Usual Adult Dose for Duodenal Ulcer

300 mg orally once a day at bedtime OR 150 mg orally 2 times a day
Duration of therapy: Up to 8 weeks

Comment: Most patients heal within 4 weeks.

Use: Treatment of active duodenal ulcer

Usual Adult Dose for Duodenal Ulcer Prophylaxis

150 mg orally once a day at bedtime
Duration of therapy: Up to 1 year

Comment: Efficacy and safety data for the maintenance treatment of duodenal ulcer beyond 1 year are unknown.

Use: Maintenance therapy for duodenal ulcer patients after healing of an active duodenal ulcer

Usual Adult Dose for Gastric Ulcer

300 mg orally once a day at bedtime OR 150 mg orally 2 times a day
Duration of therapy: Up to 12 weeks

Comment: Malignant gastric ulceration should be excluded prior to starting treatment.

Use: Treatment of active benign gastric ulcer

Usual Adult Dose for Erosive Esophagitis

150 mg orally 2 times a day
Duration of therapy: Up to 12 weeks

Use: Treatment of endoscopically diagnosed esophagitis (including erosive and ulcerative esophagitis) and associated heartburn due to gastroesophageal reflux disease (GERD)

Usual Adult Dose for Gastroesophageal Reflux Disease

150 mg orally 2 times a day
Duration of therapy: Up to 12 weeks

Use: Treatment of endoscopically diagnosed esophagitis (including erosive and ulcerative esophagitis) and associated heartburn due to gastroesophageal reflux disease (GERD)

Usual Pediatric Dose for Erosive Esophagitis

12 years and older: 150 mg orally 2 times a day

• Maximum dose: 300 mg/day
• Duration of therapy: Up to 8 weeks

Use: Treatment of endoscopically diagnosed esophagitis (including erosive and ulcerative esophagitis) and associated heartburn due to GERD

Usual Pediatric Dose for Gastroesophageal Reflux Disease

12 years and older: 150 mg orally 2 times a day

• Maximum dose: 300 mg/day
• Duration of therapy: Up to 8 weeks

Use: Treatment of endoscopically diagnosed esophagitis (including erosive and ulcerative esophagitis) and associated heartburn due to GERD

Renal Dose Adjustments

Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer Treatment:

• CrCl 20 to 50 mL/min: 150 mg orally once a day
• CrCl less than 20 mL/min: 150 mg orally every other day

Maintenance Therapy:

• CrCl 20 to 50 mL/min: 150 mg orally every other day
• CrCl less than 20 mL/min: 150 mg orally every 3 days

Renal failure: Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component, other histamine-2 (H2)-receptor antagonists, or any of the ingredients

Safety and efficacy of capsules have not been established in pediatric patients.
Safety and efficacy of oral solutions have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Once a day doses should be given at bedtime.

Storage requirements:

• Oral solution: Protect from light.

Patient advice:

• Patients should be advised that symptomatic response to treatment does not preclude the presence of a gastric malignancy.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.