Nitrofurantoína

Nitrofurantoin

Usos autorizados

• Nitrofurantoin capsules (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.
• To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (monohydrate/macrocrystals) 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.
• Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.

Formas y dosis

• Nitrofurantoin Capsules USP (monohydrate/macrocrystals), 100 mg are opaque black and opaque yellow size '0' hard gelatin capsule imprinted with 'Z' on cap and '66' on body with grey ink.

Cómo se toma

• Nitrofurantoin capsules (monohydrate/macrocrystals) should be taken with food.
• Adults and Pediatric Patients Over 12 Years: One 100 mg capsule every 12 hours for seven days.

No debe usarse en caso de

• Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications.
• Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug.
• Because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability), the drug is contraindicated in pregnant patients at term (38 to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent.
• For the same reason, the drug is contraindicated in neonates under one month of age.

Interacciones

• Antacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce both the rate and extent of absorption.
• The mechanism for this interaction probably is adsorption of nitrofurantoin onto the surface of magnesium trisilicate.
• 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.

Advertencias y precauciones

• Pulmonary Reactions ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN.
• IF THESE REACTIONS OCCUR, NITROFURANTOIN (MONOHYDRATE/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.

Efectos adversos frecuentes

• In clinical trials of nitrofurantoin (monohydrate/macrocrystals), the most frequent clinical adverse events that were reported as possibly or probably drug-related were nausea (8%), headache (6%), and flatulence (1.5%).

Embarazo

Teratogenic Effects Several reproduction studies have been performed in rabbits and rats at doses up to six times the human dose and have revealed no evidence of impaired fertility or 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.

Mecanismo de acción

Mechanism of Action The mechanism of the antimicrobial action of nitrofurantoin is unusual among antibacterials. Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermediates which inactivate or alter bacterial ribosomal proteins and other macromolecules.

Titular de la autorización:

Aurobindo Pharma Limited

Versión de la ficha:

18 de diciembre de 2024

Las secciones anteriores están citadas de la ficha en inglés, porque es ese documento el que porta la autorización. Cuando una autoridad europea publica la misma información en español, el enlace figura en las fuentes. No traducimos por nuestra cuenta los textos reguladores: un error de traducción en una contraindicación sería más peligroso que una línea en otro idioma.

Esta sección recoge la ficha técnica autorizada. El texto está condensado a partir del resumen de la propia autoridad, y el documento completo figura en las fuentes.