Usual Adult Dose for Duodenal Ulcer

20 mg orally once a day

• Duration of therapy: 4 weeks

Comments:

• While most patients achieve ulcer healing after 4 weeks, some patients may need an additional course of therapy to achieve ulcer healing.
• The dose should be taken after the morning meal.

Use: Short-term treatment for the healing and symptomatic relief of duodenal ulcers

Usual Adult Dose for Erosive Esophagitis

20 mg orally once a day

• Duration of therapy: 4 to 8 weeks

Comment: If patients are not healed after 8 weeks, treatment for another 8 weeks may be considered.

Use: Short-term treatment for healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD)

Usual Adult Dose for Gastric Ulcer

20 mg orally once a day

• Duration of therapy: 4 to 8 weeks

Comment: If patients are not healed after 8 weeks, treatment for another 8 weeks may be considered.

Use: Short-term treatment for healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD)

Usual Adult Dose for Duodenal Ulcer Prophylaxis

20 mg orally once a day

• Duration of therapy: Up to 12 months

Comment: Controlled studies for maintenance therapy have not extended beyond 12 months.

Use: Maintenance of healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative GERD

Usual Adult Dose for Gastroesophageal Reflux Disease

20 mg orally once a day

• Duration of therapy: Up to 4 weeks

Comment: If symptoms do not resolve after 4 weeks of therapy, an additional course of treatment may be considered.

Uses:

• Treatment of daytime and nighttime heartburn and other symptoms associated with GERD
• Treatment of symptomatic GERD

Usual Adult Dose for Helicobacter pylori Infection

20 mg orally 2 times a day, taken concomitantly with amoxicillin and clarithromycin

• Duration of therapy: 7 days

Comments:

• Refer to the manufacturer product information for dosing for amoxicillin and clarithromycin.
• All medications should be taken with morning and evening meals.
• Eradication of Helicobacter pylori has decreased the risk of duodenal ulcer recurrence.
• Patients who fail therapy should undergo susceptibility testing and/or begin alternative antimicrobial therapy. If susceptibility studies are unavailable OR patients have resistance to clarithromycin, clarithromycin, alternative antimicrobial treatment should be selected.

Use: Treatment and eradication of H pylori and active/history of duodenal ulcer disease within 5 years

Usual Adult Dose for Zollinger-Ellison Syndrome

Initial dose: 60 mg orally once a day
Maintenance dose: 60 mg orally 2 times a day or 100 mg orally once a day
Duration of therapy: Up to 1 year

Comments:

• Doses should be patient-specific and should continue for as long as clinically necessary.
• Divided dosing may be required in some patients.

Use: Long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome)

Usual Pediatric Dose for Gastroesophageal Reflux Disease

1 to 11 years:
Less than 15 kg: 5 mg orally once a day, with the option to increase to 10 mg if inadequate response
15 kg or more: 10 mg orally once a day
Duration of therapy: Up to 12 weeks

12 years or older: 20 mg orally once a day

• Duration of therapy: Up to 8 weeks

Uses:

• Treatment of GERD
• Treatment of symptomatic GERD

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild to moderate hepatic impairment (Child-Pugh A and B): No adjustment recommended.
Severe hepatic impairment (Child-Pugh C): Not recommended. If treatment is necessary, patients should be monitored for adverse reactions.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component, substituted benzimidazoles, or any of the ingredients
• 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 have not been established in patients younger than 1 year (sprinkle formulations) OR 12 years (tablet formulations).

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Avoid chewing/crushing/splitting the dose form.
• Tablets may be taken without regard to food.
• Capsule/granules should be taken 30 minutes before a meal.

Storage requirements: The manufacturer product information should be consulted.

General:

• Patients on long-term therapy should be evaluated regularly for the continued need of this drug.
• Compliance for once a day dosing may improve if this drug is taken in the morning before eating.
• There are no data for use with antibiotic therapy in patients with renal or hepatic impairment.
• Patients using this drug to treat gastroesophageal reflux disease symptoms for longer than 6 months should be further reevaluated.

Monitoring:

• HEMATOLOGIC: INR and prothrombin time in patients receiving concomitant treatment with warfarin
• METABOLIC: Magnesium levels, especially in patients taking other drugs that could result in hypomagnesemia or those on long-term therapy; calcium, vitamin D, and 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:

• Capsules may be opened and sprinkled onto room temperature or colder soft food or into a small amount of liquid. Patients should consume the whole dose within 15 minutes of preparation.
• If using this drug to treat Helicobacter pylori, tell patients that it is important to complete the 7-day regimen.
• Instruct patients to seek medical attention if signs/symptoms of hypersensitivity, Clostridium difficile, or systemic cutaneous lupus erythematosus occur.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.