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 ( |
|
GERD with or without esophagitis and ulcerations ( |
0.5 mg/kg twice daily ( Maximum of 40 mg twice daily ( |
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|
|
|
40 mg once daily; or 20 mg twice daily |
Up to 8 weeks |
|
40 mg once daily |
Up to 8 weeks |
|
20 mg twice daily |
Up to 6 weeks |
|
20 mg twice daily; or 40 mg twice daily |
Up to 12 weeks |
|
Starting dosage: 20 mg every 6 hours; adjust dosage to individual patient needs Maximum dosage 160 mg every 6 hours |
As clinically indicated |
|
20 mg once daily |
1 year |
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|
|
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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 weeks |
|
Birth to less than 3 months |
Starting dosage 0.5 mg/kg once daily. May increase to 1 mg/kg once daily |
Up to 8 weeks |
3 months to less than 1 year |
Starting dosage 0.5 mg/kg twice daily. May increase to 1 mg/kg twice daily Maximum of 40 mg per day |
||
|
1 year to less than 17 years |
0.5 mg/kg twice daily Maximum of 40 mg twice daily |
6 to 12 weeks |
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|
|
|
|
|
20 mg once daily; or 40 mg every other day |
10 mg once daily; or 20 mg every other day |
|
20 mg once daily; or 40 mg every other day |
10 mg once daily; or 20 mg every other day |
|
20 mg once daily |
10 mg once daily; or 20 mg every other day |
|
20 mg once daily; or 40 mg every other day |
10 mg once daily; or 20 mg every other day |
40 mg once daily |
20 mg once daily |
|
|
Avoid use |
|
|
10 mg once daily; or 20 mg every other day |
10 mg every other day |
|
|
Pediatric Patients |
26 ± 13 |
Adults |
|
Healthy adult subjects |
26.5 ± 10.3 |
Adult patients with upper GI bleeding |
18.7 ± 10.8 |
Infants from Birth to 12 Months (N=5) |
Pediatric Patients 11 Years to 15 Years (N=8) |
|
AUC0-∞(ng*hr/mL) |
645 ± 249 |
580 ± 60 |
Cmax (ng/mL) |
79.2 |
97.3 |
Tmax (hr) |
2.0 (1.0, 4.1) |
2.3 (2.1, 2.9) |
T1/2 (hr) |
5.82 |
2.13 |
40 mg at bedtime (N=89) |
20 mg twice daily (N=84) |
at bedtime (N=97) |
|
Week 2 |
32% |
38% |
17% |
Week 4 |
70% |
67% |
31% |
U.S. Study (N=149) |
International Study (N=294) |
|||
40 mg at bedtime (N=74) |
at bedtime (N=75) |
40 mg at bedtime (N=149) |
at bedtime (N=145) |
|
Week 4 |
45% |
39% |
47% |
31% |
Week 6 |
66% |
44% |
65% |
46% |
Week 8 |
78% |
64% |
80% |
54% |
20 mg twice daily (N=154) |
40 mg at bedtime (N=149) |
at bedtime (N=73) |
|
Week 6 |
82% |
69% |
62% |
40 mg twice daily (N=127) |
20 mg twice daily (N=125) |
twice daily (N=66) |
|
Week 6 |
48% |
32% |
18% |
Week 12 |
69% |
54% |
29% |
40 mg twice daily (N=175) |
20 mg twice daily (N=93) |
150 mg twice daily (N=172) |
|
Week 6 |
48% |
52% |
42% |
Week 12 |
71% |
68% |
60% |
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|
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|
16714-244-01 |
40 mg |
Bottle |
White to off-white powder. When constituted as directed, famotidine suspension is a smooth, mobile, off-white, homogeneous suspension with a cherry-mint flavor, containing 40 mg of famotidine per 5 mL. |