a day at bedtime OR 20 mg orally 2 times a day
• Maintenance dose: 20 mg orally once a day at bedtime
• Duration of therapy: 4 weeks

• Usual dose: 20 mg IV every 12 hours

• Most patients who received oral formulations healed within 4 weeks, with few patients requiring treatment for 6 to 8 weeks; there are no safety data for the treatment of uncomplicated active duodenal ulcer beyond 8 weeks. Studies have not been conducted in patients receiving oral maintenance therapy for longer than 1 year.
• Parenteral treatment should be limited to patients who cannot tolerate oral formulations.

• Short-term treatment of active duodenal ulcer
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer
• Hospitalized patients with intractable ulcers, or as an alternative to the oral dosage forms for short-term use in patients who are unable to take oral medication for active duodenal ulcers
• Alternative to the oral dosage forms for short-term use in specific hospitalized patients who are unable to take oral medication for duodenal ulcer maintenance therapy

Usual Adult Dose for Gastric Ulcer

Oral:

• Usual dose: 40 mg orally once a day at bedtime
• Duration of therapy: 6 weeks

• Usual dose: 20 mg IV every 12 hours

• Most patients who received oral formulations healed within 6 weeks; there are no safety data for the treatment of uncomplicated active benign gastric ulcer beyond 8 weeks.
• Parenteral treatment should be limited to patients who cannot tolerate oral formulations.

• Short-term treatment of active benign gastric ulcer
• Hospitalized patients with intractable ulcers, or as an alternative to the oral dosage forms for short-term use in patients who are unable to take oral medication for active benign gastric ulcers

Usual Adult Dose for Gastroesophageal Reflux Disease

Oral:

• Usual dose: 20 mg orally 2 times day
• Duration of therapy: Up to 6 weeks

• Usual dose: 20 mg IV every 12 hours

• Parenteral treatment should be limited to patients who cannot tolerate oral formulations.

• Short-term treatment of gastroesophageal reflux disease (GERD)
• Alternative to the oral dosage forms for short-term use in specific hospitalized patients who are unable to take oral medication for GERD

Usual Adult Dose for Erosive Esophagitis

Oral:

• Usual dose: 20 to 40 mg orally 2 times a day
• Duration of therapy: Up to 12 weeks

• Usual dose: 20 mg IV every 12 hours

• Parenteral treatment should be limited to patients who cannot tolerate oral formulations.

• Short-term treatment of esophagitis due to gastroesophageal reflux disease (GERD), including erosive/ulcerative disease diagnosed by endoscopy
• Alternative to the oral dosage forms for short-term use in specific hospitalized patients who are unable to take oral medication for esophagitis due to GERD

Usual Adult Dose for Zollinger-Ellison Syndrome

Oral:

• Initial dose: 20 mg orally every 6 hours
• Maximum dose: 160 mg orally every 6 hours

• Usual dose: 20 mg IV every 6 to 12 hours

• Parenteral treatment should be limited to patients who cannot tolerate oral formulations.
• Dosing should be determined on an individual basis.
• Treatment should be continued for as long as clinically necessary.

• Treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome and multiple endocrine adenomas
• Some hospitalized patients with pathological hypersecretory conditions

Usual Adult Dose for Pathological Hypersecretory Conditions

Oral:

• Initial dose: 20 mg orally every 6 hours
• Maximum dose: 160 mg orally every 6 hours

• Usual dose: 20 mg IV every 6 to 12 hours

• Parenteral treatment should be limited to patients who cannot tolerate oral formulations.
• Dosing should be determined on an individual basis.
• Treatment should be continued for as long as clinically necessary.

• Treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome and multiple endocrine adenomas
• Some hospitalized patients with pathological hypersecretory conditions

Usual Adult Dose for Dyspepsia

Oral:
Over-the-Counter (OTC) Formulations:

• Treatment dose: 10 to 20 mg orally once
• Symptom prevention: 10 to 20 mg orally once 10 to 60 minutes prior to consuming food/beverages that cause heartburn
• Maximum dose: 2 tablets/day
• Maximum duration of therapy: 14 days

• OTC tablet formulations should be taken with a glass of water.
• Chewable tablet formulations should be chewed completely before swallowing.

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

Usual Pediatric Dose for Peptic Ulcer

1 TO 16 YEARS:
Oral:

• Usual dose: 0.5 mg/kg orally once a day at bedtime OR 0.25 mg/kg orally 2 times a day
• Maximum dose: 40 mg/day

• Initial dose: 0.25 mg/kg IV injected over at least 2 minutes OR infused over 15 minutes every 12 hours
• Maximum dose: 40 mg/day

• Usual dose: 40 mg orally once a day at bedtime OR 20 mg orally 2 times a day
• Maintenance dose: 20 mg orally once a day at bedtime
• Duration of therapy: 4 weeks

• Usual dose: 20 mg IV every 12 hours

• Uncontrolled clinical trials have used oral doses up to 1 mg/kg in patients 1 to 16 years of age.
• Gastric acid suppression occurred at IV doses of 0.5 mg/kg every 12 hours.

• Short-term treatment of active duodenal ulcer
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer
• Hospitalized patients with intractable ulcers, or as an alternative to the oral dosage forms for short-term use in patients who are unable to take oral medication for active duodenal ulcers
• Alternative to the oral dosage forms for short-term use in specific hospitalized patients who are unable to take oral medication for duodenal ulcer maintenance therapy

Usual Pediatric Dose for Gastroesophageal Reflux Disease

LESS THAN 3 MONTHS:
Oral:

• Initial dose: 0.5 mg/kg orally once a day
• Duration of therapy: Up to 8 weeks

• Initial dose: 0.5 mg/kg orally 2 times a day
• Duration of therapy: Up to 8 weeks

• Usual dose: 0.5 mg/kg/day orally 2 times a day
• Maximum dose: Up to 40 mg/dose

• Initial dose: 0.25 mg/kg IV injected over at least 2 minutes OR infused over 15 minutes every 12 hours
• Maximum dose: 40 mg/day

• Usual dose: 20 mg orally 2 times day
• Duration of therapy: Up to 6 weeks

• Usual dose: 20 mg IV every 12 hours

• The concomitant use of conservative measures (e.g., thickened feedings) should be considered during treatment.
• Parenteral treatment should be limited to patients who cannot tolerate oral formulations.
• Uncontrolled clinical trials have used oral doses up to 2 mg/kg in patients 1 to 16 years of age with gastroesophageal reflux disease (GERD) with/without esophagitis (including erosions ad ulcerations).
• Oral dissolving tablets may be used in patients 6 years and older, but should be taken as an intact tablet.

• Short-term treatment of esophagitis due to gastroesophageal reflux disease, including erosive/ulcerative disease diagnosed by endoscopy
• Alternative to the oral dosage forms for short-term use in specific hospitalized patients who are unable to take oral medication for GERD

Usual Pediatric Dose for Dyspepsia

12 YEARS AND OLDER:
Oral:
Over-the-Counter (OTC) Formulations:

• Treatment dose: 10 to 20 mg orally once
• Symptom prevention: 10 to 20 mg orally once 10 to 60 minutes prior to consuming food/beverages that cause heartburn
• Maximum dose: 2 tablets/day
• Maximum duration of therapy: 14 days

• OTC formulations should be taken with a glass of water.
• Chewable tablet formulations should be chewed completely before swallowing.

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

Renal Dose Adjustments

Mild renal dysfunction (CrCl 50 to 90 mL/min): No adjustment recommended.
Moderate (CrCl less than 50 mL/min) to severe renal dysfunction (CrCl less than 10 mL/min): Reduce the dose by 50% and/or prolong the dosing interval to 36 to 48 hours

Liver Dose Adjustments

Data not available

Dose Adjustments

Elderly patients: Dose selection should take into account age-related changes in renal function, and additional renal function monitoring may be necessary. Elderly patients with moderate to severe renal function should follow renal dose adjustments.

Precautions

Safety and efficacy of parenteral formulations have not been established in patients younger than 1 year.

Safety and efficacy of oral dissolving tablets have not been established in patients younger than 6 years, and the safety and efficacy of over-the-counter formulations have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Patients may use antacids concomitantly with treatment.
• Oral suspension: Patients should shake the oral suspension vigorously for 5 to 10 seconds prior to use.
• Oral dissolving tablets (ODT): Tablets should be removed just prior to use. Patients should take the tablet out of the bottle with dry hands and place on the tongue to be dissolved and swallowed. ODTs typically disintegrate within 2 minutes.
• Tablets: Patients should avoid chewing tablets during administration.

• The manufacturer product information should be consulted.

• The manufacturer product information should be consulted.

• The manufacturer product information should be consulted.

• This drug was not found to affect fasting or postprandial gastrin levels, gastric emptying, or exocrine pancreatic function.
• Patients with hypersecretory conditions have used this drug for over 1 year without experiencing tachyphylaxis or significant adverse effects.

• Renal function, especially in patients with/at risk of renal dysfunction

• Patients should be told to discard any oral suspension remaining after 30 days.
• Inform patients that this drug may cause dizziness, confusion, or hallucinations, and they should avoid driving or operating machinery until the full effects of the drug are seen.
• 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.

Frequently asked questions

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