- Oral suspension 25 mg per 5 mL
- Capsules 100 mg (as monohydrate/macrocrystals)
- Capsules 25 mg
- Capsules 50 mg
- Capsules 100 mg
May interfere with bacterial cell wall formation and bacterial duplication. Inhibits bacterial carbohydrate metabolism. Bacteriostatic in low concentrations; bactericidal at higher concentrations.
Nitrofurantoin is well absorbed from the GI tract, macrocrystalline form is absorbed more slowly, and food increases bioavailability.
Nitrofurantoin protein binding is approximately 60%.
Approximately 50% to 70% of nitrofurantoin is rapidly metabolized by body tissues.
Nitrofurantoin is eliminated in urine (30% to 50% unchanged). The t ½ in healthy patients is 20 min, and the t ½ in anephric patients is 60 min.
Special PopulationsRenal Function Impairment
Nitrofurantoin accumulates in serum.
Indications and Usage
Treatment of UTI caused by susceptible strains of Escherichia coli , enterococci , Staphylococcus aureus , certain strains of Klebsiella and Enterobacter species.
Renal function impairment (CrCl less than 60 mL/min); anuria or oliguria; pregnant women at term; infants younger than 1 mo of age.
Dosage and AdministrationAdults and Children (older than 12 yr of age)
PO 50 to 100 mg 4 times daily with meals for 7 days minimum and for at least 3 days after sterile urine is obtained. Monohydrate microcrystals: 100 mg every 12 h for 7 days.Children (older than 1 mo of age)
PO 5 to 7 mg/kg/24 h in 4 divided doses with meals and at bedtime for minimum of 7 days and for at least 3 days after sterile urine is obtained.Long-Term Suppressive Therapy
PO 50 to 100 mg at bedtime.Children
PO 1 mg/kg per 24 h as a single or 2 divided doses.
- Administer with food to improve absorption and tolerability.
- Shake oral suspension well before measuring dose.
Store capsules at controlled room temperature (59° to 86°F). Store oral suspension at controlled room temperature (68° to 77°F). Protect from freezing.
Drug InteractionsAnticholinergic drugs and food
Increased absorption of nitrofurantoin.Magnesium salts
May reduce anti-infective action by decreasing absorption.Probenecid
May increase nitrofurantoin serum levels by reducing renal elimination.
Laboratory Test Interactions
Urinary creatinine elevation and false-positive urine glucose determination with Benedict reagent (copper sulfate solution) may occur.
Dizziness; drowsiness; headache; malaise; nystagmus; peripheral neuropathy.
Alopecia; angioedema; erythema multiforme; exfoliative dermatitis; maculopapular, erythematous, or eczematous eruption; photosensitivity; pruritus; urticaria.
Optic neuritis (postmarketing).
Abdominal pain; anorexia; diarrhea; emesis; flatulence; nausea; parotiditis; pancreatitis; pseudomembranous colitis.
Agranulocytosis; aplastic anemia; decreased hemoglobin; eosinophilia; granulocytopenia; hemolytic anemia from G-6-PD deficiency; leukopenia; megaloblastic anemia; thrombocytopenia.
Cholestatic jaundice; chronic active hepatitis; hepatic necrosis; hepatitis; hepatotoxicity; increased AST and ALT; increased bilirubin and alkaline phosphatase; jaundice; permanent liver dysfunction.
Increased serum phosphorous.
Acute, subacute, or chronic pulmonary reaction (eg, shortness of breath, chest pain, cough, fever, chills); permanent pulmonary impairment.
Allergic reactions (including lupus-like syndrome); anaphylaxis; arthralgia; asthmatic attack in patient with history of asthma; benign intracranial hypertension; drug fever; muscular aches; sialadenitis; superinfection.
Monitor patient for signs and symptoms of pulmonary hypersensitivity reaction. Monitor patient for signs and symptoms of liver dysfunction.
Category B . Contraindicated in women at term. Do not give to pregnant patient with G-6-PD deficiency.
Excreted in breast milk.
Contraindicated in infants younger than 1 mo of age. Monohydrate microcrystals: Safety and efficacy not established in children younger than 12 yr of age.
Prolonged or repeated therapy with antibiotics may result in overgrowth of nonsusceptible bacteria or fungi.
Hemolytic anemia has occurred, apparently linked to G-6-PD deficiencies. Discontinue at any sign of hemolysis.
May become severe or irreversible; fatalities have been reported. Predisposing conditions such as renal function impairment, anemia, diabetes, electrolyte imbalance, vitamin B deficiency, and debilitating diseases may increase risk.
Consider in patients who develop diarrhea.
Acute and chronic reactions, including interstitial pneumonia, respiratory failure and death, have occurred. Do not give to any patient who has had pulmonary reaction to drug.
- Remind patient to shake nitrofurantoin suspension before measuring dose.
- Instruct patient to take medication with food or milk.
- Inform patient to expect urine to be orange or brown in color while taking medication.
- Teach patient importance of completing full course of antibiotic to avoid recurrent infection.
- Instruct patient to report the following symptoms to health care provider: shortness of breath, difficulty breathing, changes in urination (other than orange discoloration), nausea, vomiting, diarrhea, cramping, skin changes, chest pain, cough, fever, headache, dizziness, vision changes, unusual bleeding (ie, red or black urine or stool), yellowing of skin, light-colored stools or edema.
- Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.
Copyright © 2009 Wolters Kluwer Health.