Each hard gelatin capsule contains: Nitrofurantoin USP 100 mg.
Pharmacology: Mechanism of Action: Nitrofurantoin interferes with cell metabolism and cell wall synthesis by inhibiting several enzyme systems including acetyl coenzyme A. It is bactericidal to most gram-positive and gram-negative urinary tract pathogens.
Pharmacokinetics and Metabolism: Absorption: Readily absorbed from GI tract. Food may increase bioavailability and prolong the duration of therapeutic urinary concentrations.
Distribution: Concentrations in blood and body tissues are low; crosses the placenta and the blood-brain barrier and distributes in breastmilk (trace amounts).
Metabolism: Hepatic and in most body tissues.
Excretion: Via urine (30-40% of a dose excreted rapidly as unchanged drug); some tubular reabsorption may occur in acid urine.
Plasma half-life: 0.3-1 hr.
Urinary tract infections due to susceptible strains of E. coli, S. aureus & certain susceptible strains of Klebsiella and Enterobacter.
Adults: 50-100 mg 6 hourly with meals.
Children: 6 mg/kg body weight daily in 4 divided doses.
Or as prescribed by the physician.
Hypersensitivity, anuria, oliguria, hepatitis, pregnancy at term (during labor & delivery), and infants <1 month.
Elderly: Monitor hepatic and pulmonary function during prolonged therapy. Pre-existing pulmonary, hepatic, neurological, or allergic disorders, predisposition to peripheral neuropathy, e.g., renal impairment, anemia, electrolyte imbalance, debility, vitamin B deficiency. Withdraw if signs of peripheral neuropathy occur. Lactation.
Nausea, emesis, anorexia, abdominal pain, diarrhea, pulmonary hypersensitivity reaction, peripheral neuropathy, exfoliative dermatitis, erythema multiforme, lupus-like syndrome, urticaria, rash, agranulocytosis, leukopenia, and granulocytopenia.
Reduced excretion with probenecid or sulfinpyrazone. Absorption reduced by magnesium trisilicate. Antagonistic effects with quinolone antibacterials. Reduced effects with carbonic anhydrase inhibitors or urinary alkalinisers.
Store at temperatures not exceeding 30°C.
J01XE01 - nitrofurantoin ; Belongs to the class of nitrofuran derivative antibacterials. Used in the systemic treatment of infections.
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