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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving nitrofurantoin. If signs and symptoms of a hypersensitivity reaction occurs, immediately discontinue nitrofurantoin oral suspension. ( 5.1 ) • Pulmonary Reactions: Discontinue if sign and symptoms of pulmonary reactions occur and take appropriate measures. ( 5.2 ) • Hepatotoxicity: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests. ( 5.3 ) • Neuropathy: Peripheral neuropathy has occurred. ( 5.4 ) • Hemolytic Anemia: Discontinue if sign and symptoms of hemolysis occur. ( 5.5 ) • Clostridioides difficile -associated diarrhea: Evaluate patients if diarrhea occurs. ( 5.6 ) 5.1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving nitrofurantoin [see Adverse Reactions ( 6 )]. If signs and symptoms of a hypersensitivity reaction occurs, immediately discontinue nitrofurantoin oral suspension and initiate appropriate medications and/or supportive care. Nitrofurantoin oral suspension 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 nitrofurantoin. If these reactions occur, discontinue nitrofurantoin oral suspension 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 nitrofurantoin oral suspension immediately, and take appropriate me...
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adverse reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Pulmonary Reactions [see Warnings and Precautions ( 5.2 )] • Hepatotoxicity [see Warnings and Precautions ( 5.3 )] • Neuropathy [see Warnings and Precautions ( 5.4 )] • Hemolytic anemia [see Warnings and Precautions ( 5.5 )] • Clostridioides difficile -associated Diarrhea [see Warnings and Precautions ( 5.6 )] • Persistence or Reappearance of Bacteriuria [see Warnings and Precautions ( 5.7 )] The following adverse reactions associated with the use of nitrofurantoin formulations, including, nitrofurantoin oral suspension were identified in clinical studies or post-marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Respiratory: chronic, subacute, or acute pulmonary hypersensitivity reactions have occurred. Chronic pulmonary reactions have occurred generally in patients who have received continuous treatment for six months or longer. Malaise, dyspnea on exertion, cough, and altered pulmonary function are common manifestations which can occur insidiously. Radiologic and histologic findings of diffuse interstitial pneumonitis or fibrosis, or both, are also common manifestations of the chronic pulmonary reaction. Fever is prominent. The severity of chronic pulmonary reactions and their degrees of resolution appear to be related to the duration of therapy after the first clinical signs appear. Pulmonary function may be impaired permanently, even after cessation of therapy. The risk is greater when chronic pulmonary reactions are not recognized early. In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form. Upon cessation of therapy, recovery may require several months. If the symptoms are not recognized as being drug-related and nitrofurantoin therapy is not stopped, the symptoms may become more severe. Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnea, pulmonary infiltration with consolidation of pleural effusion on x-ray, and eosinophilia. Acute reactions usually occur within the first week of tr...