Prescription Drug Information: Famotidine (Page 4 of 5)

14.2 Active Gastric Ulcer

In both a U.S. and an international multicenter, double-blind trials in patients with endoscopically confirmed active gastric ulcer (GU), orally administered famotidine 40 mg at bedtime was compared to placebo. Antacids were permitted during the trials, but consumption was not significantly different between the famotidine and placebo groups.

As shown in Table 5, the incidence of GU healing confirmed by endoscopy (dropouts counted as unhealed) with famotidine was greater than placebo at Weeks 6 and 8 in the U.S. trial, and at Weeks 4, 6 and 8 in the international trial. In these trials, most famotidine tablets-treated patients healed within 6 weeks. Trials have not assessed the safety of famotidine tablets in uncomplicated active GU for periods of more than 8 weeks.

Table 5: Patients with Endoscopically Confirmed Healed Gastric Ulcers

U.S. Study (N=149)

International Study (N=294)

Famotidine 40 mg at bedtime (N=74)

Placebo at bedtime (N=75)

Famotidine 40 mg at bedtime (N=149)

Placebo at bedtime (N=145)

Week 4

45%

39%

47% a

31%

Week 6

66% a

44%

65% a

46%

Week 8

78% b

64%

80% a

54%

a p≤0.01 vs. placebo

b p≤0.05 vs. placebo

Time to complete relief of daytime and nighttime pain was statistically significantly shorter for patients receiving famotidine than for patients receiving placebo; however, neither trial demonstrated a statistically significant difference in the proportion of patients whose pain was relieved by the end of the trial (Week 8).

14.3 Symptomatic Gastroesophageal Reflux Disease (GERD)

Orally administered famotidine was compared to placebo in a U.S. trial that enrolled patients with symptoms of GERD and without endoscopic evidence of esophageal erosion or ulceration. As shown in Table 6, patients treated with famotidine 20 mg twice daily had greater improvement in symptomatic GERD than patients treated with 40 mg at bedtime or placebo.

Table 6: Patients with Improvement of Symptomatic GERD (N=376)

Famotidine 20 mg twice daily (N=154)

Famotidine 40 mg at bedtime (N=149)

Placebo at bedtime (N=73)

Week 6

82% a

69%

62%

a p≤0.01 vs. placebo

14.4 Erosive Esophagitis due to GERD

Healing of endoscopically verified erosion and symptomatic improvement were studied in a U.S. and an international double-blind trials. Healing was defined as complete resolution of all erosions visible with endoscopy. The U.S. trial comparing orally administered famotidine 40 mg twice daily to placebo and orally administered famotidine 20 mg twice daily showed a significantly greater percentage of healing of erosive esophagitis for famotidine 40 mg twice daily at Weeks 6 and 12 (Table 7).

Table 7: Patients with Endoscopic Healing of Erosive Esophagitis — U.S. Study (N=318)

Famotidine 40 mg twice daily (N=127)

Famotidine 20 mg twice daily (N=125)

Placebo twice daily (N=66)

Week 6

48% a,b

32%

18%

Week 12

69% a,c

54% a

29%

a p≤0.01 vs. placebo

b p≤0.01 vs. famotidine 20 mg twice daily

c p≤0.05 vs. famotidine 20 mg twice daily

As compared to placebo, patients in the U.S. trial who received famotidine had faster relief of daytime and nighttime heartburn, and a greater percentage of famotidine tablets-treated patients experienced complete relief of nighttime heartburn. These differences were statistically significant.

In the international trial, when orally administered famotidine 40 mg twice daily was compared to orally administered ranitidine 150 mg twice daily, a statistically significantly greater percentage of healing of erosive esophagitis was observed with famotidine 40 mg twice daily at Week 12 (Table 8). There was, however, no significant difference in symptom relief among treatment groups.

Table 8: Patients with Endoscopic Healing of Erosive Esophagitis — International Study (N=440)

Famotidine

40 mg twice daily (N=175)

Famotidine

20 mg twice daily (N=93)

Ranitidine

150 mg twice daily (N=172)

Week 6

48%

52%

42%

Week 12

71% a

68%

60%

a p≤0.05 vs ranitidine 150 mg twice daily

14.5 Pathological Hypersecretory Conditions

In trials of patients with pathological hypersecretory conditions such as Zollinger-Ellison syndrome with or without multiple endocrine neoplasias, famotidine significantly inhibited gastric acid secretion and controlled associated symptoms. Orally administered famotidine dosages from 20 mg to 160 mg every 6 hours maintained basal acid secretion below 10 mEq/hour; initial dosages were titrated to the individual patient need and subsequent adjustments were necessary with time in some patients.

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.