Furadantin

FURADANTIN — nitrofurantoin suspension
Casper Pharma LLC

1 INDICATIONS & USAGE

FURADANTIN 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
FURADANTIN is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions (5.7)].
UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of FURADANTIN and other antibacterial drugs, FURADANTIN 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.

2 DOSAGE & ADMINISTRATION

2.1 Recommended Dosage and Administration in Adult Patients

The recommended dosage is 50 mg to 100 mg of FURADANTIN 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 FURADANTIN with food to improve drug absorption [see Clinical Pharmacology (12.3)] and, in some patients, tolerance.

2.2 Recommended Dosage and Administration in Pediatric Patients (1 month of age and older)

The recommended dosage of FURADANTIN 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 FURADANTIN with food to improve drug absorption [see Clinical Pharmacology (12.3)] and, in some patients, tolerance.
Table 1 lists individual dosage volumes for two different strengths of FURADANTIN (25 mg/5 mL and 50 mg/5 mL) based on body weight for pediatric patients. Table 1: FURADANTIN Pediatric Dosing Table for Pediatric Patients 1 month of Age and Older

furadantin-table1
(click image for full-size original)

To measure the correct pediatric doses, it is important to administer FURADANTIN 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)].

3 DOSAGE FORMS & STRENGTHS

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

4 CONTRAINDICATIONS


FURADANTIN 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)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving FURADANTIN [see Adverse Reactions (6)]. If signs and symptoms of a hypersensitivity reaction occurs, immediately discontinue FURADANTIN and initiate appropriate medications and/or supportive care. FURADANTIN is contraindicated in patients with known hypersensitivity to nitrofurantoin.

5.2 Pulmonary Reactions


Acute, subacute, or chronic pulmonary reactions have been reported in patients treated with FURADANTIN. If these reactions occur, discontinue FURADANTIN 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)].

5.3 Hepatotoxicity

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 FURADANTIN immediately, and take appropriate measures.

5.4 Neuropathy


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)].

5.5 Hemolytic 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 FURADANTIN immediately; hemolysis ceases when the drug is withdrawn.

5.6 Clostridioides difficile -associated Diarrhea


Clostridioides difficile -associated Diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including FURADANTIN, 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. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antibacterial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and institute surgical evaluation as clinically indicated.

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