NITROFURANTOIN MONO-MACRO (nitrofurantoin monohydrate/macrocrystals)

There are 8 contraindications. Absolute contraindication.

Contraindication List
Anuria
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Drug-induced hepatitis
Glucose-6-phosphate dehydrogenase (g6Pd) deficiency
Hemoglobin H disease
Hemolytic anemia from pyruvate kinase and g6PD deficiencies
Oliguria

There are 10 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Acute hepatitis
Cholestasis
Chronic hepatitis
Clostridioides difficile infection
Interstitial pneumonitis
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Optic neuritis
Peripheral neuropathy
Pulmonary fibrosis
Vitamin B deficiency

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Diabetes mellitus

There are 32 severe adverse reactions.

More Frequent	Less Frequent
Interstitial pneumonitis	Granulocytopenic disorder Leukopenia Megaloblastic anemia Polyneuropathy

Rare/Very Rare

Agranulocytosis Allergic dermatitis Anaphylaxis Clostridioides difficile infection Erythema multiforme Exfoliative dermatitis Glucose-6-phosphate dehydrogenase (g6Pd) deficiency anemia Hemolytic anemia Hepatic necrosis Hepatitis Idiopathic intracranial hypertension Increased alanine transaminase Increased aspartate transaminase Lupus-like syndrome Methemoglobinemia Obstructive hyperbilirubinemia Optic neuritis Pancreatitis Peripheral neuropathy Pruritus of skin Pulmonary fibrosis Sialoadenitis Skin rash Stevens-johnson syndrome Thrombocytopenic disorder Urticaria Vasculitis

There are 20 less severe adverse reactions.

More Frequent	Less Frequent
Anorexia Headache disorder Nausea Urine discoloration Vomiting	Acute abdominal pain Diarrhea Flatulence

Rare/Very Rare
Alopecia Chills Constipation Dizziness Drowsy Dyspepsia Fever General weakness Malaise Nystagmus Toxic amblyopia Vertigo

Reproduction studies in rats and rabbits using nitrofurantoin in doses up to 6 times the usual human dose have not revealed evidence of harm to the fetus. However, growth retardation and a low incidence of minor and common malformations were observed when nitrofurantoin doses 68 times the usual human dose were administered to pregnant mice; fetal malformations were not observed following administration of nitrofurantoin doses 25 times the usual human dose. Lung papillary adenomas of unknown importance were observed in first generation offspring of mice whose mothers received nitrofurantoin doses 19 times the usual human dose.

The relevance of these reproduction studies to humans is not known. There are no adequate and controlled studies to date using nitrofurantoin in pregnant women, and the drug should be used during pregnancy only when clearly indicated. Nitrofurantoin is contraindicated in pregnant women at term (38-42 weeks gestation), including during labor and delivery or when onset of labor is imminent, because of the possibility of hemolytic anemia in the neonate secondary to immature enzyme systems.

Nitrofurantoin is distributed into milk. Because of the potential for adverse effects of nitrofurantoin in nursing infants younger than 1 month old or in infants who are known or suspected to have glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced Geriatric Use information available for this drug.