FUROXONE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FUROXONE (FUROXONE).
Furazolidone is a nitrofuran antimicrobial that inhibits bacterial monoamine oxidase and disrupts bacterial DNA synthesis by undergoing reduction by bacterial nitroreductases to reactive intermediates that cause DNA cross-linking and damage.
| Metabolism | Primarily metabolized in the liver via reduction and conjugation; active metabolites are unknown. |
| Excretion | Primarily renal (approximately 65%) as unchanged drug; biliary/fecal excretion accounts for about 35%. |
| Half-life | Terminal elimination half-life is approximately 1.5–2 hours; clinically, this supports dosing every 6 hours for sustained antibacterial effect. |
| Protein binding | Approximately 25% bound to serum albumin. |
| Volume of Distribution | Approximately 1.1 L/kg; indicates extensive extravascular distribution including into tissues and fluids. |
| Bioavailability | Oral: approximately 60–70%; absorption is variable and may be affected by food. |
| Onset of Action | Oral: within 1–2 hours after administration. |
| Duration of Action | Approximately 6–8 hours; clinical effect is maintained with every 6-hour dosing. |
| Action Class | Nitrofuran & its derivatives |
| Brand Substitutes | Furachlor 100mg Tablet |
100 mg orally four times daily
| Dosage form | TABLET |
| Renal impairment | Contraindicated in renal impairment (CrCl < 50 mL/min). No dose adjustment data available for lesser impairment; use with caution. |
| Liver impairment | Contraindicated in Child-Pugh B and C cirrhosis. Dose adjustment not defined for mild impairment; monitor closely. |
| Pediatric use | 5 mg/kg/day orally divided into four doses for children over 5 years; not recommended under 1 month of age. |
| Geriatric use | Initiate at 50 mg orally three times daily; titrate cautiously due to increased risk of adverse effects and renal clearance decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FUROXONE (FUROXONE).
| Breastfeeding | Furoxone is excreted in human milk. M/P ratio not determined. Due to potential for adverse effects in nursing infants, especially hemolysis in G6PD deficiency, avoid use in breastfeeding. Recommend alternative therapy. |
| Teratogenic Risk | Furoxone (furazolidone) is contraindicated during pregnancy. Animal studies have shown teratogenic effects, and there are no adequate human studies. Risk of fetal harm if administered during pregnancy, particularly in the first trimester. Use only if clearly needed and no safer alternative exists. |
■ FDA Black Box Warning
Furazolidone should not be used in patients with known hypersensitivity to nitrofurans, or in infants under 1 month of age due to the risk of hemolytic anemia. Also carries a warning for disulfiram-like reactions when co-administered with alcohol.
| Serious Effects |
["Hypersensitivity to furazolidone or other nitrofurans","Infants less than 1 month of age","Concurrent use of alcohol or alcohol-containing preparations","Concurrent use of medications with MAOI activity or tyramine-rich foods","Pregnancy (relative contraindication; avoid unless potential benefit outweighs risk)"]
| Precautions | ["May cause hemolytic anemia in glucose-6-phosphate dehydrogenase (G6PD) deficiency","May produce disulfiram-like reactions with alcohol","Monoamine oxidase inhibitor (MAOI) activity: avoid concurrent use of tyramine-containing foods, sympathomimetics, and other MAOIs","Potential for antibacterial resistance with prolonged use","Use caution in patients with renal impairment"] |
Loading safety data…
| Fetal Monitoring |
| Monitor for signs of hypersensitivity, hemolytic anemia (especially in G6PD deficiency), and MAOI interactions (e.g., hypertensive crisis). In pregnancy, monitor fetal growth and well-being if inadvertent exposure occurs. |
| Fertility Effects | No specific data on furazolidone effects on fertility. However, as a nitrofuran derivative, potential for genotoxicity; consider risks with long-term use. Animal studies not well characterized for fertility effects. |