Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
06/06/2002
Trade Name:
Pepcid
Generic Name or Proper Name (*):
famotidine
Indications Studied:
Gastroesophageal reflux
Label Changes Summary:
Labeling for patients less than 1 year of age including information on dose, PK/PD parameters and AE profile Lower dose recommended in patients <3 months of age Pediatric patients 0-3 months of age had clearance values 2 to 4-fold less than those in older patients and adults In a clinical study of 35 pediatric patients <1 year of age, agitation was observed in 5 patients on famotidine and resolved upon discontinuation of the drug
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Merck
Pediatric Exclusivity Granted Date:
11/21/2000
NNPS:
FALSE'
Therapeutic Category:
Antiulcerative
-
-