For the treatment and prevention of acute or recurrent uncomplicated lower urinary tract infections or pyelitis, whether occurring spontaneously or following surgical procedures. Nitrofurantoin is specifically indicated when infections are caused by susceptible strains of Escherichia coli, enterococci, staphylococci, Citrobacter, Klebsiella, and Enterobacter.

Each capsule contains

• Nitrofurantoin (macrocrystals) USP 25 mg
• and Nitrofurantoin monohydrate USP equivalent to 75 mg of Nitrofurantoin.

Each capsule contains two forms of nitrofurantoin. About 25% is macrocrystalline nitrofurantoin, which dissolves and absorbs more slowly than the monohydrate form. The remaining 75% is nitrofurantoin monohydrate in a powder mixture that forms a gel-like matrix when it comes into contact with gastric and intestinal fluids, allowing gradual release of the drug over time. The capsule is highly soluble in urine and may turn the urine brown in color. Food intake increases the bioavailability of nitrofurantoin by approximately 40%.

Adults and children over 12 years of age

• Acute or recurrent uncomplicated urinary tract infections & pyelitis: Nitrofurantoin Modified Release 100 mg (one Umactin-BD 100 capsule) 2 times daily for 7 days.
• Surgical Prophylaxis: Nitrofurantoin Modified Release 100 mg (one Umactin-BD 100 capsule) 2 times daily on the day of the procedure and for 3 days thereafter.

Children and Infants over 3 months of age

• Acute urinary tract infections: Nitrofurantoin 3 mg/kg/day (Umactin Suspension 0.6 ml/kg) in 4 divided doses for 7 days.
• Long term suppression of UTI: Nitrofurantoin 1 mg/kg (Umactin Suspension 0.25 ml/kg), once a day.

Elderly Provided there is no significant renal impairment, in which Nitrofurantoin is contra-indicated, the dosage should be that for any normal adult.

• Absorption is increased when taken with food or agents that delay gastric emptying.
• Absorption is reduced when used with magnesium trisilicate.
• Renal excretion of nitrofurantoin is decreased by probenecid and sulphinpyrazone.
• Antibacterial activity may be reduced by carbonic anhydrase inhibitors and by alkalinization of urine.
• Quinolone antibiotics may antagonize its antibacterial effect.
• It may also interfere with some urine glucose test results.

Nitrofurantoin is contraindicated in patients with renal impairment (creatinine clearance below 60 ml/min or elevated serum creatinine), infants under 3 months of age, and pregnant women at term (during labour and delivery) due to the risk of haemolytic anaemia in the fetus or newborn. It is also contraindicated in patients with known hypersensitivity to nitrofurantoin or other nitrofurans.

Respiratory reactions may include acute, subacute, or chronic pulmonary effects; these can range from fever, cough, chills, and shortness of breath to rare chronic lung changes, especially in long-term or elderly patients. ECG changes may occur in association with pulmonary toxicity. The drug should be stopped immediately if respiratory symptoms develop.

Hepatic reactions such as cholestatic jaundice and chronic active hepatitis are rare, and treatment should be discontinued at the first sign of liver toxicity. Neurological effects include peripheral neuropathy and optic neuritis, which may cause sensory or motor symptoms and can become severe or irreversible; therapy should be stopped immediately if such signs appear. Gastrointestinal effects such as nausea and loss of appetite may occur.

Animal studies have shown no teratogenic effects, and clinical experience since 1952 suggests Nitrofurantoin can be used in pregnancy when necessary. It should be given at the lowest effective dose after careful evaluation. However, it is contraindicated during labour and delivery due to the risk of haemolysis in newborns. Caution is required during breastfeeding, especially if the infant has or is suspected to have erythrocyte enzyme deficiency, as small amounts of the drug pass into breast milk.

Nitrofurantoin is not suitable for treating infections in a non-functioning kidney. In recurrent or severe infections, surgical causes should be ruled out. It should be used cautiously in patients with lung disease, liver dysfunction, neurological disorders, and allergic tendencies. Peripheral neuropathy may occur and can be severe or irreversible; treatment should be stopped at the first sign of nerve involvement (e.g., tingling). Caution is required in patients with anemia, diabetes, electrolyte imbalance, debilitating illness, or vitamin B/folate deficiency. Chronic lung reactions may develop gradually, especially in elderly patients, so long-term users require close monitoring. It should be stopped immediately if haemolysis occurs in patients with suspected G6PD deficiency. Gastrointestinal side effects can be reduced by taking the drug with food or milk or adjusting the dose.

Overdose may cause nausea, vomiting, and gastric irritation. There is no specific antidote. In recent ingestion, haemodialysis may help remove the drug. Treatment includes gastric lavage or induced vomiting. Monitoring of blood count, liver function, and lung function is recommended. Adequate fluid intake should be maintained to enhance urinary excretion.

Systemic urinary anti-infective agent

Store in a cool, dry place away from light.