NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE- nitrofurantoin monohydrate capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L), NITROFURANTOIN MONOHYDRATE (UNII: E1QI2CQQ1I) (NITROFURANTOIN - UNII:927AH8112L)

थमां उपलब्ध:

DIRECT RX

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. 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 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. 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 approve

उत्पाद समीक्षा:

Nitrofurantoin monohydrate/macrocrystals capsules are available as 100 mg opaque black and yellow capsules imprinted “(band) Macrobid (band)” on one half and “52427-285” on the other. NDC 47781-303-01 bottle of 100 Store at controlled room temperature (59° to 86°F or 15° to 30°C). Meets USP Dissolution Test 2 Rx Only

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE- NITROFURANTOIN
MONOHYDRATE CAPSULE
DIRECT RX
----------
NITRO/MONO/MACRO 100MG
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 bacteria.
Nitrofurantoin is an antibacterial agent specific for urinary tract
infections. 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.
The chemical name of nitrofurantoin macrocrystals is
1-[[[5-nitro-2-furanyl]methylene] amino]-2,4-
imidazolidinedione. The chemical structure is the following:
[structure-1]
Molecular Weight: 238.16
The chemical name of nitrofurantoin monohydrate is
1-[[[5-nitro-2-furanyl]methylene] amino]-2,4-
imidazolidinedione monohydrate. The chemical structure is the
following:
[structure-2]
Molecular Weight: 256.17
Inactive Ingredients: Each capsule contains carbomer 934P, corn
starch, compressible sugar, D&C
Yellow No. 10, edible gray ink, FD&C Blue No. 1, FD&C Red No. 40,
gelatin, lactose, magnesium
stearate, povidone, talc, and titanium dioxide.
Each nitrofurantoin monohydrate/macrocrystals capsule contains two
forms of nitrofurantoin. Twenty-
five percent is macrocrystalline nitrofurantoin, which has slower
dissolution and absorption than
nitrofurantoin monohydrate. 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. 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