Famotidine intravenous
Other products: Famotidine
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From MedlinePlus, U.S. National Library of Medicine
Histamine-2 Receptor Antagonist
Dosing in kidney impairment
Published uncontrolled studies in pediatric patients 1 to 16 years of age have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased.
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Preparation and administration
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Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied. Dosage for Pediatric Patients 1 to 16 Years of Age See PRECAUTIONS, Pediatric Patients 1 to 16 Years of Age . The studies described in PRECAUTIONS, Pediatric Patients 1 to 16 Years of Age suggest that the starting dose in pediatric patients 1 to 16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day.
To prepare intravenous solutions, aseptically dilute 2 mL of Famotidine Injection (solution containing 10 mg/mL) with Sodium Chloride Injection 0.9% or other compatible intravenous solution (see Stability ) to a total volume of either 5 mL or 10 mL and inject over a period of not less than 2 minutes. To prepare intravenous infusion solutions, aseptically dilute 2 mL of Famotidine Injection with 100 mL of Dextrose 5% or other compatible solution (see Stability ), and infuse over a 15 to 30 minute period.
Concomitant Use of Antacids Antacids may be given orally concomitantly if needed. Stability Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. When added to or diluted with most commonly used intravenous solutions, e.g., Water for Injection, Sodium Chloride Injection 0.9%, Dextrose Injection 5% and 10% or Lactated Ringer's Injection, diluted Famotidine Injection is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature — see HOW SUPPLIED, Storage Conditions .
When added to or diluted with Sodium Bicarbonate Injection 5%, Famotidine Injection at a concentration of 0.2 mg/mL (the recommended concentration of famotidine intravenous infusion solutions) is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature — see HOW SUPPLIED, Storage Conditions .
Drug interactions
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- Famotidine intravenous
Label text (1 paragraph)
Drug Interactions No drug interactions have been identified. Studies with famotidine in man, in animal models, and in vitro have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.
Supplement interactions
Dietary supplement interactions
1 noted- Gastric acid inhibitors include proton pump inhibitors, such as omeprazole (Prilosec) and lansoprazole (Prevacid), and histamine 2-receptor antagonists, such as cimetidine (Tagamet) and ranitidine (Zantac). They can interfere with vitamin B12 absorption from food by slowing the release of gastric acid into the stomach and thereby lead to vitamin B12 deficiency.
Contraindications
Hypersensitivity to any component of these products. Cross sensitivity in this class of compounds has been observed. Therefore, Famotidine Injection should not be administered to patients with a history of hypersensitivity to other H 2 -receptor antagonists.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
CLikelihood score C: Probable rare cause of clinically apparent liver injury.
Famotidine is a histamine type 2 receptor antagonist (H2 blocker) which is commonly used for treatment of acid-peptic disease and heartburn. Famotidine has been linked to rare instances of clinically apparent acute liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
Pregnancy Reproductive studies have been performed in rats and rabbits at oral doses of up to 2,000 and 500 mg/kg/day, respectively, and in both species at IV 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. 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 (250 times the usual human dose) 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.
Lactation
Nursing Mothers Studies performed in lactating rats have shown that famotidine is secreted into breast milk. Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of at least 600 times the usual human dose. Famotidine is detectable in human milk. Because of the potential for serious adverse reactions in nursing infants from famotidine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Breastfeeding (LactMed)
Famotidine doses in breastmilk result in infant dosages that are lower than those used in newborn infants. Famotidine would not be expected to cause any adverse effects in breastfed infants. No special precautions are required.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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