FURADANTIN- nitrofurantoin suspension

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)

から入手可能:

Casper Pharma LLC

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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)]. Usage To 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. 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)]. 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.  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 FURADANTIN 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 FURADANTIN and any potential adverse effects on the breastfed infant from FURADANTIN or from the underlying maternal condition. Monitor these infants for vomiting, diarrhea, and rash. 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 produce a slight to moderate spermatogenic arrest with a decrease in sperm count. The effect on fertility is unknown.  FURADANTIN 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 FURADANTIN in pediatric patients aged 1 month of age and older for the treatment of urinary tract infections have been established. 

製品概要:

How Supplied FURADANTIN oral suspension (25 mg/5 mL) is available in: NDC 70199-006-32 PET amber bottle of 230 mL FURADANTIN oral suspension (50 mg/5 mL) is available in: NDC 70199-036-60 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.

認証ステータス:

New Drug Application

製品の特徴

FURADANTIN - NITROFURANTOIN SUSPENSION
CASPER PHARMA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FURADANTIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FURADANTIN.
FURADANTIN (NITROFURANTOIN) ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1953
RECENT MAJOR CHANGES
Dosage and Administration (2) 1/2024
INDICATIONS AND USAGE
FURADANTIN 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
FURADANTIN 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 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. (1)
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)
DOSAGE FORMS AND STRENGTHS
Oral Suspension: 25 mg/5 mL and 50 mg/5 mL. (3)
CONTRAINDICATIONS
• 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 PRECAUTIONS
• Hypersensitivity Reactions: Serious and occasionally fatal
hypersensitivity (anaphylactic) reactions have
been rep