Label: NITROFURANTOIN suspension

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 14, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use NITROFURANTOIN ORAL SUSPENSION safely and effectively. See full prescribing information for NITROFURANTOIN ORAL ...
  • Table of Contents
    Table of Contents
  • 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 ...
  • 2 DOSAGE AND ADMINISTRATION
    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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Nitrofurantoin oral suspension, USP is available as an opaque, yellow liquid oral suspension containing 25 mg/5 mL of nitrofurantoin.
  • 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 ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hypersensitivity Reactions - Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving nitrofurantoin oral suspension [see Adverse ...
  • 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 ...
  • 7 DRUG INTERACTIONS
    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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    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 ...
  • 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 ...
  • 11 DESCRIPTION
    Nitrofurantoin Oral Suspension, USP contains nitrofurantoin, a synthetic nitrofuran antibacterial agent specific for urinary tract infections. The chemical name is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Nitrofurantoin is an antibacterial drug [see Microbiology (12.4)]. 12.2 Pharmacodynamics - Pharmacodynamic effects of nitrofurantoin oral suspension are ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Nitrofurantoin was not carcinogenic when fed to female Holtzman rats for 44.5 weeks or to female Sprague-Dawley rats ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - Nitrofurantoin oral suspension, USP (25 mg/5 mL) is available in: NDC 70377-118-31 PET amber bottle of 230 mL - Storage and Handling - Avoid exposure to strong light which may darken ...
  • 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 ...
  • PRINCIPAL DISPLAY PANEL
    NDC 70377-118-31 - Nitrofurantoin Oral Suspension USP, 25 mg/5 mL - 230 mL - Rx only
  • INGREDIENTS AND APPEARANCE
    Product Information