Nitrofurantoin

Nitrofurantoin oral suspension is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli, Enterococcus species, Staphylococcus aureus, Klebsiella species and Enterobacter species. Limitations of Use Nitrofurantoin oral suspension is not indicated for the treatment of pyelonephritis or perinephric abscesses. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin oral suspension and other antibacterial drugs, nitrofurantoin oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

Nitrofurantoin is an antibacterial drug.

Adult Patients: 50 mg to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections. Pediatric Patients: 5 mg/kg to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).

Nitrofurantoin oral suspension is contraindicated in: • patients with known hypersensitivity to nitrofurantoin. • patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. • patients who have anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) due to an increased risk of toxicity resulting from impaired excretion of the drug.

• Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving nitrofurantoin oral suspension. If signs and symptoms of a hypersensitivity reaction occurs, immediately discontinue nitrofurantoin oral suspension. • Pulmonary Reactions: Discontinue if sign and symptoms of pulmonary reactions occur and take appropriate measures. • Hepatotoxicity: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests. • Neuropathy: Peripheral neuropathy has occurred. • Hemolytic Anemia: Discontinue if sign and symptoms of hemolysis occur. • Clostridioides difficile -associated diarrhea: Evaluate patients if diarrhea occurs.

The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: • Hypersensitivity Reactions • Pulmonary Reactions • Hepatotoxicity • Neuropathy • Hemolytic anemia • Clostridioides difficile -associated Diarrhea • Persistence or Reappearance of Bacteriuria The following adverse reactions associated with the use of nitrofurantoin formulations, including, nitrofurantoin oral suspension were identified in clinical studies or post-marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Respiratory: chronic, subacute, or acute pulmonary hypersensitivity reactions have occurred.

Antacids: Decreased absorption of nitrofurantoin. Uricosuric drugs: Inhibit renal tubular secretion of nitrofurantoin. Antacids Antacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of nitrofurantoin onto the surface of magnesium trisilicate. If coadministration of nitrofurantoin with antacids containing magnesium trisilicate cannot be avoided, monitor for lack of efficacy. Uricosuric Drugs Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin. The resulting increase in nitrofurantoin serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial.

It is stable when stored between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from freezing.