Nitrofurantoin

Nitrofurantoin 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 is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions (5.7)]. …

• 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)
• Recommended Dosage and Administration in Adult Patients The recommended dosage is 50 mg to 100 mg of nitrofurantoin four times a day
• For long-term suppressive therapy
• In adults, a reduction of dosage to 50 mg to 100 mg at bedtime may be adequate
• The benefits of long-term suppressive therapy should be balanced against the increased potential for systemic toxicity and for the development of antibacterial resistance [see Warnings and Precautions ]
• Administer nitrofurantoin with food to improve drug absorption [see Clinical Pharmacology ] and, in some patients, tolerance
• Recommended Dosage and Administration
• In Pediatric Patients (1 month of age and older) The recommended dosage of nitrofurantoin is 5 mg/kg to 7 mg/kg of body weight per 24 hours, given in four divided doses
• In pediatric patients aged 1 month and older. Administer nitrofurantoin with food to improve drug absorption [ s ee Clinical Pharmacology ] and, in some patients, tolerance
• Table 1 lists individual dosage volumes for nitrofurantoin oral suspension (25 mg/5 mL) based on body weight for pediatric patients. …

Nitrofurantoin Oral Suspension, USP is available as a lemon-yellow liquid with cherry flavor, free from extraneous particles for oral suspension containing 25 mg/5 mL of nitrofurantoin. Oral Suspension: 25 mg/5 mL. (3)

• Nitrofurantoin is contraindicated
• In pediatric patients younger than 1 month of age because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability). [see Contraindications and Warnings and Precautions ]
• The safety and effectiveness of nitrofurantoin
• In pediatric patients aged 1 month of age and older for the treatment of urinary tract infections have been established

Nitrofurantoin is contraindicated in: patients with known hypersensitivity to nitrofurantoin [see Warnings and Precautions (5.1)]. patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin [see Warnings and Precautions (5.3)]. …

Antacids : Decreased absorption of nitrofurantoin. (7.1) Uricosuric drugs: Inhibit renal tubular secretion of nitrofurantoin. (7.2) 7.1 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 [see Clinical Pharmacology (12.3)] . …

Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving nitrofurantoin. If signs and symptoms of a hypersensitivity reaction occurs, immediately discontinue nitrofurantoin. (5.1) Pulmonary Reactions: Discontinue if sign and symptoms of pulmonary reactions occur and take appropriate measures. (5.2) Hepatotoxicity: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests. (5.3) Neuropathy: Peripheral neuropathy has occurred. (5.4) Hemolytic Anemia: Discontinue if sign and symptoms of hemolysis occur. …

The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Pulmonary Reactions [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.3)] Neuropathy [see Warnings and Precautions (5.4)] Hemolytic anemia [see Warnings and Precautions (5.5)] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.6)] Persistence or Reappearance of Bacteriuria [see Warnings and Precautions (5.7)] The following adverse reactions associated with the use of nitrofurantoin formulations, including nitrofurantoin oral suspension, were identifi …

8.1 Pregnancy Risk Summary Nitrofurantoin is contraindicated in pregnant women at term (38 weeks to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent because of the possibility of hemolytic anemia in the infant (see Clinical Considerations). …

Incidents of acute overdosage of nitrofurantoin have resulted in symptoms such as vomiting. Induction of emesis is recommended. There is no specific antidote, but a high fluid intake should be maintained to promote urinary excretion of the drug. Nitrofurantoin is dialyzable.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.