In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, 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.ĪCUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin monohydrate/macrocrystals capsules, other therapeutic agents with broader tissue distribution should be selected. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. Consequently, many patients who are treated with nitrofurantoin monohydrate/macrocrystals capsules are predisposed to persistence or reappearance of bacteriuria. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. Nitrofurantoin monohydrate/macrocrystals capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. When nitrofurantoin monohydrate/macrocrystals capsules are administered with food, the bioavailability of nitrofurantoin is increased by approximately 40%.
Nitrofurantoin is highly soluble in urine, to which it may impart a brown color. Plasma nitrofurantoin concentrations after a single oral dose of the 100 mg nitrofurantoin monohydrate/macrocrystals capsules are low, with peak levels usually less than 1 mcg/mL. Approximately 20% to 25% of a single dose of nitrofurantoin is recovered from the urine unchanged over 24 hours. Based on urinary pharmacokinetic data, the extent and rate of urinary excretion of nitrofurantoin from the 100 mg nitrofurantoin monohydrate/macrocrystals capsule are similar to those of the 50 mg or 100 mg nitrofurantoin macrocrystals capsule. The remaining 75% is nitrofurantoin monohydrate contained in a powder blend which, upon exposure to gastric and intestinal fluids, forms a gel matrix that releases nitrofurantoin over time. Twenty-five percent is macrocrystalline nitrofurantoin, which has slower dissolution and absorption than nitrofurantoin monohydrate. 40, gelatin, lactose, magnesium stearate, povidone, talc, and titanium dioxide.Įach nitrofurantoin monohydrate/macrocrystals capsule contains two forms of nitrofurantoin. Inactive Ingredients: Each capsule contains carbomer 934P, corn starch, compressible sugar, D&C Yellow No. The chemical name of nitrofurantoin monohydrate is 1-methylene] amino]-2,4- imidazolidinedione monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-methylene] amino]-2,4-imidazolidinedione. The nitrofurantoin monohydrate/macrocrystals capsules brand of nitrofurantoin is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. Nitrofurantoin is an antibacterial agent specific for urinary tract infections.
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