United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

advanz pharma - nitrofurantoin - oral tablet - 50mg

Ireland - English - HPRA (Health Products Regulatory Authority)

mercury pharmaceuticals ltd - nitrofurantoin - tablet - 50 milligram(s) - nitrofuran derivatives; nitrofurantoin

Ireland - English - HPRA (Health Products Regulatory Authority)

amdipharm limited - nitrofurantoin - tablet - 50 milligram(s) - nitrofuran derivatives; nitrofurantoin

Ireland - English - HPRA (Health Products Regulatory Authority)

mercury pharmaceuticals ltd - nitrofurantoin - tablet - 100 milligram(s) - nitrofuran derivatives; nitrofurantoin

Ireland - English - HPRA (Health Products Regulatory Authority)

amdipharm limited - nitrofurantoin - tablet - 100 milligram(s) - nitrofuran derivatives; nitrofurantoin

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

advanz pharma - nitrofurantoin - oral tablet - 100mg

Malta - English - Medicines Authority

mercury pharmaceuticals limited capital house, 85 king william street, london ec4n 7bl, united kingdom - nitrofurantoin - tablet - nitrofurantoin 50 mg - antibacterials for systemic use

United States - English - NLM (National Library of Medicine)

shionogi inc. - nitrofurantoin (unii: 927ah8112l) (nitrofurantoin - unii:927ah8112l) - furadantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of escherichia coli , enterococci, staphylococcus aureus , and certain susceptible strains of klebsiella and enterobacter species. nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. consequently, many patients who are treated with furadantin are predisposed to persistence or reappearance of bacteriuria. urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. if persistence or reappearance of bacteriuria occurs after treatment with furadantin , other therapeutic agents with broader tissue distribution should be selected. in considering the use of furadantin , lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development

United States - English - NLM (National Library of Medicine)

casper pharma llc - nitrofurantoin (unii: 927ah8112l) (nitrofurantoin - unii:927ah8112l) - 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. 

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

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