Clinical Information:NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE CAP 100 MG
Gen. Code and Des.
16598 nitrofurantoin monohyd/m-cryst ORAL CAPSULE 100 MG
GCN and Des.
49001 nitrofurantoin monohyd/m-cryst ORAL CAPSULE 100 MG
Strength
100MG BID
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
8360000 URINARY ANTI-INFECTIVES
Active Ingredients
2852 nitrofurantoin 67209
2853 nitrofurantoin macrocrystalline 67209
UD NITROFURANTION MACROCRYSTALS - nitrofurantoin capsule
Alvogen Inc.
nitrofurantoin-macrocrystals-25mgnitrofurantoin-macrocrystals-50mgnitrofurantoin-macrocrystals-100mg
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Macrocrystals and other antibacterial drugs, Nitrofurantoin Macrocrystals should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Nitrofurantoin Macrocrystals is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin Macrocrystals is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione
Inactive Ingredients: Each capsule contains edible black ink, gelatin, lactose, starch, talc, titanium dioxide, and may contain FD&C Yellow No. 6 and D&C Yellow No. 10.
CLINICAL PHARMACOLOGY
Nitrofurantoin Macrocrystals is a larger crystal form of nitrofurantoin. The absorption of Nitrofurantoin Macrocrystals is slower and its excretion somewhat less when compared to nitrofurantoin. Blood concentrations at therapeutic dosage are usually low. It is highly soluble in urine, to which it may impart a brown color.
Following a dose regimen of 100 mg q.i.d. for 7 days, average urinary drug recoveries (0-24 hours) on day 1 and day 7 were 37.9% and 35.0%.
Unlike many drugs, the presence of food or agents delaying gastric emptying can increase the bioavailability of Nitrofurantoin Macrocrystals, presumably by allowing better dissolution in gastric juices.
MICROBIOLOGY
Nitrofurantoin is a nitrofuran antimicrobial agent with activity against certain Gram-positive and Gram-negative bacteria.
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 acromolecules. 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. Nitrofurantoin is bactericidal in urine at therapeutic doses. 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.
