COMPOSITION
Each hard gelatin capsule contains:
Nitrofurantion IP
(Hydrous/anhydrous- Macrocrystals)
eq. to Nitrofurantion 100mg
Approved colours used in capsule shells.
HIGHLIGHTS
NITORUN (Nitrofurantion) is an antibacterial agent specific for urinary tract infections.
THERAPEUTIC INDICATIONS & USAGE
NITORUN is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug resistant bacteria and maintain the effectiveness of NITORUN and other antibacterial drugs, NITORUN sholud 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. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with NITORUN are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with NITORUN, other therapeutic agents with broader tissue distribution should be selected. In considering the use of NITORUN, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
RECOMMENDED DOSAGE & ADMINISTRATION
For >12 yrs and Adults: One NITORUN Capsule two times daily for 7 days or as directed by the Physician
PHARMCOKINETIC PROPERTIES
Nitrofurantoin is readily absorbed from the gastrointestinal tract. The absorption rate is dependent on crystal size. The macrocrystalline form has slower dissolution and absorption rates, produces lower serum concentrations than that of microcrystalline form, and takes longer to achieve peak concentrations in the urine. The presence of food in the gastrointestinal tract may increase the bioavailability of Nitrofurantion and prolong the duration of therapeutic urinary concentrations.
On absorption, concentrations in blood and body tissues is low because of rapid elimination, and antibaterial concentrations are not achieved. Nitrofurantoin crosses the placenta and blood brain barrier and traces have been detected in breast milk. The plasma half life is reported to range from 0.3=1 hour.
Nitrofurantion is metabolized in the liver and most body tissues while about 30-40% of a dose is excreted rapidly in the urine as unchanged nitrofurantion. Some tubular reabsorption may occur in acid urine. Average doses give a concentration of 50 to 200 micrograms/ml in the urine in patients with normal renal function.
PHARMACODYNAMIC PROPERTIES
Microbilogy:
Nitrofurantion is bactericidal in urine at therapeutic doses. The mechanism of the antimicrobial action of nitrofurantoin is unusual among antibacterials. Nitrofurantion is reduced by bacterial flavoproteins to reactive intermediates which inactivate or alter bacterial ribosomal proteins and other macromolecules.
UTI Related Link
▶ Nitorun
▶ UT-Run
▶ Levorun
▶ Farocin