Cross-resistance with antibiotics and sulfonamides has not been observed, and transferable resistance is, at most, a very rare phenomenon. The clinical significance of this finding is unknown.ĭevelopment of Resistance: Development of resistance to nitrofurantoin has not been a significant problem since its introduction in1953. In vitro between nitrofurantoin and quinolone antimicrobials. Interactions with Other Antibiotics: Antagonism has been demonstrated The broad-based nature of this mode of action may explain the lack of acquired bacterial resistance to nitrofurantoin, as the necessary multiple and simultaneous mutations of the target macromolecules would likely be lethal to the bacteria. Nitrofurantoin is bactericidal in urine at therapeutic doses. As a result of such inactivations, the vital biochemical processes of protein synthesis, aerobic energy metabolism, DNA synthesis, RNA synthesis, and cell wall synthesis are inhibited. Mechanism of Action: The mechanism of the antimicrobial action of nitrofurantoin is unusual among antibacterials.Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermediates which inactivate or alter bacterial ribosomal proteins and other macromolecules. Nitrofurantoin is a nitrofuran antimicrobial agent with activity against certain Gram-positive and Gram-negative bacteria. Is 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 Capsules, USP (monohydrate/ macrocrystals) are low, with peak levels usually less than 1 mcg/mL.
Approximately 20-25% 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 Capsules, USP (monohydrate/ macrocrystals) are similar to those of the 50 mg or 100 mg nitrofurantoin (macrocrystals). 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. 10, FD&C Red No.40, gelatin, titanium dioxide, lactose, magnesium stearate, povidone, talc, sodium lauryl sulfate, colloidal silicon dioxide and Opacode® black ink S-1-17843 (consist of shellac, ferrosoferric oxide, butyl alcohol, propylene glycol, isopropyl alcohol and ammonia).įDA approved dissolution test specifications differ from USP.Įach Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) contains two forms of nitrofurantoin. Inactive Ingredients: Each capsule contains carbomer 974P, pregelatinized starch, sucrose, FD&C Blue No.1, FD&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. , USP (monohydrate/macrocrystals)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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