Nitrofurantoin 25 mg/5mL Suspension
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
- Nitrofurantoin is an antibiotic specifically for urinary tract infections — think bladder infections, not kidney infections. It works by concentrating in your urine where it kills...
- What exactly is nitrofurantoin used for?
- Yes, every time. Taking nitrofurantoin with food isn't just about avoiding an upset stomach — food actually helps your body absorb more of the medication, so it works better. Even...
- Do I really need to take it with food every single time?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Nitrofurantoin — tap one for details:
Nitrofurantoin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 4AJZ4765R9
A flavoring agent derived from bananas that gives medicine a banana taste. It's added to make oral medications more palatable, especially for children.
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UNII K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII XLI9KNX1FT
A naturally occurring mineral compound used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed and prevents settling in the formulation.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII FV98Z8GITP
A natural flavoring from mint plants. It's added to medicines to mask bitter tastes and improve how the medicine tastes, making it easier to take.
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UNII 9E0S3UM200
A sugar alcohol solution derived from glucose that stays liquid without forming crystals. It functions as a sweetener, humectant (moisture-retaining agent), and solvent in liquid medications and syrups.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
11 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.718 | $395.19 / 230 ml |
| Medicaid paysCMS SDUD · 12 mo | $3.31 | $761.97 / 230 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nitrofurantoin 25 mg/5mLthis 59651-0206-23 | Aurobindo | 1 bottle | $1.718 | AB | Availability likely | — |
| Nitrofurantoin 25 mg/5mL 64980-0593-24 | Rising | 1 bottle | $1.718 | AB | Availability likely | — |
| Nitrofurantoin 25 mg/5mL 69238-2512-09 | Amneal | 1 bottle | $1.718 | — | Availability likely | — |
| Nitrofurantoin 25 mg/5mL 70069-0829-01 | Somerset | 1 bottle | $1.718 | AB | Availability likely | — |
| Nitrofurantoin 25 mg/5mL 70377-0118-31 | Biocon | 1 bottle | $1.718 | AB | Availability likely | — |
| Nitrofurantoin 25 mg/5mL 70954-0496-10 | ANI | 230 ml | $1.718 | AB | Availability likely | — |
| Nitrofurantoin 25 mg/5mL 72603-0176-01 | NorthStar | 1 bottle | $1.718 | AB | Availability likely | — |
| Nitrofurantoin 25 mg/5mL 31722-0491-23 | Camber | 1 bottle | — | AB | FDA listed | — |
| Nitrofurantoin 25 mg/5mL 40032-0450-11 | Novel | 1 bottle | — | AB | FDA listed | — |
| Nitrofurantoin 25 mg/5mL 43386-0450-11 | Lupin | 1 bottle | — | AB | FDA listed | — |
| Nitrofurantoin 25 mg/5mL 65162-0689-88 | Amneal | 230 ml | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 59651-0206-23 You're viewing this | 1 BOTTLE in 1 CARTON (59651-206-23) / 230 mL in 1 BOTTLE | 2023-05-11 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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 [see Warnings and Precautions (5.7) ]. 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. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoin oral suspension is a nitrofuran antibacterial indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections caused by susceptible bacteria.
( 1 ) Limitations of Use Nitrofurantoin oral suspension is not indicated for the treatment of pyelonephritis or perinephric abscesses. ( 1 ) 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. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Adult Patients: 50 mg to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections. ( 2.2 ) 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). ( 2.2 )
2.1Recommended Dosage and Administration in Adult Patients The recommended dosage is 50 mg to 100 mg of nitrofurantoin oral suspension 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 (5.2 , 5.4 , 5.6) ].
Administer nitrofurantoin oral suspension with food to improve drug absorption [see Clinical Pharmacology (12.3) ] and, in some patients, tolerance.
2.2Recommended Dosage and Administration in Pediatric Patients (1 month of age and older) The recommended dosage of nitrofurantoin oral suspension 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 oral suspension with food to improve drug absorption [ s ee Clinical Pharmacology (12.3) ] and, in some patients, tolerance. Table 1 lists individual dosage volumes for two different strengths of nitrofurantoin oral suspension (25 mg/5 mL) based on body weight for pediatric patients.
Table 1: Nitrofurantoin oral suspension Pediatric Dosing Table for Pediatric Patients 1 month of Age and Older Weight in Kilograms (kg) Pediatric Doses (mL), Frequency: Four times Daily 25 mg/5 mL oral suspension 4 kg or lower 1 Greater than 4 kg to 5 kg
1.4 Greater than 5 kg to 7 kg
1.8 Greater than 7 kg to 10 kg
2.5 Greater than 10 kg to 14 kg
3.5Greater than 14 kg to 20 kg 5 Greater than 20 kg to 25 kg 7 Greater than 25 kg to 30 kg
8.5Greater than 30 kg to 40 kg 10 40 kg or greater See Adult Dose To measure the correct pediatric doses, it is important to administer nitrofurantoin oral suspension with an appropriate size oral dosing syringe with graduations that align with the volume prescribed in Table 1 above. Continue therapy for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation.
For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate [see Warnings and Precautions (5.2 , 5.4 , 5.6) ].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Nitrofurantoin oral suspension, USP is available as a yellow color, flavored homogenous suspension free of lumps or aggregates containing 25 mg/5 mL of nitrofurantoin. Oral Suspension: 25 mg/5 mL. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Nitrofurantoin oral suspension 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) ]. 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 [see Warnings and Precautions (5.4) ]. pregnant patients at term (38 weeks to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent and 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 Warnings and Precautions (5.5) and Use in Specific Populations (8.1 and 8.4) ].
Known hypersensitivity to nitrofurantoin. ( 4 ) History of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. ( 4 ) Patients who have anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine).
( 4 ) Pregnant patients at term (38 weeks to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent. ( 4 ) Pediatric Patients under one month of age. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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. ( 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. ( 5.5 ) Clostridioides difficile -associated diarrhea: Evaluate patients if diarrhea occurs. ( 5.6 )
5.1Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving nitrofurantoin oral suspension [see Adverse Reactions (6) ]. If signs and symptoms of a hypersensitivity reaction occurs, immediately discontinue nitrofurantoin oral suspension and initiate appropriate medications and/or supportive care. Nitrofurantoin oral suspension is contraindicated in patients with known hypersensitivity to nitrofurantoin.
5.2Pulmonary Reactions Acute, subacute, or chronic pulmonary reactions have been reported in patients treated with nitrofurantoin oral suspension. If these reactions occur, discontinue nitrofurantoin oral suspension and take appropriate measures. Reports have cited pulmonary reactions as a contributing cause of death.
Chronic pulmonary reactions (diffuse interstitial pneumonitis or pulmonary fibrosis, or both) can develop insidiously. These reactions occur generally in patients receiving therapy for six months or longer. Close monitoring of the pulmonary condition of patients receiving long-term therapy is warranted and requires that the benefits of therapy be weighed against potential risks [see Adverse Reactions (6) ].
5.3Hepatotoxicity Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, has occurred. Fatalities have been reported. The onset of chronic active hepatitis may be insidious. Monitor patients periodically for changes in biochemical tests that would indicate liver injury. If hepatitis occurs, discontinue nitrofurantoin oral suspension immediately, and take appropriate measures.
5.4Neuropathy Peripheral neuropathy, which may become severe or irreversible, has occurred. Fatalities have been reported. Conditions such as renal impairment (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating disease may enhance the occurrence of peripheral neuropathy.
Monitor patients receiving long-term therapy periodically for changes in renal function. Optic neuritis has been reported with nitrofurantoin formulations [see Adverse Reactions (6) ] .
5.5Hemolytic Anemia Cases of hemolytic anemia of the primaquine-sensitivity type have been induced by nitrofurantoin. Hemolysis appears to be linked to a glucose-6-phosphate dehydrogenase deficiency in the red blood cells of the affected patients. This deficiency is found in 10 percent of Blacks and a small percentage of ethnic groups of Mediterranean and Near-Eastern origin.
If hemolysis occurs, discontinue nitrofurantoin oral suspension immediately; hemolysis ceases when the drug is withdrawn.
5.6Clostridioides difficile- associated Diarrhea Clostridioides difficile -associated Diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including nitrofurantoin oral suspension, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 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. Chronic pulmonary reactions have occurred generally in patients who have received continuous treatment for six months or longer.
Malaise, dyspnea on exertion, cough, and altered pulmonary function are common manifestations which can occur insidiously. Radiologic and histologic findings of diffuse interstitial pneumonitis or fibrosis, or both, are also common manifestations of the chronic pulmonary reaction. Fever is prominent.
The severity of chronic pulmonary reactions and their degrees of resolution appear to be related to the duration of therapy after the first clinical signs appear. Pulmonary function may be impaired permanently, even after cessation of therapy. The risk is greater when chronic pulmonary reactions are not recognized early.
In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form. Upon cessation of therapy, recovery may require several months. If the symptoms are not recognized as being drug-related and nitrofurantoin oral suspension therapy is not stopped, the symptoms may become more severe.
Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnea, pulmonary infiltration with consolidation of pleural effusion on x-ray, and eosinophilia. Acute reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Resolution often is dramatic .
Changes in EKG (e.g., non-specific ST/T wave changes, bundle branch block) have been reported in association with pulmonary reactions. Cyanosis has been reported. Hepatic : Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, have occurred .
Neurologic: Peripheral neuropathy, which may become severe or irreversible, has occurred. Fatalities have been reported. Conditions such as renal impairment (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating diseases may increase the possibility of peripheral neuropathy .
Asthenia, vertigo, nystagmus, dizziness, headache, and drowsiness also have been reported with the use of nitrofurantoin. Benign intracranial hypertension (pseudotumor cerebri), confusion, depression, optic neuritis, and psychotic reactions have been reported. Bulging fontanels, as a sign of benign intracranial hypertension in infants, have been reported rarely.
Dermatologic: Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson syndrome) have been reported. Alopecia also has been reported. Allergic: A lupus-like syndrome associated with pulmonary reactions to nitrofurantoin has been reported.
Also, angioedema; maculopapular, erythematous, or eczematous eruptions; pruritus; urticaria; anaphylaxis; arthralgia; myalgia; drug fever; and vasculitis (sometimes associated with pulmonary r…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Antacids : Decreased absorption of nitrofurantoin. ( 7.1 ) Uricosuric drugs: Inhibit renal tubular secretion of nitrofurantoin. ( 7.2 )
7.1Antacids 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 oral suspension with antacids containing magnesium trisilicate cannot be avoided, monitor for lack of efficacy [see Clinical Pharmacology (12.3) ] .
7.2Uricosuric 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. Therefore, monitor for nitrofurantoin adverse reactions when co-administering nitrofurantoin oral suspension with uricosuric drugs.
7.3Drug Interference with Laboratory Tests The presence of nitrofurantoin can cause a false-positive reaction for glucose in the urine when using Benedict's or Fehling's copper reduction reaction to determine the amount of reducing substances like glucose in the urine. Use glucose tests based on enzymatic glucose oxidase reactions to detect glucose in the urine.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended in infants under one month of age or with glucose-6-phosphate dehydrogenase (G6PD) deficiency. ( 8.2 ) Pediatric Use: nitrofurantoin oral suspension is contraindicated in pediatric patients under one month of age. ( 8.4 )
8.1Pregnancy 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). Published epidemiological studies, including cohort studies and case control studies, have reported inconsistent findings related to nitrofurantoin use during the first trimester and risk of major birth defects. These studies cannot definitively establish the presence or absence of risk due to several methodological limitations.
The limited number of epidemiological studies available have not identified drug-associated risks of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, no fetotoxicity was observed when nitrofurantoin was administered orally to pregnant rats and rabbits, during organogenesis, at up to 6 times the recommended human dose (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Nitrofurantoin is not recommended 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 due to immature erythrocyte enzyme systems (glutathione instability) [see Contraindications (4) and Warnings and Precautions (5.4) ].
Data Animal Data Several reproduction studies have been performed in rabbits and rats at doses up to six times the human dose and have revealed no harm to the fetus due to nitrofurantoin. In a single published study conducted in mice at 68 times the human dose (based on mg/kg administered to the dam), growth retardation and a low incidence of minor and common malformations were observed. However, at 25 times the human dose, fetal malformations were not observed.
Nitrofurantoin has been shown in one published transplacental carcinogenicity study to induce lung papillary adenomas in the F1 generation mice at doses 19 times the human dose on a mg/kg basis. The relationship of this finding to potential human carcinogenesis is presently unknown.
8.2Lactation Risk Summary Nitrofurantoin is present in human breast milk following oral administration. There are insufficient data on the effect of nitrofurantoin on milk production. Infants less than one month of age or who have glucose-6-phosphate dehydrogenase (G6PD) deficiency are at risk for hemolytic anemia from nitrofurantoin oral suspension exposure.
Therefore, breastfeeding is not recommended in these infants. In a breastfed infant over the age of one month and with normal G6PD, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for nitrofurantoin oral suspension and any potential adverse effects on the breastfed infant from nitrofurantoin oral suspension or from the underlying maternal condition. Monitor these infants for vomiting, diarrhea, and rash.
8.3Females and Males of Reproductive Potential Infertility Male Based on findings from a fertility study conducted in 36 healthy male volunteers and an animal fertility study, nitrofurantoin may reversibly decrease spermatogenesis [see Nonclinical Toxicology (13.1) ] . Nitrofurantoin doses of 10 mg/kg/day or greater in healthy human males may…
🤰 Pregnancy ▾
8.1Pregnancy 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). Published epidemiological studies, including cohort studies and case control studies, have reported inconsistent findings related to nitrofurantoin use during the first trimester and risk of major birth defects. These studies cannot definitively establish the presence or absence of risk due to several methodological limitations.
The limited number of epidemiological studies available have not identified drug-associated risks of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, no fetotoxicity was observed when nitrofurantoin was administered orally to pregnant rats and rabbits, during organogenesis, at up to 6 times the recommended human dose (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Nitrofurantoin is not recommended 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 due to immature erythrocyte enzyme systems (glutathione instability) [see Contraindications (4) and Warnings and Precautions (5.4) ].
Data Animal Data Several reproduction studies have been performed in rabbits and rats at doses up to six times the human dose and have revealed no harm to the fetus due to nitrofurantoin. In a single published study conducted in mice at 68 times the human dose (based on mg/kg administered to the dam), growth retardation and a low incidence of minor and common malformations were observed. However, at 25 times the human dose, fetal malformations were not observed.
Nitrofurantoin has been shown in one published transplacental carcinogenicity study to induce lung papillary adenomas in the F1 generation mice at doses 19 times the human dose on a mg/kg basis. The relationship of this finding to potential human carcinogenesis is presently unknown.
🧒 Pediatric Use ▾
8.4Pediatric Use Nitrofurantoin oral suspension 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 (4) and Warnings and Precautions (5.4) ]. The safety and effectiveness of nitrofurantoin oral suspension in pediatric patients aged 1 month of age and older for the treatment of urinary tract infections have been established.
🆘 Overdosage ▾
10 OVERDOSAGE Incidents of acute overdosage of nitrofurantoin oral suspension 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Nitrofurantoin is an antibacterial drug [ see Microbiology (12.4) ] .
12.2Pharmacodynamics Pharmacodynamic effects of nitrofurantoin oral suspension are unknown.
12.3Pharmacokinetics Absorption Orally administered nitrofurantoin oral suspension is readily absorbed. Blood concentrations at therapeutic dosage are usually low. Effect of Food The presence of food or agents delaying gastric emptying can increase the bioavailability of nitrofurantoin oral suspension.
Distribution Nitrofurantoin is highly soluble in urine. Nitrofurantoin lacks the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Elimination Excretion Nitrofurantoin is rapidly excreted in urine, to which it may impart a brown color.
Following a dose regimen of 100 mg four times a day for 7 days, average urinary drug recoveries (0 hour to 24 hours) on Day 1 and Day 7 were 42.7% and 43.6%. Nitrofurantoin is dialyzable. Specific Populations The pharmacokinetics of nitrofurantoin oral suspension are unknown for the geriatric patients, pediatric patients, patients with hepatic impairment, or pregnant women.
Differences between male and female patients, and racial or ethnic groups are unknown. Patients with Renal Impairment The reported urinary recoveries of nitrofurantoin after a single 100 mg oral dose and 100 mg four times a day in patients with varying renal function showed approximate linear relationship between the amount of nitrofurantoin recovered and creatinine clearance. Drug Interaction Studies Antacids such as magnesium trisilicate In a cross-over study, the in vivo absorption characteristics of nitrofurantoin and nitrofurantoin-magnesium trisilicate combination were evaluated in 6 healthy males.
The administration of 5 g magnesium trisilicate with 100 mg nitrofurantoin reduced the rate and extent of nitrofurantoin excretion reflecting decrease in both rate and extent of its absorption [see Drug Interaction (7.1) ]. Propantheline In a crossover study, the in vivo absorption characteristics of nitrofurantoin and propantheline (an anticholinergic agent) combination were evaluated in six subjects. Administration of 30 mg of propantheline 45 min prior to nitrofurantoin 100 mg administration resulted in a statistically significant increase in nitrofurantoin excretion, however, the clinical significance of this effect is unknown.
12.4Microbiology Mechanism 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. Resistance Nitrofurantoin is not active against most strains of Proteus species or Serratia species. It has no activity against Pseudomonas species.
Although cross-resistance with other antibacterials may occur, cross resistance with sulfonamides has not been observed. Interaction with Other Antibacterials Antagonism has been demonstrated in vitro between nitrofurantoin and quinolones. Antibacterial Activity Nitrofurantoin has been shown to be active against most of the following bacteria both in vitro and in clinical infections: Aerobic bacteria Gram-positive bacteria Staphylococcus aureus Enterococcus species Gram-negative bacteria Escherichia coli Enterobacter species Klebsiella species 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 efficacy of nitrofurantoin in treating clinical infections due to these bacteria have not been established in adequate and well-controlled clinical trials. Aerobic bacteria Gram-positive bacteria Coagulase-negative staphylococci (including Staphylococcus epidermidis and Staphylococcus saprophyticus ) Streptococcus agalactiae Viridans group streptococci Gram-negative bacteria Citrobacter koseri Citrobacter freundii Klebsiella oxytoca Susceptibility Testing For specific i…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Nitrofurantoin is an antibacterial drug [ see Microbiology (12.4) ] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Nitrofurantoin Oral Suspension USP, 25 mg/5 mL is a yellow color, flavored homogenous suspension free of lumps or aggregates, available in: Bottle of 230 mL NDC 59651-206-23 Storage and Handling Avoid exposure to strong light which may darken the drug. It is stable when stored between 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Protect from freezing.
Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days.
📋 Description ▾
11 DESCRIPTION Nitrofurantoin oral suspension, USP contains nitrofurantoin, a synthetic nitrofuran antibacterial agent specific for urinary tract infections. The chemical name is 1-[[(5-nitro-2-furanyl)methylene]amino]-2,4imidazolidinedione monohydrate. The molecular formula is C8H6N4O5·H2O and the molecular weight is 256.17.
The structural formula is: Nitrofurantoin is a stable, lemon-yellow, crystalline powder. Nitrofurantoin oral suspension, USP is available as an yellow color, flavored homogenous suspension for oral administration containing 25 mg/5 mL of nitrofurantoin. Nitrofurantoin oral suspension, USP also contains the following inactive ingredients: banana flavor, carboxymethylcellulose sodium, citric acid monohydrate, glycerin, magnesium aluminum silicate, methylparaben, N&A mint flavor, non-crystallizing sorbitol solution, propylparaben, purified water and sodium citrate. str
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Administration Instructions Instruct the patients to: complete the full course of therapy; however, advise the patients or their caregiver to contact their physician if any unusual symptoms occur during therapy. take daily doses of nitrofurantoin oral suspension with food, as food will further enhance tolerance and improve the absorption of the drug. shake nitrofurantoin oral suspension vigorously before use each time. use an oral dosing syringe to correctly measure the prescribed amount of nitrofurantoin oral suspension.
Inform patients or caregivers that an appropriate size oral dosing syringe with graduations that align with the volume prescribed may be obtained from their pharmacy. Serious Allergic Reactions Advise patients that allergic reactions, including serious allergic reactions, could occur with nitrofurantoin oral suspension and that serious reactions require immediate treatment. Advise patients to discontinue nitrofurantoin oral suspension at the first sign of allergic reactions [see Warnings and Precautions (5.1) ].
Diarrhea Advise patients that diarrhea is a common problem caused by antibacterial drugs, including nitrofurantoin oral suspension which usually ends when the antibacterial drug is discontinued. Sometimes frequent watery and bloody diarrhea (with or without stomach cramps and fever) may occur even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, advise patients to contact their physician as soon as possible [see Warnings and Precautions (5.6) ] .
Drug Interactions with Antacids Advise patients not to use antacid preparations containing magnesium trisilicate while taking nitrofurantoin oral suspension [see Drug Interactions (7.1) ] . Lactation Advise women not to breastfeed infants who are less than one month of age or who have G6PD deficiency during treatment with nitrofurantoin oral suspension [see Use in Specific Populations (8.2) ]. Antibacterial Resistance Patients should be counseled that antibacterial drugs including nitrofurantoin oral suspension should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When nitrofurantoin oral suspension is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by nitrofurantoin oral suspension or other antibacterial drugs in the future.
Change in Urine Color Inform patients that nitrofurantoin oral suspension may impart a brown color to their urine [see Clinical Pharmacology (12.3)] . Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 03/2024