Transcription of PRODUCT MONOGRAPH
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PRODUCT MONOGRAPH
PRODUCT MONOGRAPH . Pr pms-NITROFURANTOIN BID. Nitrofurantoin Capsules, House Standard (nitrofurantoin monohydrate/macrocrystals). 100 mg Urinary Tract Antibacterial PHARMASCIENCE INC. Date of Revision: 6111 Royalmount Ave., Suite 100 August 26, 2020. Montr al, Canada H4P 2T4. Submission Control No: 237005. Pr pms-NITROFURANTOIN BID. Nitrofurantoin capsules, House Standard (nitrofurantoin monohydrate/macrocrystals). THERAPEUTIC CLASSIFICATION. Urinary Tract Antibacterial ACTIONS AND CLINICAL PHARMACOLOGY. Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermediates which inactivate or alter bacterial ribosomal proteins and other macromolecules. As a result of such inactivation, the vital biochemical processes of protein synthesis, aerobic energy metabolism, DNA synthesis, RNA synthesis, and cell wall synthesis are inhibited. 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.
pms-NITROFURANTOIN BID is indicated for the treatment of acute uncomplicated urinary tract infections, e.g., cystitis, when due to susceptible strains of Escherichia coli, and Staphylococcus saprophyticus. pms-NITROFURANTOIN BID is not indicated for the treatment of associated renal cortical or perinephric abscesses.
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