Usual Adult Dose for Duodenal Ulcer

20 mg orally once a day

• Duration of therapy: 4 weeks

Comment: If patients are not fully healed after 4 weeks, treatment may continue for another 4 weeks.

Use: Short-term treatment of active duodenal ulcer

Usual Adult Dose for Helicobacter pylori Infection

Dual therapy: 40 mg orally once a day, taken concomitantly with clarithromycin

• Duration of therapy: 14 days

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

• Duration of therapy: 10 days

Comments:

• Patients presenting with an ulcer at the time of treatment should continue treatment with a 20 mg dose orally once a day for 14 days (dual therapy) or 18 days (triple therapy).
• Antibiotic selection should be determined by local bacterial resistance, duration of treatment, and appropriate use.
• Refer to the manufacturer product information for dosing for amoxicillin and/or clarithromycin.
• Patients who failed therapy were more likely to develop clarithromycin resistance when they received dual therapy.
• Susceptibility testing should be performed in patients who fail treatment; alternative antimicrobial therapy should be used when clarithromycin resistance is demonstrated, or susceptibility testing is not possible.

Uses: Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence

• TRIPLE THERAPY: In combination with clarithromycin and amoxicillin for the treatment of patients with H pylori infection and active or a history of duodenal ulcer disease (within 1 year) to eradicate H pylori
• DUAL THERAPY: In combination with clarithromycin for the treatment of patients with H pylori infection and duodenal ulcer disease to eradicate H pylori

Usual Adult Dose for Gastric Ulcer

40 mg orally once a day

• Duration of therapy: 4 to 8 weeks

Use: Short-term treatment of active benign gastric ulcer

Usual Adult Dose for Erosive Esophagitis

Treatment: 20 mg orally once a day

• Duration of therapy: 4 to 8 weeks

Maintenance: 20 mg orally once a day

Comments:

• Controlled studies for maintenance therapy did not extend past 12 months.
• Patients who do not respond after 8 weeks of treatment may continue for an additional 4 weeks.
• If there is a recurrence of erosive esophagitis (EE) or gastroesophageal reflux disease (GERD) symptoms, an additional 4 to 8-week course of treatment should be considered.

Uses:

• Short-term treatment of EE due to acid-mediated GERD that has been diagnosed by endoscopy
• Maintenance of healing of EE due to acid-mediated GERD

Usual Adult Dose for Multiple Endocrine Adenomas

Initial dose: 60 mg orally once a day
Maximum dose: 360 mg/day (as 120 mg orally 3 times a day)

Comments:

• Doses higher than 80 mg should be given in divided doses.
• The treatment duration should be for as long as clinically necessary. Some patients with Zollinger-Ellison Syndrome have been treated for longer than 5 years.

Use: Long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis)

Usual Adult Dose for Systemic Mastocytosis

Initial dose: 60 mg orally once a day
Maximum dose: 360 mg/day (as 120 mg orally 3 times a day)

Comments:

• Doses higher than 80 mg should be given in divided doses.
• The treatment duration should be for as long as clinically necessary. Some patients with Zollinger-Ellison Syndrome have been treated for longer than 5 years.

Use: Long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis)

Usual Adult Dose for Zollinger-Ellison Syndrome

Initial dose: 60 mg orally once a day
Maximum dose: 360 mg/day (as 120 mg orally 3 times a day)

Comments:

• Doses higher than 80 mg should be given in divided doses.
• The treatment duration should be for as long as clinically necessary. Some patients with Zollinger-Ellison Syndrome have been treated for longer than 5 years.

Use: Long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis)

Usual Adult Dose for Hypersecretory Conditions

Initial dose: 60 mg orally once a day
Maximum dose: 360 mg/day (as 120 mg orally 3 times a day)

Comments:

• Doses higher than 80 mg should be given in divided doses.
• The treatment duration should be for as long as clinically necessary. Some patients with Zollinger-Ellison Syndrome have been treated for longer than 5 years.

Use: Long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis)

Usual Adult Dose for Gastroesophageal Reflux Disease

20 mg orally once a day

• Duration of therapy: Up to 4 weeks

Use: Treatment of heartburn and other symptoms associated with GERD

Usual Adult Dose for Dyspepsia

Over-the-Counter (OTC) formulations: 20 mg orally once a day in the morning

• Duration of therapy: 14 days

Comments:

• A 14-day course of treatment may be repeated every 4 months.
• This drug should be taken with a full glass of water prior to eating.
• Some patients may experience symptom relief within 24 hours of taking the first dose.

Use: Treatment of frequent heartburn (occurring 2 or more days a week)

Usual Pediatric Dose for Gastroesophageal Reflux Disease

1 to 16 years:

• Weight 5 to less than 10 kg: 5 mg orally once a day
• Weight 10 to less than 20 kg: 10 mg orally once a day
• Weight 20 kg and greater: 20 mg orally once a day

Duration of therapy: Up to 4 weeks

16 to 18 years: 20 mg orally once a day

• Duration of therapy: Up to 4 weeks

Use: Treatment of heartburn and other symptoms associated with GERD

Usual Pediatric Dose for Erosive Esophagitis

TREATMENT:
1 month to less than 1 year:

• Weight 3 to less than 5 kg: 2.5 mg orally once a day
• Weight 5 to less than 10 kg: 5 mg orally once a day
• Weight 10 kg and greater: 10 mg orally once a day

Duration of therapy: Up to 6 weeks

1 to 16 years:

• Weight 5 to less than 10 kg: 5 mg orally once a day
• Weight 10 to less than 20 kg: 10 mg orally once a day
• Weight 20 kg and greater: 20 mg orally once a day

Duration of therapy: 4 to 8 weeks

16 to 18 years: 20 mg orally once a day

• Duration of therapy: 4 to 8 weeks

MAINTENANCE:
1 to 16 years:

• Weight 5 to less than 10 kg: 5 mg orally once a day
• Weight 10 to less than 20 kg: 10 mg orally once a day
• Weight 20 kg and greater: 20 mg orally once a day

16 to 18 years: 20 mg orally once a day

Comments:

• Patients who do not respond after 8 weeks of treatment may continue for an additional 4 weeks.
• If there is a recurrence of EE or GERD symptoms, an additional 4 to 8-week course of treatment should be considered.
• Controlled studies for the treatment EE did not extend past 8 weeks, and maintenance studies did not extend beyond 12 months.

Uses:

• Short-term treatment of EE due to acid-mediated GERD that has been diagnosed by endoscopy
• Short-term treatment of EE due to acid-mediated GERD
• Maintenance of healing of EE due to acid-mediated GERD

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Maintenance of healing of EE: 10 mg orally once a day

Dose Adjustments

Maintenance of healing of EE in Asian patients: 10 mg orally once a day

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component, substituted benzimidazoles, or any of the ingredients
• The concomitant 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 month (prescription formulations) or 18 years (OTC formulations).

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Tablet and capsule formulations should be swallowed whole, without crushing/chewing.
• The delayed-release capsule may be opened and sprinkled onto a tablespoon of applesauce and swallowed immediately. Do not chew or crush granules.
• The delayed-release oral suspension may be emptied into a small volume of water, allowed to thicken (approximately 2 to 3 minutes), and swallowed within 30 minutes. Remaining material should be mixed with more water and swallowed immediately.
• The suspension may be mixed with water 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:

• The IV formulation should be used when oral formulations are inappropriate; IV use should be discontinued as soon as treatment with an oral formulation is possible. A single 10 mg IV dose was shown to be equivalent to a single 20 mg oral tablet dose.
• Antacids may be used concomitantly during treatment.

Monitoring:

• 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

Patient advice:

• Patients should be advised that use is not intended for immediate relief. Patients may not experience full effects for up to 4 days.
• 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, dizziness, vertigo, and/or visual disturbances. They should avoid driving or operating machinery until the full effects of the drug are seen.
• Patients should ask their healthcare provider before use if they are taking a prescription drug.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

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