Overview
Famotidine is a competitive histamine-2 (H) receptor antagonist that works to inhibit gastric acid secretion. It is commonly used in gastrointestinal conditions related to acid secretion, such as gastric ulcers and gastroesophageal reflux disease (GERD), in adults and children. Compared to other H receptor antagonists, famotidine displays high selectivity towards this receptor; in a study consisting of healthy volunteers and patients with acid hypersecretory disease, famotidine was about 20 to 50 times more potent at inhibiting gastric acid secretion than cimetidine and eight times more potent than ranitidine on a weight basis. Famotidine is used in various over-the-counter and off-label uses. While oral formulations of famotidine are more commonly used, the intravenous solution of the drug is available for use in hospital settings.
Indication
Famotidine is indicated in pediatric and adult patients (with the bodyweight of 40 kg and above) for the management of active duodenal ulcer (DU), active gastric ulcer, symptomatic non-erosive gastroesophageal reflux disease (GERD), and erosive esophagitis due to GERD, diagnosed by biopsy. It is also indicated in adult patients for the treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine neoplasias) and reduction of the risk of DU recurrence. The intravenous formulation of famotidine is available for some hospitalized patients with pathological hypersecretory conditions or intractable ulcers or as an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication. Over-the-counter famotidine is used for the management and prevention of heartburn caused by gastroesophageal reflux in children and adults. Off-label uses of famotidine include the reduction of NSAIDs-associated gastrointestinal effects, treatment of refractory urticarial, prevention of stress ulcer in critically-ill patients, and symptomatic relief of gastritis.
Associated Conditions
- Chronic Back Pain
- Duodenal Ulcer
- Erosive Esophagitis
- Extra-Articular Rheumatism
- Gastritis
- Heartburn
- Helicobacter Pylori Infection
- Multiple Endocrine Neoplasia
- Muscle Spasms
- Nonspecific Pain Post Traumatic Injury
- Osteoarthritis (OA)
- Postoperative pain
- Stress Ulcers
- Symptomatic Non-erosive Gastroesophageal Reflux Disease
- Zollinger-Ellison Syndrome
- Active Gastric ulcer
- Acute Duodenal Ulcers
- Gastrointestinal ulceration
- Pathological hypersecretory conditions
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/05/20 | Phase 2 | Completed | |||
2014/03/27 | Phase 1 | Completed | |||
2013/09/19 | Phase 2 | UNKNOWN | Jesper Ekelund | ||
2013/09/09 | Phase 2 | Completed | |||
2013/08/27 | Phase 4 | Completed | |||
2012/01/19 | Phase 1 | Completed | |||
2011/12/26 | Phase 3 | Completed | |||
2011/08/03 | Phase 3 | Completed | |||
2010/11/02 | Phase 4 | Completed | |||
2010/08/12 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Major Pharmaceuticals | 0904-7193 | ORAL | 20 mg in 1 1 | 8/10/2022 | |
| AvPAK | 50268-303 | ORAL | 20 mg in 1 1 | 1/9/2024 | |
| Teva Pharmaceuticals USA, Inc. | 0093-8107 | ORAL | 26.6 mg in 1 1 | 2/9/2022 | |
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8301 | ORAL | 40 mg in 1 1 | 9/6/2023 | |
| Hikma Pharmaceuticals USA Inc. | 0641-6023 | INTRAVENOUS | 10 mg in 1 mL | 1/18/2024 | |
| direct rx | 72189-141 | ORAL | 20 mg in 1 1 | 9/29/2022 | |
| Lupin Pharmaceuticals,Inc. | 43386-500 | ORAL | 40 mg in 5 mL | 11/21/2017 | |
| XLCare Pharmaceuticals, Inc. | 72865-215 | ORAL | 40 mg in 1 1 | 12/10/2021 | |
| RedPharm Drug, Inc. | 67296-1121 | ORAL | 20 mg in 1 1 | 1/13/2021 | |
| Bryant Ranch Prepack | 71335-9724 | ORAL | 40 mg in 1 1 | 6/30/2022 |
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| No EMA approvals found for this drug. | |||
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| No UK EMC drug information found for this drug. | |||||
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