APO-NITROFURANTOIN

What it is

APO-NITROFURANTOIN contains nitrofurantoin, a synthetic antibacterial nitrofuran derivative. The medicine is available in capsules containing either 50 mg or 100 mg of nitrofurantoin. APO-NITROFURANTOIN should be taken with food or milk.

Approved indications

— Treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens.

Dosing overview

Adults: 50–100 mg four times a day, not exceeding 400 mg daily. Prophylactic therapy: 50 mg or 100 mg once nightly. Children: dosage should be calculated on the basis of 5–7 mg/kg body weight per 24 hours, given in divided doses four times a day. Therapy should be continued for at least one week and for at least 3 days after sterility of the urine is obtained.

Key safety warnings

Peripheral neuropathy, including optic neuritis, which may become severe or irreversible, has occurred, with fatalities reported. Conditions such as renal impairment, anaemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating disease may enhance the occurrence of peripheral neuropathy. If numbness or tingling occurs in any area, administration of the drug should be discontinued. Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis and hepatic necrosis occur rarely, with fatalities reported. Patients should be monitored periodically for changes in liver function. Acute, subacute or chronic pulmonary reactions have been observed and can be life threatening; treatment should be stopped immediately if they occur. Chronic pulmonary reactions (diffuse interstitial pneumonitis or pulmonary fibrosis) can develop insidiously and occur rarely, generally in patients receiving therapy for six months or longer. Haemolytic anaemia of the primaquine-sensitivity type has been induced by nitrofurantoin and appears to be linked to glucose-6-phosphate dehydrogenase deficiency in red blood cells. Any sign of haemolysis is an indication to discontinue the drug, and haemolysis ceases when the drug is withdrawn. Antibiotic-associated pseudomembranous colitis has been reported with nitrofurantoin, with severity ranging from mild to life threatening, caused by a toxin produced by Clostridium difficile.

Contraindications

APO-NITROFURANTOIN is contraindicated in anuria and oliguria or extensive impairment of renal function (creatinine clearance under 60 mL/min or clinically significant elevated serum creatinine); hypersensitivity to furan derivatives; pregnancy during labour and delivery or when the onset of labour is imminent; and infants under one month of age, because of the possibility of producing haemolytic anaemia due to immature enzyme systems in the early neonatal period.

Regulatory history

APO-NITROFURANTOIN 50 mg and 100 mg capsules were first listed on the ARTG on 21 December 2018.