PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER (PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER).
Competitive histamine H2-receptor antagonist; inhibits gastric acid secretion by blocking H2 receptors on parietal cells.
| Metabolism | Hepatic metabolism via CYP450 enzymes; primarily CYP3A4 and CYP2D6; also undergoes sulfoxidation and N-demethylation. |
| Excretion | Renal (65–70% unchanged via tubular secretion and glomerular filtration); biliary/fecal (minor, <10%) |
| Half-life | 2.5–3.5 hours in normal renal function; prolonged to 6–8 hours in moderate renal impairment (CrCl <50 mL/min) and up to 20 hours in severe renal failure (CrCl <10 mL/min) |
| Protein binding | 15–20%, primarily to albumin |
| Volume of Distribution | 1.0–1.3 L/kg; distributes widely into tissues, including breast milk and across placenta |
| Bioavailability | Oral: 40–50% (first-pass metabolism); IV: 100% |
| Onset of Action | Oral: 60 minutes; IV: 15–30 minutes; onset of acid suppression within 1 hour for oral |
| Duration of Action | Oral: 10–12 hours; IV: 12 hours; acid suppression persists for up to 12 hours after a single dose, allowing twice-daily dosing for gastric acid-related disorders |
20 mg intravenously every 12 hours; or 40 mg intravenously once daily. For Zollinger-Ellison syndrome, initial dose 20 mg intravenously every 6 hours; adjust based on acid output.
| Dosage form | INJECTABLE |
| Renal impairment | For CrCl < 50 mL/min: reduce dose by 50% or extend interval to every 24-36 hours. For CrCl < 10 mL/min: 20 mg intravenously every 24-36 hours. |
| Liver impairment | Child-Pugh Class B or C: no dose adjustment required; use with caution. |
| Pediatric use | 1-16 years: 0.5-1 mg/kg/dose intravenously every 6-12 hours; maximum dose 40 mg/day. For Zollinger-Ellison syndrome: individualize based on acid secretion. |
| Geriatric use | Initiate at lowest effective dose; monitor renal function. In elderly with CrCl < 50 mL/min, adjust per renal guidelines. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER (PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER).
| Breastfeeding | Excreted in human milk. M/P ratio not established. Use with caution; potential for adverse effects in nursing infants including CNS effects. |
| Teratogenic Risk | Pregnancy Category B. Animal studies have not demonstrated fetal risk, but no adequate controlled studies in pregnant women. Known to cross the placenta. No evidence of teratogenicity in first trimester. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to famotidine or any component of the formulation","Patients with history of serious adverse reaction to other H2 receptor antagonists"]
| Precautions | ["May cause hepatotoxicity and hepatitis","Monitor renal function in elderly and renally impaired patients; dose adjustment required","Avoid use in patients with serious hepatic impairment","May cause cross-sensitivity in patients allergic to other H2 receptor antagonists","Long-term use may increase risk of fractures, pneumonia, and vitamin B12 deficiency","Reversible mental confusion reported, especially in elderly or severely ill patients"] |
Loading safety data…
| No specific monitoring required beyond standard prenatal care. Watch for adverse effects like headache, dizziness, or GI disturbances. |
| Fertility Effects | No known effects on fertility in animal studies or human reports. |