PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rising ® NDC 16571-740-24

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Nitrofurantoin Oral Suspension
25 mg/5 mL
** Urinary Tract Antibacterial**

** 230 mL**
****Rx only

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** Carton label**

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Container Label


Rising ® NDC 16571-888-06

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Nitrofurantoin Oral Suspension
50 mg/5 mL
** Urinary Tract Antibacterial**

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** 60 mL**
****Rx only

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** Carton label**

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Container label
****

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RECENT MAJOR CHANGES SECTION

RECENT MAJOR CHANGES

Dosage and Administration (2) 1/2024

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DESCRIPTION SECTION

11 DESCRIPTION

Nitrofurantoin oral suspension 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 C8H6N4O5ꞏH2O and the molecular weight is 256.17. The structural formula is:


Nitrofurantoin is a stable, yellow, crystalline compound.

Nitrofurantoin oral suspension is available as an opaque, yellow liquid suspension for oral administration containing 25 mg/5 mL and 50 mg/5 mL of nitrofurantoin. Nitrofurantoin oral suspension also contains the following inactive ingredients: carboxymethylcellulose sodium, citric acid, flavors, glycerin, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium citrate, and sorbitol.

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INDICATIONS & USAGE SECTION

1 INDICATIONS & 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.

DOSAGE FORMS & STRENGTHS SECTION

3 DOSAGE FORMS & STRENGTHS

Nitrofurantoin oral suspension is available as an opaque, yellow liquid oral suspension containing 25 mg/5 mL and 50 mg/5 mL of nitrofurantoin.

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OVERDOSAGE SECTION

10 OVERDOSAGE

Incidents of acute overdosage of nitrofurantoin 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.

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INFORMATION FOR PATIENTS SECTION

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 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 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:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Made in India

Code: AP/DRUGS/04/2016

Revised: 02/2024

PIA88806-01

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HOW SUPPLIED SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Nitrofurantoin oral suspension (25 mg/5 mL) is available in:

NDC 16571-740-24 PET amber bottle of 230 mL

Nitrofurantoin oral suspension (50 mg/5 mL) is available in:

NDC 16571-888-06 PET amber bottle of 60 mL

Storage and Handling

Avoid exposure to strong light which may darken the drug. It is stable when stored between 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°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.

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