Nitrofurantoin

Nitrofurantoin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Nitrofurantoin is an anti-infective agent that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Urinary tract infectious disease

• Dosing Information

• Dosage

Urinary tract infectious disease; Prophylaxis

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Nitrofurantoin in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nitrofurantoin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Urinary tract infectious disease

• Dosing Information

• Dosage

Urinary tract infectious disease; Prophylaxis

• Dosing Information

• Dosage

There is limited information regarding FDA-Labeled Use of Nitrofurantoin in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Nitrofurantoin in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nitrofurantoin in pediatric patients.

Contraindications

• Condition1

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Nitrofurantoin in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Nitrofurantoin in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nitrofurantoin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Nitrofurantoin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Nitrofurantoin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Nitrofurantoin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Nitrofurantoin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Nitrofurantoin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Nitrofurantoin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Nitrofurantoin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Nitrofurantoin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Nitrofurantoin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Nitrofurantoin in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Nitrofurantoin in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Nitrofurantoin in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Nitrofurantoin in the drug label.

Pharmacology

File:Nitrofurantoin image.png

Mechanism of Action

Structure

• Furadantin (nitrofurantoin), a synthetic chemical, is a stable, yellow, crystalline compound. Furadantin is an antibacterial agent for specific urinary tract infections. Furadantin is available in 25mg/5mL liquid suspension for oral administration.

1-(((5-nitro-2-furanyl)methylene)amino)-2, 4-imidazolidinedione

Inactive Ingredients

Furadantin Oral Suspension contains carboxymethylcellulose sodium, citric acid, flavors, glycerin, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium citrate, and sorbitol.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Nitrofurantoin in the drug label.

Pharmacokinetics

Orally administered Furadantin is readily absorbed and rapidly excreted in urine. Blood concentrations at therapeutic dosage are usually low. It is highly soluble in urine, to which it may impart a brown color.

Following a dose regimen of 100 mg q.i.d. for 7 days, average urinary drug recoveries (0-24 hours) on day 1 and day 7 were 42.7% and 43.6%.

Unlike many drugs, the presence of food or agents delaying gastric emptying can increase the bioavailability of Furadantin, presumably by allowing better dissolution in gastric juices.

Microbiology

Mode of Action

Nitrofurantoin is reduced by a wide range of enzymes including bacterial flavoproteins to reactive intermediates which are damaging to macromolecules such as DNA and proteins.

Cross-Resistance

Although cross-resistance with other antimicrobials may occur, cross resistance with sulfonamides has not been observed.

Interaction with Other Antimicrobials

Antagonism has been demonstrated in vitro between nitrofurantoin and quinolone antimicrobial agents. Nitrofurantoin, in the form of nitrofurantoin oral suspension, has been shown to be active against most of the following bacteria both in vitro and in clinical infections :(See INDICATIONS AND USAGE).

Gram-positive Aerobes Staphylococcus aureus Enterococcus species

Gram-Negative Aerobes Escherichia coli

NOTE: Some strains of Enterobacter species and Klebsiella species are resistant to nitrofurantoin.

The following in vitro data are available, but their clinical significance is unknown. Nitrofurantoin exhibits in vitro activity against the following bacteria; however, the safety and effectiveness of nitrofurantoin in treating clinical infections due to these bacteria have not been established in adequate and well controlled clinical trials.

Gram-Positive Aerobes Coagulase-negative staphylococci (including Staphylococcus epidermidis and Staphylococcus saprophyticus)

Streptococcus agalactiae Viridans group streptococci

Gram-Negative Aerobes Citrobacter koseri Citrobacter freundii Klebsiella oxytoca

Nitrofurantoin is not active against most strains of Proteus species or Serratia species. It has no activity against Pseudomonas species.

Susceptibility Tests Methods

When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug product for treatment.

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MIC's). These MIC's provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MIC's should be determined using a standardized test method1,3 (broth or agar). The MIC values should be interpreted according to the criteria in Table 1.

Diffusion Techniques

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized method.2 This procedure uses paper disks impregnated with 300 mcg of nitrofurantoin to test the susceptibility of bacteria to nitrofurantoin. The disk diffusion interpretive criteria are provided in Table 1.

File:Nitrofurantoin table 1.png

A report of "Susceptible" indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentration at the infection site necessary to inhibit growth of the pathogen. A report of "Intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body site where the drug is physiologically concentrated. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site; other therapy should be selected.

Quality Control

Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test.1, 2,3 Standard nitrofurantoin powder should provide the following MIC values provided in Table 2. For the diffusion technique using the 300-mcgnitrofurantoin disk the criteria provided in Table 2 should be achieved.

File:Nitrofurantoin table2.png

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Nitrofurantoin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Nitrofurantoin in the drug label.

How Supplied

Storage

There is limited information regarding Nitrofurantoin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Nitrofurantoin in the drug label.

Precautions with Alcohol

• Alcohol-Nitrofurantoin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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