Indicated for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.

Macrobid is approved for adults and children over 12 years of age. Other forms of Nitrofurantoin (Furadantin or Macrodantin) are approved for adults and infants over the age of 1 month because they are lower strengths than Macrobid.

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 nitrofurantoin capsules, USP (macrocrystals) are predisposed to persistence or reappearance of bacteriuria.

Acute, subacute, or chronic pulmonary reactions have been observed in patients treated with nitrofurantoin. If these reactions occur, nitrofurantoin (macrocrystals) should be discontinued and appropriate measures taken. 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 rarely and 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.

Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, occur rarely. Fatalities have been reported. The onset of chronic active hepatitis may be insidious, and patients should be monitored periodically for changes in biochemical tests that would indicate liver injury.

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.

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.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including nitrofurantoin, and may range in severity from mild diarrhea to fatal colitis.

Optic neuritis has been reported rarely in postmarketing experience with nitrofurantoin formulations.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including nitrofurantoin, and may range from mild to life threatening.

Nitrofurantoin is contraindicated in patients with:

• anuria 
• oliguria 
• significant impairment of renal function (creatinine clearance under 60 mL per minute
• clinically significant elevated serum creatinine
• pregnant patients at term (38 to 42 weeks’ gestation)
• during labor and delivery, or when the onset of labor is imminent
• in neonates under one month of age
• a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin

Patients should be advised not to use antacid preparations containing magnesium trisilicate while taking nitrofurantoin.

Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin. The resulting increase in nitrofurantoin serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial.

There are no adequate and well-controlled studies in pregnant women. Animal studies:growth retardation, malformations, and lung papillary adenomas.

Nitrofurantoin has been detected in human breast milk in trace amounts. Because of the potential for serious adverse reactions from nitrofurantoin in nursing infants under one month of age, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource 

• Use of Macrobid in patients under the age of 12. GoToSource

• Use of Furadantin and Macrodantin in patients under the age of 1 month. GoToSource

• Complicated urinary tract infections. GoToSource

• Prostatitis. GoToSource

• Reduce risk of urosepsis. GoToSource

Liver damage including cases of hepatitis and death, lupus-like syndrome, arthralgias (joint pain), leukopenia (low white blood cell count), hemolysis (rupture or destruction of red blood cells), pneumonitis (inflammation of lung tissue), nephritis (kidney inflammation) and pulmonary fibrosis (scarring of the lungs). GoToSource

Clostridium difficile-associated diarrhea. GoToSource

Drug-induced lung disease. GoToSource

Peripheral neuropathy (nerve damage). GoToSource 

Anemia in infants and birth defects. GoToSource 

Increased charcot-marie-tooth neuropathy (group of inherited disorders affecting the peripheral nerves). GoToSource

Drug reaction/rash with eosinophilia and systemic symptoms. GoToSource

Increased intracranial hypertension. GoToSource

Thrombotic thrombocytopenic purpura (clotting in small blood vessels of the body) or TTP-like illness manifested by microangiopathic haemolytic anaemia and thrombocytopenia. GoToSource

Lawsuits filed for liver failure and pulmonary fibrosis.