Nitrofurantoin
Generic Name: nitrofurantoin
Brand Names:
Nitrofurantoin
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]-2,4-imidazolidinedione monohydrate. The molecular formula is C 8 H 6 N 4 O 5 .H 2 O and the molecular weight is 256.17. The structural formula is: Nitrofurantoin is a stable, yellow, crystalline compound.
Overview
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]-2,4-imidazolidinedione monohydrate. The molecular formula is C 8 H 6 N 4 O 5 .H 2 O and the molecular weight is 256.17. The structural formula is: Nitrofurantoin is a stable, yellow, crystalline compound.
Uses
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.
Dosage
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). (2.3) 2.1 Recommended 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 )].
Side Effects
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.
Interactions
7 DRUG INTERACTIONS 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 oral suspension with antacids containing magnesium trisilicate cannot be avoided, monitor for lack of efficacy [see Clinical Pharmacology (12.3) ] . 7.2 Uricosuric Drugs Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin.
Warnings
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. 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) ].
Pregnancy
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). 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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Nitrofurantoin oral suspension, USP (25 mg/5 mL) is available in: NDC 70069-829-01 PET amber bottle of 230 mL 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); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Frequently Asked Questions
What is Nitrofurantoin used for?▼
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.
What are the side effects of Nitrofurantoin?▼
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.
Can I take Nitrofurantoin during pregnancy?▼
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). 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.
What are the important warnings for Nitrofurantoin?▼
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. 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) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.