Active DU | 40 mg once daily; or 20 mg twice daily |
Active GU | 40 mg once daily |
Symptomatic Nonerosive GERD | 20 mg twice daily |
Erosive Esophagitis due to GERD | 20 mg twice daily; or 40 mg twice daily |
Pathological Hypersecretory Conditions |
20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours |
Risk Reduction of DU Recurrence | 20 mg once daily |
Peptic Ulcer Disease |
Starting dosage 0.5 mg/kg once daily; or 0.25 mg/kg twice daily; may increase to 1 mg/kg once daily at bedtime or 0.5 mg/kg twice daily; Maximum of 40 mg per day |
GERD |
Starting dosage 0.5 mg/kg once daily; may increase to 1 mg/kg once daily |
Starting dosage 0.5 mg/kg twice daily; may increase to 1 mg/kg twice daily; Maximum of 40 mg per day |
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GERD with or without esophagitis and ulcerations |
0.5 mg/kg twice daily Maximum of 40 mg twice daily |
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Active DU | 40 mg once daily, or 20 mg twice dailyb | Up to 8 weeksc,d |
Active DU | 40 mg once daily | Up to 8 weeksd |
Symptomatic nonerosive GERD | 20 mg twice daily | Up to 6 weeksd |
Erosive esophagitis due to GERD, diagnosed by endoscopy | 20 mg twice daily; or 40 mg twice dailyb | Up to 12 weeks |
Pathological hypersecretory conditions | Starting dosage: 20 mg every 6 hours; adjust dosage to individual patient needs Maximum dosage 160 mg every 6 hours | As clinically indicated |
Reduction of the risk of DU recurrence | 20 mg once daily | 1 yearc,d or as clinically indicated |
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Peptic Ulcer Disease |
1 year to less than 17 years |
Starting dosage 0.5 mg/kg once daily; or 0.25 mg/kg twice daily. May increase to 1 mg/kg once daily at bedtime or 0.5 mg/kg twice daily Maximum of 40 mg per day |
8 weeksb |
GERD |
Birth to less than 3 months | Starting dosage 0.5 mg/kg once daily. May increase to 1 mg/kg once dailyb |
Up to 8 weeksb,c,d |
3 months to less than 1 year |
Starting dosage 0.5 mg/kg twice daily. May increase to 1 mg/kg twice dailyc
Maximum of 40 mg per day |
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GERD with or without esophagitis and ulcerations | 1 year to less than 17 years | 0.5 mg/kg twice daily Maximum of 40 mg twice daily |
6 to 12 weeksb |
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Creatinine clearance 30 to 60 mL/minute | Creatinine clearance less than 30 mL/minute | |
Active DU | 20 mg once daily; or 40 mg every other day | 10 mg once daily; or 20 mg every other day |
Active GU | 20 mg once daily; or 40 mg every other day | 10 mg once daily; or 20 mg every other day |
Symptomatic nonerosive GERD | 20 mg once daily | 10 mg once daily; or 20 mg every other day |
Erosive esophagitis due to GERD, diagnosed by endoscopya |
20 mg once daily; or 40 mg every other dayb | 10 mg once daily; or 20 mg every other dayb |
40 mg once dailyb | 20 mg once dailyb | |
Pathological hypersecretory conditions | Avoid useb | |
Reduction of the risk of DU recurrence | 10 mg once daily; or 20 mg every other day | 10 mg every other day |
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Pediatric Patients | 26 ± 13 |
Adults | |
Healthy adult subjects | 26.5 ± 10.3 |
Adult patients with upper GI bleeding | 18.7 ± 10.8 |
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Infants From Birth to 12 Months (N=5) |
Pediatric Patients 11 Years to 15 Years (N=8) |
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AUC0-∞ (ng*hr/mL) a | 645 ± 249 | 580 ± 60 |
Cmax (ng/mL) | 79.2 | 97.3 |
Tmax (hr)b | 2.0 (1.0, 4.1) c | 2.3 (2.1, 2.9) d |
T1/2 (hr) | 5.82 | 2.13 |
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40 mg at bedtime (N=89) |
20 mg twice daily (N=84) |
at bedtime (N=97) |
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Week 2 | 32%a | 38%a | 17% |
Week 4 | 70%a | 67%a | 31% |
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U.S. Study (N=149) |
International Study (N=294) |
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40 mg at bedtime (N=74) |
at bedtime (N=75) |
40 mg at bedtime (N=149) |
at bedtime (N=145) |
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Week 4 | 45% | 39% | 47%a | 31% |
Week 6 | 66%a | 44% | 65%a | 46% |
Week 8 | 78%b | 64% | 80%a | 54% |
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20 mg twice daily (N=154) |
40 mg at bedtime (N=149) |
at bedtime (N=73) |
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Week 6 | 82%a | 69% | 62% |
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40 mg twice daily (N=127) |
20 mg twice daily (N=125) |
twice daily (N=66) |
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Week 6 | 48%a,b | 32% | 18% |
Week 12 | 69%a,c | 54%a | 29% |
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40 mg twice daily (N=175) |
20 mg twice daily (N=93) |
150 mg twice daily (N=172) |
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Week 6 | 48% | 52% | 42% |
Week 12 | 71%a | 68% | 60% |