Famotidine
Famotidine Prescribing Information
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.
- Recommended adult dosage by indication (2.1):
| 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 |
- Recommended pediatric dosage by indication (2.2):
| Peptic Ulcer Disease | 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 |
| GERD | Birth to less than 3 months Starting dosage 0.5 mg/kg once daily; may increase to 1 mg/kg once daily |
| 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 | |
| GERD with or without esophagitis and ulcerations | 1 year to less than 17 years 0.5 mg/kg twice daily Maximum of 40 mg twice daily |
- See full prescribing information for complete dosing information in adults and pediatrics, recommended treatment duration by indication, and dosage adjustment for adult patients with renal impairment. (2.1, 2.2, 2.3)
- Take once daily before bedtime or twice daily in the morning and before bedtime with or without food.
For Oral Suspension: 400 mg as a white to off-white powder. When constituted as directed, famotidine for oral suspension USP is a white to off-white powder forming a white to off-white homogenous suspension with a cherry-banana flavor, containing 40 mg of famotidine per 5 mL.
- Geriatric Use:Use the lowest effective dose for an elderly patient and monitor renal function. (2.2, 5.1, 8.5)
- Renal Impairment:Risk of CNS adverse reactions and QT prolongation in patients with moderate and severe renal impairment; reduce the dosage in adults. (2.2, 8.6)
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.
- Central Nervous System (CNS) Adverse Reactions:Elderly patients and patients with renal impairment at increased risk; reduce the dosage. (2.2, 5.1, 8.5, 8.6)
- GI Malignancy:Absence of GI symptoms does not preclude the presence of gastric malignancy; evaluate prior to initiating therapy. (5.2)