Famotidine Suspension Generic Name & Formulations
Legal Class
Rx
General Description
Famotidine 40mg/5mL; pwd for reconstitution; cherry-banana-mint flavor.
Pharmacological Class
H2 blocker.
See Also
How Supplied
Contact supplier
Manufacturer
Mechanism of Action
Famotidine is a competitive inhibitor of histamine-2 (H2) receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output.
Famotidine Suspension Indications
Indications
In adults with: active duodenal ulcer; reduction of the risk duodenal ulcer recurrence; active gastric ulcer; symptomatic nonerosive gastroesophageal reflux disease (GERD); erosive esophagitis (EE); pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas). In children aged ≥1 year: peptic ulcer disease; GERD with or without esophagitis and ulcerations. In newborns to <1yr: GERD.
Famotidine Suspension Dosage and Administration
Adult
Duodenal ulcer: 40mg once daily at bedtime or 20mg twice daily for up to 8 weeks. Recurrence: 20mg once daily at bedtime for up to 1 year or as clinically indicated. Gastric ulcer: 40mg once daily at bedtime for up to 8 weeks. GERD: 20mg twice daily for up to 6 weeks. EE: 20mg or 40mg twice daily for up to 12 weeks. Hypersecretory conditions: initially 20mg every 6hrs; individualize; max 160mg every 6hrs. Renal impairment: see full labeling.
Children
Peptic ulcer: <1yr: not established. 1–16yrs: initially 0.5mg/kg/day at bedtime or 0.25mg/kg twice daily; may increase to 1mg/kg/day or 0.5mg/kg twice daily; max 40mg/day. Treat for 8 weeks. GERD: Birth–<3mos: initially 0.5mg/kg/day; may increase to 1mg/kg/day. 3mos–<1yr: initially 0.5mg/kg twice daily; may increase to 1mg/kg twice daily; max 40mg/day. 1–16yrs: 0.5mg/kg twice daily; max 40mg twice daily. Treat for up to 8 weeks (birth–<1yr) or up to 6–12 weeks (1–16yrs).
Famotidine Suspension Contraindications
Contraindications
History of serious hypersensitivity reactions to H2 receptor antagonists.
Famotidine Suspension Boxed Warnings
Not Applicable
Famotidine Suspension Warnings/Precautions
Warnings/Precautions
Symptomatic response does not preclude gastric malignancy; evaluate prior to initiation. Moderate to severe renal impairment (CrCl <50mL/min): reduce to ½ the dose or prolong dosing interval to 36–48hrs. Elderly: use low doses. Pregnancy. Nursing mothers.
Famotidine Suspension Pharmacokinetics
Elimination
Renal (65-70%). Half-life: 2.5–3.5 hours.
Famotidine Suspension Interactions
Interactions
Concomitant dasatinib, delavirdine mesylate, cefditoren, fosamprenavir: not recommended. May alter absorption of pH-dependent drugs (eg, atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, rilpivirine). May potentiate CYP1A2 substrates (eg, tizanidine); avoid; if necessary, monitor for hypotension, bradycardia, drowsiness. May give antacids concomitantly.
Famotidine Suspension Adverse Reactions
Adverse Reactions
Headache, dizziness, constipation, diarrhea, inj site reactions; rare: CNS reactions, prolonged QT interval in renal impairment (moderate and severe).
Famotidine Suspension Clinical Trials
See Literature
Famotidine Suspension Note
Notes
Formerly known under the brand name Pepcid.
Famotidine Suspension Patient Counseling
See Literature