NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE- nitrofurantoin monohydrate/macrocrystalline capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

NITROFURANTOIN

Composition:

NITROFURANTOIN 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 othe

Product summary:

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 43063-582-10 bottle of 10 NDC 43063-582-14 bottle of 14 Store at controlled room temperature (59°F to 86°F or 15°C to 30°C). Rx Only

Authorization status:

New Drug Application

Summary of Product characteristics

NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE- NITROFURANTOIN
MONOHYDRATE/MACROCRYSTALLINE CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES
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.
DESCRIPTION
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:
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:
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.
Meets USP Dissolution Test 8.
CLINICAL PHARMACOLOGY
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
nitrofurant