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Nitrofurantoin: Pediatric drug information

Nitrofurantoin: Pediatric drug information
(For additional information see "Nitrofurantoin: Drug information" and see "Nitrofurantoin: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Macrobid;
  • Macrodantin
Brand Names: Canada
  • Auro-Nitrofurantoin;
  • Macrobid [DSC];
  • PMS-Nitrofurantoin BID;
  • TEVA-Nitrofurantoin
Therapeutic Category
  • Antibiotic, Miscellaneous
Dosing: Pediatric

Dosage guidance:

Dosage form information: Oral suspension products are available in 2 concentrations (25 mg/5 mL [5 mg/mL] and 50 mg/5 mL [10 mg/mL]); verify product selection and avoid confusion between the different concentrations; dose should be clearly presented as "mg" instead of "mL."

Urinary tract infection, treatment

Urinary tract infection (UTI), treatment: Note: Reserve for cystitis; should not be used for pyelonephritis or to treat febrile infants with UTI because renal and serum concentrations may not be adequate (Ref).

Furadantin, Macrodantin:

Weight-directed dosing: Infants, Children, and Adolescents: Oral: 5 to 7 mg/kg/day divided every 6 hours for 7 days; maximum dose: 100 mg/dose.

Fixed dosing: Infants, Children, and Adolescents: Furadantin oral suspension:

≤4 kg: Oral: 5 mg every 6 hours.

>4 to 5 kg: Oral: 7 mg every 6 hours.

>5 to 7 kg: Oral: 9 mg every 6 hours.

>7 to 10 kg: Oral: 12.5 mg every 6 hours.

>10 to 14 kg: Oral: 17.5 mg every 6 hours.

>14 to 20 kg: Oral: 25 mg every 6 hours.

>20 to 25 kg: Oral: 35 mg every 6 hours.

>25 to 30 kg: Oral: 42.5 mg every 6 hours.

>30 to 40 kg: Oral: 50 mg every 6 hours.

≥40 kg: Oral: 50 to 100 mg every 6 hours.

Macrobid (macrocrystal/monohydrate): Adolescents: Oral: 100 mg every 12 hours for 7 days.

Urinary tract infection, prophylaxis

Urinary tract infection, prophylaxis: Furadantin, Macrodantin: Infants, Children, and Adolescents: Oral: 1 to 2 mg/kg/day in a single dose (at bedtime) or divided twice daily; maximum daily dose: 100 mg/day. Note: In infants and children <24 months, prophylaxis should only be considered for those with grade III or V reflux or with recurrent febrile UTI; data supporting the routine use of continuous antimicrobial prophylaxis are limited (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Altered kidney function: Infants, Children, and Adolescents:

CrCl ≥60 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; based on experience in adults, no dosage adjustment necessary (Ref).

CrCl 30 to <60 mL/minute: Use is contraindicated per the manufacturer's labeling. In adults, limited data suggest nitrofurantoin is safe and effective for short-term treatment of uncomplicated acute cystitis in patients with an eGFR or CrCl 30 to 60 mL/minute (Ref). One retrospective cohort study reported increased risk of pulmonary adverse events in adult females with eGFR <50 mL/minute (Ref).

CrCl <30 mL/minute: Use is contraindicated (manufacturer's labeling).

Hemodialysis, intermittent (thrice weekly): Based on adult information, avoid use (likely to be ineffective) (Ref).

Peritoneal dialysis: Based on adult information, avoid use (likely to be ineffective) (Ref).

Dosing: Hepatic Impairment: Pediatric

Infants, Children, and Adolescents: There are no dosage adjustments provided in manufacturer's labeling. Contraindicated in patients with a previous history of cholestatic jaundice or hepatic dysfunction associated with nitrofurantoin.

Dosing: Adult

(For additional information see "Nitrofurantoin: Drug information")

Dosage guidance:

Dosage form information: Nitrofurantoin is available in the United States as a combination product (nitrofurantoin monohydrate and nitrofurantoin macrocrystals [Macrobid]), which is typically dosed twice daily for the treatment of acute infections, and a preparation that consists solely of nitrofurantoin macrocrystals (oral suspension, Macrodantin), which is typically dosed 4 times daily for the treatment of acute infections. Regardless of the formulation used, advise patients to administer with food to improve absorption.

Asymptomatic bacteriuria in pregnancy

Asymptomatic bacteriuria (≥105 CFU per mL) in pregnancy:

Note: Although contraindicated by the manufacturer in pregnant patients at term (38 to 42 weeks' gestation), during labor and delivery, or when the onset of labor is imminent due to the possibility of hemolytic anemia in the newborn, the American College of Obstetricians and Gynecologists does not restrict use of nitrofurantoin during the third trimester. Based on available safety data, nitrofurantoin may also be used as an alternative therapy during the first trimester (Ref).

Nitrofurantoin monohydrate/macrocrystals (Macrobid): Oral: 100 mg twice daily for 5 to 7 days (Ref).

Cystitis, acute uncomplicated or acute simple cystitis, treatment

Cystitis, acute uncomplicated or acute simple cystitis (infection limited to the bladder without signs/symptoms of upper tract, prostate, or systemic infection), treatment:

Note: Consider use of a different empiric agent in patients with suspected pyelonephritis, patients who have received nitrofurantoin in the last 3 months, or patients who have had a urine isolate with documented resistance to nitrofurantoin in the last 3 months (Ref).

Nitrofurantoin monohydrate/macrocrystals (Macrobid): Oral: 100 mg twice daily; treat females for 5 days and males for 7 days (Ref).

Nitrofurantoin macrocrystals (oral suspension, Macrodantin): Oral: 50 to 100 mg every 6 hours; treat females for 5 days and males for 7 days (Ref). Note: The recommended duration of therapy with this formulation is based on the recommendation for the nitrofurantoin monohydrate/macrocrystal formulation as well as expert opinion.

Cystitis, prophylaxis for recurrent infection

Cystitis, prophylaxis for recurrent infection:

Note: May be considered in nonpregnant women with bothersome, frequently recurrent cystitis despite nonantimicrobial preventive measures. The optimal duration has not been established; duration ranges from 3 to 12 months, with periodic reassessment (Ref). Prolonged use (>6 months) of nitrofurantoin has been associated with diffuse interstitial pneumonitis and/or pulmonary fibrosis, chronic hepatitis, and the development of neuropathy (Ref).

Continuous prophylaxis:

Nitrofurantoin monohydrate/macrocrystals (Macrobid) (off-label use): Oral: 100 mg once daily at bedtime (Ref).

Nitrofurantoin macrocrystals (oral suspension, Macrodantin): Oral: 50 to 100 mg once daily at bedtime.

Postcoital prophylaxis (females with cystitis temporally related to sexual intercourse):

Nitrofurantoin monohydrate/macrocrystals (Macrobid) (off-label use): Oral: 100 mg as a single dose taken within 2 hours of sexual intercourse (Ref).

Nitrofurantoin macrocrystals (oral suspension, Macrodantin): Oral: 50 to 100 mg as a single dose taken within 2 hours of sexual intercourse (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function:

CrCl ≥60 mL/minute: No dosage adjustment necessary.

CrCl 30 to <60 mL/minute: Although contraindicated in the manufacturer's labeling, limited data suggest nitrofurantoin is safe and effective for short-term treatment of uncomplicated acute cystitis in patients with an eGFR or CrCl 30 to 60 mL/minute (Ref). One retrospective cohort study reported increased risk of pulmonary adverse events in patients with eGFR <50 mL/minute (Ref).

CrCl <30 mL/minute: Avoid use (Ref).

Hemodialysis, intermittent (thrice weekly): Avoid use (Ref).

Peritoneal dialysis: Avoid use (Ref).

CRRT: Avoid use (Ref).

PIRRT (eg, sustained low-efficiency diafiltration): Avoid use (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. Contraindicated in patients with a previous history of cholestatic jaundice or hepatic dysfunction associated with nitrofurantoin.

Adverse Reactions (Significant): Considerations
Clostridioides difficile infection

Clostridioides difficile infection has occurred with nitrofurantoin, including Clostridioides difficile associated diarrhea and Clostridioides difficile colitis (Ref).

Onset: Varied; may start on the first day of antibiotic therapy or up to 3 months postantibiotic (Ref).

Risk factors:

• Antibiotic exposure (highest risk factor) (Ref)

• Type of antibiotic (Ref)

• Long durations in a hospitalization or other health care setting (recent or current) (Ref)

• Older adults (Ref)

• Immunocompromised conditions (Ref)

• A serious underlying condition (Ref)

• GI surgery/manipulation (Ref)

• Antiulcer medications (eg, proton pump inhibitors, H2 blockers) (Ref)

• Chemotherapy (Ref)

Drug-induced liver injury (DILI)

A wide range of drug-induced liver injury (DILI) has been reported with nitrofurantoin, including acute hepatitis, granulomatous reaction, cholestatic jaundice, autoimmune hepatitis, and chronic active hepatitis that may lead to hepatic cirrhosis or death (Ref). Acute liver injury usually presents with a hepatocellular pattern with or without jaundice and is commonly associated with fever and skin rash and typically resolves with discontinuation. Chronic liver injury usually presents with autoimmune features and is associated with fatigue, weakness, dark urine, and jaundice (Ref).

Mechanism: Not clearly established; oxidative-free radicals may damage hepatocytes. An autoimmune mechanism may also contribute (Ref).

Onset: Varied; acute liver injury may vary in onset from 1 to 6 weeks of use and chronic liver injury may vary in onset from months (typically >6 months) to years of use (Ref).

Risk factors:

• Older patients (Ref)

• Females (Ref)

• Prolonged use (>6 months) (Ref)

Peripheral neuropathy

Peripheral neuropathy may occur with nitrofurantoin and typically presents as sensorimotor polyneuropathy (Ref).

Mechanism: Non–dose-related; idiosyncratic (Ref).

Risk factors:

• Older patients

• Anemia

• Debilitating disease

• Diabetes

• Electrolyte imbalance

• Kidney impairment (CrCl <60 mL/minute)

• Vitamin B deficiency

Pulmonary toxicity

Pulmonary toxicity may occur with nitrofurantoin and ranges from acute pulmonary reaction, subacute pulmonary reaction, and/or chronic pulmonary reaction (Ref).

Mechanism: Acute reactions: Non–dose-related; immunologic (Ref). Chronic reactions: Unknown. May be T-cell mediated (non–dose-related) or direct toxicity (dose-related) (Ref).

Onset: Varied; acute reactions can vary in onset from days to weeks while chronic reactions often occurs after months to years of use (Ref).

Risk factors:

• Older patients (Ref)

• Females (Ref)

• Prolonged use (>6 months) (for chronic pulmonary reactions) (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Endocrine & metabolic: Increased serum phosphate (1% to 5%)

Gastrointestinal: Flatulence (2%), nausea (8%)

Hematologic & oncologic: Decreased hemoglobin (1% to 5%), eosinophilia (1% to 5%)

Hepatic: Increased serum alanine aminotransferase (1% to 5%), increased serum aspartate aminotransferase (1% to 5%)

Nervous system: Headache (6%)

<1%:

Dermatologic: Alopecia, pruritus, urticaria

Gastrointestinal: Abdominal pain, constipation, diarrhea, dyspepsia, vomiting

Nervous system: Chills, dizziness, drowsiness, malaise

Ophthalmic: Amblyopia

Respiratory: Acute pulmonary reaction (including cough, dyspnea, dyspnea on exertion, pleural effusion, pleuritic chest pain, pulmonary infiltrates)

Miscellaneous: Fever

Frequency not defined: Respiratory: Chronic pulmonary reaction (including diffuse interstitial pneumonitis, pulmonary fibrosis), subacute pulmonary reaction

Postmarketing:

Cardiovascular: Bundle branch block (Dibagh Gandorta 2017), ECG changes, nonspecific T wave on ECG, vasculitis

Dermatologic: Eczematous rash, erythema multiforme, exfoliative dermatitis, maculopapular rash, Stevens-Johnson syndrome (Davis 2018)

Gastrointestinal: Anorexia, Clostridioides difficile associated diarrhea (Hirschhorn 1994), Clostridioides difficile colitis, pancreatitis (Mouallen 2003), sialadenitis

Hematologic & oncologic: Agranulocytosis (Roberts 2005), aplastic anemia, glucose-6-phosphate dehydrogenase deficiency anemia, granulocytopenia, hemolytic anemia, leukopenia, megaloblastic anemia, methemoglobinemia, thrombocytopenia (Dibagh Gandorta 2017)

Hepatic: Autoimmune hepatitis (Sakaan 2014), cholestatic jaundice (Sakaan 2014), chronic active hepatitis (Sakaan 2014), hepatic cirrhosis (Sakaan 2014), hepatic necrosis (Sakaan 2014), hepatitis (acute) (Sakaan 2014)

Hypersensitivity: Anaphylaxis, angioedema

Nervous system: Asthenia, bulging fontanel (infants), confusion, depression, idiopathic intracranial hypertension, peripheral neuropathy (Tan 2012), psychotic reaction, vertigo

Neuromuscular & skeletal: Arthralgia, lupus-like syndrome, myalgia

Ophthalmic: Nystagmus disorder, optic neuritis

Respiratory: Cyanosis

Contraindications

Anuria, oliguria, or significant impairment of renal function (creatinine clearance [CrCl] <60 mL/minute or clinically significant elevated serum creatinine); previous history of cholestatic jaundice or hepatic dysfunction associated with prior nitrofurantoin use; hypersensitivity to drug or any component of the formulation.

Note: The manufacturer's contraindication in patients with CrCl <60 mL/minute has been challenged in the literature; limited data suggest that an alternative creatinine clearance threshold may be considered (Oplinger 2013).

Because of the possibility of hemolytic anemia caused by immature erythrocyte enzyme systems (glutathione instability), the drug is contraindicated in pregnant patients at term (38 to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent; also contraindicated in neonates younger than 1 month of age.

Warnings/Precautions

Concerns related to adverse effects:

• Superinfection: Prolonged use may result in fungal or bacterial superinfection.

Disease-related concerns:

• Hemolytic anemia: Use caution in patients with G6PD deficiency; may be at increased risk for hemolytic anemia. Discontinue therapy if occurs.

• Hepatic impairment: Use is contraindicated in patients with a history of nitrofurantoin associated cholestatic jaundice or hepatic dysfunction.

• Renal impairment: Urinary nitrofurantoin concentrations are variable in patients with impaired renal function. Use with caution. The manufacturer contraindicates use in CrCl <60 mL/minute; however, limited data suggest nitrofurantoin is safe and effective for short-term treatment of uncomplicated urinary tract infection (UTI) in patients with CrCl 30 to 60 mL/minute (Cuhna 2017; Oplinger 2013; Santos 2016; Singh 2015).

Special populations:

• Older adult: Avoid long-term use in older adult patients.

• Pediatric: Use is contraindicated in children <1 month of age (at increased risk for hemolytic anemia).

Other warnings/precautions:

• Appropriate use: Pyelonephritis: Not indicated for the treatment of pyelonephritis or perinephric abscesses.

Warnings: Additional Pediatric Considerations

Nitrofurantoin should not be used to treat UTIs in febrile infants and young children; nitrofurantoin concentrates in the urine and does not reach therapeutic serum and possibly parenchymal concentrations making it ineffective to treat pyelonephritis or urosepsis (AAP 2011).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Macrobid: 100 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), quinoline yellow (d&c yellow #10)]

Macrodantin: 25 mg

Macrodantin: 50 mg, 100 mg [contains fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]

Generic: 25 mg, 50 mg, 100 mg

Suspension, Oral:

Generic: 25 mg/5 mL (230 mL, 240 mL); 50 mg/5 mL (60 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Capsules (Macrobid Oral)

100 mg (per each): $7.14

Capsules (Macrodantin Oral)

25 mg (per each): $14.06

50 mg (per each): $3.15

100 mg (per each): $6.62

Capsules (Nitrofurantoin Macrocrystal Oral)

25 mg (per each): $7.03 - $12.64

50 mg (per each): $2.13 - $2.43

100 mg (per each): $3.38 - $3.53

Capsules (Nitrofurantoin Monohyd Macro Oral)

100 mg (per each): $2.77 - $6.78

Suspension (Nitrofurantoin Oral)

25 mg/5 mL (per mL): $3.18 - $14.61

50 mg/5 mL (per mL): $56.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Macrobid: 100 mg [DSC] [contains corn starch, edetate (edta) calcium disodium, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), quinoline yellow (d&c yellow #10)]

Generic: 50 mg, 100 mg

Tablet, Oral:

Generic: 50 mg, 100 mg

Administration: Pediatric

Oral: Administer with food to improve absorption and decrease adverse effects. Shake suspension well before use and administer using an oral dosing syringe. The monohydrate/macrocrystals capsules (twice-daily formulation [eg, Macrobid]) should not be opened; the macrocrystals capsules (4-times-daily formulation [eg, Macrodantin]) may be opened and the contents mixed with food or juice for immediate use (data on file from manufacturer).

Administration: Adult

Oral: Administer with meals to improve absorption and decrease adverse effects; suspension may be mixed with water, milk, or fruit juice. Shake suspension well before use. The monohydrate/macrocrystals capsules (twice-daily formulation [Macrobid]) should not be opened; the macrocrystals capsules (4-times-daily formulation [Macrodantin]) may be opened and the contents mixed with food or juice for immediate use (data on file from manufacturer).

Storage/Stability

Capsules: Store at controlled room temperature, 15°C to 30°C (59°F to 86°F). Dispense in a tight container using a child-resistant closure.

Oral suspension: Avoid exposure to strong light, which may darken the drug. It is stable when stored between 20°C and 25°C (68°F and 77°F). Protect from freezing. Dispense in glass amber bottles.

Use

Treatment and long-term suppression (prevention) of urinary tract infection (UTI) caused by susceptible bacteria (Furadantin, Macrodantin: FDA approved in ages ≥1 month and adults); treatment of acute uncomplicated UTI caused by susceptible strains (Macrobid: FDA approved in ages >12 years and adults).

Medication Safety Issues
Sound alike/look alike issues:

Macrobid may be confused with microK, Nitro-Bid.

Nitrofurantoin may be confused with Neurontin, nitroglycerin.

Older Adult: High-Risk Medication:

Beers Criteria: Nitrofurantoin is identified in the Beers Criteria as a potentially inappropriate medication to be avoided in patients 65 years and older (independent of diagnosis or condition) due to its potential for pulmonary toxicity, hepatotoxicity and peripheral neuropathy, particularly when given long-term; safer alternatives exist. Avoid use in patients with a CrCl less than 30 mL/minute or for long-term suppressive therapy (Beers Criteria [AGS 2023]).

Pediatric patients: High-risk medication:

KIDs List: Nitrofurantoin, when used in neonates, is identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of hemolytic anemia (weak recommendation; very low quality of evidence) (PPA [Meyers 2020]).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy

Magnesium Trisilicate: May decrease the absorption of Nitrofurantoin. Risk X: Avoid combination

Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy

Norfloxacin: Nitrofurantoin may diminish the therapeutic effect of Norfloxacin. Risk X: Avoid combination

Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy

Probenecid: May diminish the therapeutic effect of Nitrofurantoin. Probenecid may increase the serum concentration of Nitrofurantoin. Risk C: Monitor therapy

Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Food Interactions

Nitrofurantoin serum concentrations may be increased if taken with food. Management: Administer with meals.

Dietary Considerations

Take with meals to improve absorption and decrease adverse effects.

Reproductive Considerations

Nitrofurantoin in doses >10 mg/kg/day may cause spermatogenic arrest and decrease sperm count. This was observed in some patients treated for 2 weeks; sperm counts returned to normal between 13 and 32 weeks after therapy was discontinued. Consider avoiding use in patients planning to father a child (Drobnis 2017).

Pregnancy Considerations

Nitrofurantoin crosses the placenta (Perry 1967).

Current studies evaluating maternal use of nitrofurantoin during pregnancy and the development of congenital anomalies have had mixed results (ACOG 2023; Crider 2009; Goldberg 2013; Goldberg 2015; Muanda 2017; Nordeng 2013). An increased risk of neonatal jaundice was observed following maternal nitrofurantoin use during the last 30 days of pregnancy (Nordeng 2013).

Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of nitrofurantoin may be altered. Based on a study of 30 women administered nitrofurantoin prior to abortion, maternal serum concentrations of nitrofurantoin may be decreased and urine concentrations may be increased during pregnancy (Philipson 1979).

Urinary tract infections are associated with adverse pregnancy outcomes including preterm birth and delivery of low-birth-weight infants. Treatment with a targeted antibiotic is recommended when asymptomatic bacteriuria or acute cystitis are diagnosed. According to the manufacturer, nitrofurantoin is contraindicated in pregnant patients at term (38 to 42 weeks' gestation), during labor and delivery, or when the onset of labor is imminent due to the possibility of hemolytic anemia in the newborn. However, nitrofurantoin may be used for the treatment of asymptomatic bacteriuria and acute cystitis in pregnant patients when appropriate. Nitrofurantoin may be used in the first trimester when alternative antibiotics cannot be used and may be considered as a first-line antibiotic in the second and third trimesters. Avoid use in pregnant patients with G6PD deficiency (ACOG 2023).

Monitoring Parameters

Signs of pulmonary reaction; signs of numbness or tingling of the extremities; periodic liver and renal function tests; CBC. Observe for change in bowel frequency.

Mechanism of Action

Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermediates that inactivate or alter bacterial ribosomal proteins leading to inhibition of protein synthesis, aerobic energy metabolism, DNA, RNA, and cell wall synthesis. Nitrofurantoin is bactericidal in urine at therapeutic doses. The broad-based nature of this mode of action may explain the lack of acquired bacterial resistance to nitrofurantoin, as the necessary multiple and simultaneous mutations of the target macromolecules would likely be lethal to the bacteria.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Well absorbed; macrocrystalline form absorbed more slowly due to slower dissolution (causes less GI distress)

Distribution: Vd: 0.8 L/kg

Protein binding: 60% to 90%

Metabolism: Body tissues (except plasma) metabolize 60% of drug to inactive metabolites

Bioavailability: Increased with food by ~40%

Half-life elimination: 20 to 60 minutes; prolonged with renal impairment

Excretion:

Suspension: Urine (~40%) and feces (small amounts) as metabolites and unchanged drug

Macrocrystals: Urine (20% to 25% as unchanged drug)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Nitrofurantoin accumulates in serum.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Uvamin;
  • (AR) Argentina: Furadantina | Furadantina mc | Urodantina | Urofuran;
  • (AT) Austria: Furadantin;
  • (AU) Australia: Apo-nitrofurantoin | Arx nitrofurantoin | Furadantin | Macrodantin | Nitrofurantoin bnm | Ralodantin;
  • (BD) Bangladesh: Nft | Nintoin | Nintoin sr | Nitrobac | Nitrofur | Ofuran sr | Rantoin | Umactin | Uritro | Urobak | Urocure;
  • (BE) Belgium: Furadantine;
  • (BG) Bulgaria: Orafuran;
  • (BR) Brazil: Hantina | Macrodantina | Nitrofen | Nitrofurantoina | Urogen;
  • (CH) Switzerland: Urodin | Uvamin;
  • (CL) Chile: Macrodantina | Macrosan | Nitrofurantoina;
  • (CN) China: Nitrofurantion;
  • (CO) Colombia: Macrodantina | Macrodantina infantil | Nitrofurantoina | Nitrofurantoina mk | Urfadyne;
  • (CZ) Czech Republic: Furantoin | Furolin | Nifurantin | Nitrofurantoin ratiopharm;
  • (DE) Germany: Furadantin | Ituran | Nifurantin | Nifuretten | Nitrofurantoin ratiopharm | Uro-tablinen;
  • (DK) Denmark: Nitrofurantoin "DAK";
  • (DO) Dominican Republic: Chemiofuran | Furantoina | Macrodantina | Nitrofurantoina | Nitrofurantoina mk | Nyvu retard | Urigen;
  • (EC) Ecuador: Furextol | Ivumod | Macrodantina | Nitrofurantoina | Nitrofurantoina mk | Urantoin | Uribiol | Urimax f | Urodantina | Urorelax | Uvamin;
  • (EE) Estonia: Apo-nitrofurantoin | Furadonin | Nifurantin | Nitrofurantoiin ns | Nitrofurantoin dak | Piyeloseptyl;
  • (EG) Egypt: Colifuran | Macrodantin | Macrofuran | Mepafuran | Uvamin | Uvamine;
  • (ES) Spain: Furantoina | Furobactina;
  • (FI) Finland: Furadantin | Macrofuran | Macrotoin | Urofuran;
  • (FR) France: Furadantine | Furadoine | Microdoine;
  • (GB) United Kingdom: Berkfurin | Furadantin | Genfura | Macrobid | Nitrofurantoin bristol laboratories | Nitrofurantoin cox | Nitrofurn kent old | Urantoin;
  • (GR) Greece: Furadantin | Furolin | Nitrotoin;
  • (HK) Hong Kong: Apo-nitrofurantoin | Furadantin;
  • (HR) Croatia: Ninur | Prevuro;
  • (HU) Hungary: Nitrofurantoin q pharma | Nitrofurantoina arena;
  • (ID) Indonesia: Centran | Macrofuran;
  • (IE) Ireland: Furadantin | Macrobid | Macrodantin | Uro-tablinen;
  • (IL) Israel: Macrodantin | Uvamin;
  • (IN) India: Bactofuran | Furadantin | Furakem | Furent | Hiftas | Infura | Martifur | Nftor | Nifleri | Nifnext | Niftas | Niftran | Nifty | Nifutin | Nitbid sr | Nitfur | Nitro | Nitro f | Nitrobact | Nitrobest | Nitrofem | Nitrofur | Nitrostar | Rezfuran | Saftoin | Troydantin | Uribid | Urifar | Urifast | Urinif | Uristream nf | Uritop | Utirantin | Utitroy | Utivax nf | Xonift;
  • (IQ) Iraq: Samafurantin;
  • (IT) Italy: Furadantin | Furecis | Furil | Macrodantin | Neo furadantin | Nitrofurantoina mylan;
  • (JO) Jordan: Furolin;
  • (JP) Japan: Furadantin | Uretoin azusa | Uretoin mitsubishi;
  • (KE) Kenya: Nifuran;
  • (KR) Korea, Republic of: Boryung nitrofurantoin | Pricetin | Uroin;
  • (KW) Kuwait: Uvamine;
  • (LB) Lebanon: Nitrafuron | Uvamin;
  • (LT) Lithuania: Furadantin | Furadonim | Furadonin | Furantoin | Orafuran | Urosept | Uvamin;
  • (LU) Luxembourg: Furadantine | Nitrofurantoin ratiopharm;
  • (LV) Latvia: Furadonin | Furantoin | Orafuran | Urosept | Uvamin;
  • (MA) Morocco: Furadantine | Furadoine;
  • (MX) Mexico: Anmic | Biofurin | Dutarina | Furadantina | Furitex | Futroken | Ircilus | Macrodantina | Macrodantina infantil | Macrofurin | Nitrofurantoina | Nitrofurantoina biomep | Nitrofurantoina bioresearch | Nitrofurantoina darier | Nitrofurantoina exakta | Nitrofurantoina farmadem | Nitrofurantoina loeffler | Nitrofurantoina ultra | Nitrofurantoina valeant | Suronit | Terfhicid;
  • (MY) Malaysia: Nifurantin;
  • (NG) Nigeria: De shalom nitrofurantoin | Nitrofrat;
  • (NL) Netherlands: Furabid | Furadantine | Nitrofurantoin Aurobindo MC | Nitrofurantoine m.c.;
  • (NO) Norway: Furadantin | Furadantine | Furantoina | Nifurantin | Nitrofurantoine;
  • (NZ) New Zealand: Furadantin | Macrobid | Nifuran;
  • (PE) Peru: Apo-nitrofurantoin | Eraceplus | Infurin | Macrodantina | Nifurin | Nitrofurantoina | Urodantina | Urofurin | Urofurin xr | Urotoin;
  • (PH) Philippines: Macrodantin | Nitro | Nitromic | Norfuran | Urontin | Usa lab nitrofurantoin;
  • (PK) Pakistan: Anatrin | Furadantin | Furadin | Furalin | Furantin | Urifast;
  • (PL) Poland: Furadantin | Furantoin | Nifuratio | Siraliden;
  • (PR) Puerto Rico: Furadantin | Macrobid | Macrodantin | Nitrofurant macro | Nitrofurantoin | Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin macrocrystals | Nitrofurantoin Mono/Mac | Nitrofurantoin mono/macro | Nitrofurantoin monohydrate/macrocrystals;
  • (PT) Portugal: Furadantina | Furocape | Nitrofurantoina;
  • (PY) Paraguay: Urotoina | Urotoina pediatrica;
  • (QA) Qatar: Colifuran | Piyeloseptyl | Uvamin Retard;
  • (RU) Russian Federation: Furadonin | Furadonin avexima;
  • (SA) Saudi Arabia: Apo-nitrofurantoin | Colifuran;
  • (SE) Sweden: Furadantin | Nitrofurantoin alternova;
  • (SG) Singapore: Apo-nitrofurantoin;
  • (SI) Slovenia: Furadantin | Macrobid | Macrodantin | Ninur;
  • (SK) Slovakia: Furantoin;
  • (TH) Thailand: Macrodantin | Manopill;
  • (TN) Tunisia: Apo-nitrofurantoin | Furadantine | Furadoine;
  • (TR) Turkey: Piyeloseptyl | Urineks;
  • (TW) Taiwan: Frantin | Furadantin-Mc | Limicon | Litolin | Macrodantin | Nifutoin | Ninru | Nitoson | Nitrofurabtoin | Nitrofurantin | Tirin | Yumenin;
  • (UA) Ukraine: Furadonin | Urosept | Uvamin;
  • (UG) Uganda: Agotoin;
  • (UY) Uruguay: Brandtoina | Furanpur | Macrofuran;
  • (VE) Venezuela, Bolivarian Republic of: Furadina | Macrodantina | Nitrofur | Nitrofurantoina | Urodantina;
  • (ZA) South Africa: Furadantin | Macrodantin | Nitrofurantoin cipla | Turanto | Unitro | Urantin;
  • (ZM) Zambia: Kantibac;
  • (ZW) Zimbabwe: Urantoin
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