United States - English - NLM (National Library of Medicine)

golden state medical supply, inc. - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidine 20 mg - famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of: • active duodenal ulcer. • active gastric ulcer. • symptomatic non-erosive gastroesophageal reflux disease (gerd). • erosive esophagitis due to gerd, diagnosed by biopsy. famotidine tablets are indicated in adults for the: • treatment of pathological hypersecretory conditions (e.g., zollinger- ellison syndrome, multiple endocrine neoplasias). • reduction of the risk of duodenal ulcer recurrence. famotidine is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (h 2 ) receptor antagonists. 8.1 pregnancy risk summary available data with h 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establ

United States - English - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidine 20 mg - famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: - active duodenal ulcer (du). - active gastric ulcer (gu). - symptomatic nonerosive gastroesophageal reflux disease (gerd). - erosive esophagitis due to gerd, diagnosed by biopsy. famotidine tablets are indicated in adults for the: - treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome, multiple endocrine neoplasias). - reduction of the risk of duodenal ulcer recurrence. famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (h 2 ) receptor antagonists. risk summary available data with h 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse development effects were ob

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidine 20 mg - famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: - active duodenal ulcer (du). - active gastric ulcer (gu). - symptomatic nonerosive gastroesophageal reflux disease (gerd). - erosive esophagitis due to gerd, diagnosed by biopsy. famotidine tablets are indicated in adults for the: - treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome, multiple endocrine neoplasias). - reduction of the risk of duodenal ulcer recurrence. famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (h 2 ) receptor antagonists. risk summary available data with h 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse development effects were ob

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidine 20 mg - famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: famotidine tablets are indicated in adults for the: famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (h2 ) receptor antagonists. risk summary available data with h2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see data) . the estimated background risk for major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or o

United States - English - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidine 20 mg - famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: - active duodenal ulcer (du). - active gastric ulcer (gu). - symptomatic nonerosive gastroesophageal reflux disease (gerd). - erosive esophagitis due to gerd, diagnosed by biopsy. famotidine tablets are indicated in adults for the: - treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome, multiple endocrine neoplasias). - reduction of the risk of duodenal ulcer recurrence. famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (h2 ) receptor antagonists. risk summary available data with h2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse development effects were observed with oral administrat

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidine 20 mg - famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: famotidine tablets are indicated in adults for the: famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (h2 ) receptor antagonists. available data with h2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see data) . the estimated background risk for major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse

United States - English - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidine 40 mg - famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: - active duodenal ulcer (du). - active gastric ulcer (gu). - symptomatic nonerosive gastroesophageal reflux disease (gerd). - erosive esophagitis due to gerd, diagnosed by biopsy. famotidine tablets are indicated in adults for the: - treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome, multiple endocrine neoplasias). - reduction of the risk of duodenal ulcer recurrence. famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (h 2 ) receptor antagonists. risk summary available data with h 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse development effects were ob

United States - English - NLM (National Library of Medicine)

legacy pharmaceutical packaging, llc - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidine 40 mg - famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (du). - active gastric ulcer (gu). - active gastric ulcer (gu). - symptomatic nonerosive gastroesophageal reflux disease (gerd). - erosive esophagitis due to gerd, diagnosed by biopsy. famotidine tablets are indicated in adults for the: - treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome, multiple endocrine neoplasias). - reduction of the risk of duodenal ulcer recurrence. famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (h2) receptor antagonists. risk summary available data with h2-receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see data) . the estimated background risk for major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data reproductive studies have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine tablets. while no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher. there are, however, no adequate or well-controlled studies in pregnant women. because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. risk summary there are limited data available on the presence of famotidine in human breast milk. there were no effects on the breastfed infant. there are no data on famotidine effects on milk production. famotidine is present in the milk of lactating rats (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for famotidine and any potential adverse effects on the breastfed child from famotidine tablets or from the underlying maternal condition. data animal data transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of famotidine at least 600 times the usual human dose. the safety and effectiveness of famotidine tablets have been established in pediatric patients for the treatment of peptic ulcer disease (i.e., duodenal ulcer, gastric ulcer) and gerd (i.e., symptomatic nonerosive gerd, erosive esophagitis as diagnosed by endoscopy). the use of famotidine tablets and the recommended dosage of famotidine tablets in these pediatric patients is supported by evidence from adequate and well-controlled studies of famotidine tablets in adults and published pharmacokinetic and pharmacodynamic data in pediatric patients [see dosage and administration (2.1), clinical pharmacology (12.2, 12.3)] . in pediatric patients, the safety and effectiveness for the treatment of pathological hypersecretory conditions and reduction of risk of duodenal ulcer recurrence have not been established. famotidine 20 and 40 mg tablets are not recommended for use in pediatric patients weighing less than 40 kg because these tablet strengths exceed the recommended dose for these patients [see dosage and administration (2.1)] . for pediatric patients weighing less than 40 kg, consider another famotidine formulation (e.g., oral suspension, lower dose tablet). of the 1442 famotidine tablets-treated patients in clinical studies, approximately 10% were 65 and older. in these studies, no overall differences in safety or effectiveness were observed between elderly and younger patients. in postmarketing experience, cns adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine tablets [see warnings and precautions (5.1)] . famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine tablets may be greater in elderly patients, particularly those with impaired renal function [see use in specific populations (8.6)] . in general, use the lowest effective dose of famotidine tablets for an elderly patient and monitor renal function [see dosage and administration (2.2)]. cns adverse reactions and prolonged qt intervals have been reported in patients with moderate and severe renal impairment [see warnings and precautions (5.1)]. the clearance of famotidine is reduced in adults with moderate and severe renal impairment compared to adults with normal renal function [see clinical pharmacology (12.3)]. no dosage adjustment is needed in patients with mild renal impairment (creatinine clearance greater than or equal to 60 ml/minute). dosage reduction is recommended in adult and pediatric patients greater than or equal to 40 kg with moderate or severe renal impairment (creatinine clearance less than 60 ml/minute) [see dosage and administration (2.2)].

United States - English - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidine 40 mg in 5 ml - famotidine for oral suspension is indicated in adults for the treatment of: - active duodenal ulcer (du). - active gastric ulcer (gu). - symptomatic nonerosive gastroesophageal reflux disease (gerd). - erosive esophagitis due to gerd, diagnosed by biopsy. - treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome, multiple endocrine neoplasias). - reduction of the risk of duodenal ulcer recurrence. famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of: - peptic ulcer disease. - gerd with or without esophagitis and ulcerations. famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of: - gerd. famotidine for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (h2 ) receptor antagonists. risk summary available data with

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidine 40 mg - famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: famotidine tablets are indicated in adults for the: famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (h2 ) receptor antagonists. risk summary available data with h2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see data) . the estimated background risk for major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or o