Usual Adult Dose for Erosive Esophagitis

Treatment: 30 mg orally once a day

• Duration of therapy: Up to 8 weeks

Maintenance: 15 mg orally once a day

Comments:

• Controlled maintenance studies did not extend beyond 12 months.
• If patients are not healed after 8 weeks OR if erosive esophagitis recurs, treatment for another 8 weeks may be considered.

Uses:

• Short-term treatment for healing and symptom relief of all grades of erosive esophagitis
• Maintain healing of erosive esophagitis

Usual Adult Dose for Duodenal Ulcer

Treatment: 15 mg orally once a day

• Duration of therapy: Up to 4 weeks

Maintenance: 15 mg orally once a day

Comment: Controlled maintenance studies did not extend beyond 12 months.

Uses:

• Short-term treatment for healing and symptom relief of active duodenal ulcers
• Maintain healing of duodenal ulcers

Usual Adult Dose for Duodenal Ulcer Prophylaxis

Treatment: 15 mg orally once a day

• Duration of therapy: Up to 4 weeks

Maintenance: 15 mg orally once a day

Comment: Controlled maintenance studies did not extend beyond 12 months.

Uses:

• Short-term treatment for healing and symptom relief of active duodenal ulcers
• Maintain healing of duodenal ulcers

Usual Adult Dose for Duodenal Ulcer Maintenance

Treatment: 15 mg orally once a day

• Duration of therapy: Up to 4 weeks

Maintenance: 15 mg orally once a day

Comment: Controlled maintenance studies did not extend beyond 12 months.

Uses:

• Short-term treatment for healing and symptom relief of active duodenal ulcers
• Maintain healing of duodenal ulcers

Usual Adult Dose for Gastroesophageal Reflux Disease

15 mg orally once a day

• Duration of therapy: 14 days (over-the-counter [OTC] formulations); up to 8 weeks (prescription formulations)

Comments:

• Treatment may take 1 to 4 days for full effect; this drug should not be used for immediate heartburn relief.
• Patients may repeat an OTC course of treatment every 4 months.

Uses:

• Treatment of frequent heartburn occurring at least 2 days a week (OTC formulations)
• Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)

Usual Adult Dose for Gastric Ulcer

30 mg orally once a day

• Duration of therapy: Up to 8 weeks

Use: Short-term treatment for healing and symptom relief of active benign gastric ulcers

Usual Adult Dose for Multiple Endocrine Adenomas

Initial dose: 60 mg orally once a day
Maintenance dose: 60 to 180 mg/day

Comments:

• A daily dose higher than 120 mg should be given as divided doses.
• Doses should be patient-specific and should continue as long as clinically necessary. Some patients with Zollinger-Ellison syndrome (ZES) have been on treatment for longer than 4 years.

Use: Long-term treatment of pathological hypersecretory conditions, including ZES with/without multiple endocrine adenomas

Usual Adult Dose for Systemic Mastocytosis

Initial dose: 60 mg orally once a day
Maintenance dose: 60 to 180 mg/day

Comments:

• A daily dose higher than 120 mg should be given as divided doses.
• Doses should be patient-specific and should continue as long as clinically necessary. Some patients with Zollinger-Ellison syndrome (ZES) have been on treatment for longer than 4 years.

Use: Long-term treatment of pathological hypersecretory conditions, including ZES with/without multiple endocrine adenomas

Usual Adult Dose for Zollinger-Ellison Syndrome

Initial dose: 60 mg orally once a day
Maintenance dose: 60 to 180 mg/day

Comments:

• A daily dose higher than 120 mg should be given as divided doses.
• Doses should be patient-specific and should continue as long as clinically necessary. Some patients with Zollinger-Ellison syndrome (ZES) have been on treatment for longer than 4 years.

Use: Long-term treatment of pathological hypersecretory conditions, including ZES with/without multiple endocrine adenomas

Usual Adult Dose for Helicobacter pylori Infection

Triple Therapy: 30 mg orally 2 times a day, taken concomitantly with amoxicillin and clarithromycin

• Duration of therapy: 10 to 14 days

Dual Therapy: 30 mg orally 3 times a day, taken concomitantly with amoxicillin

• Duration of therapy: 14 days

Comments:

• Refer to the manufacturer product information for dosing for amoxicillin and/or clarithromycin.
• Eradication of Helicobacter pylori has been shown to reduce duodenal ulcer recurrence, and may result in duodenal/gastric ulcer healing without the need for continued therapy.

Uses:

• Triple therapy: In combination with amoxicillin and clarithromycin for the treatment of patients with H pylori infection and duodenal ulcer disease (active/1-year history of a duodenal ulcer) to eradicate H pylori
• Dual therapy: In combination with amoxicillin for the treatment of patients with H pylori infection and duodenal ulcer disease (active/1-year history of a duodenal ulcer) who are either allergic/intolerant to clarithromycin OR in whom resistance to clarithromycin is known/suspected

Usual Adult Dose for NSAID-Induced Gastric Ulcer

30 mg orally once a day

• Duration of therapy: Up to 8 weeks

Comment: Treatment studies did not extend beyond 8 weeks.

Use: Treatment of NSAID-associated gastric ulcer in patients who continue NSAID use

Usual Adult Dose for NSAID-Induced Ulcer Prophylaxis

15 mg orally once a day

• Duration of therapy: Up to 12 weeks

Comment: Prophylaxis studies did not extend beyond 12 weeks.

Use: Reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID

Usual Pediatric Dose for Gastroesophageal Reflux Disease

1 to 11 years:

• Less than or equal to 30 kg: 15 mg orally once a day
• Greater than 30 kg: 30 mg orally once a day
• Duration of therapy: Up to 12 weeks

12 years and older: 15 mg orally once a day

• Duration of therapy: Up to 8 weeks

Uses:

• Short-term treatment of GERD and other symptoms associated with GERD
• Short-term treatment of symptomatic, non-erosive GERD

Usual Pediatric Dose for Erosive Esophagitis

1 to 11 years:

• Less than or equal to 30 kg: 15 mg orally once a day
• Greater than 30 kg: 30 mg orally once a day
• Duration of therapy: Up to 12 weeks

12 to 17 years: 30 mg orally once a day

• Duration of therapy: Up to 8 weeks

Use: Short-term treatment for healing and symptom relief of all grades of erosive esophagitis

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh Class A to B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh Class C): 15 mg orally once a day

Dose Adjustments

Patients receiving high-dose methotrexate: Temporary withdrawal of this drug should be considered.

Precautions

CONTRAINDICATIONS:

• Known severe hypersensitivity to the active component or any of the ingredients
• Use with rilpivirine-containing products

For the treatment of H pylori (as combination therapy): Refer to the contraindications section of the other antibacterial agents for further information.

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

Safety and efficacy of over-the-counter formulations have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be taken prior to eating and should not be crushed/chewed. Ideally, this drug should be taken in the morning, 30 minutes prior to breakfast.
• The oral dissolvable tablet should be placed on the tongue and allowed to disintegrate.
• The delayed-release capsule may be opened and sprinkled onto a tablespoon of applesauce, pudding, cottage cheese, yogurt, or strained pears and swallowed immediately. Do not chew or crush granules. Alternatively, it may also be emptied into a small volume (60 mL) of either apple juice, orange juice or tomato juice and swallowed immediately. Rinse glass with more juice and swallow 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.

General:

• Children younger than 1 year of age did not show beneficial effects when treated for gastroesophageal reflux disease.
• H pylori eradication rates reach 90% when this drug is combined with clarithromycin and amoxicillin/metronidazole. Lower eradication rates were seen in the combination of this drug, amoxicillin, and metronidazole.
• Treatment should be given at least an hour prior to sucralfate or antacids.
• A single, 30 mg dose inhibited stimulated acid secretion by 30%; after repeated dosing over 7 days, 90% of stimulated acid secretion was inhibited.

Monitoring:

• METABOLIC: Magnesium levels, especially in patients taking other drugs that could result in hypomagnesemia or those on long-term therapy
• METABOLIC: Vitamin B12 levels, especially in patients on long-term therapy
• MUSCULOSKELETAL: Bone fractures, especially in patients at high risk for osteoporosis-related events

Patient advice:

• 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.
• Inform patients that this drug may cause drowsiness, somnolence, dizziness, vertigo, and/or visual disturbances. They should avoid driving or operating machinery until the full effects of the drug are seen.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.